BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE COLONOVIDEOSCOPE

    MDR report key: 20863524 · Received December 6, 2024

    Report

    Report Number
    9610595-2024-40391
    Event Type
    Malfunction
    Date Received
    December 6, 2024
    Date of Event
    November 7, 2024
    Report Date
    February 21, 2025
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    E1: FACILITY NAME: (B)(6) HOSPITAL. E2/E3: NO INFORMATION AVAILABLE FOR THE OCCUPATION OF THE INITIAL REPORTER OR WHETHER THEY ARE A HEALTHCARE PROFESSIONAL. 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 REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE FOLLOWING FIELDS WERE UPDATED: D4, D10, H2, H4 AND H6 CODING. THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION, AND THE CUSTOMER'S REPORTED EVENT WAS CONFIRMED. BASED ON THE INFORMATION PROVIDED FROM THE INVESTIGATION, THE CAUSE OF THE SCOPE COMMUNICATION ERROR WAS DUE TO DAMAGE TO THE IMAGE SENSOR UNIT (E.G., DISCONNECTION) OR FAILURE OF MOUNTED COMPONENTS (IC CHIP, CAPACITOR, ETC.) ON THE ELECTRICAL BOARD DUE TO STRESS FROM USE, EXTERNAL FACTORS, OR HANDLING. HOWEVER, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED; THE SUBJECT DEVICE HAD NO IMAGE. THE ISSUE WAS FOUND DURING A DIAGNOSTIC COLONOSCOPY PROCEDURE AND WAS COMPLETED USING A SIMILAR DEVICE. NO PATIENT HARM WAS REPORTED BY THE CUSTOMER.

    Description of Event or Problem · 0

    NO NEW INFORMATION PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2094456 EVIS LUCERA ELITE COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. CF-HQ290ZI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown