BEUDAMED
    FDA Adverse Event Summary report: N

    OLYMPUS

    MDR report key: 476392 · Received July 21, 2003

    Report

    Report Number
    MW4003557
    Date Received
    July 21, 2003
    Report Date
    May 27, 2003
    Manufacturer
    OLYMPUS AMERICA INC.
    Product Code
    FDF
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    OLYMPUS BRAND COLONOSCOPES, MODEL CFQ 160AL, WERE NOT ADEQUATELY STERILIZED AS THEY DID NOT BEAR ADEQUATE DIRECTIONS FOR STERILIZATION. THE MODEL CFQ160AL, HAS A NEW IRRIGATION PORT WHICH THE OLDER MODELS DID NOT HAVE, AND APPARENTLY OLYMPUS DID NOT PROVIDE ITS CUSTOMERS WITH ADEQUATE LABELING, NOR THE PROPER STERILIZATION CONNECTOR, TO FACILITATE THE PROPER CARE AND CLEANING OF THIS PORT. THIS RESULTED IN THE USER FACILITY NOT REALIZING IT WAS SUPPOSED TO CLEAN THIS PORT. SUBSEQUENTLY, THE HOSP CONFIRMED ITS USER ERROR SITUATION, THEN NOTIFIED OVER 700 PTS, INCLUDING THE CONSUMER, THAT THEY MAY HAVE CONTACTED AN INFECTIOUS DISEASE. THE HOSP HAS DETERMINED 3 PTS HAVE INFECTIOUS DISEASE. THE HOSP HAS DETERMINED 3 PTS HAVE INFECTIOUS DISEASES WHICH ARE POSSIBLY RELATED TO USE OF THE COLONOSCOPES. THE CONSUMER IS CONCERNED THAT THIS PROBLEM EXTENDS TO OTHER HOSPITALS (IT DOES) AND STATES (UNK), AND THAT THEY MAY HAVE CONTRACTED AN INFECTIOUS DISEASE, OTHER THAN THE LIMITED NUMBER OF DISEASES FOR WHICH THE HOSP IS TESTING PTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS COLONOSCOPE FDF OLYMPUS AMERICA INC. * NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *