BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP

    MDR report key: 3844949 · Received May 20, 2014

    Report

    Report Number
    3844949
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    January 8, 2014
    Report Date
    May 20, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE SURGEON WAS USING THE LIGACLIP APPLIER DURING THE PROCEDURE AND STATED THAT THE CLIPS WERE NOT CLOSING. THEY WERE INSTEAD FALLING OUT OF THE DEVICE. THEY WERE ABLE TO ACCOUNT FOR ALL THE FAILED CLIPS AND THE DEVICE WAS REMOVED FROM THE STERILE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298833 LIGACLIP CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, INC. * J4CM12

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR NO OTHER THERAPIES