BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM 2 SYSTEM

    MDR report key: 3123768 · Received May 14, 2013

    Report

    Report Number
    3006524618-2013-00185
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 17, 2013
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K071709
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SUBACROMIAL DECOMPRESSION PROCEDURE USING THE QUANTUM 2 SYS WITH AN UNK ARTHROWAND, THE WAND STOPPED WORKING WHILE IN THE MIDDLE OF THE PROCEDURE. A NEW WAND OPENED, HOWEVER, THE CONTROLLER WOULD NOT ACTIVATE THIS WAND AT ALL. THE PROCEDURE WAS ULTIMATELY COMPLETED USING A COMPETITOR'S DEVICE. 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
    212853 QUANTUM 2 SYSTEM OPERATOR, CONSOLE, DIATHERMY UNIT GEI ARTHROCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other UNK ARTHROWAND - QTY 2