BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROCISE MAX

    MDR report key: 3050386 · Received April 8, 2013

    Report

    Report Number
    3006524618-2013-00145
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K033257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ADENOIDECTOMY PROCEDURE USING THE PROCISE MAX WAND, THE WAND BEGAN BILLOWING SMOKE DURING THE PROCEDURE. THE SURGEON OPTED TO COMPLETE THE PROCEDURE USING A COMPETITOR'S PRODUCT INSTEAD. 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
    142466 PROCISE MAX ELECTRODE, ELECTROSURGICAL, ACTIVE, FOOT GEI ARTHROCARE CORPORATION KM04310-A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other