MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. SEROSAFUSE® IMPLANTABLE FASTENER KIT; ENDOSCOPIC SUTURE/PLICATION SYSTEM

Catalog Number	R2275
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hernia (2240); Vascular Dissection (3160)
Date of Event	06/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A medwatch was received reporting an event with a merit esophyx device.It was reported that during a tif (transoral incisionless fundoplication) procedure (transoesophageal incision less fundoplication) for gerd and esophagitis.No hernia noted.The esophyx 2 (hd) device implanted.Symptoms worsened.Egd (esophagogastroduodenoscopy) showed a medium hiatal hernia with tif surgical wrap inside hernia.Surgery incarcerated type 2 para esophageal hernia with ge (gastroesophageal) junction and stomach in mediastinum.Extensive dissection.Tif scarred and left in."on (b)(6) 2023, i had a tif (transoral incisionless fundoplication) procedure (transesophageal incisionless fundoplication) for gerd and esophagitis.No hernia noted.Esophyx 2 (hd) device implanted.Symptoms worsened.Egd(esophagogastroduodenoscopy) (b)(6) 2026, medium hiatal hernia with tif surgical wrap inside hernia.Surgery (b)(6) 2026, incarcerated type 2 para esophageal hernia with ge (gastroesophageal) junction and stomach in mediastinum.Extensive dissection.Tif scarred and left in.".
Additional Manufacturer Narrative
The suspect device is not expected to be returned for evaluation.Follow up will be sent when the investigation is completed.

• Brand Name: SEROSAFUSE® IMPLANTABLE FASTENER KIT
• Common Device Name: ENDOSCOPIC SUTURE/PLICATION SYSTEM
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: lisa perz msn, rn, pmp ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 25611478
• Report Number: 1721504-2026-00243
• Device Sequence Number: 5405821
• Product Code: ODE
• UDI-Device Identifier: 00810275014011
• UDI-Public: 00810275014011
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2026

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: R2275
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2026
• Supplement Date Received by Manufacturer: 07/01/2026
• Initial Report FDA Received Date: 06/24/2026
• Supplement Report FDA Received Date: 07/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown