BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS EVIS EXERA II COLONOVIDEOSCOPE

    MDR report key: 1924982 · Received November 23, 2010

    Report

    Report Number
    8010047-2010-00237
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 27, 2010
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY VIA TELEPHONE AND IN WRITING, HOWEVER, NO ADD'L INFO WAS PROVIDED. THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVAL. THE EVAL CONFIRMED THE USERS REPORT OF IMAGE DIFFICULTY. THE UNIT DISPLAYED A COLOR BAR PATTERN, AND THERE WAS NO ENDOSCOPE IDENTIFICATION DATA TRANSMISSION. SWITCH FOUR WAS NOT WORKING. THE DEVICE WAS EXTENSIVELY FLUID INVADED, WITH FLUID FOUND INSIDE THE BENDING SECTION, CONTROL BODY, ELECTRICAL CONNECTOR, ENDOSCOPE CONNECTOR, AND ELECTRICAL CONNECTOR. THERE WERE SCRATCHES ON THE OBJECTIVE LENSES. THERE WERE FOUR BROKEN LIGHT GUIDE BUNDLES. SWITCH #4 WAS NOT FUNCTION. THE CAUSE OF THE IMAGE DIFFICULTY WAS ATTRIBUTED TO FLUID INVASION. THE CAUSE OF THE FLUID INVASION COULD NOT BE CONCLUSIVELY DETERMINED, HOWEVER, AS THE DEVICE PASSED LEAK TESTING, USER HANDLING IS LIKELY. THIS REPORT IS BEING SUBMITTED AS MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A UNSPECIFIED COLONOSCOPY PROCEDURE, THE USERS EXPERIENCED A COMPLETE LOSS OF IMAGE. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. THERE WAS NO PT INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK