BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX 5

    MDR report key: 3893436 · Received June 23, 2014

    Report

    Report Number
    3893436
    Event Type
    Malfunction
    Date Received
    June 23, 2014
    Date of Event
    May 7, 2014
    Report Date
    June 23, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CLIP MISFIRED DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366831 LIGAMAX 5 CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, INC. * K4DA93

    Patients

    Seq Age Sex Outcome Treatment
    1 *