BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA XENON LIGHT SOURCE

    MDR report key: 9514544 · Received December 24, 2019

    Report

    Report Number
    8010047-2019-04581
    Event Type
    Malfunction
    Date Received
    December 24, 2019
    Date of Event
    December 2, 2019
    Report Date
    December 23, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GCT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) INVESTIGATED THE SUBJECT DEVICE AND FOUND THAT THE RGB FILTER WAS MISSING. THERE IS A POSSIBILITY THAT THE ABNORMAL NOISE WAS ATTRIBUTED TO FALLING OFF OF THE RGB FILTER DURING ROTATION. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. OMSC SURMISED THAT THE RGB FILTER WAS DAMAGED DUE TO DEGRADED WITH AGE. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING THE PROCEDURE OF ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD), AN ABNORMAL NOISE OCCURRED FROM THE SUBJECT DEVICE AND THE ENDOSCOPIC IMAGE BECAME MONOCHROME. THE USER REPLACED THE USED ENDOSCOPIC SYSTEM WITH A SIMILAR SYSTEM AND COMPLETED THE PROCEDURE. AFTER THE PROCEDURE, THE FIELD ENGINEER CHECKED THE SUBJECT DEVICE AND FOUND THAT THE RGB FILTER OF THE SUBJECT DEVICE WAS NOT ROTATING. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT. THE USER FACILITY DID NOT PROVIDE OTHER DETAILED INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1310427 EVIS LUCERA XENON LIGHT SOURCE XENON LIGHT SOURCE GCT OLYMPUS MEDICAL SYSTEMS CORP. CLV-260SL

    Patients

    Seq Age Sex Outcome Treatment
    1