BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROCISE MLW PLASMA WAND

    MDR report key: 3292429 · Received August 12, 2013

    Report

    Report Number
    3006524618-2013-00330
    Event Type
    Malfunction
    Date Received
    August 12, 2013
    Date of Event
    July 18, 2013
    Report Date
    July 18, 2013
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K033257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MICRO LARYNGEAL SURGERY USING THE PROCISE MLW PLASMA WAND, THE WAND SUCTION WAS CLOGGING THROUGHOUT THE PROCEDURE. THE SURGEON ALLEGED THERE WAS TOO MUCH POOLING AT THE SURGICAL SITE AND OPTED TO COMPLETE THE PROCEDURE USING A COMPETITOR'S DEVICE. THERE WERE NO SIGNIFICANT DELAYS OR PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385587 PROCISE MLW PLASMA WAND ELECTRODE, ELECTROSURGICAL, ACTIVE, FOOT GEI ARTHROCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other