BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III VIDEO SYSTEM CENTER

    MDR report key: 22413415 · Received July 7, 2025

    Report

    Report Number
    3002808148-2025-10172
    Event Type
    Malfunction
    Date Received
    July 7, 2025
    Date of Event
    June 9, 2025
    Report Date
    July 7, 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
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER CONTACTED OLYMPUS TECHNICAL ASSISTANCE SUPPORT (TAC). THE CUSTOMER INFORMED TAC OF THE EVENT THAT WHEN CONNECTING THE SDI CABLE TO SDI OUT 1 AND 2 IN THE CV-190 TO SDI IN 1 ON THE OEV-262H AND SELECTED SDI 1 ON PORT A BUT NO IMAGE DISPLAYED. TAC INSTRUCTED CUSTOMER TO CONNECT THE SDI CABLE TO COMP OUT IN THE CV-190 TO VIDEO IN IN THE OEV-262H AND SELECT VIDEO ON PORT A AND HE CONFIRMED THE IMAGE DISPLAYED NORMALLY. 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 SUBJECT DEVICE EXHIBITED NO IMAGE ISSUE. THE ISSUE OCCURRED DURING SET UP / INSPECTION FOR USE (DURING SET UP IN ROOM / BEFORE PATIENT IN ROOM). THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2756704 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 OEV-262H