BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS VISERA ELITE XENON LIGHT SOURCE

    MDR report key: 2800306 · Received October 9, 2012

    Report

    Report Number
    8010047-2012-00329
    Event Type
    Malfunction
    Date Received
    October 9, 2012
    Date of Event
    September 10, 2012
    Report Date
    September 10, 2012
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GCT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CLV-S190 WAS RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION FOUND THAT THE COOLING FAN OF THE CLV-S190 SOUNDED ABNORMAL NOISE AND AFTER A FEW MINUTES, IT WAS DISAPPEARED. THEN THE CLV-S190 OPERATED CORRECTLY. OLYMPUS CONFIRMED THE INSIDE OF THE CLV-S190 OPERATED CORRECTLY. OLYMPUS CONFIRMED THE INSIDE OF THE CLV-S190, THERE WAS NO ABNORMALITY. THERE WAS A POSSIBILITY THAT TEMPORARY PROBLEM OF THE FAN ATTRIBUTED TO THIS PHENOMENON, BUT EXACT CAUSE OF THE USER'S EXPERIENCE COULD NOT BE CONCLUSIVELY DETERMINED. ALSO, OLYMPUS CHECKED THE MANUFACTURE HISTORY OF THE SUBJECT DEVICE; THERE WAS NO IRREGULARITY FOUND. OLYMPUS STATED THE APPROPRIATE HANDLING OF THE CLV-S190 IN THE INSTRUCTION MANUAL WHEN THE CLV-S190 HAD ABNORMALITIES. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED. 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 LAPAROSCOPIC APPENDECTOMY, THE MAIN LAMP OF THE CLV-S190 WENT OUT AND THE SPARE LAMP OF THE CLV-S190 WAS LIT. BECAUSE THE MAIN LAMP WAS NOT LIT ANYMORE, THE PHYSICIAN CHANGED THE SYSTEM TO ANOTHER ONE. THE PROCEDURE WAS COMPLETED. THERE WAS NO PT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS VISERA ELITE XENON LIGHT SOURCE LIGHT SOURCE GCT OLYMPUS MEDICAL SYSTEMS CORPORATION CLV-S190 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR