BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON (JOHNSON & JOHNSON)

    MDR report key: 1963734 · Received January 5, 2011

    Report

    Report Number
    MW5018999
    Event Type
    Malfunction
    Date Received
    January 5, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 3, 2011
    Manufacturer
    ETHICON ENDO-SURGERY
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ETHICON LIGAMAX 5MM CLIP APPLIER FAILED DURING LAPAROSCOPIC GALLBLADDER CASE. DEVICE JAMMED AFTER A SNAPPING NOISE WAS HEARD. CLIP WAS REMOVED BY SURGEON, FROM PT. ANOTHER CLIP APPLIER WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON (JOHNSON & JOHNSON) LIGAMAX 5 GDO ETHICON ENDO-SURGERY EL5ML G4UF6M

    Patients

    Seq Age Sex Outcome Treatment
    1