BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROCISE XP

    MDR report key: 1241897 · Received November 18, 2008

    Report

    Report Number
    1241897
    Event Type
    Malfunction
    Date Received
    November 18, 2008
    Date of Event
    November 11, 2008
    Report Date
    November 18, 2008
    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

    THE COBLATOR TIP WAS CAUTERIZING, BUT NO SUCTION OCCURRING. THE SUCTION UNIT WAS WORKING WELL. THE DEVICE WAS REMOVED AND A NEW COBLATOR DEVICE WAS OPENED AND WORKED WELL. NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROCISE XP HANDPIECE, ESU, COBLATOR GEI ARTHROCARE CORPORATION * R714870-A

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR