BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDRIVE ULTRA POWERED HANDLE 1

    MDR report key: 3896703 · Received May 20, 2014

    Report

    Report Number
    1219930-2014-00383
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 25, 2014
    Report Date
    April 28, 2014
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K121510
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: ESOPHAGECTOMY. ACCORDING TO THE REPORTER: THE ADAPTER FULLY SEATED ADN CALIBRATED ON THE IDRIVE HANDLE. HOWEVER, WHEN RELOADS WERE ATTEMPTED TO LOAN ONTO THE SHAFT, THEY WERE UNABLE TO FULLY SEAT ON THE SHAFT. THE SCRUB TECH SAID THERE WAS RESISTANCE THAT PREVENTED HER FROM FULLY SEATING THE RELOAD ONTO THE SHAFT. THE TECH OPENED ANOTHER RELOAD. THEN, WITHOUT PUSHING THE CLOSE BUTTON, THE PRODUCT CLOSED COMPLETELY ON ITS OWN. IT HAPPENED TWICE THROUGHOUT THE BEGINNING PART OF THE CASE; HOWEVER, DID NOT HAPPEN AGAIN IN THE SECOND PART OF THE CASE. IN ADDITION, THERE WERE STAPLE LINES WITH A LOT OF BLEEDING. THE SURGEON WAS FIRING ON STOMACH USING 60MM PURPLE RELOADS. THE SURGEON HAD TO CLIP ALONG AN ENTIRE TWO FIRINGS OF 60MM PURPLE RELOADS. THE NEXT FIRING OF THE PURPLE RELOAD WENT SMOOTHLY AND IT WAS THE LAST FIRE FOR THAT SPECIFIC PART OF THE CASE. ONCE THE PT WAS REPOSITIONED AND THE SURGEON MOVED TO THE CHEST PART OF THE CASE, HE DID ANOTHER EIGHT FIRINGS THAT ALL WENT SMOOTHLY. NO REINFORCEMENT MATERIAL WAS USED. THERE WAS NO UNANTICIPATED TISSUE LOSS. THERE WAS NO TISSUE DAMAGE. THERE WAS NO BLEEDING REPORTED IN EXCESS OG 500CC. THE CAUSE WAS NOT EXTENDED BY MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299321 IDRIVE ULTRA POWERED HANDLE 1 REUSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY US SURGICAL N4C1302UX

    Patients

    Seq Age Sex Outcome Treatment
    1 ENDO GIA APAPTER STANDARD, EGIAADAPT,| SERIAL #(B)(4), LOT#N4D0669UX,| MFG DATE: 12/01/2013, K121510| EGIA 60 ARTICULATING MED/THICK SULU, EGIA60AMT,| EXP DATE: 06/30/2016, K083519| LOT#N1F0807ULX, MFG DATE: 06/01/2011,