BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROCISE XP

    MDR report key: 3063348 · Received April 11, 2013

    Report

    Report Number
    3006524618-2013-00147
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 17, 2012
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K033257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TONSILLECTOMY PROCEDURE USING THE PROCISE XP WAND, THE WAND ALLEGEDLY SPARKED AND SMOKED WHEN TRYING TO ABLATE AND THEN STOPPED WORKING. THE SURGEON CHOSE TO COMPLETE THE PROCEDURE USING A COMPETITOR'S PRODUCT. THERE WAS NO SIGNIFICANT DELAY OR ANY PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154727 PROCISE XP ELECTRODE, ELECTROSURGICAL, ACTIVE, FOOT GEI ARTHROCARE CORPORATION 3620920-A

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other