S2276 Adverse Events Associated With Full-Thickness Resection Devices in Gastrointestinal Endoscopy: Analysis of the FDA MAUDE Database

Introduction: Endoscopic full-thickness resection (EFTR) using full-thickness resection devices (FTRDs) offers a minimally invasive approach for complex gastrointestinal (GI) lesions, especially those involving deeper layers like the muscularis propria. Despite growing adoption, limited comprehensive safety data restrict the development of procedural guidelines and broader clinical acceptance. Understanding the safety profile and efficacy of EFTR is crucial for optimizing patient outcomes and establishing best practices. Methods: We conducted a retrospective analysis using the FDA Manufacturer and User Facility Device Experience (MAUDE) database from January 2014 to December 2025. Reports involving the FTRD were reviewed to classify device malfunctions and patient-related adverse events. Statistical analysis utilized SPSS, and results were reported as frequencies. Results: Sixty-eight FTRD cases were reviewed, with colonic FTRD used in 79.4% of cases, and gastroduodenal and diagnostic sets each at 10.3%. Among device-related issues (n = 69), clip non-deployment was most prevalent (79.7%). Snare malfunctions (breakage, slippage, resection failure) accounted for 10.1%, and clip detachment occurred in 5.8%. Grasper malfunction (2.9%), improper clip placement, and thread rupture (each 1.5%) were less frequent. Patient adverse events (n = 77) were mainly colonic perforations (69.5%), with delayed gastric and colonic perforations each at 3.9%. Duodenal perforations, hemorrhage, and esophageal perforations with mediastinitis occurred in 2.6% each. Four fatalities (5.2%) occurred, 2 from unrecognized esophageal perforation causing mediastinitis and sepsis, and 2 post-surgery in patients with significant comorbidities. Surgical intervention was required in 78.7% of complications, with endoscopic clipping alone successful in 3.3% and combined endoscopic/OTSC clipping with surgery in 16.4%. Conclusion: Device maldeployment and perforation are among the 2 most significant adverse events associated with the use of the FTRD. Although these complications are relatively rare, they can lead to serious clinical consequences. To minimize these risks, comprehensive initial training is essential, along with periodic refresher training—particularly in low-volume centers. Additionally, careful patient selection and ongoing improvements in device engineering are crucial to further enhance the safety and efficacy of this valuable therapeutic tool.