BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVAC 70 XTRA WITH INTEGRATED CABLE

    MDR report key: 3111337 · Received May 9, 2013

    Report

    Report Number
    3006524618-2013-00177
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 12, 2013
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K033257
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TONSILLECTOMY/ADENOIDECTOMY PROCEDURE USING AN EVAC 70 XTRA WAND AND COBLATOR II CONTROLLER, WHILE THE WAND WAS ACTIVATED IT CAME IN CONTACT WITH AN ALICE CLAMP INSIDE THE PATIENT'S MOUTH AND ARCHED, CAUSING A MINOR BURN. THE BURN DID NOT REQUIRE ANY FURTHER TREATMENT, AS IT WAS VERY MINOR. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SIGNIFICANT DELAY USING A BACK UP WAND. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204901 EVAC 70 XTRA WITH INTEGRATED CABLE ELECTRODE, ELECTROSURGICAL, ACTIVE, FOOT GEI ARTHROCARE CORPORATION 1032597

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Other COBLATOR II: PART #13546-59, SERIAL #(B)(4)