Analysis of Reported Adverse Events Related to Over-the-Scope Clips: A MAUDE Database Analysis

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<h2>Abstract</h2><h3>Background</h3> Over-the-scope clips (OTSC) have been increasingly used in the management of bleeding, perforations, fistulae, and anastomotic leaks in the gastrointestinal tract. However, since their Food and Drug Administration (FDA) approval in 2010, data on the adverse events of OTSC systems has been lacking. Our study aims to report and analyze adverse events and device failures associated with OTSC systems using the FDA's Manufacturer and User Facility Device Experience (MAUDE) database. <h3>Methods</h3> We analyzed the post-marketing surveillance data from the FDA MAUDE database of the two OTSC systems available in the United States from January 2013 through May 2022. <h3>Results</h3> Forty medical device reporting claims were found from January 2013 through May 2022. Adverse events were classified as device-related problems and patient-related adverse events. Forty device-related problems were reported, along with twenty device-related adverse events Most device-related problems were reported in the Padlock defect closure system (n=23), followed by the Padlock pro clip system (n=8) and Ovesco ® OTSC clip system (n=9). The most common device-related problem was related to the failure of deployment of OTSC (n=13), followed by material protrusion or extrusion (n=7). The most common patient adverse events were perforation (n=4), esophageal laceration (n=4), bleeding (n=3), and luminal stenosis (n=3). All four patients required surgical management of the perforation. No deaths related to the use of OTSC were reported. <h3>Conclusion</h3> Failure of OTSC deployment and perforation were the most common device-related problem and patient-related adverse events, respectively. As the use of OTSC systems continue to increase, it is important for endoscopists to be mindful of the common as well as rare adverse events associated with OTSC use.