Adverse events and device failures of the transoral incisionless fundoplication system: a MAUDE database analysis.

BACKGROUND: Transoral incisionless fundoplication (TIF) using the EsophyX device, with or without concomitant laparoscopic hiatal hernia repair (cTIF), is increasingly used for GERD. Postmarketing safety data are limited. We analyzed the FDA MAUDE database to characterize adverse events and device failures. METHODS: We extracted MDRs for the EsophyX device family and SerosaFuse fastener kit submitted through March 2026. Duplicates were removed by MDR identifier and narrative matching. Reports were classified for patient adverse events and device failures; severity was graded using a modified Cotton lexicon. RESULTS: After deduplication, 192 unique MDRs were analyzed (130 Injury, 60 Malfunction, 2 Death). Annual reports rose from 8.8/year in 2016-2019 to 26, 40, and 33 in 2023-2025. Adverse events occurred in 138 reports (71.9%) and device failures in 88 (45.8%). Most frequent events were perforation (58.0%), esophageal/mucosal injury (27.5%), pulmonary/pleural complications (21.0%), pain (21.0%), infection/sepsis (20.3%), and bleeding (19.6%). Five procedure-related deaths (3.6% of patient-event reports) were identified, of which only two were filed by FDA under the Death classification. By Cotton severity, 49.3% were severe and 3.6% fatal. Surgical intervention occurred in 34.4%, hospitalization in 29.2%, endoscopic rescue in 16.7%. Perforation was reported in cTIF in 56.6% and 30.3% TIF alone. Dominant failures were insertion/advancement/removal difficulty (30.7%), component detachment (23.9%), breakage (23.9%), and mechanical jam (22.7%). CONCLUSIONS: MAUDE reports have risen sharply since 2020, dominated by severe patient harm, particularly perforation, pulmonary complications, bleeding, and mechanical failures. Despite MAUDE's limitations, the predominance of severe events warrants procedural standardization, credentialing pathways, and prospective safety registries as TIF/cTIF use expands.