BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III VIDEO SYSTEM CENTER

    MDR report key: 24618284 · Received March 17, 2026

    Report

    Report Number
    3002808148-2026-07136
    Event Type
    Malfunction
    Date Received
    March 17, 2026
    Date of Event
    February 18, 2026
    Report Date
    May 29, 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
    OH, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ENDOSCOPY ACCOUNT MANAGER (EAM) CALLED OLYMPUS TECHNICAL ASSISTANCE SUPPORT (TAC) FROM THE CUSTOMER SITE AND REPORTED NO IMAGE WHEN SCOPE WAS ATTACHED. THE ISSUE WAS ORIGINALLY DISCOVERED BY THE CUSTOMER THE DAY BEFORE AND WAS CONFIRMED BY EAM. THE CUSTOMER WILL CALL BACK TO ARRANGE FOR RETURN MERCHANDISE AUTHORIZATION (RMA). 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 THE VIDEO SYSTEM CENTER HAD NO IMAGE DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484905 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 180 SERIES SCOPES| MAJ-1430