BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBLATOR II

    MDR report key: 2885053 · Received December 19, 2012

    Report

    Report Number
    3006524618-2012-00971
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 15, 2012
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K030108
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TWO WEEK POST OPERATIVE VISIT FOLLOWING AN ADENOIDECTOMY PROCEDURE THE SURGEON NOTICED THAT THE TURBINATES SHOWED MORE THERMAL LESION THAN EXPECTED. THE SURGEON WAS CONCERNED THAT THERE MAY HAVE BEEN GREATER CELL DEATH THAN IS NORMAL AFTER THIS PARTICULAR PROCEDURE. THERE WERE NO OTHER PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBLATOR II OPERATOR CONSOLE, DIATHERMY UNIT GEI ARTHROCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other (B)(4) FLOW CONTROL CABLE: LOT#W42329| (B)(4) FOOT SWITCH: LOT#105164| (B)(4) COBLATOR II FLOW VALVE: LOT#FV04413