BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 962874 · Received May 11, 2007

    Report

    Report Number
    8010047-2007-00066
    Event Type
    Malfunction
    Date Received
    May 11, 2007
    Date of Event
    April 1, 2007
    Report Date
    April 13, 2007
    Manufacturer
    OLYMPUS OPTICAL CO. LTD
    Product Code
    GCK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS FORWARDED TO REGULATORY AFFAIRS FOR INVESTIGATION. THE INVESTIGATION RESULTS CONFIRMED THE USER'S CLAIM OF THE INTERMITTENT IMAGE PROBLEMS AFTER TESTING THE ENDOSCOPE FOR SEVERAL HOURS. THE SOURCE OF THE DIFFICULTY APPEARS TO BE RELATED TO THE CHARGE-COUPLER DEVICE (CCD) UNIT. THIS REPORT IS BEING FILED AS AN MDR IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY CLAIMED THAT DURING A PROCEDURE, THE VIDEO IMAGE INTERMITTENTLY GOES BLACK. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT, BUT SIMILAR DEVICE. THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS GASTROSCOPE GCK OLYMPUS OPTICAL CO. LTD GIF-Q160 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN