BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX

    MDR report key: 4091742 · Received July 25, 2014

    Report

    Report Number
    4091742
    Event Type
    Malfunction
    Date Received
    July 25, 2014
    Date of Event
    July 21, 2014
    Report Date
    July 25, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, INC
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING LAPAROSCOPIC CHOLECYSTECTOMY, THE 5MM ENDOSCOPIC CLIP APPLIER FAILED DURING USE. THE CLIPS DID NOT LINE-UP WHEN DEPLOYED AND WITH THE LAST FEW CLIPS, IT WAS OUT OF ALIGNMENT AND WOULD NOT CLOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437102 LIGAMAX CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, INC 5MM L4EU5H

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR