BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SerosaFuse® Implantable Fastener Kit

    MDR report key: 16350772 · Received February 10, 2023

    Report

    Report Number
    16350772
    Event Type
    Malfunction
    Date Received
    February 10, 2023
    Date of Event
    December 28, 2022
    Report Date
    January 31, 2023
    Manufacturer
    ENDOGASTRIC SOLUTIONS, INC.
    Product Code
    ODE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DISRUPTION OF FLEXIBLE PLASTIC HOUSING OF TIF ANCHOR SYSTEM, NOTED AT TIME OF REMOVAL DURING EGD WHILE PATIENT WAS UNDER GENERAL ANESTHESIA. SURGEON CALLED REP, REP UNABLE TO HELP D/T NEVER HAVING EXPERIENCED SIMILAR SITUATION. SURGEON TROUBLESHOT AND WAS ABLE TO REMOVE THE ANCHOR SYSTEM SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1066194 SerosaFuse® Implantable Fastener Kit ENDOSCOPIC SUTURE/PLICATION SYSTEM, GASTROESOPHAGEAL REFLUX DISEASE (GERD) ODE ENDOGASTRIC SOLUTIONS, INC. R2275 403452

    Patients

    Seq Age Sex Outcome Treatment
    1 13870 DA Male