BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM SYSTEM

    MDR report key: 2872460 · Received December 11, 2012

    Report

    Report Number
    3006524618-2012-00954
    Event Type
    Malfunction
    Date Received
    December 11, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 15, 2012
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K071709
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ELBOW PROCEDURE USING THE QUANTUM SYSTEM AND A TOPAZ ICW WAND, THE WAND STOPPED FUNCTIONING AFTER 10 SECONDS OF ACTIVATION. THE PROCEDURE WAS ULTIMATELY COMPLETED WITH A COMPETITOR'S 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
    1 QUANTUM SYSTEM OPERATOR CONSOLE, DIATHERMY UNIT GEI ARTHROCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other