BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS EVIS EXERA II COLONOVIDEOSCOPE

    MDR report key: 2050904 · Received March 31, 2011

    Report

    Report Number
    8010047-2011-00064
    Event Type
    Other
    Date Received
    March 31, 2011
    Date of Event
    November 16, 2010
    Report Date
    November 16, 2010
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED WAS NOT RETURNED TO OLYMPUS FOR EVAL. THE USERS WERE REPORTEDLY FLUSHING EACH PORT USING A 20 CC SYRINGE, AND THE SCOPE WAS MANUALLY DISINFECTED WITH HIGH LEVEL DISINFECTANT (CIDEX OPA). AN OLYMPUS ENDOSCOPE SUPPORT SPECIALIST HAS PROVIDED IN-SERVICE TRAINING TO USERS AT THIS FACILITY AND REVIEWED APPROPRIATE REPROCESSING OF THIS DEVICE. IF ADD'L AND SIGNIFICANT INFO BECOMES AVAILABLE AT A LATER TIME, THEN THIS REPORT WILL BE SUPPLEMENTED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED BY THE USER FACILITY DURING AN IN-SERVICE THAT THE FACILITY REPROCESSED A SCOPE FOLLOWING A PROCEDURE USING THE SAME CLEANING SOLUTION FROM THE PREVIOUS PROCEDURE. THE WATER AND THE DETERGENT WERE NOT MEASURED. A DISPOSABLE CLEANING BRUSH WAS BEING REUSED. THE SUCTION CLEANING ADAPTER WAS NOT BEING USED. THE AUXILLIARY WATER TUBE WAS SHORTENED IN LENGTH AND THE SUCTION CLEANING ADAPTOR WAS NOT BEING UTILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS EVIS EXERA II COLONOVIDEOSCOPE COLONOSCOPE FDF OLYMPUS MEDICAL SYSTEM CORPORATION CF-H180AL NA

    Patients

    Seq Age Sex Outcome Treatment
    1