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

Catalog Number	R2007
Medical Device Problem Codes	Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Fever (1858); Pain (1994)
Date of Event	08/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is not expected to return 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.Should the device be returned at a later date, the investigation will be reopened.
Event or Problem Description
The account alleges that a patient underwent a concomitant hiatal hernia/endoscopic fundoplication [ctif] procedure on (b)(6) 2024.The patient presented back to the hospital 5 days post-procedure with abdominal pain and fever and was treated for an "abscess" the account states that the abscess was successfully drained.The patient was admitted for observation and was discharged with no additional patient consequences to report.The patient tolerated the procedure well.There was a concern from the surgeon who treated the abscess that a serosafuse fastener may have gotten "caught up" with the mesh used to repair the hiatal hernia causing the abscess.The actual device was discarded at the account and will not be returned for merit medical evaluation.

• Brand Name: SEROSAFUSE IMPLANTABLE FASTENER KIT.
• Common Device Name: ENDOSCOPIC SUTURE/PLICATION SYSTEM
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit pkwy; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit pkwy; south jordan UT 84095
• Manufacturer Contact: bryson heaton rn ; 1600 merit pkwy; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 20197229
• Report Number: 1721504-2024-00065
• Device Sequence Number: 15145932
• Product Code: ODE
• UDI-Device Identifier: 00810275014011
• UDI-Public: 00810275014011
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K172811
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/23/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: R2007
• 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: 08/23/2024
• Initial Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Sex: Unknown