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	Unspecified Tissue Injury (4559)
Date of Event	10/01/2025
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.Nonconformances of this nature are monitored by the operation team.This complaint will be used to trend for similar complaints.
Event or Problem Description
The account alleges that during a concomitant transoral incisionless fundoplication (ctif) procedure, the physician elected to abort the procedure prior to completion.After placement of twelve fasteners to secure the anterior and posterior corners of the fundoplication wrap, the physician noted a loss of insufflation.Upon inspection away from the esophagogastric (eg) junction and into the gastric wall area, the physician observed what appeared to be a tear in the stomach wall.The physician subsequently applied nine endoscopic clips to close the suspected tear after the merit medical device was removed from the patient.No additional fasteners were deployed, and the case was concluded at that point.

• 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 (Section G): 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: 23405385
• Report Number: 1721504-2025-00572
• Device Sequence Number: 17372537
• Product Code: ODE
• UDI-Device Identifier: 00810275014011
• UDI-Public: 00810275014011
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/28/2025

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: 10/01/2025
• Initial Report FDA Received Date: 10/28/2025
• 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
• Patient Sex: Unknown