BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS VISERA XENON LIGHT SOURCE

    MDR report key: 4914624 · Received July 15, 2015

    Report

    Report Number
    8010047-2015-00577
    Event Type
    Malfunction
    Date Received
    July 15, 2015
    Date of Event
    April 30, 2015
    Report Date
    June 18, 2015
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GCT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS CONFIRMED THAT THE SPARE LAMP ON THE SUBJECT CLV-S45 LIGHTED UP WHEN THE SUBJECT DEVICE WAS TURNED ON. THE SUBJECT DEVICE WORKED PROPERLY TO REPLACE THE SUBJECT XENON LAMP TO ANOTHER ONE. THE SUBJECT XENON LAMP LIGHTED UP WHEN BEING EQUIPPED WITH ANOTHER CLV-S45. OLYMPUS CHECKED THE IGNITER UNIT AND THE XENON LAMP SUSPECTED AS THE CAUSE OF THIS PHENOMENON IN DETAIL, BUT THERE WAS NO ABNORMALITY IN THESE PARTS SO FAR. OLYMPUS ALSO CHECKED THE MANUFACTURING HISTORY OF THE SUBJECT DEVICE, AND THERE WAS NO IRREGULARITY FOUND. THE ISSUE IS UNDER INVESTIGATION, SO OLYMPUS WILL SUBMIT A SUPPLEMENTAL MDR REPORT AFTER THE CAUSE OF THIS PHENOMENON IS DETERMINED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Additional Manufacturer Narrative · 1

    THIS IS A SUPPLEMENTAL REPORT FOR MFR REPORT #8010047-2015-00577 TO PROVIDE DEVICE EVALUATION RESULTS. AS FOR THE FURTHER INVESTIGATION FOR THIS PHENOMENON, OLYMPUS CONFIRMED THAT THE SUBJECT XENON LAMP TURNED ON PROPERLY AFTER THE XENON LAMP AND THE IGNITER UNIT WERE MOUNTED ON A SPARE CLV-S45. OLYMPUS COULD NOT DETERMINE THE CAUSE OF THIS PHENOMENON BECAUSE THE PHENOMENON WAS NOT REPRODUCED. THE PHENOMENON MIGHT BE ATTRIBUTED TO LIGHTING FAILURE BY TEMPORARY IMPROPER BEHAVIOR OF THE IGNITER UNIT OR TO VOLTAGE BOOST FAILURE BY HUMIDITY AND ATMOSPHERIC PRESSURE IN THE FACILITY. IN ADDITION, LAMP SUPPLY VOLTAGE FROM THE CONVERTOR OF THE SUBJECT DEVICE MIGHT DROP, OR SUPPLY VOLTAGE OF THE SUBJECT DEVICE MIGHT LOWER DUE TO THE FACILITY SURROUNDINGS. THE INSTRUCTION MANUAL OF CLV-S45 ALREADY MENTIONS CAUTIONS FOR THE DEVICE HANDLING. THERE WERE NO FURTHER DETAILS PROVIDED. 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 THE MONITOR BECAME DARK AND THE IMAGE TURNED RED DURING THE LAPAROSCOPIC APPENDECTOMY. THE FACILITY CONVERTED THE PROCEDURE TO AN OPEN SURGERY AND COMPLETED IT. THE PATIENT IS DOING WELL AFTER THE OPEN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458686 OLYMPUS VISERA XENON LIGHT SOURCE LIGHT SOURCE GCT OLYMPUS MEDICAL SYSTEMS CORPORATION CLV-S45

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization