BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROCISE XP

    MDR report key: 3212322 · Received July 1, 2013

    Report

    Report Number
    3212322
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    May 22, 2013
    Report Date
    July 1, 2013
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    COBLATOR TIP ELECTRODES BROKE AND DID NOT WORK. THERE WAS NO HARM TO THE PATIENT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?TONSILLECTOMY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297295 PROCISE XP ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ARTHROCARE CORPORATION * 1031103

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR