MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC SerosaFuse®; Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)

Catalog Number	R2275/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/11/2026
Type of Reportable Event	Serious Injury

• 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: lisa perz msn, rn, pmp ; 1600 merit parkway; south jordan, UT 84095 ; +1(801)208-4225
• MDR Report Key: 50698698
• Report Number: 1721504-2026-00431
• Device Sequence Number: 17615241
• Product Code: ODE
• UDI-Device Identifier: 00884450848135
• UDI-Public: 00884450848135
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K240879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2026

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/A
• Device Lot Number: H3510727
• 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: 08/11/2026
• Supplement Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 09/09/2026
• Supplement Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/03/2026
• 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; Other
• Patient Sex: Unknown