BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III VIDEO SYSTEM CENTER

    MDR report key: 25211770 · Received May 18, 2026

    Report

    Report Number
    3002808148-2026-16622
    Event Type
    Malfunction
    Date Received
    May 18, 2026
    Date of Event
    April 28, 2026
    Report Date
    May 18, 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
    WI, US
    Reporter Occupation
    501

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VIDEO SYSTEM CENTER HAD DISPLAYED NO IMAGE. THE ISSUE WAS FOUND DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT. THE CUSTOMER CONTACTED OLYMPUS TECHNICAL ASSISTANCE SUPPORT (TAC) VIA PHONE, AND TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER REPORTED THAT THEY WERE NOT ABLE TO OBTAIN AN IMAGE USING THE CV-190 CONNECTED TO THE OEV-262 MONITOR. IT WAS FOUND THAT VIDEO WAS BEING SENT TO THE OEV-262 MONITOR ON THE BOOM AND TO THE LMD-2451 ON THE CART. IT WAS ALSO FOUND THAT THE CV-190 SDI 1 VIDEO OUTPUT WAS CONNECTED TO THE WALL, ROUTING TO THE OEV-262H BOOM MONITOR, AND THE SDI 2 VIDEO OUTPUT WAS CONNECTED TO THE PROVATION COMPUTER, WHICH WAS CURRENTLY DOWN. THE CUSTOMER STATED THAT THE LMD-2451 DID NOT DISPLAY AN IMAGE AND WAS INSTRUCTED TO SELECT THE COMPOSITE INPUT USING THE BUTTON ON THE TOP LEFT OF THE LMD-2451 MONITOR. AFTER THIS, AN IMAGE WAS OBTAINED. THE CUSTOMER WAS ALSO INSTRUCTED TO CONFIRM THAT SDI 1 WAS SELECTED ON THE OEV-262H MONITOR (PORT A SELECTION), AND AN IMAGE WAS OBTAINED. ALL MONITORS ARE CURRENTLY WORKING WITH THE CV-190 VIDEO OUTPUTS. THE CUSTOMER WILL NOW WORK WITH PROVATION TO RESOLVE THE NETWORK ISSUES. THE DEVICE WILL NOT BE RETURNED TO OLYMPUS FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263945 EVIS EXERA III VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET SHIRAKAWA OLYMPUS CO., LTD. CV-190 04953170298622

    Patients

    Seq Age Sex Outcome Treatment
    1