ArticleSurgical endoscopy2026
Adverse events and device failures of the transoral incisionless fundoplication system: a MAUDE database analysis.
Article in Surgical endoscopy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTransoral 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.
methodsWe 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.
resultsAfter 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%).
conclusionsMAUDE 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.
Indexed as
Identifiers
42595909What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.