BEUDAMED
    FDA Adverse Event Injury Summary report: N

    33MM HEMORRHOID STAPLER 3.5MM STAPLES

    MDR report key: 1872023 · Received October 8, 2010

    Report

    Report Number
    1219930-2010-00790
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    July 3, 2010
    Report Date
    September 10, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K083078
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    PROCEDURE: HEMORRHOIDECTOMY. ACCORDING TO THE REPORTER: THE STAPLER AT THE TIME OF CLOSING WOULD NOT CLOSE BESIDES THE ANVIL SIDE HOWEVER, THE GREEN INDICTOR APPEARED. THEREFORE, THE DEVICE DID NOT STAPLE. AN ANAL TISSUE NECROSIS OCCURRED. DURING THE PROCEDURE, THE HEMORRHOIDAL PACKAGE WAS CUT. OPERATIVE TIME WAS EXTENDED BY TWO HOURS. THE SURGEON USED THE FERGUSSON TECHNIQUE WHICH IS A MANUAL TECHNIQUE. THERE WAS NO ADDITIONAL BLOOD LOSS AND NOTHING FELL INTO THE PATIENT'S CAVITY. THE PATIENT IS NOW WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 33MM HEMORRHOID STAPLER 3.5MM STAPLES DISPOSABLE STAPLER GDW UNITED STATES SURGICAL NOA0047K

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| S