BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 3964853 · Received July 16, 2014

    Report

    Report Number
    1219930-2014-00538
    Event Type
    Injury
    Date Received
    July 16, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 23, 2014
    Manufacturer
    COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES
    Product Code
    GDW
    PMA / PMN Number
    K900129
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: SLEEVE GASTRECTOMY. ACCORDING TO THE REPORTER: THE KNIFE BAR STARTED BENDING OUT DURING THE ATTEMPT TO FIRE. THEY OPENED ANOTHER BLACK RELOAD AND MANUAL HANDLE AND FIRED ON THE INSIDE OF THE STAPLE LINE AND REMOVED THE ENTIRE STAPLE LINE FROM THE FIRST HANDLE. HE FINISHED THE CASE WITHOUT INCIDENT WITH THE SECOND HANDLE. REINFORCEMENT WAS USED ON THE FIRST HANDLE. THERE WAS UNANTICIPATED TISSUE LOSS. THERE WAS NO UNANTICIPATED TISSUE DAMAGE. THERE WAS NO UNANTICIPATED EXTENSION FOR THE INCISION MORE THAN ONE INCH. THERE WAS NO BLOOD LOSS OF MORE THAN 500CC. THERE WAS NO DELAY OVER 30 MINUTES. NO DEVICE FRAGMENT FELL IN THE PATIENT CAVITY. NO DEVICE FRAGMENT WAS LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415927 ENDO GIA UNIVERSAL 12MM SINGLE USE INST DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES

    Patients

    Seq Age Sex Outcome Treatment
    1 Other EGIA60AXT, EGIA 60 ARTICULATING XTRA THICK SULU,| (B)(4).