BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II XENON LIGHT SOURCE

    MDR report key: 2232971 · Received July 22, 2011

    Report

    Report Number
    8010047-2011-00169
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 29, 2011
    Report Date
    June 29, 2011
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GCT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS F/U WITH THE USER FACILITY TO OBTAIN ADD'L INFO REGARDING THIS REPORT. THE USER FACILITY REPORTED THAT THE REPORTED PHENOMENON OCCURRED TOWARD THE END OF THE PROCEDURE WHEN THE ENDOSCOPE WAS BEING WITHDRAWN FROM THE CECUM. THE PROCEDURE WAS REPORTEDLY ABORTED. THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVAL, HOWEVER, THE MAIN XENON LAMP WAS NOT RETURNED WITH THE UNIT. THE UNIT WAS OPERATED FOR SEVERAL HOURS WITH THE MAIN XENON LAMP POWERED-ON, AND THE DEVICE OPERATED APPROPRIATELY. THE LIGHT SOURCE WAS ABLE TO IGNITE THE XENON LAMP WITHOUT ANY ISSUES, AND THE SPARE LAMP WAS CONFIRMED TO OPERATE APPROPRIATELY. FURTHER INSPECTION NOTED THAT THE CONVERTER FUSE WAS DISCOLORED AND THERE WAS EVIDENCE OF A HIGH TEMPERATURE EVENT, HOWEVER, IT COULD NOT BE DETERMINED IF THIS FINDING WAS ASSOCIATED WITH THE REPORTED EVENT. THE CONVERTER FUSE WAS DISCOLORED AND BORE EVIDENCE OF HIGH HEAT. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER. 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 TOWARD THE END OF AN UNSPECIFIED COLONOSCOPY PROCEDURE, THE SUBJECT DEVICE SHUT DOWN COMPLETELY, AND THE USERS EXPERIENCED A COMPLETE LOSS OF IMAGE. THERE WAS NO PT HARM REPORTED, HOWEVER, THE PROCEDURE WAS SAID TO HAVE BEEN ABORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNIDENTIFIED MODEL OF OLYMPUS COLONOSCOPE