BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS EVIS EXERA II XENON LIGHT SOURCE

    MDR report key: 1661491 · Received April 13, 2010

    Report

    Report Number
    8010047-2010-00072
    Event Type
    Malfunction
    Date Received
    April 13, 2010
    Date of Event
    March 16, 2010
    Report Date
    March 16, 2010
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    LYK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LIGHT SOURCE AND POWER CORD WERE RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION CONFIRMED THE USER'S REPORT THAT THE SYSTEM WOULD NOT POWER ON. ADDITIONALLY, THE LAMP COVER WAS FOUND TO BE DENTED AT THE KNOB. THERE WAS A BROWN DISCOLORATION AT THE FEMALE CONNECTOR OF THE POWER CORD, INDICATIVE OF A HIGH-TEMPERATURE EVENT. THE REAR PANEL FUSES WERE FOUND TO BE OPEN, AND THE CONVERTER UNIT WAS DAMAGED AND MELTED AT THE FUSE BOX. THE FUSES AND CONVERTER UNIT WERE REPLACED, AND THE LIGHT SOURCE PASSED ALL FUNCTIONAL AND ELECTRICAL TESTS. THE DEVICE WAS REPAIRED 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

    THE USER FACILITY REPORTED THAT THE LIGHT SOURCE POWERED OFF DURING THE START OF A DIAGNOSTIC COLONOSCOPY AND COULD NOT BE RESTARTED. THE USERS ATTEMPTED TO REPLACE THE POWER CORD WITHOUT SUCCESS. BROWN DISCOLORATION WAS REPORTEDLY OBSERVED ON THE END OF THE POWER CORD THAT HAD BEEN CONNECTED TO THE REAR PANEL OF THE DEVICE. THE USER FACILITY REPORTED THAT THE USERS WITHDREW THE UNIDENTIFIED ENDOSCOPE FROM THE PT, AND TRANSFERRED THE PT TO A DIFFERENT ROOM TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS SAID TO HAVE BEEN COMPLETED WITH A DIFFERENT, BUT SIMILAR VIDEO CART AND THE SAME ENDOSCOPE. THERE WAS NO PT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNIDENTIFIED ENDOSCOPE