BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLONOVIDEOSCOPE

    MDR report key: 23338240 · Received October 20, 2025

    Report

    Report Number
    9610595-2025-26713
    Event Type
    Malfunction
    Date Received
    October 20, 2025
    Date of Event
    September 22, 2025
    Report Date
    October 20, 2025
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    UDI-DI
    04953170334184
    PMA / PMN Number
    K112680
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE CUSTOMER REPORTED FAILURE WAS NOT CONFIRMED. HOWEVER IT WAS DISCOVERED THAT THE IMAGE HAD LINEAR SCRATCHES. BASED ON THE RESULTS OF THE INVESTIGATION, A ROOT CAUSE FOR THE BLINKING IMAGE COULD NOT BE DETERMINED AS THE ISSUE WAS NOT REPRODUCED. IN REGARDS TO THE LINEAR SCRATCHES ON THE IMAGE, IT IS LIKELY THIS ISSUE OCCURRED DUE TO A DAMAGED CHARGED COUPLED DEVICE (CDD) UNIT. 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 REPORTED THAT THE SUBJECT DEVICE'S IMAGE BLINKED. THE ISSUE OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968312 COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. CF-H170I 04953170334184

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown