BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDRIVE ULTRA POWERED HANDLE 1

    MDR report key: 4243361 · Received November 11, 2014

    Report

    Report Number
    1219930-2014-01043
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 21, 2014
    Report Date
    October 21, 2014
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    GDW
    PMA / PMN Number
    K121510
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) REFER TO THE SAME CASE.

    Description of Event or Problem · 1

    PROCEDURE: SLEEVE GASTRECTOMY. ACCORDING TO THE REPORTER: WHEN DOING A SLEEVE GASTRECTOMY THEY TRIED TO FIRE THE FIRST RELOAD, A EGIA45AMT, BUT THE IDRIVE STOPPED AND THEY THOUGHT THE TISSUE WAS TOO THICK. THE EGIA45AMT PARTIALLY FIRED. THEY CHANGED TO A BLACK RELOAD, EGIA45AXT, BUT THE SAME THING HAPPENED AGAIN, THEY TOOK ANOTHER BLACK RELOAD AND THE SAME THING HAPPENED ONCE MORE. AFTER THIS THEY TOOK A NEW IDRIVE HANDLE AND WHEN DOING THIS THEY COULD FIRE WITH THEIR REGULAR PURPLE RELOADS. THE SALE REP AND THE PRODUCT SPECIALIST TESTED THE HANDLE THEY USED A PURPLE RELOAD AND THE IDRIVE COULD NOT STAPLE THROUGH A THIN PIECE OF PAPER. IT SEEMS LIKE IT HAS LOST ITS POWER TO COMPROMISE THE TISSUE MAKING IT STOP WHEN TRYING TO FIRE THE RELOAD. NO EXTENSION OF SURGERY TIME BY MORE THAN 30 MINUTES, NO BLOOD LOSS OF MORE THAN 250 CC, NO EXTENSION OF THE INCISION OF MORE THAN 1 INCH. NO UNANTICIPATED OR IRREVERSIBLE DAMAGE TO VASCULAR TISSUE, NOTHING FELL INTO PATIENT CAVITY, NO REINFORCEMENT MATERIAL WAS USED. THERE WAS PROPER STAPLE FORMATION. THERE WAS NO UNANTICIPATED TISSUE LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725131 IDRIVE ULTRA POWERED HANDLE 1 REUSABLE SURGICAL STAPLER GDW COVIDIEN, FORMERLY US SURGICAL A DIVISON IDRVULTRA1 N3H1181UX

    Patients

    Seq Age Sex Outcome Treatment
    1 PRODUCT NUMBER: EGIAADAPT,