BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMBIENT MEGAVAC 90

    MDR report key: 2852678 · Received November 14, 2012

    Report

    Report Number
    3006524618-2012-00882
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 16, 2012
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K033584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT IDENTIFIER, AGE AND WEIGHT WERE NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE, THE AMBIENT MEGAVAC 90 WAND WORKED FOR A SHORT TIME AND THEN GAVE AN ERROR MESSAGE. THIS EVENT LED TO A 45 MINUTE SURGICAL DELAY BUT THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE USING A BACKUP AMBIENT MEGAVAC 90. THERE WERE NO PT CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMBIENT MEGAVAC 90 ELECTROSURGICAL CUTTING & COAGULATION DE GEI ARTHROCARE CORPORATION H14220-A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other