BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE VIDEO SYSTEM CENTER

    MDR report key: 18914344 · Received March 15, 2024

    Report

    Report Number
    3002808148-2024-02472
    Event Type
    Malfunction
    Date Received
    March 15, 2024
    Date of Event
    March 4, 2024
    Report Date
    April 12, 2024
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE CUSTOMER'S NO VIDEO MALFUNCTION WAS CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 8 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS PRESUMED THAT DUE TO PROLONGED USE, A SHORT CIRCUIT ON PRINTED CIRCUIT BOARD (DX BOARD) CAUSED NO VIDEO OUTPUT FROM SERIAL DIGITAL INTERFACE (SDI) OUTPUT TERMINAL. HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED AND THE EVALUATION FOUND NO VIDEO FROM THE SERIAL DIGITAL INTERFACE OUTPUT TERMINAL DUE TO HAVING NO IMAGE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED, THE VIDEO SYSTEM CENTER HAD NO IMAGE FROM THE SERIAL DIGITAL INTERFACE OUTPUT TERMINAL. THE ISSUE OCCURRED DURING PREPARATION FOR USE FOR AN UNSPECIFIED PROCEDURE. THE PROCEDURE WAS COMPLETED BY OUTPUTTING FROM A DIFFERENT TERMINAL; USING THE SAME SET OF EQUIPMENT. THERE WERE NO REPORTS OF DELAY, PATIENT HARM, INJURY, OR DEATH. ADDITIONAL DETAILS RELATING TO THE PATIENT AND THE EVENT HAVE BEEN REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1411451 EVIS LUCERA ELITE VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET SHIRAKAWA OLYMPUS CO., LTD. CV-290

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown LIGHT SOURCE