BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE XENON LIGHT SOURCE

    MDR report key: 8127795 · Received December 4, 2018

    Report

    Report Number
    8010047-2018-02367
    Event Type
    Malfunction
    Date Received
    December 4, 2018
    Date of Event
    November 12, 2018
    Report Date
    March 15, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GCT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) INVESTIGATED THE SUBJECT CLV-290 AND COULD REPRODUCE THE REPORTED PHENOMENON. AS A RESULT OF INVESTIGATION, THE MOTOR OF THE RGB FILTER UNIT WAS BROKEN IN THE SUBJECT CLV-290. THEREFORE, IT IS CONSIDERED THAT AN ERROR OCCURRED BECAUSE THE RGB FILTER UNIT WAS NOT SET AT AN APPROPRIATE POSITION AND COULD NOT OPERATE CORRECTLY. OMSC SURMISED THAT FAILURE OF THE MOTOR OF THE RGB FILTER UNIT WAS ATTRIBUTED TO THE FOLLOWING. -AGING DEGRADATION -THE USAGE ENVIRONMENT OF THE FACILITY, SUCH AS THE INGRESS OF THE DUST. THE CLV-290 INSTRUCTION MANUAL STATES THE CORRESPONDING METHOD WHEN THERE IS AN ABNORMALITY FOR THE DEVICE. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS SUBMITTING TO CORRECT "DEVICE PRODUCT CODE".

    Additional Manufacturer Narrative · 1

    THE SUBJECT CLV-290 HAS BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION, HOWEVER THE EVALUATION IS IN PROGRESS AT THIS TIME. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. THE CLV-290 INSTRUCTION MANUAL STATES THE CORRESPONDING METHOD WHEN THERE IS AN ABNORMALITY FOR THE DEVICE. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    DURING THE PROCEDURE OF PEG (PERCUTANEOUS ENDOSCOPIC GASTROSTOMY), THE ERROR "E202" OCCURRED AND THE ENDOSCOPIC IMAGE WAS DISAPPEARED. ¿E202¿ IS THE ERROR THAT ¿THE LIGHT SOURCE HAS BROKEN DOWN¿. THE USER REPLACED THE SUBJECT CLV-290 WITH THE SIMILAR DEVICE, AND COMPLETED THE PROCEDURE. THERE WAS NO REPORT OF THE PATIENT¿S INJURY REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    971448 EVIS LUCERA ELITE XENON LIGHT SOURCE XENON LIGHT SOURCE GCT OLYMPUS MEDICAL SYSTEMS CORP. CLV-290

    Patients

    Seq Age Sex Outcome Treatment
    1