BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE COLONOVIDEOSCOPE

    MDR report key: 23301920 · Received October 15, 2025

    Report

    Report Number
    9610595-2025-25991
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Report Date
    December 2, 2025
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    BASED ON THE RESULTS OF THE INVESTIGATION, AND SINCE THE DEVICE MALFUNCTION WAS NOT CONFIRMED DURING EVALUATION, THE DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE. UPDATED FIELDS: D8, H2, H3, H6, H11.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE COLONOVIDEOSCOPE EXHIBITED NO IMAGE. THE REPORTED ISSUE OCCURRED DURING INSPECTION FOR USE BEFORE THE EXAMINATION AND THERE WERE NO REPORTS OF PATIENT HARM. *THIS INQUIRY IS A CLONE OF PARENT INQUIR INQ-596506. THIS INQUIRY CAPTURES PRODUCT PCF-H290ZI PREVIOUS OCCURENCE, SEE INQ-596995 FOR CV-1500 PREVIOUS OCCURENCE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2337496 EVIS LUCERA ELITE COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. PCF-H290ZI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CV-1500