BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS EVIS EXERA II COLONOVIDEOSCOPE

    MDR report key: 1901659 · Received November 11, 2010

    Report

    Report Number
    8010047-2010-00226
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 5, 2010
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY SENT THE DEVICE TO OLYMPUS FOR EVAL. THE EVAL FOUND THE IMAGE TO BE FLICKERING AND STAINED. THE UNIT FAILED LEAK TESTING, AND WAS FOUND TO BE LEAKING AT THE BENDING SECTION. THE DEVICE ALSO FAILED THE DISTAL END INSULATION TEST AND CRACKS WERE OBSERVED IN THE DISTAL END COVER. THE BENDING SECTION COVER GLUE WAS PEELING AND DISCOLORED, AND THE LIGHT GUIDE LENSES WERE CHIPPED. THE INSERTION TUBE AND LIGHT GUIDE TUBES WERE BUCKLED, AND THE SWITCHES WERE NOT FUNCTIONAL. THERE WAS NO DATA TRANSMISSION FROM THE ID CHIP AND FLUID WAS PRESENT IN THE SCOPE CONNECTOR. THE DEVICE HAS BEEN REFURBISHED. THIS REPORT IS BEING SUBMITTED AS AN MDR IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A DIAGNOSTIC COLONOSCOPY, THE UNIT INITIALLY DISPLAYED LINES ON THE IMAGE, BUT THEN PROGRESSED TO A TOTAL LOSS OF IMAGE. THE USERS SWITCHED THE VIDEO CART ATTEMPTING TO OBTAIN AN IMAGE, HOWEVER THE LOSS OF IMAGE PERSISTED. THE PROCEDURE WAS COMPLETED WITH A SIMILAR BUT DIFFERENT ENDOSCOPE. THERE WAS NO PT INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1