BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 330203 · Received May 1, 2001

    Report

    Report Number
    8010047-2001-00035
    Event Type
    Malfunction
    Date Received
    May 1, 2001
    Report Date
    April 2, 2001
    Manufacturer
    THE OLYMPUS OPTICAL CO.
    Product Code
    FTJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A HOSPITAL NURSE MANAGER REPORTED THAT THE VIDEO IMAGE FROZE DURING A COLONOSCOPY PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SECOND SCOPE AND THERE WERE NO COMPLICATIONS RELATED TO THE OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20069 OLYMPUS COLONOSCOPE FTJ THE OLYMPUS OPTICAL CO. PCF-140L NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN