BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGIA ULTRA UNIVERSAL STAPLER

    MDR report key: 3131036 · Received May 21, 2013

    Report

    Report Number
    1219930-2013-00391
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 30, 2013
    Manufacturer
    COVIDIEN, FORMERLY US
    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 TYPE: LOBECTOMY. ACCORDING TO THE RPTR: UPON FIRING, THE SURGEON RECOGNIZED DIFFICULTY IN SQUEEZING THE HANDLE AND WAS UNABLE TO COMPLETE THE FIRING. ANOTHER DEVICE AND NEW CARTRIDGE WERE OPENED TO TRY AND FIRE AGAIN BUT THE SAME INCIDENT OCCURRED. THE SURGEON COMMENTED THAT THE LUNG TISSUE ON THE PT WAS NOT ESPECIALLY THICK. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINS. THERE WAS NO TISSUE DAMAGE, HOWEVER THERE WAS UNANTICIPATED TISSUE LOSS AS A RESULT OF THIS PROBLEM. THE LOT NUMBERS OF THE REPORTED DEVICE STAPLERS AND RELOADS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225350 EGIA ULTRA UNIVERSAL STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY US

    Patients

    Seq Age Sex Outcome Treatment
    1 EGIA 60 ARTICULATING XTRA THICK SULU, (B)(4),| #K093410