Analysis of Reported Adverse Events Associated with Over-the-Scope Endoscopic Suturing System: an FDA MAUDE Database Study.

Abstract

The over-the-scope endoscopic suturing system (ESS) (OverStitch™) is one of the most widely utilized endoscopic suturing systems in current clinical practice; however, data on the adverse events associated with this device is scarce. Our study aims to evaluate the adverse events and complications associated with the over-the-scope ESS using the FDA's Manufacturer and User Facility Device Experience (MAUDE) database. We analyzed the post-marketing surveillance data from the FDA MAUDE database for the over-the-scope ESS from January 2008 through June 2022. Eighty-three reports were filed from January 2008 to June 2022. Adverse events were classified as device-related complications and patient-related adverse events. Seventy-seven device-related issues and 87 patient adverse events were identified. The most common device-related issue was difficulty to remove after deployment (n=12, 15.58%) followed by mechanical problem (n=10, 12.99%), mechanical jam (n=9, 11.69%), or entrapment of device (n=9, 11.69%). Of the 87 patient-related adverse events, the most common was perforation (n=19; 21.84%), followed by device embedded in tissue or plaque (n=10; 11.49%), and abdominal pain (n=8; 9.20%). Of the 19 patients who experienced perforation, two required open surgical repair and one required laparoscopic surgical repair. The overall adverse events from the over-the-scope ESS remain acceptable as evidenced by the number of reported cases since 2008. However, it is important to note that adverse event rates might increase as the use of the device increases; therefore, it is essential for endoscopists to be aware of the potential common and rare adverse events associated with the use of the over-the-scope ESS device.