BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDRIVE ULTRA POWERED HANDLE 1

    MDR report key: 3882831 · Received February 20, 2014

    Report

    Report Number
    1219930-2014-00124
    Event Type
    Malfunction
    Date Received
    February 20, 2014
    Date of Event
    January 29, 2014
    Report Date
    January 30, 2014
    Manufacturer
    COVIDIEN LP,
    Product Code
    GDW
    PMA / PMN Number
    K121510
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: SPLENECTOMY. ACCORDING TO THE REPORTER: AFTER PROPERLY LOADING 2 DIFFERENT EGIA45CTAMT ON THE SAME IDRIVE/ADAPTER COMBO, THE RELOAD WOULD ARTICULATE FULLY TO THE RIGHT AND RECALIBRATE. THE ERROR KEPT HAPPENING AND PREVENTED FIRING ON THE PATIENTS HILUM OF THE SPLEEN. THE TECH PROPERLY LOADED THE CARTRIDGE EACH TIME, CYCLED THE IDRIVE SO THAT ALL INDICATOR LIGHTS WERE SOLID GREEN. AFTER INTRODUCTION INTO THE PT, THE SURGEON PUSHED THE SILVER OPEN BUTTON TO OPEN THE CARTRIDGE FOR PLACEMENT. UPON OPENING, THE RELOAD ARTICULATED FULLY RIGHT, PRODUCED THE RECALIBRATION NOISE AND THE WHITE INDICATOR LIGHTS APPEARED AS IF A RELOAD WAS TAKEN OFF THE ADAPTER. TWO DIFFERENT TAN CTS WERE USED WITH THE SAME ERROR EACH TIME. THE RELOADS WERE NEVER FIRED IN THE PT. AFTER THE CASE, THE STAPLER WAS EXAMINED, OPENED, AND CLOSED, ARTICULATED WITH NO PROBLEMS EVIDENT - DID NOT REPRODUCE THE SAME ERROR EXPERIENCED PRIOR. THERE WAS NO PT INJURY. THERE WAS NO UNANTICIPATED TISSUE LOSS. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THE CASE WAS NO EXTENDED BY MORE THAN 30 MINUTES. NO REINFORCEMENT MATERIAL WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106991 IDRIVE ULTRA POWERED HANDLE 1 REUSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN LP, N3L0849UX

    Patients

    Seq Age Sex Outcome Treatment
    1 MFG DATE:12/2013, K121510| EXP DATE: 07/31/2018, K101444| EGIAADAPT, ENDO GIA ADAPTER STANDARD,| LOT#N3M0043UX, SERIAL#C2013M007,| VAS/MED SULU, LOT #N3G010ULX, MFG DATE:07/2013| EGIA45CTAVM, EGIA 45 CURVED TIP ARTICULATING,