BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBLATOR II SYSTEM

    MDR report key: 2149414 · Received June 28, 2011

    Report

    Report Number
    2951580-2011-00081
    Event Type
    Injury
    Date Received
    June 28, 2011
    Date of Event
    January 1, 2011
    Report Date
    June 1, 2011
    Manufacturer
    ARTHROCARE CORP
    Product Code
    GEI
    PMA / PMN Number
    K030108
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PT'S AGE AND GENDER WERE REQUESTED, BUT TO DATE HAVE NOT BEEN PROVIDED. DATE OF EVENT WAS REQUESTED, BUT TO DATE HAS NOT BEEN PROVIDED, THEREFORE AN ESTIMATED YEAR WAS USED. THE SECOND DEVICE (EVAC 70 XTRA WITH INTEGRATED CABLE ARTHROCARE WAND) USED IN THE SAME PROCEDURE IS REPORTED UNDER MEDWATCH NUMBER 2951580-2011-00082.

    Description of Event or Problem · 1

    DURING A PROCEDURE USING AN EVAC 70 XTRA WITH INTEGRATED CABLE ARTHROCARE WAND AND COBLATOR II CONTROLLER, THE WAND ALLEGEDLY SPARKED AND PT SUSTAINED A BURN. NO OTHER INFO WAS PROVIDED FOR THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBLATOR II SYSTEM ELECTROSURGICAL CUTTING & COAGULATION DE GEI ARTHROCARE CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other