BEUDAMED
    FDA Adverse Event Injury Summary report: N

    33MM HEMORRHOID STAPLER 3.5MM STAPLES

    MDR report key: 1802562 · Received August 10, 2010

    Report

    Report Number
    1219930-2010-00619
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    July 27, 2010
    Report Date
    July 28, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K0830781
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: HEMORRHOID. ACCORDING TO THE REPORTER: THE PRESSURE PLATE WAS PLACED AND ADAPTED IN THE TISSUE. UPON OPENING OF THE PRESSURE PLATE ON THE INSTRUMENT, THE PRESSURE PLATE PULLED FROM THE INSTRUMENT BY BOTH PRODUCTS. BOTH INSTRUMENTS COULD NOT BE CLOSED. THE SURGERY WAS CHANGED TO MILLIGAN MORGEN OPEN PROCEDURE. THERE WAS NO PT INJURED, OPERATIVE TIME WAS EXTENDED BY MORE THAN 30 MINUTES, NO ADD'L BLOOD LOSS, AND NO LOSS AND/OR DAMAGE OF TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 33MM HEMORRHOID STAPLER 3.5MM STAPLES DISPOSABLE SURGICAL STAPLER GDW UNITED STATES SURGICAL N0A0371UK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other