BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 1038518 · Received May 2, 2008

    Report

    Report Number
    8010047-2008-00081
    Event Type
    Malfunction
    Date Received
    May 2, 2008
    Report Date
    April 4, 2008
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GCK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR INVESTIGATION. THE INVESTIGATION DUPLICATED THE USER'S REPORT OF A COMPLETE LOSS OF IMAGE WITH HORIZONTAL LINES ON THE IMAGE. THE DEVICE PASSED THE LEAK TEST AND THERE WAS NO EVIDENCE OF FLUID INVASION IN THE DEVICE. THE CAUSE OF THE USER'S EXPERIENCE WAS ATTRIBUTED TO A DAMAGED CHARGE COUPLED DEVICE (CCD) UNIT DUE TO EXTENSIVE USAGE. THIS REPORT IS BEING FILED AS AN MDR IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A DIAGNOSTIC GASTROSCOPY, LINES WERE OBSERVED ON THE IMAGE AND VISUALIZATION WAS LOST. THE PROCEDURE WAS REPORTEDLY COMPLETED WITH A DIFFERENT, BUT SIMILAR DEVICE AND THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GCK OLYMPUS MEDICAL SYSTEMS CORPORATION GIF-Q160 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK