BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROCISE XP

    MDR report key: 2061462 · Received March 28, 2011

    Report

    Report Number
    2061462
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 28, 2011
    Manufacturer
    ARTHROCARE ENT
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE DEVICE STOPPED WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROCISE XP COBLATION PLASMA WAND GEI ARTHROCARE ENT * 3631900-A

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR