BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS X1 VIDEO SYSTEM CENTER

    MDR report key: 21185722 · Received January 17, 2025

    Report

    Report Number
    3002808148-2025-01101
    Event Type
    Malfunction
    Date Received
    January 17, 2025
    Date of Event
    December 19, 2024
    Report Date
    January 17, 2025
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    PMA / PMN Number
    K222861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE RESULTS OF THE INVESTIGATION, IT WAS CONFIRMED THAT THE PROBLEM OF NO IMAGE OUTPUT COULD BE RESOLVED BY REPLACING THE CIRCUIT BOARD. A DEFINITE ROOT CAUSE OF THE REPORTED ISSUE 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 FOUND DURING DEVICE EVALUATION THAT THERE WAS NO VIDEO OUTPUT FROM THE THIRD GENERATION SERIAL DIGITAL INTERFACE (3G-SGI) OF THE VIDEO SYSTEM CENTER. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876598 EVIS X1 VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET SHIRAKAWA OLYMPUS CO., LTD. CV-1500

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown