BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS EVIS EXERA II XENON LIGHT SOURCE

    MDR report key: 2101933 · Received May 17, 2011

    Report

    Report Number
    8010047-2011-00098
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 18, 2011
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GCT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED-UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFO REGARDING THIS REPORT. THE USER FACILITY STATED THAT THE COMPLETE LOSS OF IMAGE OCCURRED IN THE MIDDLE OF THE PROCEDURE WHEN THE USER HAD NOT YET REACHED THE CECUM. THE USER FACILITY REPORTEDLY ATTEMPTED TO COMPLETE THE INTENDED PROCEDURE WITH A DIFFERENT ENDOSCOPE BUT WAS UNABLE TO RECOVER THE IMAGE. THE PROCEDURE WAS REPORTEDLY DELAYED FOR AN UNSPECIFIED PERIOD OF TIME. THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVAL. THE EVAL DID NOT CONFIRM THE USER'S REPORT, AND FOUND THE DEVICE TO OPERATE APPROPRIATELY, HOWEVER THE AIR JOINT ON THE ENDOSCOPE CONNECTOR WAS NOTED TO BE WORN. THE DEVICE 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 A DIAGNOSTIC COLONOSCOPY PROCEDURE, THE USERS EXPERIENCED AN IMAGE THAT INCLUDED A BRIGHT LIGHT IN THE CENTER, BUT WAS DARK AROUND THE EXTERIOR OF THE BRIGHT AREA, AND THE IMAGE COULD NOT BE VIEWED. THE PROCEDURE WAS REPORTEDLY NOT COMPLETED. THERE WAS NO REPORT OF PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS EVIS EXERA II XENON LIGHT SOURCE LIGHT SOURCE GCT OLYMPUS MEDICAL SYSTEMS CORPORATION CLV-180 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS CV-180 VIDEO PROCESSOR: SERIAL NUMBER UNK