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

Catalog Number	R2275
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Internal Organ Perforation (1987)
Date of Event	12/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.
Event or Problem Description
Customer alleged a transoral incisionless fundoplication (ctif) and hiatal hernia repair was completed on (b)(6) 2025 without incident and the patient went home the next morning.The patient re-entered the hospital in the icu on (b)(6) 2026 as she was becoming septic.On (b)(6) 2026 the patient had epigastric pain and an elevated white cell count.On the evening of (b)(6) 2026, a cta of the patients' chest confirmed bilateral plural effusions, identifying a "leak/perforation".A right chest tube was then placed and an esophagogastroduodenoscopy (egd) was performed confirming a proximal perforation to the gastroesophageal junction.A covered stent was placed to seal the injury and stabilize the patient.The perforation itself was in the area of the serosafuse fasteners, placed by the esophyx device.

• Brand Name: SEROSAFUSE®
• 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: adrian cole ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 24066480
• Report Number: 1721504-2026-00818
• Device Sequence Number: 13099097
• Product Code: ODE
• UDI-Device Identifier: 00810275014011
• UDI-Public: 00810275014011
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/14/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown