BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON LIGAMAX 5MM

    MDR report key: 1212048 · Received October 24, 2008

    Report

    Report Number
    MW5008779
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    October 20, 2008
    Report Date
    October 24, 2008
    Manufacturer
    ETHICON ENDO-SURGERY
    Product Code
    GDO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ETHICON LIGAMAX 5MM ENDO CLIP APPLIER UTILIZED DURING LAPAROSCOPIC CHOLECYSTECTOMY. DEVICE WAS OUT OF CLIPS AND ON THE CLOSURE OF THE APPLIER AFTER THE LAST CLIP, THE DEVICE REMAINED CLAMPED TO AN ARTERY. THE PHYSICIAN WAS NOT ABLE TO MANIPULATE ITS RELEASE. THE ARTERY WAS DAMAGED AND THE CASE PROCEEDED TO AN OPEN ABDOMEN CASE FOR REPAIR. PT WAS ADMITTED TO THE HOSPITAL. DIAGNOSIS OR REASONS FOR USE: LAPAROSCOPIC CHOLECYSTECTOMY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization