BEUDAMED
    FDA Adverse Event Death Summary report: N

    ETHICON ENDO SURGERY

    MDR report key: 383724 · Received March 19, 2002

    Report

    Report Number
    383724
    Event Type
    Death
    Date Received
    March 19, 2002
    Date of Event
    February 28, 2002
    Report Date
    March 17, 2002
    Manufacturer
    ETHICON ENDO SURGERY
    Product Code
    GDO
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AT 0730, THE PT UNDERWENT AN L5,S1 ANTERIOR RETROPERITONEAL FUSION, L4-5/ANTERIOR LUMBAR FUSION/POSTERIOR BILATERAL MICRODECOMPRESSION L5, S1 PEDICLE INSTRUMENTATION AND FUSION LUMBAR MICRODECOMPRESSION. DURING MOBILIZATION OF THE LT. COMMON ILIAC VEIN (LCIV) 6-8 TRIBUTARIES WERE TAKEN BETWEEN THE CLIPS. THE CLIPS ON THE ILIAC VEIN STARTED TO FALL OFF ONCE THE VEIN WAS MOBILIZED CAUSING MASSIVE HEMORRHAGE. THE PT WAS RAPIDLY TRANSFUSED; HOWEVER, RESUSCITATIVE EFFORTS WERE UNSUCCESSFUL AND THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDO SURGERY LIGACLIP MULTIPLE CLIP APPLIER 20.2CM GDO ETHICON ENDO SURGERY A92367POO CE0123

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death