BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLONOVIDEOSCOPE

    MDR report key: 22968500 · Received September 4, 2025

    Report

    Report Number
    9610595-2025-19952
    Event Type
    Malfunction
    Date Received
    September 4, 2025
    Date of Event
    August 14, 2025
    Report Date
    September 4, 2025
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    PMA / PMN Number
    K250432
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: DUE TO DAMAGE ON J-TUBE (AUXILIARY WATER CHANNEL) IN CONTROL UNIT, THE J-TUBE HAS FOREIGN OBJECTS. 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 OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED FOREIGN OBJECTS IN THE AUXILIARY WATER CHANNEL. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1675976 COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. CF-EZ1500DL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown