BEUDAMED
    FDA Adverse Event Other Summary report: N

    EVAC 70 XTRA PLASMAWAND WITH INTEGRATED CABLE

    MDR report key: 2163627 · Received June 10, 2011

    Report

    Report Number
    2951580-2011-00083
    Event Type
    Other
    Date Received
    June 10, 2011
    Date of Event
    May 1, 2011
    Report Date
    June 10, 2011
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K070374
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR INVESTIGATION. THE INVESTIGATION IS CURRENTLY IN PROGRESS. A FOLLOW UP REPORT WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    DURING A TONSILLECTOMY AND ADENOIDECTOMY PROCEDURE, USING AN EVAC 70 XTRA PLASMAWAND, AN ELECTRODE ALLEGEDLY BROKE OFF THE WAND. NO ADDITIONAL INFO IS AVAILABLE FOR THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVAC 70 XTRA PLASMAWAND WITH INTEGRATED CABLE ELECTROSURGICAL CUTTING & COAGULATION DE GEI ARTHROCARE CORPORATION B207510-A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other