BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM 2 CONTROLLER

    MDR report key: 3813310 · Received March 28, 2014

    Report

    Report Number
    3006524618-2014-00098
    Event Type
    Malfunction
    Date Received
    March 28, 2014
    Date of Event
    February 11, 2014
    Report Date
    February 27, 2014
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K071709
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO THE START OF A SHOULDER PROCEDURE USING A QUANTUM 2 CONTROLLER WITH AN UNKNOWN ARTHROWAND, UPON CONNECTING THE WAND TO THE CONTROLLER, THE UNIT GAVE AN ERROR MESSAGE. A NEW WAS OPENED AND CONNECTED, HOWEVER YIELDED THE SAME RESULT. THE SURGEON OPTED TO COMPLETE THE PROCEDURE USING A COMPETITIVE DEVICE. THERE WERE NO SIGNIFICANT DELAYS OR PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184829 QUANTUM 2 CONTROLLER OPERATOR CONSOLE, DIATHERMY UNIT GEI ARTHROCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1