BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH DEFINITION LCD MONITOR

    MDR report key: 23511446 · Received November 10, 2025

    Report

    Report Number
    3002808148-2025-21773
    Event Type
    Malfunction
    Date Received
    November 10, 2025
    Date of Event
    October 16, 2025
    Report Date
    March 2, 2026
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    UDI-DI
    04953170363498
    PMA / PMN Number
    K102379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER CONTACTED OLYMPUS TECHNICAL ASSISTANCE SUPPORT (TAC) VIA PHONE. CUSTOMER POWERED CYCLED THE MONITOR AND THE ISSUE WAS RESOLVED. THE CUSTOMER INFORMED TAC OF THE EVENT. THE DEVICE WILL NOT BE RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE FINAL INVESTIGATION. UPDATED FIELDS: D8, H2, H6, H11. THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR INSPECTION, AND THE REPORTED FAILURE WAS NOT CONFIRMED. HOWEVER, TECHNICAL ASSISTANCE CENTER (TAC) PROVIDED REMOTE TROUBLESHOOTING, AFTER A REPORT THAT THE OEV-262H / 7193270 DISPLAY MONITOR SHOWED A SOLID GREEN IMAGE DURING A DIAGNOSTIC ENDOSCOPY PROCEDURE, WITH NO ERROR CODES DISPLAYED. THE ISSUE OCCURRED WHILE ALL INSTRUMENTS WERE OUTSIDE THE PATIENT AND NO SEDATION HAD TAKEN PLACE. THE CUSTOMER POWER-CYCLED THE MONITOR, AFTER WHICH NORMAL IMAGE WAS RESTORED. BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. 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 THAT THE MONITOR HAD GREEN IMAGE. THE ISSUE WAS FOUND DURING A DIAGNOSTIC ENDOSCOPY PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1928239 HIGH DEFINITION LCD MONITOR HIGH DEFINITION LCD MONITOR FET SHIRAKAWA OLYMPUS CO., LTD. OEV262H 04953170363498

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown