BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO CLIP

    MDR report key: 2161236 · Received July 6, 2011

    Report

    Report Number
    2161236
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    May 2, 2011
    Report Date
    July 6, 2011
    Manufacturer
    COVIDIEN
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC CHOLECYSTECTOMY THE 5MMM ENDO CLIP APPLIER, LOT NUMBER N1B0280, CATALOG # 176620, MALFUNCTIONED AND THE CLIPS WOULD NOT DEPLOY. A SECOND CLIP APPLIER WAS OPENED AND USED WITHOUT INCIDENT. NO HARM TO THE PATIENT. WILL SEND BACK UPON REQUEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO CLIP CLIP APPLIER FZP COVIDIEN * N1B0280

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR