BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPR S90

    MDR report key: 1883518 · Received October 5, 2010

    Report

    Report Number
    1883518
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 30, 2010
    Manufacturer
    DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US

    Narratives

    Description of Event or Problem · 1

    HEALTH CARE PROFESSIONAL WAS USING THE VAPR S90 ELECTRODE DURING SHOULDER ARTHROSCOPY AND IT STARTED TO SPARK AFTER AWHILE.======================HEALTH PROFESSIONAL'S IMPRESSION======================NO ADVERSE EVENT. STOPPED IMMEDIATELY AND OPENED NEW DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAPR S90 SUCTION ELECTRODE GEI DEPUY MITEK, A JOHNSON & JOHNSON COMPANY * M1003133R

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR