Medical Device Reports Research Articles

P‐IS‐1 | Automated Blood Grouping and Antibody Testing Systems: An Analysis of Medical Device Reports for False‐Negative Results

P‐IS‐1 | Automated Blood Grouping and Antibody Testing Systems: An Analysis of Medical Device Reports for False‐Negative Results

Nasal Epistaxis Balloons: A Comprehensive MAUDE Database Analysis

BackgroundWhile nasal epistaxis balloons are generally seen as safe and routinely utilized by both surgical and nonsurgical providers, the complication profile related to this type of device has not been well defined. ObjectiveThe objective of this study was to utilize the FDA MAUDE (Manufacturer and User Facility Device Experience) database to better assess adverse events (AE) related to use of nasal epistaxis balloons. Reports were individually tabulated and events were categorized with special attention to AEs. MethodsThe FDA MAUDE database was queried for all medical device reports (MDR) related to nasal epistaxis balloon devices from January 2012 to November 2022. Results19 MDRs met inclusion criteria. 5 MDRs were classified as device related (26.3 %); two events were reported for balloon leak and deflation, two events were reported for device breakage, and one device related event was unknown. 14 MDRs (73.7 %) were classified as patient related. Two documented MDRs were patient deaths due to exsanguination. Additional serious AEs included balloon ingestion and subsequent small bowel perforation (n = 1), cerebrospinal fluid leak (n = 1), skull base violation and intracranial placement of the device (n = 1), and respiratory distress (n = 3). ConclusionThough epistaxis control with nasal balloons is generally seen as a safe procedure, there have been several concerning AEs reported. While two reports of death due to exsanguination were the most severe AEs, multiple other life-threatening AEs were also documented. Increased awareness of associated complications can be used to better counsel patients during the informed consent process as well as providers in their clinical decision making.

Eustachian Tube Balloon Dilation: A Comprehensive Analysis of Adverse Events.

Eustachian tube balloon dilation (ETBD) has been Food and Drug Administration (FDA) approved for refractory Eustachian tube dysfunction since 2016. While ETBD is generally seen as safe, the complication profile has not been well defined. The objective of this study was to utilize the FDA manufacturer and user facility device experience (MAUDE) database to better assess adverse events (AE) related to ETBD. This is a study of a multiinstitutional database maintained by the U.S. FDA. A database analysis was performed via the collaboration of multiple clinicians at tertiary referral centers. The FDA MAUDE database was queried for all medical device reports (MDR) related to ETBD devices from January 2012 to November 2022. Eighty-eight unique MDR were identified, 16 of which met inclusion criteria. Three MDRs were classified as device-related (18.8%); none resulted in an AE. Thirteen MDRs (81.3%) were patient-related; all were classified as AEs. The most common AE was postoperative subcutaneous emphysema (n = 6, 46.2%). Of the patients with subcutaneous emphysema, there was a wide range of severity. The most severe AE (n = 1, 6.3%) was postoperative stroke secondary to carotid artery dissection. Though ETBD is generally seen as a safe procedure, there have been several concerning AEs reported to date. Increased awareness of ETBD complications can serve as a primer for improved patient education and counseling during the informed consent process and aid surgeons in clinical decision-making. Future studies with standardized reporting protocols are warranted to create a central registry for ETBD.

The Role of Healthcare Technology Management Professionals in Adverse Event Reporting

Healthcare technology management professionals play a key role in the medical device environment. By sharing their insights and expertise on medical devices issues with the US Food and Drug Administration, healthcare technology management professionals help the agency resolve medical device safety concerns and help improve patient safety. This article presents two real-world case study examples in which medical device reports containing critical healthcare technology management input were submitted to the US Food and Drug Administration's MedSun (Medical Product Safety Network) reporting program and helped contribute to 2 recalls. The details in the reports, provided by the hospital reporting team, offer a unique perspective for identifying the device concern and greatly contribute to the investigation and resolution of the reported device safety issue.

Complications associated with minimally invasive surgical therapies (MIST) for surgical management of benign prostatic hyperplasia: a Manufacturer and User Facility Device Experience (MAUDE) database review.

MAUDE database houses medical device reports of suspected device-related complications received by Food and Drug Administration. In the present study we aim to evaluate the MAUDE database for reported complications of MIST procedures. The database was queried using keywords: rezum, urolift, prostate embolization (PAE), transurethral needle ablation (TUNA), transurethral microwave therapy (TUMT), prostate stent and Temporarily Implanted Nitinol Device (iTIND) on 10/1/22 to extract information regarding device problems and procedure-related complications. Gupta classification system was used to stratify complications. Statistical analysis was performed to compare frequency of complications among MIST procedures. We found a total of 692 reports (Rezum-358, urolift-226, PAE-53, TUNA-31, TUMT-19, prostatic stent-4, and iTIND-1). Most complications related to device or users were minor (level 1 and 2) and there was no significant difference among various MIST procedures. The screen/system error was responsible for 93% and 83% aborted cases in Rezum and TUNA, respectively, and PAE showed 40% of device component detachment/fracture. Overall Urolift and TUMT were associated with statistically significant higher incidence of major (level 3 and 4) complications (23% and 21%, respectively) as compared with Rezum (7%). Most major complications needing hospitalization after Urolift included hematoma and hematuria with clots and those after Rezum included urinary tract infection and sepsis. Thirteen deaths were reported, mostly due to cardiovascular events, which were classified as not associated with the proposed treatment. MIST for BPH can occasionally cause significant morbidity. Our data should assist urologists and patients in shared decision-making process.

Adverse events associated with AveirTM VR leadless pacemaker: A Food and Drug Administration MAUDE database study.

Leadless pacemaker (LP) offers an innovative approach for treating bradyarrhythmia, thus avoiding pacemaker pocket and lead-related complications. The Food and Drug Administration (FDA) has recently approved the Aveir™ leadless pacing system (screw-in type LP). We queried the FDA MAUDE database to study the safety profile and assess the types of complications with this relatively novel device technology. A MAUDE database search was conducted on January 20, 2023, for reports received post-FDA approval to capture all adverse events. A total of 98 medical device report were reported for Aveir™ LP. After excluding duplicate, programmer-related, or introducer-sheath-related entries (n = 34), 64 entries were included. The most commonly encountered problem was high threshold/noncapture (28.1%, 18 events), followed by stretched helix (17.2%, 11 events) and device dislodgement (15.6%, ten events-5 intraprocedural, while 5 in the postoperative Day 1). Other reported events included high impedance (14.1%, nine events), sensing issues (12.5%, eight events), bent/broken helix (7.8%, five events), premature separation (4.7%, three events), interrogation problem (3.1%, two events), low impedance (3.1%, two events), premature battery depletion (1.6%, one event) and inadvertent MRI mode switch (1.6%, one event) and miscellaneous (15.6%, n = 10). There were eight serious patient injury events-pericardial effusion requiring pericardiocentesis (7.8%, five events) due to cardiac perforation that resulted in two deaths (3.1%) followed by sustained ventricular arrhythmias (4.6%, n = 3). In our study assessing the real-world safety profile of the Aveir™ LP, serious adverse events have been reported-life-threatening ventricular arrhythmias, pericardial effusion, device explantation/reimplantation, and death.

MP35-11 TRENDS AND INCIDENCE OF REPORTED EVENTS ASSOCIATED WITH URETERAL STENTS: AN ANALYSIS OF THE FOOD AND DRUG ADMINISTRATION'S MANUFACTURER AND USER FACILITY DEVICE EXPERIENCE DATABASE

MP35-11 TRENDS AND INCIDENCE OF REPORTED EVENTS ASSOCIATED WITH URETERAL STENTS: AN ANALYSIS OF THE FOOD AND DRUG ADMINISTRATION'S MANUFACTURER AND USER FACILITY DEVICE EXPERIENCE DATABASE

PD41-08 DEVICE-RELATED ADVERSE EVENTS DURING BENIGN PROSTATIC HYPERTROPHY SURGERY: REVIEW OF THE MANUFACTURER AND USER FACILITY DEVICE EXPERIENCE DATABASE

You have accessJournal of UrologyCME1 Apr 2023PD41-08 DEVICE-RELATED ADVERSE EVENTS DURING BENIGN PROSTATIC HYPERTROPHY SURGERY: REVIEW OF THE MANUFACTURER AND USER FACILITY DEVICE EXPERIENCE DATABASE Daniel Heidenberg, Ethan Nethery, Nathanael Judge, Kevin Wymer, Scott Cheney, and Mitchell Humphreys Daniel HeidenbergDaniel Heidenberg More articles by this author , Ethan NetheryEthan Nethery More articles by this author , Nathanael JudgeNathanael Judge More articles by this author , Kevin WymerKevin Wymer More articles by this author , Scott CheneyScott Cheney More articles by this author , and Mitchell HumphreysMitchell Humphreys More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003346.08AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Benign prostatic hyperplasia (BPH) affects most men over 60 years old. The Manufacturer and User Facility Device Experience (MAUDE) database is an FDA maintained public database that contains anonymous, voluntary medical device reports. Herein, we review device-related adverse events reported in the MAUDE database associated with BPH surgeries. METHODS: The MAUDE database was queried for “Aquablation, Rezum, Loop Resection, Morcellator, Greenlight Laser, Holmium Laser, and Urolift” from 2018 through 2021. A complication classification system (Level 1-4) based on the Clavien-Dindo system was used to categorize events based on outcomes. These events were then correlated with device malfunctions and classified as “product related” and “non-product related.” Chi squared analysis was performed to identify associations between BPH surgery type and complication classification distribution. RESULTS: A total of 873 device related events were identified. The entries by surgical subtype included: rezum 304 (35%), urolift 33 (4%), TURP 134 (15%), HOLEP 40 (4%), Aquablation 294 (34%), Greenlight laser 68 (8%). 553 complications (63%) were Level I (mild/none), 138 (16%) were Level II (medical management), 164 (19%) were Level III (surgical management), and 16 (2%) was Level IV (life threatening). The most common level II-IV complications by BPH surgery type: aquablation - hematuria (50%), rezum - lower urinary tract symptoms (23%), HOLEP – retained adenoma (23%), urolift – acute urinary retention (12%), greenlight laser – urethral necrosis (2%), transurethral resection of prostate – bladder perforation (3%). Using chi squared analysis, aquablation (p<0.017) and Rezum (p<0.012) were associated with the highest risk of Level II-IV complications compared with other device classes. Overall, “product related” malfunctions were not associated with level II-IV complications. CONCLUSIONS: Aquablation and rezum were associated with a higher proportion of level II-IV complications. However, this difference is not accounted for by “product related” malfunctions, which highlights surgeon experience or other unknown factors as potential sources for adverse events with newer products. A limitation of this study is the total complications per surgical subtype are not fully captured. Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e1061 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Daniel Heidenberg More articles by this author Ethan Nethery More articles by this author Nathanael Judge More articles by this author Kevin Wymer More articles by this author Scott Cheney More articles by this author Mitchell Humphreys More articles by this author Expand All Advertisement PDF downloadLoading ...

Assessment of adverse events for a home-use intense pulsed light hair removal device using postmarketing surveillance.

