BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE VIDEO SYSTEM CENTER

    MDR report key: 18141778 · Received November 15, 2023

    Report

    Report Number
    3002808148-2023-12917
    Event Type
    Malfunction
    Date Received
    November 15, 2023
    Date of Event
    October 24, 2023
    Report Date
    December 22, 2023
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND THE CUSTOMER'S IMAGE ISSUE WAS NOT REPRODUCED. THE DEVICE EVALUATION FOUND THE APPEARANCE OF THE PRODUCT WAS NOT DAMAGED, NO ABNORMALITIES FOUND INTERNALLY, THE ENDOSCOPE IMAGE WAS NORMAL. IT'S CONFIRMED THAT THE DVI SIGNAL, SDL SIGNAL, AND YC SIGNAL WERE ALL OUTPUT NORMALLY. THE REPORTED ISSUE WASN'T FOUND. THE INVESTIGATION IS ONGOING AND FOLLOW UP WITH THE USER FACILITY IS CURRENTLY BEING PERFORMED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, THE ROOT CAUSE COULD NOT BE IDENTIFIED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, THE EVIS LUCERA ELITE VIDEO SYSTEM CENTER VIDEO OUTPUT HAD NO SIGNAL. THE ISSUE WAS FOUND DURING PREPARATION BEFORE USE FOR A DIAGNOSTIC GASTROSCOPY. THERE WERE NO REPORTS OF PATIENT HARM. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292145 EVIS LUCERA ELITE VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET SHIRAKAWA OLYMPUS CO., LTD. CV-290

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CLV-290SL EVIS LUCERA XENON LIGHT SOURCE.