BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP

    MDR report key: 4861680 · Received June 5, 2015

    Report

    Report Number
    4861680
    Event Type
    Malfunction
    Date Received
    June 5, 2015
    Date of Event
    April 30, 2015
    Report Date
    June 5, 2015
    Manufacturer
    ETHICON ENDO-SURGERY, INC
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    DEVICE WOULD NOT GRIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366375 LIGACLIP STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, INC * M4H334

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR