BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS EVIS EXERA II DUODENOVIDEOSCOPE

    MDR report key: 2843790 · Received October 23, 2012

    Report

    Report Number
    8010047-2012-00401
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Report Date
    October 4, 2012
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FDT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH AN OLYMPUS CLINICAL ENDOTHERAPY SPECIALIST (CES) TO OBTAIN ADDITIONAL INFO. PER CES, DURING A ERCP, THE IMAGE WOULD COME AND GO. THE PROCEDURE WAS COMPLETED USING A DIFFERENT, BUT SIMILAR DEVICE. THE DEVICE WAS RETURNED TO OLYMPUS FOR EVAL. THE EVAL CONFIRMED TOTAL LOSS OF IMAGE. THE IMAGE WAS FLICKERING AND DISTORTED (BLACK AND WHITE). THE #1-4 SWITCHES WERE NOT WORKING PROPERLY. THE GLUE ON THE BENDING SECTION WAS CRACKED AND PEELING. THERE WAS MOISTURE INSIDE THE SCOPE CONNECTOR AND CORROSION IN THE ELECTRICAL CONNECTOR. THE IMAGE PROBLEM WAS ATTRIBUTED TO LOOSE OR POOR CONNECTION BETWEEN THE CHARGED COUPLE DEVICE (CDC) UNIT AND CONTROL BOARD INSIDE THE ELECTRICAL CONNECTOR, AND MINOR FLUID INVASION IN THE SCOPE CONNECTOR. THIS REPORT IS BEING SUBMITTED AS AN MDR IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ECRP), THE SCREEN WENT DARK, THEN BLACK. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS EVIS EXERA II DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORPORATION TJF-Q180V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK