BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX

    MDR report key: 4173611 · Received September 2, 2014

    Report

    Report Number
    4173611
    Event Type
    Malfunction
    Date Received
    September 2, 2014
    Date of Event
    August 28, 2014
    Report Date
    September 2, 2014
    Manufacturer
    ETHICON ENDO-SURGERY
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    LAPAROSCOPIC CLIP APPLIER MALFUNCTIONED, CAUSING SLIGHT DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532501 LIGAMAX CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY EL5ML L4F015

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR