User Facility Device Experience Research Articles

Complications Associated with AMBU™ Scope Use: An FDA MAUDE Analysis.

Ambu® aScope™ is a disposable flexible videoscope used for a wide range of medical procedures. However, adverse events associated with this device can occur. The Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database was explored for patient-related adverse events associated with Ambu® aScope™ use between January 1, 2000 and December 15, 2023. Search terms included "Ambu" and "Ascope." Thirty unique adverse events were identified. Twenty-one of the events were associated with patient injury, and 9 with device malfunction. Eight patient-reported problems were documented as foreign bodies, 3 events as airway obstruction, desaturation, or hypoxic events, and 1 event as anxiety/cardiac arrest. The remaining 18 reported insufficient information other than associated with patient injury. We found that Ambu® aScope™ flexible nasolaryngoscopes and bronchoscopes are a common and effective tool for airway evaluations that may infrequently serve as a rare form of foreign body with potentially life-threatening consequences.

Reasons for Revision Surgery after Cervical Disc Arthroplasty based on Medical Device Reports Maintained by the United States Food and Drug Administration.

Retrospective Database review. Analyze revisions of CDAs reported to the MAUDE database. Cervical disc arthroplasty (CDA) has emerged as a motion-preserving alternative to anterior cervical discectomy and fusion (ACDF) for degenerative cervical disease, demonstrating comparable outcomes. Despite the availability of variable CDA designs, there is limited data on the specific complications of individual CDAs. The Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database has been used to systematically report complications associated with CDAs. However, data on specific reasons for CDA revision remains scarce. The purpose of this study is to compare common complications associated with revision for different CDAs. The MAUDE database was queried from January 2005 to September 2023, including all nine FDA-approved CDAs. The full-text reports of each complication were categorized based on whether revision surgery was performed, the complications and the type of CDA collected and compared. A total of 678 revisions for nine CDAs were reported: Mobi-C (239), M6 (167), Prodisc-C (88), Prestige (60), PCM (44), Bryan (35), Secure (23), Simplify (21), and Discover (1). The top three complications associated with revision were migration (23.5%), neck pain (15.5%), and heterotopic ossification (6.6%). The most common complications per device were migration for Mobi-C (26.4%), Prodisc-C (21.3%), Prestige (24.6%), PCM (84.1%), Bryan (48.6%), Secure (30.4%), and Discover (100%). For M6, the most common complications associated with revision surgery were osteolysis (18.6%) and neck pain (18.6%), while neck pain (23.8%) was the most common for the Simplify. The MAUDE database highlights complications related to CDA revision in which the primary complications consistently include implant migration, neck pain, and heterotopic ossification ,varying in their rerelvance depending on the CDA.

A Comprehensive Analysis of Reported Adverse Events and Device Failures Associated with Esophageal Self-Expandable Metal Stents: An FDA MAUDE Database Study.

Esophageal Stents are used to maintain esophageal lumen patency in esophageal strictures caused by intrinsic and/or extrinsic malignancies and the occlusion of concomitant esophageal fistulas. While data on the efficacy and safety of esophageal stents exist, comprehensive evaluation of adverse events is limited. The aim of this study is to investigate the reported adverse events and device failures associated with esophageal self-expandable metal stents (SEMS) using the FDA's Manufacturer and User Facility Device Experience (MAUDE) database. Post-marketing surveillance data for the esophageal SEMSs were analyzed using the FDA's MAUDE database from January 2014 to December 10, 2023. The outcomes of interest were patient-related adverse events and device failures. Statistical analysis was performed using Microsoft Excel 2010 and SPSS. Pooled numbers and percentages were calculated for each adverse event. Continuous variables underwent analysis using a two-tailed student t test, and significance was set to p ≤ 0.05. During the study period, 548 MAUDE reports revealed 873 device failures and 186 patient-related adverse events. The most common device issues were stent activation, positioning, or separation problems (4 n = 403; 46.2%), followed by device detachment or migration (n = 109, 12.5%), and material problems (n = 93, 10.7%). Patient complications included dysphagia/odynophagia (10%), perforation, pain, and bleeding (each 7.6%). The most common device failures in over-the-wire (OTW) stents and through-the-scope (TTS) stents were activation, positioning, or separation problems (TTS: n = 183, 52.6% vs OTW: n = 220, 41.9%). Compared to OTW stents, TTS stents had higher migration and breakage (13.5% vs. 11.8%, p = 0.24), and (9.2% vs. 6.7%, p = 0.08) respectively, while OTW stents had more challenges with stent advancement or removal (5.1% vs. 0.3%, p < 0.001 and 4.6% vs 3.4%, p = 0.19, respectively) and material problems (14.7% vs. 4.6%, p < 0.001). Activation, positioning, and separation problems were the most frequent device failures in fully covered (FC) and partially covered (PC) stents (FC: n = 62, 32.8%, PC: n = 168, 43.5%). FC stents had higher migration rates (20.6% vs 9.8%, p < 0.001), while PC stents exhibited more material problems (17.4% vs. 5.8%, p < 0.001) and difficulties with advancing the stents (6.7% vs. 0%, p < 0.001). Our examination showed a prevalence of reported device complications associated with stent activation, positioning, and separation problems. Dysphagia or odynophagia emerged as the most frequently reported patient complication. Furthermore, our analysis, provides insights into TTS vs. OTW and FC vs. PC esophageal SEMSs, enabling endoscopists and manufacturers to better understand adverse events and potentially optimize device design for future iterations.

Auditory brainstem implants: an analysis of adverse events in the MAUDE database

ObjectiveAuditory Brainstem Implants (ABI) are used to restore hearing in patients lacking appropriate cochlear anatomy and/or cochlear nerve. The objective of this study was to examine the Manufacture and User Facility Device Experience (MAUDE) database to analyze adverse events. Study designThis is a study of a multi-institutional database maintained by the US FDA. SettingA database analysis was performed via collaboration of multiple clinicians at tertiary referral centers. MethodsThe MAUDE database was queried for Medical Device Reports (MDRs) relating to ABIs. MDRs were identified using the advanced search term “Implant, Auditory Brainstem” and reviewing all reports with the basic search term “Brainstem Implant”. All collected reports were individually reviewed. ResultsA total of 265 individual patient reports were reviewed, of which 55 reports met inclusion criteria. Reports regarding audiologic outcome included failure to provide hearing benefit (n = 27), implant failure/device malfunction (n = 10), and device non-use (n = 6). Postoperative complications included local skin infection (n = 3), CSF leak (n = 3), elevated ICP (n = 1), surgical site dehiscence (n = 1), swelling (n = 1), seroma formation requiring drainage (n = 1), and meningitis (n = 2). Two patients had dislodged magnets during 1.5 Tesla MRI acquisition. There were 35 instances of full explantation of the device and 1 partial removal; 13 patients had a new device implanted following explantation. ConclusionsPoor hearing results, device failure, and non-use were commonly reported causes for explanation in this analysis. This information can aid physicians in counseling patients and family members and managing device expectations.

What is the MAUDE Database Telling us about 510(k) Authorization? Evaluation of Two Generations of Endovascular Arteriovenous Fistula Devices

In 2019, Bard Peripheral Vascular Inc (BV; now Becton, Dickinson and Company; Sparks, Maryland) received FDA approval to begin marketing the The WavelinQ™ EndoAVF System through a process known as 510(k) authorization. Such authorization relies on BV proving that the new WavelinQ™ EndoAVF System was of "substantial equivalence" to the WavelinQ™ 4F EndoAVF System. We set forth to analyze patient problems and device issues reported for the new device and determine if they were significantly different from the predicate device its 510(k) approval was based on. FDA database Manufacturer and User Facility Device Experience (MAUDE) was queried for all adverse report events for the WavelinQ™ EndoAVF System and WavelinQ™ 4F EndoAVF System. Data was collected on patient issues and device issues. Fisher's Exact test was utilized. There was a total of 125 reports for the WavelinQ™ 4F EndoAVF System and 78 for the WavelinQ™ EndoAVF System. There was a significant increase in patient problem "hypertension" (0% vs. 5.1%; p=0.02) for the WavelinQ™ EndoAVF System but a statistically significant decrease in device issue "failure to align" for the WavelinQ™ EndoAVF System (24.8% vs. 10.3%; p=<0.01). There were changes in device and patient outcomes between the WavelinQ™ EndoAVF System and WavelinQ™ 4F EndoAVF System. While we noted a decrease in device problem "failure to align", there was an overall increase in patients' "hypertension" rates. This highlights the importance of the FDA MAUDE reporting in ensuring that device safety is maintained when devices are approved for marketing through the 510(k) process.

Intraocular Inflammation with faricimab: insights from Manufacturer and User Facility Device Experience (MAUDE) database.

Intraocular Inflammation with faricimab: insights from Manufacturer and User Facility Device Experience (MAUDE) database.

Major Clinical Adverse Events of Breast Implant in the Manufacturer and User Facility Device Experience Database.

Search the Manufacturer and User Facility Device Experience database to collect information on adverse events of breast implant. We analyzed the local complications and the breast implant illness (BII) of silicone breast implants, as well as saline breast implants separately, aim to provide a reference for women who want to breast augmentation. The Manufacturer and User Facility Device Experience database was queried for events reports related to the breast implant between July 1, 2012, and June 30, 2022. Event year and reporting year were summarized. Patient problem was collected and analyzed to distinguish between local complications and BII. A total of 108,728 adverse events in the past 3 years were analyzed, silicone breast implants accounted for 62.1% and saline breast implants accounted for 37.9%. The most common local complication of women receiving silicone breast implants was "Capsular Contracture," accounting for 48.73%. However, the incidence of "capsular contracture" in women who received saline breast implants was only 17.49%. The most common BII was "fatigue/weakness" in both women receiving 2 different breast implants, 17.20% in women receiving silicone breast implants and 24.71% in women receiving saline breast implants. Of note, in all the reports, there was a wide variation in the timing of reporting as compared with the timing of the adverse event. Although the adverse events of breast implant cannot completely be determined from this study, we provide a reference for women who want to get breast implants, so that they can choose breast implants more carefully. In addition, a better understanding of BII may allow them to think further about whether the benefits of breast implants outweigh the risks.

Infections Associated with Medtronic Duet External Ventricular Drains - Rhode Island Hospital, Providence, Rhode Island, January 2023-January 2024.

External ventricular drains (EVDs) are medical devices that are inserted into the ventricles of the brain to drain excess fluid, manage intracranial hypertension, monitor intracranial pressure, and administer medications. Unintentional disconnections and breaks or fractures (breaks) of EVDs or associated drainage system components can result in cerebrospinal fluid (CSF) leakage and increased risk for EVD-associated infections. After replacement of Integra Life Sciences EVD systems with Medtronic Duet EVD systems at Rhode Island Hospital in mid-September 2023, a threefold increase was observed in the prevalence of positive CSF cultures, from 2.8 per 1,000 days with an EVD in place (EVD days) during January-September 2023 to 11.4 per 1,000 EVD days during October 2023-January 2024 (rate ratio [RR] = 5.7; 95% CI = 1.5-22.0; p = 0.01) and an eightfold increase in the prevalence of infections, from 0.7 to 6.5 per 1,000 EVD days (RR = 9.8; 95% CI = 1.1-87.3; p = 0.04). An investigation by Rhode Island Hospital Infection Control during December 2023-January 2024 identified frequent reports of disconnections and breaks of the Medtronic Duet EVD system. A search of the Food and Drug Administration Manufacturer and User Facility Device Experience database identified 326 reports nationwide of disconnection and breaks of components of the Duet EVD system, including 175 during 2023. A Medical Product Safety Network report was filed. The Duet EVD product was ultimately recalled in January 2024, citing disconnections of the EVD system and reports of CSF leakage and infection. Given the widespread use of EVD systems by neurosurgery centers and the risk for EVD-associated infections, a strategy for future consideration by hospital infection prevention and control programs might be inclusion of EVD-associated infections in hospital surveillance programs to rapidly identify increases in these events and determine factors related to such infections to prevent additional infections.

Analysis of Reported Adverse Events Related to Hemospray: An FDA MAUDE Database Study.

Topical hemostatic powder is a mineral powder that forms an adherent barrier and coagulates active bleeding in the gastrointestinal (GI) tract. Hemospray is the first hemostatic powder approved by the Food and Drug Administration (FDA) in the United States. Hemospray has been increasingly used to manage GI bleeding. However, data on the adverse events of hemostatic powders are lacking. Therefore, we aim to report and analyze adverse events associated with Hemospray using the FDA's "Manufacturer and User Facility Device Experience" database. We analyzed the postmarketing surveillance data from the FDA's Manufacturer and User Facility Device Experience database for Hemospray, initially known as TC-325, from June 2018 through April 2022. Results of the search were classified into device-related technical issues, patient-related adverse events and health care staff-related adverse events. Five hundred two medical device reporting claims were identified from June 2018 through April 2022. Seven duplicate claims were identified, and some claims included more than one event type. Therefore, there were 558 device-related problems, 28 patient-related adverse events, and 2 adverse events in health care staff members. The most common device-related problems were activation failure or failure to fire (n = 385, 70.0%) and obstruction of carbon dioxide flow (n = 121, 21.7). The most common patient-related adverse events included tissue injury or bleeding (n = 21) and perforation (n = 5). Although Hemospray is a valuable tool in the armamentarium for endoscopists in managing GI bleeding, endoscopists must be mindful of deice-related problems and potential patient-related adverse events.

Adverse events associated with Vibrant Soundbridge: A MAUDE study

ObjectiveTo summarize adverse events and their root causes reported to the United States Food and Drug Administration (FDA) on Vibrant Soundbridge (VSB) hearing device (Med-El, Innsbruck, Austria), an active middle ear implant for patients with moderate to severe hearing loss. Materials and methodsThe FDA's Manufacturer and User Facility Device Experience (MAUDE) database was queried for reports of VSB adverse events from January 1, 2012, to July 27, 2022. ResultsSix hundred sixty-three total medical device reports were identified, from which 913 adverse events were extracted. Of these, 498 (54.5 %) were adverse events to patients (AEPs), while 415 (45.5 %) were device malfunctions (DMs). The most common AEPs were hearing performance issues 428 (85.9 %). The most common DMs were compromised conductive link 125 (30.1 %). Root causes identified for DMs were iatrogenic 85 (58.6 %), patient-related 28 (19.3 %), and trauma and external causes 32 (22.1 %). The most common iatrogenic root cause 12 (14.1 %) involved damage to the conductive link during revision surgery. The most common patient-related causes of DMs were excessive middle ear tissue growth 16 (57 %), and abrupt body movements 5 (28.6 %). The most common external cause of DM was cleaning of the ear canal or mastoid cavity 20 (62.5 %). ConclusionsDespite its well-known limitations, the MAUDE database provides valuable information on possible complications of VSB as it relates to device malfunction or adverse events for patients. Implementation of standardized reports with relevant and well-defined categories could certainly allow for a more meaningful analysis.

Are adverse events during surgery for benign prostatic hyperplasia device related? A review of the MAUDE database.

The Manufacturer and User Facility Device Experience database contains anonymous, voluntary medical device reports. A review of device-related adverse events associated with Benign Prostatic Hyperplasia surgeries was completed. The objective was to evaluate the occurrence and contributing factors to clinically significant complications in a cohort of patients electing to undergo surgical intervention for Benign Prostatic Hyperplasia. The Manufacturer and User Facility Device Experience database was queried for "Aquablation, Greenlight Laser, Holmium Laser, Morcellator, Water Vapor Thermal Therapy, Loop Resection, and Prostatic Urethral Lift" from 2018 through 2021. A complication classification system (Level I-IV) based on the Clavien-Dindo system was used to categorize events. These events were then correlated with procedural technology malfunctions and classified as "device related" and "non-device related." Chi squared analysis was performed to identify associations between procedural technology and complication classification distribution. A total of 873 adverse events were identified. The adverse events were classified into level I (minimal harm) versus levels II-IV (clinically significant). Aquablation (p < 0.017) and Water Vapor Thermal Therapy (p < 0.012) were associated with a higher proportion of reports with Level II-IV complications compared with other procedure types. Level II-IV complications were not associated with a reported device related malfunction. Aquablation and water vapor thermal therapy demonstrated noteworthy clinically significant complications which were not driven by device-related malfunctions.

Adverse events associated with anastomotic coupling devices in microvascular reconstruction

ObjectiveIn light of the recent US Food and Drug Administration (FDA) Class 2 safety recall notice for anastomotic coupling devices, it is important to understand related adverse events. The aim of this study was to characterize adverse events in anastomotic coupling devices for microvascular reconstruction. MethodsA retrospective cross-sectional analysis using the 2011 to 2021 US FDA Manufacturer and User Facility Device Experience (MAUDE) database. All reports of adverse events involving anastomotic coupling devices were retrieved from the MAUDE database. Descriptive statistics were used to analyze categorized events. ResultsThere were a total of 293 documented adverse events related to anastomotic coupling devices. These adverse events resulted in 91 (31.1 %) patient injuries and 239 (81.6 %) device malfunctions. The most frequent patient problems were thrombosis/hematoma (n = 38; 41.8 %), unspecified injury (n = 31; 34.1 %), and failure to anastomose (n = 13; 14.3 %). Free flap necrosis was reported in 42 % of thrombosis/hematoma cases (n = 16). The most common malfunctions were devices operating differently than expected (n = 74; 31.0 %), connection problems (n = 41; 17.2 %), and twisted/bent material (n = 19; 7.9 %). There was no significant trend in the number of adverse events over the study period (p > 0.05). ConclusionsAdverse events from anastomotic coupling devices represent an important and modifiable factor in free tissue failure. Adverse events are predominately related to devices operating differently than expected and may result in vascular compromise of the free flap. Reconstructive surgeons should be cognizant of defective anastomotic coupling devices and be prepared to utilize traditional hand-sewn anastomosis.

Machine learning-based analysis of adverse events in mesh implant surgery reports

AbstractMesh implant surgery, commonly used for various medical conditions, has been linked to a range of negative effects, significantly impacting patient experiences and outcomes. Additionally, the growing volume of medical data, especially text-based reports, presents challenges in deriving meaningful insights for informed healthcare decisions. To address these challenges, our study extensively analyzed the Manufacturer and User Facility Device Experience (MAUDE) dataset from 2000 to 2021. We have meticulously identified a range of adverse events associated with mesh implant surgeries, including Dyspareunia, Urinary problems, Chronic Inflammation, Prolapse Recurrence, Mesh Erosion, Urinary Tract Infections, discomfort, and sleep disturbances. Using topic modeling, we explored patient experiences and the interrelationships among these adverse events. This approach uncovered key topics linked to mesh surgery, such as Stress Urinary Incontinence, Incisional Hernia, Inguinal Hernia, and Umbilical Hernia, along with their side effects. While the analysis focused on common symptoms such as pain, infection, and bleeding, it also brought to light specific symptoms like sleeping issues, mental stress, and discomfort. We also examined the interconnectedness of these adverse events with identified topics and their temporal trends, revealing shifts in patient experiences over time. Notably, there was an increase in reports of Stress Urinary Incontinence around 2011–2012 and a surge in Inguinal Hernia concerns in 2017–2018. This study provides a comprehensive understanding of adverse events and associated topics in mesh implant surgeries, contributing valuable insights into patient experiences and aiding in informed healthcare decision-making.

Assessing the Reproducibility of Research Based on the Food and Drug Administration Manufacturer and User Facility Device Experience Data.

This article aims to assess the reproducibility of Manufacturer and User Facility Device Experience (MAUDE) data-driven studies by analyzing the data queries used in their research processes. Studies using MAUDE data were sourced from PubMed by searching for "MAUDE" or "Manufacturer and User Facility Device Experience" in titles or abstracts. We manually chose articles with executable queries. The reproducibility of each query was assessed by replicating it in the MAUDE Application Programming Interface. The reproducibility of a query is determined by a reproducibility coefficient that ranges from 0.95 to 1.05. This coefficient is calculated by comparing the number of medical device reports (MDRs) returned by the reproduced queries to the number of reported MDRs in the original studies. We also computed the reproducibility ratio, which is the fraction of reproducible queries in subgroups divided by the query complexity, the device category, and the presence of a data processing flow. As of August 8, 2022, we identified 523 articles from which 336 contained queries, and 60 of these were executable. Among these, 14 queries were reproducible. Queries using a single field like product code, product class, or brand name showed higher reproducibility (50%, 33.3%, 31.3%) compared with other fields (8.3%, P = 0.037). Single-category device queries exhibited a higher reproducibility ratio than multicategory ones, but without statistical significance (27.1% versus 8.3%, P = 0.321). Studies including a data processing flow had a higher reproducibility ratio than those without, although this difference was not statistically significant (42.9% versus 17.4%, P = 0.107). Our findings indicate that the reproducibility of queries in MAUDE data-driven studies is limited. Enhancing this requires the development of more effective MAUDE data query strategies and improved application programming interfaces.

Medical device report analyses from MAUDE: Device and patient outcomes, adverse events, and sex-based differential effects

Post-market medical device-associated failures and patient problems are reported in Medical Device Reports (MDRs) to the US Food and Drug Administration. Reports are accessible through Manufacturer and User Facility Device Experience (MAUDE), a database including both required and voluntary submissions. We present an overview of >10 million MDRs received from 2011 to 2021. Approximately 92% of reporting issues represent medical device physical or functional failures, categorized from 1704 codes related to medical device integrity or function. ∼8% were coded adverse events (AEs). Patient outcomes are reported via 998 patient codes in 19 medical specialties (cardiovascular, orthopedic, etc.). ∼40% of patient reports indicated “no health consequences”; however, a small number of devices had consistently high AE reports. While overall reports did not exhibit a sex-based dichotomy, ∼9% of the reported AEs occurred more frequently in females, many of which were related to immune effects. The analyses are subject to uncertainties and potential bias based on data available and data selected for analysis. However, such an overview of post-market MDR data, not previously published, fills a gap in understanding medical device issues and patient-based outcomes related to medical device use. Trends identified may be subjects of additional hypotheses, analysis, and research.

Major Complications and Adverse Events Related to Use of SpaceOAR Hydrogel for Prostate Cancer Radiotherapy

ObjectiveTo determine the prevalence and severity of SpaceOARTM-related adverse events using the Manufacturer and User Facility Device Experience (MAUDE) database. MethodsWe analyzed SpaceOAR-related adverse event reports in the Manufacturer and User Facility Device Experience (MAUDE) database from January 2015 to May 2023. For each report, the event type, associated device and patient problems, event description, event timing, and event severity stratified by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE) grading system were recorded. ResultsFrom 2015 to 2022, 206,619 SpaceOAR devices were sold. From January 2015 to May 2023, we identified 981 reports describing 990 SpaceOAR-related adverse events. Malfunctions were the most common event type (N=626), followed by patient injuries (N=350) with few reported deaths (N=5). Device positioning problems were the most frequent device issue (N=686). Pain was the most reported patient problem (N=216). Abscesses and fistulas related to the device were each reported in 91 events. A noteworthy portion of relevant adverse events occurred before the initiation of radiation (N=35, 22.4%), suggesting the device, rather than the radiation, was responsible. In total, 470 (50.2%) and 344 (36.7%) of the adverse events were CTCAE grade 1 and 2, respectively. There were 123 (13.1%) events that were CTCAE grade ≥ 3. ConclusionWe identified multiple reports of SpaceOAR-related adverse events, many of which are more serious than have been reported in clinical trials. While SpaceOAR use is common, suggesting these events are rare, these data highlight the need for continued postmarket surveillance.

Soft tissue injury events associated with neural integrity monitoring endotracheal tubes: A MAUDE database analysis

ObjectiveNeural integrity monitoring (NIM) endotracheal tubes are widely used to provide intraoperative monitoring of the recurrent laryngeal nerve during certain neck surgeries, especially thyroidectomy, in order to reduce the risk of nerve injury and subsequent vocal fold paralysis. The unique design of NIM tubes and the increased technical skill required for correct placement compared to standard endotracheal tubes may increase the risk of upper aerodigestive tract soft tissue injury. This study aims to describe adverse events related to NIM endotracheal tubes. Study designRetrospective cross-sectional study. SettingThe US Food and Drug Administration's MAUDE database (2010−2022); (Manufacturer and User Facility Device Experience). MethodsThe MAUDE database was queried for reports of adverse events that resulted in patient soft tissue injury involving the use of endotracheal tubes approved by the Food and Drug Administration. ResultsThere were 28 reported soft tissue injuries, with all events being related to the NIM EMG family of endotracheal tubes manufactured by Medtronic Xomed, Inc. Overall, 24 were categorized as device-related adverse events, and 4 were unspecified in the event description. The most common soft tissue injuries were edema (n = 7) and perforation (n = 7), each accounting for 25 % of adverse events. The second most common injury type was laceration (n = 4), representing 14 % of all adverse events. Overall, 9 patients (32 %) in our cohort required a surgical intervention to treat their injuries, which consisted of 6 tracheotomies and 3 instances of suture repair. ConclusionsThe most commonly reported types of soft tissue injury included edema and perforation, followed by laceration. Increased awareness of device-related patient injuries associated with NIM endotracheal tubes can be used to better inform surgeons and anesthesiologists during the process of intubation and surgical decision-making.

Considerations for Use of the MAUDE Database in Otolaryngology-Head & Neck Surgery Research.

The use of the US Food and Drug Administration's (FDA) Manufacturer and User Facility Device Experience (MAUDE) to analyze adverse events linked to medical devices has grown in recent years. MAUDE facilitates post-market surveillance, contributing to the assessment of device performance and the identification of potential safety concerns. The database is instrumental not only for mandatory reporters such as manufacturers and healthcare facilities but also offers a platform for voluntary submissions from clinicians and patients, thus widening the scope of data collection. While the database offers valuable data, there are important limitations that must be understood in order to encourage appropriate interpretation of findings. This commentary highlights the major advantages and disadvantages of the MAUDE database, as well as describes possible areas for improvement in adverse event reporting.

(215) Penuma® Penile Implant Adverse Events in the Manufacturer and User Facility Device Experience (MAUDE) Database

Abstract Introduction Penuma® is an FDA-approved penile implant intended to increase flaccid penile length and girth for improved cosmesis. It is the only FDA-approved product of its kind, with reportedly thousands of implants since 2004. There is a paucity of data on the adverse events related to this procedure. Objective To describe and characterize adverse events related to Penuma® using a national database. Methods The Manufacturer and User Facility Device Experience (MAUDE) database, a voluntary-reported database of medical device complications with data since 1991, was queried. The MAUDE adverse event classification system, a validated classification system, was used as a standardized tool to classify adverse events based on severity. All adverse events related to Penuma® were identified and quantified. Results 42 reports of adverse events related to Penuma® were identified (Figure 1). Of these, 35 patients were reported to undergo device removal most commonly due to infection (n=8) or protrusion (n=8). (Table 1). The most commonly reported adverse event was deformity/disfigurement (n=27), of which 18 cases reported loss of penile length. Other adverse events included: pain (n=16), infection (n=12), decreased sensitivity (n=10), scar tissue (n=9), erectile dysfunction (n=8), seroma (n=7), and erosion (n=6). Conclusions To our knowledge, this is the first study to systematically characterize publicly reported adverse events occurring with Penuma® implantation, using the MAUDE database. Further research is warranted to delineate the incidence of adverse events related to Penuma®. Disclosure No.

Adverse events of the single-operator cholangioscopy system: a Manufacturer and User Facility Device Experience database analysis

SpyGlass single operator cholangioscopy (SOC) system is generally considered safe but adds additional risks to those associated with standard endoscopic retrograde cholangiopancreatography. We evaluated adverse events (AEs) with the SpyGlass System reported in the United States Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database between January 2016 & August 2023. A total of 2331 device problems (SpyGlass DS:1301, SpyGlass DS II:1010) were reported. An optical problem was the most reported issue with 83 for the SpyGlass DS and 457 for the SpyGlass DS II. Patient related events were found in 62 (3.5%) of 1743 reports: 33 with SpyGlass DS, and 29 with SpyGlass DSII. The most common AEs were bleeding/hemorrhage followed by perforation, infection, fever, or sepsis and pancreatitis. Our findings add to the existing literature and provides a fuller picture of potential problems associated with SpyGlass™ SOC.