BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK ENDO GIA SULU

    MDR report key: 1231601 · Received November 13, 2008

    Report

    Report Number
    1219930-2008-00810
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    November 3, 2008
    Report Date
    November 3, 2008
    Manufacturer
    NORTH HAVEN-USS
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT SENT TO FDA ON 11/13/2008.

    Description of Event or Problem · 1

    PROCEDURE: LAPAROSCOPIC LIVER RESECTION. ACCORDING TO THE REPORTER: THE STAPLER WAS PLACED ACROSS THE ANTERIOR BRANCH OF THE PORTAL VEIN, CLOSED AND FIRED. HALF WAY THROUGH THE FIRING, THE SURGEON COMPLETED FIRING/STAPLING AT THAT POINT, THE SURGEON COMPLETED FIRING/STAPLING AND FOUND IT EXTREMELY DIFFICULT TO PULL BACK THE BLACK KNOB. THE SURGEON SUCCEEDED AND FOUND THAT THE PORTAL VEIN WAS NOT STAPLED AND THAT THE STAPLES WERE NOT INTACT AND NOT FORMED CORRECTLY. THE SURGEON COULD NOT GET THE JAWS TO CLOSE AND REMOVE THE INSTRUMENT FROM THE PORT. BLEEDING OCCURRED BUT WAS BROUGHT UNDER CONTROL, THE LOSS OF BLOOD IS 5L. THE PROCEDURE WAS CONVERTED TO AN OPEN PROCEDURE AND COMPLETED. THE PT RECEIVED A BLOOD TRANSFUSION EQUAL TO 5 UNITS. THE PROCEDURE WAS EXTENDED BY MORE THAN 30 MINS. THE PT'S CONDITION IS CRITICAL BUT STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK ENDO GIA SULU NONE GDW NORTH HAVEN-USS

    Patients

    Seq Age Sex Outcome Treatment
    1