BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE VIDEO SYSTEM CENTER

    MDR report key: 18993962 · Received March 28, 2024

    Report

    Report Number
    3002808148-2024-02939
    Event Type
    Malfunction
    Date Received
    March 28, 2024
    Report Date
    April 14, 2024
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, IT IS LIKELY THAT THE NO VIDEO OUTPUT ON SERIAL DIGITAL INTERFACE (SDI) 1, 2 OCCURRED DUE A FAILURE OF THE PRINTED CIRCUIT BOARD. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE ELITE VIDEO SYSTEM CENTER EXHIBITED NO VIDEO OUTPUT ON SERIAL DIGITAL INTERFACE (SDI) 1 AND 2. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910261 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