Home-use intense pulsed light (IPL) hair removal devices are convenient for consumers. Consumer safety associated with home-use IPL devices, however, remains a subject of interest. In this descriptive analysis, we assessed the most commonly reported adverse events (AEs) for a home-use IPL device from postmarketing surveillance and qualitatively compared these with AEs from clinical studies and medical device reports of home-use IPL treatments. For this analysis of voluntary reports, we queried a distributor's postmarketing database for IPL devices for the period beginning January 1, 2016, to December 31, 2021. All sources of comments, for example, phone, e-mail, company-sponsored web sites, were included in the analysis. AE data were coded according to the Medical Dictionary for Regulatory Activities (MedDRA) terminology. Also, we conducted a PubMed search to identify AE profiles from existing literature on home-use IPL devices and we searched the Manufacturer and User Facility Device Experience (MAUDE) database for reports on home-use IPL devices. These results were qualitatively compared to the data in the postmarketing surveillance database. A total of 1692 cases involving IPL were identified from voluntary reports of AEs between 2016 and 2021. The shipment-adjusted reporting rate for AE cases (number of AE cases/100,000 shipped IPL devices) was 67/100,000 during this 6-year period. The most commonly reported AEs were pain of skin 27.8% (470/1692), "thermal burn" 18.7% (316/1692), and erythema 16.0% (271/1692). Among the top 25 AEs reported, no unexpected health events were observed. The reported AEs were qualitatively similar to the pattern seen in clinical studies and the MAUDE database associated with such home-use IPL treatments. This is the first such report documenting AEs for home-use IPL hair removal from a postmarketing surveillance program. These data are supportive of the safety of such home-use low-fluence IPL technology.

Benefits of Healthcare Technology Management Input in Medical Product Safety Network Reports

Healthcare technology management professionals play an important role in reporting medical device adverse events to the Food and Drug Administration by helping to identify and report device concerns, providing critical context to medical device reports, and mitigating safety concerns. The expert opinions and insights shared by healthcare technology management professionals are beneficial to the Food and Drug Administration and help the agency mitigate device-related problems and improve patient safety. This article is a case study that discusses how a medical device report involving infusion pump controllers was submitted to the Food and Drug Administration's Medical Product Safety Network reporting program and contributed to a voluntary class I recall affecting more than 800,000 devices nationwide. The details and context provided in the medical device report by the reporting team helped inform the investigation into, and resolution of, a device safety concern.

Mortality related to the use of stapler devices and clip appliers: Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience database

BackgroundSurgical staplers and clip appliers are commonly used and have a potential to malfunction, which may result in serious injury or death. These events are self-reported to the Food and Drug Administration and compiled in the Food and Drug Administration’s Manufacturer and User Facility Device Experience database. This study characterizes mortality related to surgical stapler and clip applier failure reported in the Food and Drug Administration’s Manufacturer and User Facility Device Experience database. MethodsThe Food and Drug Administration’s Manufacturer and User Facility Device Experience database was reviewed between 1992 and 2016 for medical device reports related to surgical staplers and clip appliers filed under the following product codes: GAG, FZP, GDO, GDW, KOG, and GCJ. Adverse events including death and the type of device failure were reviewed. Temporal trends in reported deaths related to device failure were analyzed and the Healthcare Cost and Utilization Project database was used to adjust for annual surgical case volume using linear regression analysis. ResultsA total of 75,415 malfunctions, 21,115 injuries, and 676 deaths were associated with the use of surgical stapler and clip applier devices. Most deaths occurred postoperatively (N = 516, 76.3%) and were due to infection/sepsis (N = 89, 17.2%) or vascular injuries (N = 110, 21.3%). Intraoperative mortality (N = 79, 11.7%) was primarily due to vascular injuries (N = 73, 92.4%). Device failures resulting in death were noted both intraoperatively (N = 268, 39.6%) and postoperatively (N = 325, 48.1%). In post hoc root cause analysis, a surgical stapler and clip applier device problem was the most common attributed cause of death (N = 238, 65.4%). In the linear regression analysis, there was a significant increase in the mortality from device failure in the study period after adjusting for annual surgical volume (P < .01). ConclusionMortality related to the use of surgical staplers and clip appliers is increasing. Most deaths occurred postoperatively, and an increased awareness of potential life-threatening complications is warranted when these devices are used.

Analysis of Polyethylene-Related Revisions After Total Ankle Replacements Reported in US Food and Drug Administration Medical Device Adverse Event Database.

There are 2 general types of total ankle replacement (TAR) designs with respect to the polyethylene insert, mobile-bearing (MB) and fixed-bearing (FB) TARs. The aim of this study is to compare polyethylene-related adverse events (AEs), particularly revisions, reported for MB TARs and FB TARs using the US Food and Drug Administration's (FDA's) Manufacturer and User Facility Device Experience (MAUDE) database. A text mining method was applied to the medical device reporting (MDR) in the MAUDE database from 1991 to 2020, followed by manual reviews to identify, characterize, and describe all polyethylene-related AEs, including revisions, reported for MB and FB TARs. We found 1841 MDRs for MB (STAR Ankle only) and 1273 MDRs for 40+ FB TARs approved/cleared by the FDA. For the MB design, 33% (606/1841) of the AEs reported related to the polyethylene component, compared to 24% (291/1273) of the AEs reported for FB designs. Polyethylene fractures were reported in 11.3% (208/1841) for the MB designs compared to 0.2% (2/1273) for the FB designs. Half of the polyethylene-related revisions occurred within an average of 4.1 years after implantation for the MB design compared within an average of 5.2 years for FB designs. Analysis of this database revealed a higher proportion of reported polyethylene fractures and greater need for earlier revisions for polyethylene-related issues with use of the primary MB design in the database as compared with FB TAR designs. Further study of device-related complications with more recent designs for both MB and FB ankle replacement components are needed to improve the outcomes of total ankle replacement. Level III, retrospective comparative study.

A Comprehensive Review of Spinal Cord Stimulator Infections.

Spinal cord stimulator (SCS) is approved to treat various pain conditions and is commonly seen in the chronic pain patient population.Due to the nature of the device and its location, infections associated with SCS have a particularly high morbidity.According to post-market data and medical device reports, 87% of patients receiving SCS implants were given perioperative antibiotics as the implantable neurostimulator or receiver pocket serve as the most common sites of infection. The most common antibiotics for surgical prophylaxis given are first-generation cephalosporins (cefalexin, cefazolin) at the time of implantation.If deep infection is suspected, imaging in the form of CT scan should be obtained as physical exam is not always sufficient. For infections involving the epidural space, vertebra, or intervertebral discs, MRI is the preferred imaging modality. If meningitis is suspected, a lumbar puncture is recommended. Positive cultures can help guide antibiotic therapy.

Recommendations for inversion table therapy

In the USA, low back pain related illness accounts for approximately 149 million workdays lost each year. Initial management of back pain typically involves allied healthcare professionals who implement various treatments, such as chiropractic manipulation, physiotherapy, and acupuncture which have varying outcomes and levels of supporting evidence. Another passive treatment for back pain is inversion table therapy (ITT). It is a form of spinal traction which is thought to have a role in relieving low back pain due to the gravity-facilitated traction of the spine which distracts the lumbar vertebrae. However, ITT is not without risk. According to the Food and Drug Administration (FDA) Medical Device Reporting Events Database, ITT has resulted in serious injuries including spinal cord injury, fractures, lacerations, and death. The FDA has regulated ITT for only manufacturers that indicated medical use; however, most manufacturers have not made such medical claims and were exempt from FDA regulation. This article discusses the risks of ITT, the current regulatory process for ITT, and the need for a better understanding of the role of ITT in the treatment of spinal pain while optimizing consumer safety. Implications for rehabilitation Inversion table therapy (ITT) is a form of spinal traction which is thought to have a role in relieving low back pain due to the gravity-facilitated traction of the spine which distracts the lumbar vertebrae. According to the Food and Drug Administration (FDA) statistics, injuries due to non-powered traction from various medical devices have been rising since 2011. The FDA has regulated ITT for only manufacturers that indicated medical use; however, most manufacturers have not made such medical claims and were exempt from FDA regulation. This article discusses the risks of ITT, the current regulatory process for ITT, and the need for a better understanding of the role of ITT in the treatment of spinal pain while optimizing consumer safety.

Adverse events associated with PentaRay Mapping Catheter – MAUDE database analysis

Abstract Background The 20 pole PentaRay Mapping Catheter is a high-definition mapping catheter with five soft, flexible spines providing better and faster acquisition. Despite its design, the catheter is not without glitches. Objective We queried the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database for adverse events related to the use of the PentaRay mapping catheter. Methods The Manufacturer and User Facility Device Experience (MAUDE) database was searched for reports received between October 1, 2019, to October 31, 2021, to capture all adverse events associated with PentaRay mapping catheter using the term “PentaRay” in the “brand name” section. The adverse events were adjudicated to various categories based on the review of the event description for each medical device report (MDR). Results A total of 159 events were reported in 148 MDRs during the study period. The most common device related issues were: damaged splines 18.2% (n=29), device entrapment 17% (n=27), thrombus on device 15.1% (n=24), foreign material on splines 8.8% (n=14), sensor error 3.8% (n=6). Of the patient related events, 13.8% (n=22) were pericardial effusion, 5% (n=8) cardiac arrest, 1.2% (n=2) coronary vasospasm/STEMI, 0.6% (n=1) heart block, 0.6% (n=1) air embolism, 0.6% (n=1) tear in pulmonary veins. These events lead to procedure abortion 27.7% (n=44) and procedural delay 11.3% (n=18). Conclusion Several issues have been reported with the PentaRay mapping catheter leading to to procedure abortion, delay and patients related adverse events. Understanding and troubleshooting may help improve patient outcomes. Funding Acknowledgement Type of funding sources: None.

S1162 A Comparison of Technical Failures and Patient-Related Adverse Events Associated With Three Widely Used Mechanical Lithotripters for ERCP: Insights From the FDA MAUDE Database

Introduction: Mechanical lithotripsy is a commonly used, effective method for fragmenting large biliary or pancreatic duct stones. Real-world data on the most commonly reported complications and modes of failure associated with mechanical lithotripters are limited. We analyzed the post-marketing surveillance data from the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database for three commercially available mechanical lithotripters for use during ERCP. Methods: A search of the FDA MAUDE database from January 2010 to October 2021 was conducted for the the following mechanical lithotripters: Trapezoid RX (Boston Scientific, Natick, MA), LithoCrush (Olympus Endoscopy, Center Valley, PA), and the Fusion Lithotripsy Extraction Basket (Cook Endoscopy, Winston Salem NC). Results were compiled and reviewed. Results: 1,128 medical device reports with 2,129 device malfunctions and 205 patient complications were identified. Most device malfunctions were due to guidewire port or sheath failure (n=379, 17.8%), basket entrapment (n=357, 16.8%), and basket tip separation failure (n=315, 14.8%). The most commonly reported adverse events to patients were an additional procedure to remove an entrapped basket (n=170/205, 82.9%), bleeding (n=15/205, 7.3%), and bowel perforation (n=5/205, 2.4%). Conclusion: Findings from the MAUDE database highlight device and patient-related adverse outcomes that should be recognized to improve clinical success and reduce patient risk.

INTRAOPERATIVE MALFUNCTIONS OF STAPLER DEVICES. THE CURRENT STATE OF THE PROBLEM AND A SERIES OF CLINICAL CASES

The paper presents several medical device reports from our center identified during application of surgical staplers from different manufacturers. The revealed malfunction did not lead to postoperative complications, however, they affected the duration of the operation and the cost of treatment. Failure of the stapler devices during surgery in the absence of proper attention to the staple line can lead to an increase in the frequency of postoperative complications. It remains unclear the problem of «small» malfunctions of stapler devices, which may go unnoticed during surgery, but affect the outcomes of treatment of patients. In order to identify a possible association between these adverse events and postoperative complications, it is necessary to form a state register of events associated with the use of stapler devices.

The Hidden Risk of Wheelchair Use

Not knowing how to unfold or even sit in a wheelchair the right way can cause a catastrophic injury to patients, visitors, volunteers, and staff of a healthcare facility. Wheelchairs are one of the most common assistive devices used in healthcare facilities, from admission to discharge. They are often found at the entrance of a facility for use by both patients and visitors with mobility issues. Hospital volunteers, transport staff, and clinical staff use wheelchairs to take patients to different care areas to have tests performed. Many facilities require that patients be transported in a wheelchair upon discharge. However, not knowing the proper method of unfolding a wheelchair or where to place your hands when sitting down in the seat can cause injuries, specifically to fingers, ranging from lacerations to amputations. An analysis of reports from the Pennsylvania Patient Safety Reporting System (PA-PSRS*) over the past decade identified 12 adverse events related to finger injuries involving wheelchairs in both inpatient and outpatient settings. Additionally, the U.S. Food and Drug Administration’s Manufacturer and User Facility Device Experience (MAUDE) reporting system, which “houses medical device reports submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers,” contains hundreds of reports involving wheelchair injuries dating back to 2012. These reports indicate different kinds of wheelchairs (e.g., manual, bariatric, transport, and motorized) from myriad manufacturers are associated with these injuries. Although the type of injury and mechanism of injury reported varies from a head injury sustained from tipping over the wheelchair to a laceration from a screw, numerous reports of adverse events involved finger injuries, which are the focus of this safety announcement.

Reported Events Associated With Spine Robots: An Analysis of the Food and Drug Administration's Manufacturer and User Facility Device Experience Database.

Cross-Sectional Analysis. To summarize medical device reports (MDRs) between August 1, 2017 and November 30, 2021 relating to robot-assisted spine systems within the Manufacturer and User Facility Device Experience (MAUDE) database maintained by The Food and Drug Administration (FDA). The MAUDE database was abstract for all MDRs relating to each FDA-approved robot-assisted spine system. Event descriptions were reviewed and characterized into specific event types. Outcome measures include specific robot-assisted spine systems and reported events as detailed by the MDRs. All data is de-identified and in compliance with the Health Insurance Portability and Accountability Act (HIPAA). There were 263 MDRs consisting of 265 reported events. Misplaced screws represented 61.5% (n = 163) of reported events. Of the 163 reported events, 57.1% (n = 93) described greater than 1 misplaced screw, 15.3% (n = 25) required return to the operating room, 8.6% (n = 14) resulted in neurologic injury, 4.3% (n = 7) resulted in dural tear, and 1.2% (n = 2) resulted in hemorrhage or bleeding. Reported events other than misplaced screws included system imprecision detected prior to screw placement (58/265, 21.9%), mechanical failure (23/265, 8.7%), and software failure (18/265, 6.8%). As more robot-assisted spine systems gain FDA approval and the adoption of these systems continues to grow, documenting and understanding the range of reported events associated with each "tool" is imperative to balancing patient safety with surgical innovation. This study of the MAUDE database provides a unique summary of reported events associated with robot-assisted spine systems that is not directly linked to a research setting.

Image-Guided Surgical Device Failures in Functional Endoscopic Sinus Surgery: A MAUDE Analysis.

Image-guided surgery (IGS) devices have become widely used for anatomic localization during functional endoscopic sinus surgery (FESS). However, there are no studies that analyze the post-market complications associated with IGS device use during FESS. The objective of this study was to better characterize post-market complications associated with the use of IGS devices during sinus surgery. The US Food and Drug Administration's Manufacturer and User Facility Device Experience database was queried for event reports associated with neurological stereotaxic devices utilized in IGS between the dates of January 1, 2016 and December 31, 2020. Medical device reports that were analyzed for this study pertained strictly to FESS. There were 1873 reports involving IGS devices for FESS included in this study. Fifty-five reports involved adverse events to patients (2.9%) and 1818 (97.1%) involved device malfunctions. Of the adverse events to patients, the most common included cerebrospinal fluid leakage (45.6%), tissue damage (12.7%), and nervous system injury (3.6%). The most commonly reported device malfunction was imprecision (21.1%). IGS devices are widely utilized in FESS. Of the medical device reports between 2016 and 2020, less than 3% resulted in adverse events. Further studies of the infrequent post-market complications of IGS devices used in FESS can help guide surgeons on the risks of their clinical use. 4-Retrospective database survey without controls Laryngoscope, 133:1310-1314, 2023.