BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDRIVE ULTRA POWERED HANDLE 1

    MDR report key: 3786291 · Received April 2, 2014

    Report

    Report Number
    1219930-2014-00274
    Event Type
    Malfunction
    Date Received
    April 2, 2014
    Date of Event
    March 10, 2014
    Report Date
    March 11, 2014
    Manufacturer
    COVIDIEN, FORMERLY REGISTERED AS US SUR
    Product Code
    GDW
    PMA / PMN Number
    5121510
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PRODUCE TYPE: LOBECTOMY. ACCORDING TO THE REPORTER: WHEN THE PRODUCT WAS BEING ASSEMBLED, THE GREEN LIGHT FOR THE BATTERY AND ADAPTER WERE PROPERLY LIT UP WHEN PUT TOGETHER. ONCE A RELOAD WAS ATTACHED, THE ADAPTER WASN'T RECOGNIZING THE RELOAD. AFTER CHECKING THE PRODUCT FURTHER AND PUTTING ON ANOTHER RELOAD, THE RELOAD LIGHT WENT ON. HOWEVER, ONCE THE GREEN SAFETY BUTTON WAS PRESSED TO BEING FIRING SEQUENCE, THE BLUE LIGHT LIT UP. THIS SAME RELOAD WAS THEN LOADED ONTO AN 030349 (DISPOSABLE HANDLE) AND WAS FIRED PROPERLY ON TISSUE. THE BLUE STATUS LIGHT TEST ALSO PROVED TO BE TRUE AFTER THE CASE UPON ANALYZING THE PRODUCT. THE GREEN STATUS LIGHT NEVER WENT INTO FLASHING MODE WHEN THE RELOAD WAS CLOSED AND NORMALLY READY TO FIRE. THERE WAS NO PATIENT INJURY. THERE WAS NO UNANTICIPATED TISSUE LOSS. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. NO REINFORCEMENT MATERIAL WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200051 IDRIVE ULTRA POWERED HANDLE 1 REUSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY REGISTERED AS US SUR N4A0365UX

    Patients

    Seq Age Sex Outcome Treatment
    1 EGIAADAPT, ENDO GIA ADAPTER STANDARD,| LOT #N4B1263UX, SERIAL #(B)(4), K121510.