MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC ESOPHYX; ENDOSCOPIC SUTURE/PLICATION SYSTEM, GASTROESOPHAGEAL REFLUX DISEASE (GERD)

Catalog Number	R2007
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Esophagus (2399)
Date of Event	05/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is not expected to be returned for evaluation.A follow up report will be submitted once the product history review and investigation are complete.
Event or Problem Description
A literature search for the esophyx device family was performed and a study, "transoral incisionless fundoplication in the united kingdom: initial outcomes and learning curve experience" by norton et al.(2025), reported one event in which a patient developed an esophageal perforation with peri-esophageal fluid collection following use of the esophyx device.The event required hospital admission and treatment with intravenous antibiotics.

• Brand Name: ESOPHYX
• Common Device Name: ENDOSCOPIC SUTURE/PLICATION SYSTEM, GASTROESOPHAGEAL REFLUX DISEASE (GERD)
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: adrian cole ; south jordan, UT 84095
• MDR Report Key: 25374833
• Report Number: 1721504-2026-00084
• Device Sequence Number: 13092448
• Product Code: ODE
• UDI-Device Identifier: 00810275011089
• UDI-Public: 00810275011089
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K240879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: R2007
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown