BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON

    MDR report key: 1212030 · Received October 24, 2008

    Report

    Report Number
    MW5008770
    Event Type
    Malfunction
    Date Received
    October 24, 2008
    Date of Event
    October 20, 2008
    Report Date
    October 24, 2008
    Manufacturer
    ETHICON ENDO-SURGERY INC
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WITH ETHICON LIGAMAX 5MM ENDO CLIP APPLIER CAT # 36685 EL5ML, AFTER ALL CLIPS WERE DISPENSED, THE SURGEON, UNAWARE THAT ALL CLIPS WERE UTILIZED, CLOSED THE CLIP APPLIER OVER A STRUCTURE AND THE APPLIER STUCK CLOSED. AFTER SOME MANIPULATION, THE CLIP APPLIER WAS RELEASED WITHOUT CAUSING ADVERSE AFFECT ON THE PT. DIAGNOSIS OR REASON FOR USE: LAPAROSCOPIC CHOLECYSTECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON LIGAMAX 5MM ENDO CLIP APPLIER GDO ETHICON ENDO-SURGERY INC EL5ML E9FG53

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR