BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS EVIS EXERA DUODENOVIDEOSCOPE

    MDR report key: 1243001 · Received November 20, 2008

    Report

    Report Number
    8010047-2008-00194
    Event Type
    Malfunction
    Date Received
    November 20, 2008
    Date of Event
    October 30, 2008
    Report Date
    November 4, 2008
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FDT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR INVESTIGATION. THE INVESTIGATION FOUND EVIDENCE OF FLUID INVASION AND CORROSION IN THE ENDOSCOPE CONNECTOR AND ELECTRICAL CONNECTOR. IN ADDITION, THE DEVICE WAS FOUND TO HAVE A LEAK IN THE BIOPSY CHANNEL. ADDITIONALLY, THERE WAS SOME WHITE DISCOLORATION NOTED IN THE BENDING SECTION CEMENT. THE SUBJECT DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER. THE CAUSE OF THE LEAK COULD NOT CONCLUSIVELY BE DETERMINED, HOWEVER, THE INTERMITTENT IMAGE ISSUES WERE LIKELY DUE TO FLUID INVASION. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), WATER WAS NOTED TO EXPEL CONTINUOUSLY FROM THE NOZZLE AS THE ENDOSCOPE WAS INSERTED INTO THE PT. THE IMAGE WAS REPORTED TO HAVE FLICKERED ON AND OFF, BUT THERE WAS NO COMPLETE LOSS OF IMAGE OBSERVED. THE PROCEDURE WAS SAID TO HAVE BEEN ABORTED, AND WAS RESCHEDULED. THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS EVIS EXERA DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORPORATION TJF-160F NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK