BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP

    MDR report key: 2842776 · Received October 5, 2012

    Report

    Report Number
    2842776
    Event Type
    Malfunction
    Date Received
    October 5, 2012
    Date of Event
    August 24, 2012
    Report Date
    October 5, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE CLIP APPLIER WOULD NOT CLAMP THE CLIP. A SECOND APPLIER WAS USED AND ALSO FAILED. A THIRD CLIP APPLIER WAS SUCCESSFULLY USED.THE PATIENT WAS DISCHARGED HOME. THERE WAS NO ADDITIONAL PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, INC. MCL20 1444XOD

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR