BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE PERMANENT FIXATION SYSTEM

    MDR report key: 18649343 · Received February 6, 2024

    Report

    Report Number
    18649343
    Event Type
    Malfunction
    Date Received
    February 6, 2024
    Date of Event
    November 29, 2023
    Report Date
    December 1, 2023
    Manufacturer
    DAVOL INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    SURGEON WAS USING A PERMANENT FIXATION DEVICE (CAPSURE, REF: 0113215, LOT: HUHS2181, EXPIRATION DATE: 04/28/2025) TO FIX A MESH LAPAROSCOPICALLY. WHEN THE SURGEON FIRED THE DEVICE, THE END OF THE DEVICE WOULD STICK TO THE MUSH AND REQUIRE HIM TO USE AN INSTRUMENT TO HOLD THE MESH IN PLACE WHILE HE PULLED THE INSTRUMENT AWAY FROM THE MESH. THE PERMANENT FASTENER WOULD ALSO FAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542764 CAPSURE PERMANENT FIXATION SYSTEM STAPLE, IMPLANTABLE GDW DAVOL INC. 0113215 HUHS2181

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Unknown