BEUDAMED
    FDA Adverse Event Death Summary report: N

    COBLATOR II CONTROLLER

    MDR report key: 1407284 · Received June 24, 2009

    Report

    Report Number
    2951580-2009-00045
    Event Type
    Death
    Date Received
    June 24, 2009
    Date of Event
    May 20, 2009
    Report Date
    June 24, 2009
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    PMA / PMN Number
    K070374
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THE CONTROLLER WAS RETURNING FOR INVESTIGATION. THE CONTROLLER HAS NOT BEEN RECEIVED TO DATE. ONCE THE DEVICE HAS BEEN RETURNED, AN INVESTIGATION WILL BE PERFORMED AND A FOLLOW UP REPORT WILL BE PROVIDED. TWO DEVICES, PROCISE XP PLASMA WAND AND A COBLATOR II CONTROLLER, WERE USED IN THE SAME PROCEDURE. A SECOND MEDWATCH REPORT WILL BE FILED UNDER MDR 2951580-2009-00044 FOR THE PLASMA XP PLASMA WAND.

    Description of Event or Problem · 1

    ONE DAY FOLLOWING AN UVULOPALATOPHARYNGOPLASTY (UPPP) AND HYOID SUSPENSION PROCEDURE, THE PATIENT REPORTEDLY DIED. IT WAS ALSO REPORTED THAT 5 1/2 HOURS FOLLOWING THE PROCEDURE, THE PATIENT HAD UNDERGONE CARDIOPULMONARY ARREST AND REQUIRED A TRACHEOTOMY AND RESUSCITATION. THE PATIENT WAS CHECKED TWO HOURS AFTER CARDIOPULMONARY ARREST AND APPEARED STABLE. THE PATIENT WAS FOUND EXPIRED SEVEN HOURS LATER. AN AUTOPSY WAS DECLINED BY SPOUSE. THE EXACT CAUSE OF DEATH IS NOT KNOWN. BASED ON INFORMATION FOR THIS EVENT, THERE WAS NO INDICATION THE PATIENT WAS INJURED DURING THE PROCEDURE WITH THE DEVICE OR DETERIORATION IN HEALTH RELATED TO USE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBLATOR II CONTROLLER ELECTROSURGICAL CUTTING & COAGULATION DEVICE GEI ARTHROCARE CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death