BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS X1 VIDEO SYSTEM CENTER

    MDR report key: 23716091 · Received December 4, 2025

    Report

    Report Number
    3002808148-2025-24170
    Event Type
    Malfunction
    Date Received
    December 4, 2025
    Date of Event
    November 14, 2025
    Report Date
    February 23, 2026
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    UDI-DI
    04953170414596
    PMA / PMN Number
    K222861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE FINAL INVESTIGATION. UPDATED FIELDS: D8; G3; H2; H6 AND H11 THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR INSPECTION; HOWEVER, OLYMPUS SALES REP AND FIELD SERVICE ENGINEER (FSE) WAS IN THE CALL WITH TECHNICAL ASSISTANCE CENTER (TAC). CUSTOMER WAS SATISFIED THAT THE CABLING WAS CORRECT. TAC EMAILED THE SALES REP THE INSTALL AND CONFIGURATION FIELD GUIDE. THE SCOPE SWITCH FUNCTIONS WERE MODIFIED TO ACCOMMODATE THE PHYSICIANS. TWO SCOPE SWITCHES WERE PROGRAMMED FOR RELEASE 1, AS WELL AS SWITCHES FOR REMOTE, DIGITAL VIDEO RECORDER (DVR) START/PAUSE AND DIGITAL FILING SYSTEM. TROUBLESHOOTING WAS ABLE TO RESOLVE THE REPORTED ALLEGATION. THE COMPLAINT WAS CONFIRMED. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, THE MOST PROBABLE CAUSE WAS NOT ESTABLISHED. 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 HAD BEEN REPORTED THAT THE VIDEO SYSTEM CENTER N CARE WOULD NOT RELEASE THE VIDEO. THE EVENT OCCURRED DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1827798 EVIS X1 VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET SHIRAKAWA OLYMPUS CO., LTD. CV-1500 04953170414596

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown