BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA ROTICULATOR* 30-3.5 SULU

    MDR report key: 3924695 · Received June 25, 2014

    Report

    Report Number
    1219930-2014-00479
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 3, 2014
    Manufacturer
    COVIDIEN, FORMERLY US SUR
    Product Code
    GDW
    PMA / PMN Number
    K900129
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP SLEEVE GASTRECTOMY. ACCORDING TO THE REPORTER: AFTER SUCCESSFULLY FIRING 7 EGIA60AMT RELOADS, A 30MM BLUE ROTICULATING RELOAD WAS LOADED AND CYCLED SUCCESSFULLY, HOWEVER THE HANDLE STARTED BLINKING A BLUE STATUS LIGHT AND GREEN HANDLE LIGHT. THE STAPLER WOULD NOT OPEN. NO BUTTONS APPEARED TO DO ANYTHING ON THE DEVICE. AFTER REMOVING AND REINSERTING THE BATTERY, THE HANDLE PERFORMED A CALIBRATION CYCLE AND OPENED THE RELOAD. THE RELOAD WAS UNLOADED AND ATTEMPTED TO LOAD AGAIN, FINDING IT DIFFICULT TO ENGAGE THE RELOAD WITH THE ADAPTER. THE RELOAD STATUS LIGHT ON THE IDRIVE FIRST ILLUMINATED AND THEN WENT COMPLETELY BLANK. A THIRD ATTEMPT AT LOADING THE STAPLER WS FINALLY PERFORMED WITH FULL FUNCTIONALITY. THERE WAS NO UNANTICIPATED TISSUE LOSS. THERE WAS NO UNANTICIPATED TISSUE DAMAGE. THERE WAS NO UNANTICIPATED BLOOD LOSS OF MORE THAN 500CC. THERE WAS NO DELAY OVER 30 MINUTES. NO OTHER MANUFACTURER'S REINFORCEMENT MATERIAL WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369599 ENDO GIA ROTICULATOR* 30-3.5 SULU DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY US SUR N4A0037LX

    Patients

    Seq Age Sex Outcome Treatment
    1 LOT #N3K1365UX, SN (B)(4),| MFG DATE: 10/2013, K121510| ENDO GIA ADAPTER XL, LOT# N4C1440US, SN (B)(4),| IDRIVE ULTRA POWERED HANDLE 1,| MFG DATE: 10/2014, K121510| IDRVULTRA1,| EGIAADAPTXL,