BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE VIDEO SYSTEM CENTER

    MDR report key: 17596697 · Received August 22, 2023

    Report

    Report Number
    3002808148-2023-08733
    Event Type
    Malfunction
    Date Received
    August 22, 2023
    Date of Event
    July 27, 2023
    Report Date
    November 3, 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

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE 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. IT HAS BEEN OVER THREE (3) YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. A DEFINITIVE ROOT CAUSE WAS NOT IDENTIFIED, HOWEVER BASED ON THE RESULTS OF THE INVESTIGATION, THE PROBABLE CAUSE OF THE MALFUNCTION WOULD LIKELY BE A DEFECTIVE PRINTED CIRCUIT BOARD. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    (B)(6). THE DEVICE WAS RETURNED AND EVALUATED, AND THE CUSTOMER¿S ALLEGATION OF NO SIGNAL OUTPUT UNDER THE DIGITAL VIDEO INTERFACE CHANNEL WAS CONFIRMED. DEVICE EVALUATION FOUND NO IMAGE UNDER THE DIGITAL VIDEO INTERFACE CHANNEL WHICH WAS DUE TO A DEFECTIVE PRINTED CIRCUIT BOARD. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    Description of Event or Problem · 0

    THE OLYMPUS REPRESENTATIVE REPORTED (ON BEHALF OF THE CUSTOMER) THAT THE EVIS LUCERA ELITE VIDEO SYSTEM CENTER HAD NO SIGNAL OUTPUT UNDER THE DIGITAL VIDEO INTERFACE CHANNEL. THE ISSUE WAS FOUND DURING INSPECTION AFTER PROCEDURE, AND THE INTENDED DIAGNOSTIC PROCEDURE (GASTROSCOPE) WAS COMPLETED WITH THE SAME DEVICE AND WITHOUT DELAY. THE PATIENT WAS NOT UNDER ANESTHESIA. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53564 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 - ENDOSCOPIC LIGHT SOURCE