BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS EVIS EXERA 11 COLONOVIDEOSCOPE

    MDR report key: 1983665 · Received February 2, 2011

    Report

    Report Number
    8010047-2011-00018
    Event Type
    Malfunction
    Date Received
    February 2, 2011
    Date of Event
    January 7, 2011
    Report Date
    January 7, 2011
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS CONTACTED THE USER FACILITY TO OBTAIN ADDITIONAL INFO REGARDING THIS REPORT VIA PHONE AND IN WRITING WITH NO RESULT. THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVAL. THE EVAL INITIALLY DUPLICATED A COMPLETE LOSS OF IMAGE, WHICH WAS RESOLVED AFTER AERATION. THE ELECTRICAL CONNECTOR WAS DISASSEMBLED AND WAS FOUND TO HAVE EVIDENCE OF FLUID INVASION ON THE CCD-FPC ASSEMBLY UNIT, WHICH COULD HAVE CONTRIBUTED TO THE REPORTED PHENOMENON. THE COLONVIDEOSCOPE PASSED THE LEAKAGE TESTING. THE CAUSE OF THE FLUID INVASION WAS LIKELY RESULTED FROM USERS NOT ATTACHING THE WATER RESISTANT CAP TO THE DEVICE DURING REPROCESSING. THE SUBJECT DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED TYPE OF COLONOSCOPY PROCEDURE, THE USERS EXPERIENCED A COMPLETE LOSS OF IMAGE. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS EVIS EXERA 11 COLONOVIDEOSCOPE COLONOSCOPE FDF OLYMPUS MEDICAL SYSTEM CORPORATION CF-Q180AL NA

    Patients

    Seq Age Sex Outcome Treatment
    1