BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS EVIS EXERA COLONOVIDEOSCOPE

    MDR report key: 2200752 · Received July 27, 2011

    Report

    Report Number
    8010047-2011-00171
    Event Type
    Injury
    Date Received
    July 27, 2011
    Report Date
    June 27, 2011
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FDF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY VIA TELEPHONE AND IN WRITING TO OBTAIN ADDITIONAL INFO REGARDING THE REPORT, BUT WITH NO RESULT. THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED FOR EVAL. THE EVAL DID NOT DUPLICATE THE USER'S REPORT OF "STIFFNESS DURING ANGULATIONS," AS THE VARIABLE STIFFNESS WORKED APPROPRIATELY DURING THE EVAL OF THE DEVICE. THERE WAS A PLAY OBSERVED ON THE CONTROL KNOB DUE TO A STRETCHED ANGULATION WIRES. IN ADDITION, THE LIGHT GUIDE LENS WAS CHIPPED, AND THERE WAS NO LIGHT OUTPUT FROM ONE OF THE LIGHT GUIDE LENSES. THE BENDING SECTION COVER GLUE WAS CRACKED, PEELING, AND DISCOLORED. THE LIGHT GUIDE BUNDLE AT THE BENDING SECTION WAS FOUND TO BE DAMAGED. THE DEVICE WAS REFURBISHED. THE DEVICE INSTRUCTION MANUAL INSTRUCT USERS "TO INSPECT THE AIR/WATER NOZZLE AT THE DISTAL END OF THE ENDOSCOPE'S INSERTION SECTION FOR ABNORMAL SWELLING, BULGES, DENTS, OR OTHER IRREGULARITIES. NEVER USE THE ENDOSCOPE ON A PT IF AN IRREGULARITY IS OBSERVED. DAMAGE OR AN IRREGULARITY IN THE INSTRUMENT MAY COMPROMISE PT OR USER SAFETY." THE EXACT CAUSE OF THE PT'S OUTCOME COULD NOT BE CONCLUSIVELY DETERMINED. 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 AN UNSPECIFIED PROCEDURE, THEY EXPERIENCED STIFFNESS DURING ANGULATION, AND CLAIMED THAT THE ANGULATIONS WERE OFF AND ALLEGEDLY SCARRING THE MUCOSA. NO FURTHER INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS EVIS EXERA COLONOVIDEOSCOPE COLONOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORPORATION CF-Q160L NA

    Patients

    Seq Age Sex Outcome Treatment
    1