Adverse events associated with full-thickness resection devices in gastrointestinal endoscopy: National postmarketing surveillance study

Abstract Endoscopic full-thickness resection (EFTR) using dedicated full-thickness resection devices (FTRDs) offers a minimally invasive option for complex gastrointestinal lesions involving the muscularis propria. Despite growing use, safety data remain limited, which constrains guidelines and uptake. We performed a retrospective analysis of FDA MAUDE reports from January 2014 to March 2025. Reports involving FTRDs were reviewed to classify device malfunctions and patient adverse events (AEs). Variables were analyzed using SPSS software. Sixty-eight FTRD cases were identified. Colonic FTRD was used in 79.4% and gastroduodenal and diagnostic sets in 10.3% each. Device issues (n = 69) included clip non-deployment (79.7%), snare malfunctions (10.1%), and clip detachment (5.8%); grasper malfunctions (2.9%), improper clip placement (1.5%), and thread rupture (1.5%) were also reported. Patient AEs (n = 77) were dominated by colonic perforations (69.5%). Delayed gastric and delayed colonic perforations occurred in three cases each (3.9%). Other events included duodenal perforation (2.6%), hemorrhage (2.6%), and esophageal perforation with mediastinitis (2.6%). Four deaths (5.2%) occurred, two from unrecognized esophageal perforation with mediastinitis and sepsis and two after surgery in patients with significant comorbidities. Surgery was required in 78.7%. Endoscopic clipping alone succeeded in 3.3%. Endoscopic or over the scope clipping followed by surgery was used in 16.4%. EFTR with FTRD is associated with device malfunctions and patient complications, with colonic perforation being the most frequently reported complication. Careful patient selection and procedural expertise are critical to reduce risk.