BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 549192 · Received April 8, 2004

    Report

    Report Number
    8010047-2004-10044
    Event Type
    Malfunction
    Date Received
    April 8, 2004
    Report Date
    March 18, 2004
    Manufacturer
    OLYMPUS OPTICAL, CO. LTD.
    Product Code
    GCK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE HOSP REPORTED THEY HAD A TOTAL LOSS OF IMAGE DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE USE OF ANOTHER 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