BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III VIDEO SYSTEM CENTER

    MDR report key: 23916931 · Received December 29, 2025

    Report

    Report Number
    3002808148-2025-26764
    Event Type
    Malfunction
    Date Received
    December 29, 2025
    Date of Event
    December 27, 2024
    Report Date
    December 29, 2025
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    UDI-DI
    04953170298622
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR INSPECTION AND WAS RESOLVED WITH OLYMPUS TECHNICAL SUPPORT TEAM. THE CUSTOMER CONTACTED OLYMPUS TECHNICAL ASSISTANCE SUPPORT (TAC) VIA PHONE. THE CUSTOMER INFORMED TAC THAT COLOR BARS APPEARED WHEN THE 190-SERIES SCOPE WAS CONNECTED. AFTER TROUBLESHOOTING WITH TAC, IT WAS CONFIRMED THAT THE OEP-5'S INPUT SELECT VALUE WAS SET TO SDI, WHICH WAS THEN CHANGED TO COMPONENT. ADDITIONALLY, THE CUSTOMER WAS ASKED TO RESET BOTH THE MAJ-1933 AND MAJ-1941 CABLES AND TO REMOVE THE MAJ-1430 CABLE WHEN USING THE 190-SERIES SCOPE. THE CUSTOMER RETESTED THE 190-SERIES SCOPE AND CONFIRMED THAT THE SYSTEM NOW DETECTS THE 190-SERIES SCOPE. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THAT THE EVENT OCCURRED DUE TO THE CONFIGURATION FAILURE. THREE ATTEMPTS WERE PERFORMED TO OBTAIN ADDITIONAL INFORMATION, BUT NO RESPONSE WAS RECEIVED FROM THE CUSTOMER. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE VIDEO SYSTEM CENTER HAD COLOR BARS WHEN THE SCOPE WAS CONNECTED. THE ISSUE OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2847771 EVIS EXERA III VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET SHIRAKAWA OLYMPUS CO., LTD. CV-190 04953170298622

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown