BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGIA ULTRA UNIVERSAL SHORT STAPLER

    MDR report key: 2032575 · Received March 22, 2011

    Report

    Report Number
    1219930-2011-00224
    Event Type
    Injury
    Date Received
    March 22, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 16, 2011
    Manufacturer
    UNITED STATES SURGICAL A
    Product Code
    GDW
    PMA / PMN Number
    K083519
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LOBECTOMY. ACCORDING TO THE REPORTER: THE FIRST STAPLER HANDLE POPPED OPEN REPEATEDLY WHEN CLOSED DOWN UPON TISSUE. A NEW STAPLER HANDLE WAS BROUGHT INTO THE FIELD, AND STAPLER FIRED CORRECTLY AND WITHOUT INCIDENT ON THE FIRST FIRING. ON THE SUBSEQUENT FIRING OF THIS SECOND HANDLE, BETWEEN 30-35MM OF A 45MM STAPLE LOAD FIRED AND THEN THE STAPLER MADE A LOUD POPPING NOISE. AFTER THAT, THE KNIFE BLADE WOULD NOT ADVANCE AND THE STAPLER WAS IMPOSSIBLE TO UNLOAD. THERE WAS BLEEDING REPORTED IN EXCESS OF 2,250CC. THE CASE WAS EXTENDED BY MORE THAN 30 MINUTES. ANOTHER STAPLER WAS APPLIED TO THE TISSUE TO CONTROL THE BLEEDING. THE PT IS CURRENTLY STABLE AND UNHARMED FROM INCIDENT. THE BLOOD LOSS WAS FROM THE PARTIAL FIRING OF THE STAPLER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EGIA ULTRA UNIVERSAL SHORT STAPLER DISPOSABLE STAPLER GDW UNITED STATES SURGICAL A

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention EGIA 60 ARTICULATING MED/THICK SULU, EGIA60AMT