BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 562835 · Received May 18, 2004

    Report

    Report Number
    8010047-2004-10058
    Event Type
    Malfunction
    Date Received
    May 18, 2004
    Manufacturer
    OLYMPUS OPTICAL CO. LTD
    Product Code
    GCK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE HOSP REPORTED THEY EXPERIENCED A TOTAL LOSS OF IMAGE DURING PROCEDURE. IT IS UNK WHETHER THE PROCEDURE WAS COMPLETED, AND IF SO, WHETHER IT WAS COMPLETED WITH THE SAME 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