BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROCISE EZ PLASMA WAND

    MDR report key: 2170188 · Received July 7, 2011

    Report

    Report Number
    2951580-2011-00091
    Event Type
    Other
    Date Received
    July 7, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 7, 2011
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    PMA / PMN Number
    K033257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT WAS REQUESTED, BUT TO DATE, HAS NOT BEEN PROVIDED, THEREFORE, AN ESTIMATED YEAR WAS USED. A VISUAL INSPECTION OF THE DEVICE WAS PERFORMED PRIOR TO THE FUNCTIONAL TEST. THE ELECTRODE SCREEN SHOWED EXTENSIVE WEAR AT THE DISTAL TIP OF THE WAND. A FUNCTIONAL TEST OF THE DEVICE WAS PERFORMED. THE DEVICE WAS FIRED IN SALINE SOLUTION AT DEFAULT SETTINGS (COAG 3 AND ABLATE 7), AND MAXIMUM SETTINGS (COAG 5, AND ABLATE 9). THE SALINE AND SUCTION LINES WERE FOUND TO BE FUNCTIONAL. A LOT HISTORY REVIEW WAS PERFORMED AND NO ABNORMALITIES WERE FOUND. THE LOT MET ALL DEVICE SPECS. THE ROOT CAUSE OF THE DEVICE FAILURE IS BELIEVED TO BE DUE TO EXCESSIVE USE.

    Description of Event or Problem · 1

    THE PT UNDERWENT A PROCEDURE USING A PROCISE EZ PLASMA WAND. ALLEGEDLY, THE METAL TIP OF THE WAND CAME OFF DURING THE PROCEDURE. NO ADD'L INFO IS AVAILABLE FOR THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROCISE EZ PLASMA WAND ELECTROSURGICAL CUTTING & COAGULATION DE GEI ARTHROCARE CORP. 4532200-A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other