BEUDAMED
    FDA Adverse Event Death Summary report: N

    KII OPTICAL ACCESS SYSTEM 12X100MM

    MDR report key: 1617779 · Received February 18, 2010

    Report

    Report Number
    1617779
    Event Type
    Death
    Date Received
    February 18, 2010
    Date of Event
    November 30, 2009
    Report Date
    January 28, 2010
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FAILED LAPAROSCOPIC ENTRY WITH RECOGNITION OF IMMEDIATE AND VOLUMINOUS BLEEDING. FASCIA WAS GRASPED AND AN ALLIED MEDICAL 10-12 TROCAR WAS THEN PASSED THROUGH THE ABDOMINAL WALL. AT THIS POINT, VOLUMINOUS BLEEDING WAS NOTED AND THE PT'S ABDOMEN WAS OPENED AND IT WAS FOUND THAT THE TROCAR HAD TRANSECTED THE DESCENDING AORTA AND POSSIBLY THE VENA CAVA AS WELL. UNABLE TO CONTROL BLEEDING AND THE PT EXSANGUINATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KII OPTICAL ACCESS SYSTEM 12X100MM TROCAR 12X100MM GCJ APPLIED MEDICAL RED COR 29

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death