BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROCISE KP PLASMA WAND

    MDR report key: 1407097 · Received June 19, 2009

    Report

    Report Number
    2951580-2009-00044
    Event Type
    Death
    Date Received
    June 19, 2009
    Date of Event
    May 20, 2009
    Report Date
    June 19, 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

    SINCE THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER WAS NOT PROVIDED, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. 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 2951580-2009-00045 FOR THE COBLATOR II CONTROLLER.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROCISE KP PLASMA WAND ELECTROSURGICAL CUTTING & COAGULATION DEVICE GEI ARTHROCARE CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death