BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMX 5

    MDR report key: 3940436 · Received July 7, 2014

    Report

    Report Number
    3940436
    Event Type
    Malfunction
    Date Received
    July 7, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 7, 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 USE, IT WAS NOTED THAT THE CLIPS WERE GETTING JAMMED AND NOT COMING OUT CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394693 LIGAMX 5 CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, INC * L4EN74

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR