BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBLATOR II

    MDR report key: 2950540 · Received February 5, 2013

    Report

    Report Number
    3006524618-2013-00057
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K030108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL ANALYSIS OF THE RETURNED COBLATOR II CONTROLLER FOUND NO DISCREPANCIES WITH THE CASE OR THE INTERNAL COMPONENTS. FUNCTIONAL ANALYSIS FOUND THAT THE OUTPUT BOARD WHICH CONTROLS THE WAND WAS SHORTED OUT, MOST LIKELY BY CONNECTING A WAND WITH RESIDUAL SALINE STILL PRESENT ON THE CORD, AS THE COMPLAINANT REPORTED. THE COMPLAINT HISTORY FOR THIS LOT NUMBER WAS REVIEWED AND NO SIMILAR COMPLAINTS WERE IDENTIFIED. THE ROOT CAUSE CANNOT BE CONFIRMED BUT IS BELIEVED TO BE DUE TO A SHORT CAUSED WHEN A WET PLUG WAS CONNECTED TO THE CONTROLLER. CONTAINMENT AND CORRECTIVE ACTIONS ARE NOT DEEMED NECESSARY AT THIS TIME AS NO DEFICIENCIES WERE IDENTIFIED IN THE MANUFACTURE OR DESIGN OF THIS DEVICE WHICH HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ADENOIDECTOMY PROCEDURE USING THE COBLATOR II SYSTEM, THE CONTROLLER SEEMED TO SHORT OUT WHILE MAKING A POPPING SOUND. AS A RESULT, THE WAND WAS NOT RECEIVING ANY POWER. THE PROCEDURE WAS ULTIMATELY COMPLETED USING A COMPETITIVE PRODUCT. THERE WERE NO SIGNIFICANT DELAYS OR PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48554 COBLATOR II OPERATOR CONSOLE, DIATHERMY UNIT GEI ARTHROCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other