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

Catalog Number	R2275
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient who underwent robotic hiatal hernia repair using the merit serosafuse®, olympus h190 adult upper endoscope and tower, and davinci insufflator showed evidence of a leak at the gastroesophageal junction (gej) on barium with contrast study, one week after the procedure.No additional information is available.
Additional Manufacturer Narrative
The suspect device will not be returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.Nonconformance's of this nature are monitored by the operation team.This complaint will be used to trend for similar complaints.

• Brand Name: SEROSAFUSE®
• 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 ; 1600 merit parkway; south jordan, UT 84095 ; 8012084225
• MDR Report Key: 25233220
• Report Number: 1721504-2026-00233
• Device Sequence Number: 5238973
• Product Code: ODE
• UDI-Device Identifier: 00810275014011
• UDI-Public: 00810275014011
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/20/2026

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 05/20/2026
• 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: Other
• Patient Sex: Unknown