Background: EFTR using dedicated 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. Methods: We performed a retrospective analysis of FDA MAUDE reports from January 2014 to March 2025. Reports involving the FTRD were reviewed to classify device malfunctions and patient adverse events. Variables were analyzed using the SPSS Software. Results: Sixty eight FTRD cases were identified. The colonic FTRD was used in 79.4 percent, and gastroduodenal and diagnostic sets in 10.3 percent each. Device issues (n=69) included clip non deployment 79.7 percent, snare malfunctions 10.1 percent, and clip detachment 5.8 percent; grasper malfunctions 2.9 percent, improper clip placement 1.5 percent, and thread rupture 1.5 percent were also reported. Patient adverse events (n=77) were dominated by colonic perforations 69.5 percent. Delayed gastric and delayed colonic perforations occurred in three cases each 3.9 percent. Other events included duodenal perforation 2.6 percent, hemorrhage 2.6 percent, and esophageal perforation with mediastinitis 2.6 percent. Four deaths 5.2 percent 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 percent. Endoscopic clipping alone succeeded in 3.3 percent. Endoscopic or over the scope clipping followed by surgery was used in 16.4 percent. Conclusion: 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.
Shahzil et al. (Tue,) studied this question.