BEUDAMED
    FDA Adverse Event Other Summary report: N

    COBLATOR II SYSTEM

    MDR report key: 2094056 · Received April 29, 2011

    Report

    Report Number
    2951580-2011-00053
    Event Type
    Other
    Date Received
    April 29, 2011
    Date of Event
    January 1, 2011
    Report Date
    April 29, 2011
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    PMA / PMN Number
    K030108
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT'S AGE WAS REQUESTED BUT NOT PROVIDED. THE DATE OF THE EVENT WAS REQUESTED BUT NOT PROVIDED. TWO DIFFERENT COBLATOR II CONTROLLERS ARE RETURNING FROM THE FACILITY FOR THE INVESTIGATION. THE CONTROLLER USED IN THE PROCEDURE IS NOT KNOWN. SEE MDR 2951580-2011-00069 AND 2951580-2011-00070 FOR RESULTS OF THE INVESTIGATION OF THE CONTROLLERS RETURNED FROM THE FACILITY. A SECOND DEVICE, REFLEX ULTRA PTR PLASMAWAND WITH INTEGRATED CABLE, USED IN THE SAME PROCEDURE WAS FILED UNDER MDR 2951580-2011-00054.

    Description of Event or Problem · 1

    THE PT UNDERWENT A TURBINATE REDUCTION PROCEDURE USING A COBLATOR II SYS AND AN REFLEX ULTRA PTR PLASMAWAND WITH INTEGRATED CABLE. THE PT REQUIRED TREATMENT AT AN EMERGENCY ROOM FOR POST OPERATIVE BLEEDING 3 TO 5 WEEKS FOLLOWING THE ORIGINAL PROCEDURE. NASAL PACKING WAS ADMINISTERED TO STOP THE BLEEDING.

    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