BEUDAMED
    FDA Adverse Event Injury Summary report: N

    33MM HEMORRHOID STAPLER 3.5MM STAPLES

    MDR report key: 1920519 · Received December 6, 2010

    Report

    Report Number
    1219930-2010-00922
    Event Type
    Injury
    Date Received
    December 6, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 9, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K0831781
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: HEMORRHOID. ACCORDING TO THE REPORTER: THE STAPLER FIRED AND CUT BUT THE STAPLES DEPLOYED NOT FORMED PROPERLY. THE SURGEON HAD TO HAND SEW A CIRCLE TO CLOSE THE AREA OF TISSUE THAT WAS CUT. A SECOND STAPLER WAS FIRED TO RESECT THE TISSUE THAT WAS NOT CAPTURED WHILE USING THE ORIGINAL STAPLER. THE SECOND HOLE ON THE CENTER ROD WAS USED. NO SIGNIFICANT BLEEDING REPORTED. NO DELAY IN OPERATING ROOM TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 33MM HEMORRHOID STAPLER 3.5MM STAPLES DISPOSABLE STAPLER GDW UNITED STATES SURGICAL N0E0611UK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Disability