BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVAC 70 XTRA WITH INTEGRATED CABLE

    MDR report key: 2943968 · Received January 31, 2013

    Report

    Report Number
    3006524618-2013-00049
    Event Type
    Injury
    Date Received
    January 31, 2013
    Date of Event
    November 23, 2012
    Report Date
    January 2, 2013
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K033257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TONSILLECTOMY PROCEDURE USING THE EVAC 70 XTRA, THE WAND BECAME VERY HOT WHILE THE SURGEON WAS REMOVING THE TONSIL, RESULTING IN A BURN TO THE PT'S TISSUE. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. THERE WAS NO SIGNIFICANT DELAY OR ADDITIONAL PT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42988 EVAC 70 XTRA WITH INTEGRATED CABLE ELECTRODE, ELECTROSURGICAL, ACTIVE, FOOT GEI ARTHROCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other