BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH DEFINITION LCD MONITOR

    MDR report key: 21204860 · Received January 21, 2025

    Report

    Report Number
    3002808148-2025-01208
    Event Type
    Malfunction
    Date Received
    January 21, 2025
    Date of Event
    January 1, 2025
    Report Date
    March 28, 2025
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    UDI-DI
    04953170363498
    PMA / PMN Number
    K102379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS NOT CONFIRMED. THE CUSTOMER CONTACTED OLYMPUS TECHNICAL ASSISTANCE SUPPORT (TAC) VIA PHONE. TROUBLESHOOTING STEPS: THE OEV-262H NOW HAS A BUILT-IN AC POWER SUPPLY. THIS IS A CHANGE FROM THE OEV-261H, WHICH ALWAYS REQUIRED A SEPARATE POWER SUPPLY BOX. THE OEV-262H WORKS WITH AN AC POWER SUPPLY WITHOUT ANY SEPARATE BOX. IN ORDER TO USE A DC POWER SOURCE, AN OPTIONAL AC ADAPTER BOX IS REQUIRED. THEREFORE, THIS OPTIONAL ADAPTER BOX IS REQUIRED IN SOME WHERE THE AC CABLE CANNOT BE WIRED IN THE CEILING, WHERE THE MONITOR IS PLACED ON A BOOM AND OTHER SURGICAL AND INTEGRATION SCENARIOS. THIS ITEM CAN BE ORDERED SEPARATELY AS ITEM ¿AC-110MD¿. THE POWER SUPPLY FROM THE OEV-261H IS NOT COMPATIBLE WITH THE OEV-262H. THE CUSTOMER INFORMED TAC OF THE EVENT. THE DEVICE WILL NOT BE RETURNED TO OLYMPUS FOR EVALUATION. A ROOT CAUSE COULD NOT BE IDENTIFIED. A CAUSE CANNOT BE ESTABLISHED DUE TO NO FINDINGS AVAILABLE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    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

    NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SUBJECT DEVICE DOES NOT POWER ON WHEN USING AN OLD DC POWER ADAPTER. THE EVENT OCCURRED DURING INSTALLATION. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589720 HIGH DEFINITION LCD MONITOR HIGH DEFINITION LCD MONITOR FET SHIRAKAWA OLYMPUS CO., LTD. OEV262H 04953170363498

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown OEV-261H.