BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM II SYSTEM

    MDR report key: 2331848 · Received October 21, 2011

    Report

    Report Number
    2951580-2011-00204
    Event Type
    Malfunction
    Date Received
    October 21, 2011
    Date of Event
    September 1, 2011
    Report Date
    September 29, 2011
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    PMA / PMN Number
    K082666
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S AGE AND GENDER HAVE BEEN REQUESTED BUT THE INITIAL REPORTER REFUSED TO RELEASE SUCH INFORMATION. REFERENCE MANUFACTURER'S REPORT # 2951580-2011-00202, 2951580-2011-00203.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ARTHROSCOPIC KNEE MENISECTOMY USING THE AMBIENT SUPER TURBOVAC 90 ARTHROWAND AND A QUANTUM II CONTROLLER, THE CONTROLLER GAVE CONSISTENT UNKNOWN ERROR MESSAGES. THERE WAS A SIGNIFICANT DELAY IN THE PROCEDURE, REPORTEDLY 35-40 MINUTES. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTUM II SYSTEM ELECTROSURGICAL CUTTING & COAGULATION DE GEI ARTHROCARE CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other