BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 355446 · Received October 9, 2001

    Report

    Report Number
    8010047-2001-00069
    Event Type
    Malfunction
    Date Received
    October 9, 2001
    Report Date
    September 10, 2001
    Manufacturer
    OLYMPUS OPTICAL CO. LTD.
    Product Code
    GCK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A HOSP REP REPORTED LOSS OF IMAGE DURING A PROCEDURE. ADDITIONAL DETAILS REGARDING THE OCCURRENCE ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45398 OLYMPUS GASTROSCOPE GCK OLYMPUS OPTICAL CO. LTD. GIF-Q160 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN