BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVAC 70 XTRA PLASMAWAND WITH INTEGRATED CABLE

    MDR report key: 1910794 · Received November 23, 2010

    Report

    Report Number
    2951580-2010-00109
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    October 27, 2010
    Report Date
    November 23, 2010
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    PMA / PMN Number
    K070374
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR INVESTIGATION. THE INVESTIGATION IS CURRENTLY IN PROGRESS. A F/U REPORT WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. A SECOND DEVICE USED IN THE SAME PROCEDURE WAS FILED UNDER MDR 2951580-2010-00107.

    Description of Event or Problem · 1

    DURING A TONSILLECTOMY AND ADENOIDECTOMY PROCEDURE, USING AN EVAC 70 XTRA PLASMAWAND, THE PT WAS REPORTED TO HAVE SUSTAINED A 1 CM, SECOND DEGREE BURN ON THE SOFT PALATE. THE PHYSICIAN'S OPINION OF THE CAUSE OF THE BURN IS REPORTED AS DUE TO THE SHEATH COVERING THE EVAC 70 XTRA PLASMAWAND DID NOT EXTEND CLOSE ENOUGH TO THE TIP.

    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 CORP. B217400-A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other