BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGIA ULTRA UNIVERSAL STAPLER

    MDR report key: 3981456 · Received July 25, 2014

    Report

    Report Number
    2647580-2014-00584
    Event Type
    Injury
    Date Received
    July 25, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 4, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K083519
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: WEDGE RESECTION. ACCORDING TO THE REPORTER: PROCEDURE: NEOVEIL TUBE TYPE WAS USED WITH SETTING ON THORACO/WEDGE/SEGMENTAL. WITH THE TISSUE GRASPED, THE GREEN BUTTON WAS PRESSED; HOWEVER, FOUND THE HANDLE COULD NOT BE MOVED TO FIRE. UPON TRYING TO SQUEEZE THE HANDLE STRONGLY, CRACKING SOUNDS WERE HEARD. OPENED ANOTHER DEVICE AND THE SAME SULU WAS SET ON IT TO TRY AGAIN. HOWEVER, CONFIRMED THE SAME FAILURE EVENT WAS DUPLICATED. USING ANOTHER DEVICE WITH ATTACHING NEOVEIL TUBE TYPE, NO PROBLEM WAS CONFIRMED TO COMPLETE THE CASE. ALSO REPORTED IN THE MIDDLE OF PROCEDURE SOME BROKEN PART WAS FOUND ON THE INSTRUMENT TABLE. CONFIRMED NOTHING FELL INTO THE PATIENT BY X-RAY IMAGING. REPORTED THE NORMAL CONDITIONS OF LUNG TISSUE AND NO PROBLEM IN THE METHOD OF LOADING SULU. OUR SALES REP OBSERVED STAPLES AT THE PROXIMAL PART DEPLOYED. NO PATIENT HARM. NO PROBLEM IN CLOSING AND OPENING THE JAW HAD BEEN CONFIRMED PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436545 EGIA ULTRA UNIVERSAL STAPLER DISPOSABLE SURGICAL STAPLER GDW COVIDIEN, FORMERLY USSC PUERTO RICO P4B0136X

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention LOT #: N4B0084KX, EXP DATE 02/02/2019,| EGIA60AMT, EGIA 60 ARTICULATING MED/THICK SULU,| MFG DATE 02/2014