BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX

    MDR report key: 3167229 · Received June 3, 2013

    Report

    Report Number
    3167229
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 30, 2013
    Report Date
    June 3, 2013
    Manufacturer
    ETHICON ENDO-SUGERY, LLC
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE CLIP CAME OUT WHEN THE SURGEON SQUEEZED THE HANDLE, BUT WOULD NOT CLIP ON TO THE TISSUE. SURGEON USED ANOTHER CLIP APPLIER WITHOUT INCIDENT. NO PATIENT HARM.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LAPAROSCOPIC CHOLECYSTECTOMY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244792 LIGAMAX STAPLE, IMPLANTABLE FZP ETHICON ENDO-SUGERY, LLC * K4CP47

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR