BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 1021931 · Received March 28, 2008

    Report

    Report Number
    8010047-2008-00055
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Report Date
    February 28, 2008
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FTJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR INVESTIGATION. THE INVESTIGATION CONFIRMED THE USER'S REPORT OF IMAGE DIFFICULTY. THE IMAGE WAS FOUND TO CONTAIN STATIC AND FLICKER INTERMITTENTLY AFTER THE DEVICE WAS TESTED FOR SEVERAL HOURS. THERE WAS EVIDENCE OF FLUID FOUND INSIDE THE ENDOSCOPE CONNECTOR, AND A CRACK NOTED ON THE LIGHT GUIDE LENS. A LARGE DENT WAS OBSERVED ON THE DISTAL END COVER. ADDITIONALLY, THE VARIABLE STIFFNESS AND ANGULATION CONTROL KNOBS WERE DETERMINED TO NOT FUNCTION PROPERLY DUE TO STRETCHED COIL AND ANGLE WIRES, LIKELY DUE TO EXTENDED USE. THE BENDING COVER WAS DISASSEMBLED AND BROKEN/FRAYED WIRES WERE FOUND ON THE BENDING SECTION MESH, ALSO DUE TO EXTENSIVE USAGE. FOLLOWING AERATION, THE UNIT WAS RETESTED AND THE IMAGE WAS FOUND TO BE WITHIN STANDARD. AS THE UNIT PASSED LEAK TESTING, USER HANDLING CANNOT BE RULED OUT AS THE SOURCE OF THE FLUID INVASION. THIS REPORT IS BEING FILED AS AN MDR IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A COLONOSCOPY, A COMPLETE LOSS OF IMAGE WAS EXPERIENCED, AND THE IMAGE COULD NOT BE RECOVERED. THE PROCEDURE WAS REPORTEDLY COMPLETED WITH A DIFFERENT, BUT SIMILAR DEVICE. THERE WAS NO PATIENT INJURY AND NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS EVIS EXERA CLONOVIDEOSCOPE FTJ OLYMPUS MEDICAL SYSTEMS CORPORATION CF-Q160AL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK