BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 408081 · Received July 26, 2002

    Report

    Report Number
    8010047-2002-00071
    Event Type
    Malfunction
    Date Received
    July 26, 2002
    Report Date
    June 26, 2002
    Manufacturer
    OLYMPUS OPTICAL CO. LTD.
    Product Code
    GCK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AN OLYMPUS ENDOSCOPE FAILED THE CURRENT LEAKAGE TEST. THERE WERE NO COMPLICATIONS ASSOCIATED WITH THE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN