BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDRIVE ULTRA POWERED HANDLE 1

    MDR report key: 3841138 · Received February 26, 2014

    Report

    Report Number
    1219930-2014-00138
    Event Type
    Malfunction
    Date Received
    February 26, 2014
    Date of Event
    November 25, 2013
    Report Date
    February 3, 2014
    Manufacturer
    COVIDIEN FORMERLY REGISTERED AS UNITED STATES
    Product Code
    GDW
    PMA / PMN Number
    K121510
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: THORACO/LOBECTOMY. ACCORDING TO THE REPORTER: A 60 BLACK SULU WAS USED. THE DEVICE WAS FIRED SEVERAL TIMES. AFTER CLAMPING OVER TISSUE WITH JAWS, STATUS INDICATOR WAS ALIGHT AND GREEN BUTTON WAS PRESSED BUT THE LIGHT WAS NOT BLINKING. EGIA ULTRA WAS USED TO COMPLETE THE CASE. THERE WAS NO UNANTICIPATED TISSUE LOSS. THERE WAS NO TISSUE DAMAGE. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500 CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. NOTHING FELL INTO THE CAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118547 IDRIVE ULTRA POWERED HANDLE 1 REUSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN FORMERLY REGISTERED AS UNITED STATES

    Patients

    Seq Age Sex Outcome Treatment
    1 EGIA 60 ARTICULATING XTRA THICK SULU, EGIA60AXT,| K093410