BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGIA ULTRA UNIVERSAL SHORT STAPLER

    MDR report key: 2210072 · Received August 3, 2011

    Report

    Report Number
    1219930-2011-00652
    Event Type
    Injury
    Date Received
    August 3, 2011
    Date of Event
    May 5, 2011
    Report Date
    July 25, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: THORACOTOMY. ACCORDING TO THE REPORTER: FIRED ACROSS THE TISSUE DURING A THORACOTOMY CASE AND THE EGIA JAW WOULD NOT OPEN. TO REMOVE THE DEVICE, THE SURGEON RESECTED THE TISSUE. NORMALLY, DR LEE USES A 60 4.8 RELOAD WITH THE EGIA SHORT HANDLE. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 250CC. THE CASE WAS EXTENDED BY APPROX 60 MINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EGIA ULTRA UNIVERSAL SHORT STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GDW UNITED STATES SURGICAL N1A0643UK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other LOT# UNK, K083519| EGIA 60 ARTICULATING MED/THICK SULU, (B)(4)