BEUDAMED
    FDA Adverse Event Injury Summary report: N

    33MM HEMORRHOID STAPLER 4.8MM STAPLES

    MDR report key: 1910205 · Received November 22, 2010

    Report

    Report Number
    1219930-2010-00887
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    September 18, 2010
    Report Date
    October 25, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K0830781
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE STAPLER WAS CLOSED TILL THE GREEN INDICATOR WAS WELL VISIBLE, THE CLICK WAS FELT AND THEN THE INSTRUMENT WAS FIRED. HOWEVER, THE INSTRUMENT DID NOT CUT THE TISSUE AND THE BLADE WAS NOT DEPLOYED. ON RE-EXAMINING, THE ANVIL WAS IN POSITION AND THE PURESTRING WAS TIGHT. THE PROCEDURE WAS CONVERTED TO A CONVENTIONAL PROCEDURE, AND OPERATIVE TIME WAS EXTENDED BY MORE THAN THIRTY MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 33MM HEMORRHOID STAPLER 4.8MM STAPLES DISPOSABLE SURGICAL STAPLER GDW UNITED STATES SURGICAL N0E0411UK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R