BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGIA 60 ARTICULATING XTRA THICK SULU

    MDR report key: 4252120 · Received November 14, 2014

    Report

    Report Number
    1219930-2014-01064
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    October 27, 2014
    Report Date
    November 6, 2014
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    GDW
    PMA / PMN Number
    K083519
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LOBECTOMY. ACCORDING TO THE REPORTER: IN BRIEF, THE TISSUE WAS THICK, BUT THE HANDLE WORKED PREVIOUSLY, IT FIRED NORMALLY (ALTHOUGH WE WENT VERY SLOWLY THROUGH THE THICKER TISSUE TOWARD THE END OF THE LOAD). I COULD NOT PULL IT BACK TO OPEN THE LOAD. THE SCRUB TRIED AS WELL, AND COULD NOT GET IT TO BUDGE. I TRIED USING A NERVE HOOK TO PULL BACK ON THE BLADE (LIKE WE WERE INSTRUCTED TO DO). THAT DID NOT WORK. I STARTED TO STAPLE UNDER THAT LOAD WITH A SECOND RELOAD AND HANDLE, WHICH FIRED. BOTH THE ORIGINAL STAPLE LINES WERE RESECTED. HOWEVER, THE ANESTHESIA ATTENDING OFFERED TO TRY AND WITH MUCH FORCE HE FINALLY GOT IT TO PULL BACK AND THE JAW OPENED. THE STAPLER WAS ULTIMATELY FORCED OPEN. A NEW STAPLER WAS FIRED TO COMPLETE THE SURGERY. NO REINFORCEMENT WAS USED. THERE WAS NO UNANTICIPATED TISSUE LOSS, NO UNANTICIPATED EXT. OF INCISION MORE THAN 1 INCH, NO UNANTICIPATED BLOOD LOSS OF MORE THAN 500CC AND NO DELAY OVER 30 MINUTES. NO DEVICE FELL IN PATIENT'S CAVITY AND NO DEVICE FRAGMENT LEFT IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736768 EGIA 60 ARTICULATING XTRA THICK SULU DISPOSABLE SURGICAL STAPLER GDW COVIDIEN, FORMERLY US SURGICAL A DIVISON EGIA60AXT N2M0274UX

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention| S EGIAUSTND,EGIA ULTRA UNIVERSAL STAPLER