BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO CLIP III

    MDR report key: 3220972 · Received July 5, 2013

    Report

    Report Number
    3220972
    Event Type
    Malfunction
    Date Received
    July 5, 2013
    Date of Event
    June 23, 2013
    Report Date
    July 5, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN WAS USING THE CLIP APPLIER AND WAS ABLE TO PLACE THREE CLIPS WHEN IT STOPPED WORKING. ANOTHER CLIP APPLIER WAS OPENED TO COMPLETE PROCEDURE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LAPAROSCOPIC CHOLECYSTECTOMY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307419 ENDO CLIP III CLIP, IMPLANTABLE FZP COVIDIEN, FORMERLY US SURGICAL 176630 N3E0308MX

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR