BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 814329 · Received January 17, 2007

    Report

    Report Number
    8010047-2007-00006
    Event Type
    Malfunction
    Date Received
    January 17, 2007
    Date of Event
    November 20, 2006
    Report Date
    January 10, 2007
    Manufacturer
    OLYMPUS OPTICAL CO., LTD
    Product Code
    GCK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR INVESTIGATION. THE INVESTIGATION REVEALED THAT THERE WAS FLUID INVASION AND CORROSION NOTED IN THE BENDING SECTION AND CONTROL BODY UNIT. THERE WAS ROUND STAIN AT THE UPPER LEFT AREA OF THE IMAGE, WHICH WAS ATTRIBUTED TO THE DAMAGED 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 HOSPITAL REPORTED THAT DURING A PROCEDURE, THE IMAGE WOULD FREEZE BY ITSELF, WHICH TRIGGERED THE PHYSICIAN TO WITHDRAW THE SCOPE FROM THE PT. 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-Q180 *

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other