BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMBIENT SUPER TURBOVAC 90 WITH FINGER SWITCH

    MDR report key: 2331846 · Received October 21, 2011

    Report

    Report Number
    2951580-2011-00203
    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
    K083306
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT'S AGE AND GENDER HAVE BEEN REQUESTED BUT THE INITIAL REPORTER REFUSED TO RELEASE SUCH INFO. REFERENCE MFR'S REPORT #2951580-2011-00202, 2951580-2011-00204.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ARTHROSCOPIC KNEE MENISECTOMY USING THE AMBIENT SUPER TURBOVAC 90 ARTHOWAND AND A QUANTUM II CONTROLLER, THE FIRST WAND DISPLAYED AN UNK ERROR MESSAGE. A SECOND SUPER TURBOVAC 90 ARTHOWAND WAS PLUGGED IN AND AGAIN AN UNK ERROR MESSAGE WAS DISPLAYED. THERE WAS A SIGNIFICANT DELAY, REPORTEDLY 35-40 MINS. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE DEVICE. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMBIENT SUPER TURBOVAC 90 WITH FINGER SWITCH ELECTROSURGICAL CUTTING & COAGULATION DE GEI ARTHROCARE CORP. 0121110-A

    Patients

    Seq Age Sex Outcome Treatment
    1