BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 729901 · Received June 17, 2005

    Report

    Report Number
    8010047-2005-00061
    Event Type
    Malfunction
    Date Received
    June 17, 2005
    Report Date
    May 25, 2005
    Manufacturer
    OLYMPUS OPTICAL CO. LTD.
    Product Code
    GCK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION WAS RETURNED TO OLYMPUS FOR INVESTIGATION. THE INVESTIGATION FOUND EVIDENCE OF FLUID INVASION ON THE ELECTRICAL CONNECTOR BURNDY PINS AND AIR VENTILATION INLET THAT MOST LIKELY CAUSED AN ELECTRICAL SHORT IN THE CHARGE COUPLED DEVICE UNIT RESULTING IN THE IMAGE PHENOMENON THE USER EXPERIENCED. OLYMPUS WAS UNABLE TO CONCLUSIVELY DETERMINE THE CAUSE OF THE FLUID INVASION.

    Description of Event or Problem · 1

    THE HOSP REPORTED THEY EXPERIENCED A TOTAL LOSS OF IMAGE DURING PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE USE OF ANOTHER SIMILAR DEVICE. THERE WAS NO ALLEGATION OF HARM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN