BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROCISE MAX

    MDR report key: 3250276 · Received July 24, 2013

    Report

    Report Number
    3006524618-2013-00305
    Event Type
    Malfunction
    Date Received
    July 24, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 27, 2013
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K033257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TONSILLECTOMY/ADENOIDECTOMY PROCEDURE USING A PROCISE MAX WAND, THE WAND SUCTION CLOGGED SOON AFTER THE PROCEDURE STARTED. THE SURGEON WAS UNABLE TO UNCLOG THE AND OPTED TO COMPLETE THE PROCEDURE USING A COMPETITOR'S DEVICE. THERE WERE NO SIGNIFICANT DELAYS OR PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346735 PROCISE MAX ELECTRODE, ELECTROSURGICAL, ACTIVE, FOOT GEI ARTHROCARE CORPORATION 1034422

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Other