BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSUTURE VITAL-VUE

    MDR report key: 1412725 · Received July 3, 2009

    Report

    Report Number
    1412725
    Event Type
    Malfunction
    Date Received
    July 3, 2009
    Date of Event
    June 15, 2009
    Report Date
    July 3, 2009
    Manufacturer
    COVIDIEN
    Product Code
    JCX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING ORAL SURGERY CASE, SURGEON ATTEMPTED TO USE THE VITAL-VUE UNIT (REF 8886828206). AFTER PLUGGING IN THE HAND PIECE IT WAS OBSERVED THAT THE LIGHT WAS VERY DIM (LOT # 9030096). UNABLE TO BRIGHTEN THE LIGHT WITH ADJUSTMENT, ANOTHER VITAL-VUE HAND PIECE WAS USED AND WORKED WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOSUTURE VITAL-VUE INSTRUMENT, SUCTION/IRRIGATION/ILLUMINATION JCX COVIDIEN * 9030096

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR