BEUDAMED
    FDA Adverse Event Other Summary report: N

    COBLATOR II PLASMA WAND

    MDR report key: 1080073 · Received July 17, 2008

    Report

    Report Number
    2951580-2008-00058
    Event Type
    Other
    Date Received
    July 17, 2008
    Date of Event
    June 1, 2008
    Report Date
    July 16, 2008
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    PMA / PMN Number
    K063538
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF EVENT IS AN APPROXIMATION PROVIDED BY THE MANUFACTURER. THE COBLATOR II PLASMA WAND WAS NOT RETURNED FOR INVESTIGATION. SINCE THE DEVICE CATALOG NUMBER AND LOT NUMBER WERE NOT PROVIDED, A COMPLETE INVESTIGATION COULD NOT BE COMPLETED. NO CONCLUSION CAN BE MADE. TWO DEVICES, COBLATOR II PLASMA WAND AND COBLATOR II CONTROLLER, WERE USED IN THE SAME PROCEDURE. THE SECOND DEVICE, COBLATOR II CONTROLLER, WILL BE FILED UNDER MDR 2951580-2008-00053.

    Description of Event or Problem · 1

    IN 2008, A CLINICAL INCIDENT INVOLVING A COBLATOR II PLASMA WAND WAS REPORTED TO ARTHOCARE CORP. TWO DAYS FOLLOWING A TONSILLECTOMY PROCEDURE, THE PT HAD A SECONDARY REBLEED WHICH REQUIRED ADMITTANCE TO HOSPITAL FOR TREATMENT. THE PT REQUIRED A BLOOD TRANSFUSION, AND WAS ADMITTED TO THE ICU FOR 24 HOURS. IT WAS REPORTED THE PT HAS REHEALED, AND IS REPORTED TO RECOVERING WELL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other