BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIGACLIP/MULTICLIP APPLIER

    MDR report key: 546042 · Received September 25, 2004

    Report

    Report Number
    546042
    Event Type
    Death
    Date Received
    September 25, 2004
    Date of Event
    June 18, 2004
    Report Date
    September 23, 2004
    Manufacturer
    ETHICON
    Product Code
    GDO
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AT 4AM PT WAS FOUND EXPIRED. THIS WAS 34 HOURS POST OPERATION: LEFT FEMORAL TO ANTERIOR TIBIAL ARTERY BYPASS WITH REVERSED GREATER SAPHENOUS VEIN. MEDICAL EXAMINER'S FINAL AUTOPSY REPORT IN 2004: "A 0.8 CM DEFECT IS IDENTIFIED IN THE SUPERFICIAL FEMORAL VEIN WITH HEMORRHAGE IN THE ADVENTITIA OF THE FEMORAL VEIN IN AN AREA THAT CORRESPONDS TO THE ORIGIN OF THE SAPHENOUS VEIN. NO LIGATURE OR CLIP IS IDENTIFIED ON THIS AREA OF THE PRESUMED SAPHENOUS VEIN ORIGIN ON THE FEMORAL VEIN." OPERATIVE REPORT BY SURGEON DOCUMENTS USE OF LIGATURE CLIP. PT EXPIRED; NO INDICATION OF A DEVICE PROBLEM AT THAT TIME. PT WAS SENT TO THE MEDICAL EXAMINER'S OFFICE, WHO CONDUCTED AN AUTOPSY. MEDICAL EXAMINER'S AUTOPSY REPORTS ARE NOT ROUTINELY SENT TO THE HOSPITAL. WHEN CHART WAS BEING PREPARED FOR LEGAL AND PEER REVIEW, FACILITY REQUESTED A COPY OF THE AUTOPSY FROM THE MEDICAL EXAMINER'S OFFICE. ONCE FACILITY RECEIVED THE AUTOPSY REPORT, FACILITY IDENTIFIED THE NOTATION THAT NO "LIGATURE OR CLIP" COULD BE FOUND. THE PREPARATION OF THE 3500A WAS COMPLETED IN RESPONSE TO THIS INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP/MULTICLIP APPLIER LIGATION CLIP APPLIER - DISPOSABLE GDO ETHICON * *

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death