BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS EVIS EXERA COLONOVIDEOSCOPE

    MDR report key: 2160493 · Received June 30, 2011

    Report

    Report Number
    8010047-2011-00144
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 1, 2011
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    FTJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED-UP WITH THE USER FACILITY TO GATHER ADDITIONAL INFORMATION REGARDING THIS REPORT. THE USER FACILITY REPORTED THAT THE IMAGE BECAME INTERMITTENT, DEVELOPED HORIZONTAL AND VERTICAL LINES, AND THE REMAINING IMAGE WAS SNOWY WHEN THE SUBJECT DEVICE REACHED THE CECUM. THE USERS REPORTEDLY ATTEMPTED TO TROUBLESHOOT WITHOUT SUCCESS. THE DEVICE REFERENCE IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION CONFIRMED THAT THE IMAGE ON THE SCOPE WAS FOUND FLICKERING INTERMITTENTLY WHEN THE BENDING SECTION WAS MANIPULATED. THE CAUSE OF THE PHENOMENON WAS ISOLATED TO THE CCD UNIT. THE UNIT WAS SERVICED AND RETURNED TO THE USER FACILITY. 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 IMAGE QUALITY DEVELOPED LINES AND SNOW TO THE EXTENT THE USERS COULD NO LONGER VISUALIZE THE PATIENT'S ANATOMICAL STRUCTURES. THE INTENDED PROCEDURE WAS COMPLETED WITH A DIFFERENT OLYMPUS ENDOSCOPE. THERE WAS NO PATIENT HARM REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS COLONOSCOPE: UNSPECIFIED SERIAL/MODEL #