BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS

    MDR report key: 470144 · Received June 10, 2003

    Report

    Report Number
    470144
    Event Type
    Other
    Date Received
    June 10, 2003
    Date of Event
    October 17, 2001
    Report Date
    June 10, 2003
    Manufacturer
    OLYMPUS
    Product Code
    FTJ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    OLYMPUS CFQ 160 AL VIDEO COLONSCOPE WAS NOT PROPERLY CLEANED AND STERILIZED ACCORDING TO MFR INSTRUCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS COLONOSCOPE FTJ OLYMPUS CFQ 160 A1 *

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other