BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLONOVIDEOSCOPE

    MDR report key: 25247533 · Received May 21, 2026

    Report

    Report Number
    9610595-2026-41593
    Event Type
    Malfunction
    Date Received
    May 21, 2026
    Date of Event
    February 9, 2026
    Report Date
    May 21, 2026
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    PMA / PMN Number
    K112680
    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. THE MOST PROBABLE CAUSE OF THE LIGHT GUIDE LENS HAD CORROSION WAS CAUSE TRACED TO COMPONENT FAILURE AND FOR FOREIGN OBJECTS IN C-COVER, NOZZLE AND CONNECTING TUBE WAS CAUSE NOT DETERMINED. 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

    THE COLONOVIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF AIR/WATER FUNCTION MALFUNCTION. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, FOREIGN OBJECTS IN C-COVER, NOZZLE AND IN CONNECTING TUBE AND LIGHT GUIDE LENS HAD CORROSION WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12547 COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. CF-H170I

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown