BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 1030058 · Received April 15, 2008

    Report

    Report Number
    1219930-2008-00295
    Event Type
    Injury
    Date Received
    April 15, 2008
    Date of Event
    March 19, 2008
    Report Date
    March 24, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT SENT TO FDA ON 04/15/2008.

    Description of Event or Problem · 1

    PROCEDURE: LAPAROSCOPY. ACCORDING TO THE REPORTER: THE SURGEON COULD NOT PULL THE BLACK RETURN KNOB BACK AND THE JAWS WOULD NOT RELEASE THE TISSUE. THE INSTRUMENT WAS RESECTED WITH BIPOLAR SHEARS AND THE INSTRUMENT WAS REMOVED WITH THE PORT. UNDER 200CC BLEEDING OCCURRED. PATIENT STATUS REPORTED AS UNDER OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA UNIVERSAL 12MM SINGLE USE INST SURGICAL STAPLING DEVICE GDW NORTH HAVEN - USS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention 030455