BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 391473 · Received April 29, 2002

    Report

    Report Number
    8010047-2002-00028
    Event Type
    Malfunction
    Date Received
    April 29, 2002
    Report Date
    March 29, 2002
    Manufacturer
    THE OLYMPUS OPTICAL CO.
    Product Code
    FTJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A HOSPITAL REPORTED LOSS OF IMAGE DURING A COLONOSCOPY PROCEDURE. THE SCOPE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS VIDEO COLONOSCOPE FTJ THE OLYMPUS OPTICAL CO. CF-Q160L NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN