BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS EVIS COLONOVIDEOSCOPE

    MDR report key: 2260380 · Received August 19, 2011

    Report

    Report Number
    8010047-2011-00191
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    June 21, 2011
    Report Date
    July 21, 2011
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED-UP WITH THE USER FACILITY TO GATHER ADDITIONAL INFO REGARDING THIS REPORT. THE USER FACILITY REPORTED THAT IT WAS UNK AT WHAT POINT DURING THE PROCEDURE WAS THE COMPLETE LOSS OF IMAGE EXPERIENCED. THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION DID NOT CONFIRM THE USER'S REPORT. THE IMAGE WAS FOUND FINE. THERE WAS EVIDENCE OF FLUID INVASION IN THE ELECTRICAL CONNECTOR WHICH COULD HAVE CONTRIBUTED TO THE REPORTED PHENOMENON. THE DISTAL END COVER WAS CRACKED AND THE DEVICE FAILED THE INSULATION TEST. THE INSERTION TUBE WAS NOTED WITH DISCOLORATION WHICH WAS ATTRIBUTED TO CHEMICAL DAMAGE. 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 A DIAGNOSTIC COLONOSCOPY PROCEDURE, THE USERS EXPERIENCED A COMPLETE LOSS OF IMAGE. THE INTENDED PROCEDURE WAS COMPLETED USING A DIFFERENT BUT SIMILAR OLYMPUS COLONOSCOPE. THERE WAS NO PT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS EVIS COLONOVIDEOSCOPE COLONOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORPORATION CF-Q140L NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNSPECIFIED MODEL AND SERIAL NUMBERS OF| OLYMPUS COLONOSCOPE