BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON ENDO SURGERY LLC

    MDR report key: 2415052 · Received January 9, 2012

    Report

    Report Number
    MW5023797
    Event Type
    Malfunction
    Date Received
    January 9, 2012
    Date of Event
    November 16, 2011
    Report Date
    January 9, 2012
    Manufacturer
    ETHICON ENDOSURGERY LLC
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE LIAGMAX 5MM ENDOSCOPIC CLIP APPLIER WAS USED DURING A LAP CHOLE. WHEN THE CLIP APPLIER WAS CLOSED OVER AN ARTERY IT WOULD NOT OPEN AND HAD TO BE CUT OFF THE ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDO SURGERY LLC LIGAMAX 5 ENDOSCOPIC MULTIPLE CLIP APPLIER FZP ETHICON ENDOSURGERY LLC EL5ML H4340L

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR