BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III VIDEO SYSTEM CENTER

    MDR report key: 24377213 · Received February 18, 2026

    Report

    Report Number
    3002808148-2026-04514
    Event Type
    Malfunction
    Date Received
    February 18, 2026
    Date of Event
    January 28, 2026
    Report Date
    May 24, 2026
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    UDI-DI
    04953170298622
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE. THE CUSTOMER CONTACTED OLYMPUS TECHNICAL ASSISTANCE SUPPORT (TAC) VIA PHONE. THE CUSTOMER WAS NOT IN FRONT OF THE UNIT TO PERFORM TROUBLESHOOTING, AND THEREFORE NO TROUBLESHOOTING STEPS WERE CARRIED OUT. THE CUSTOMER WAS INSTRUCTED TO REMOVE THE SERIAL DIGITAL INTERFACE (SDI) CABLE FROM BOTH SIDES AND THEN RECONNECT THE SYSTEM BY ROUTING THE SERIAL DIGITAL INTERFACE (SDI) OUTPUT 1 TO THE SERIAL DIGITAL INTERFACE (SDI) TO DIGITAL VISUAL INTERFACE (DVI) CONVERTER BOX, AND CONNECTING THE CONVERTER BOX DIGITAL VISUAL INTERFACE (DVI) OUTPUT TO THE DIGITAL VISUAL INTERFACE (DVI) INPUT PORT ON THE SECOND NON-OLYMPUS AMERICA INC. (NON-OAI) MONITOR. THE CUSTOMER INFORMED TECHNICAL ASSISTANCE SUPPORT (TAC) OF THE EVENT. THE DEVICE WOULD NOT BE RETURNED TO OLYMPUS FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VIDEO SYSTEM CENTER HAD NO IMAGE. THE ISSUE WAS FOUND DURING THE INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44947 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