BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III COLONOVIDEOSCOPE

    MDR report key: 22208626 · Received June 15, 2025

    Report

    Report Number
    9610595-2025-11229
    Event Type
    Malfunction
    Date Received
    June 15, 2025
    Date of Event
    June 5, 2025
    Report Date
    June 15, 2025
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND A REPORTABLE MALFUNCTION WAS FOUND. BASED ON THE RESULTS OF THE INVESTIGATION, THE MOST PROBABLE CAUSE OF THE J-TUBE FOREIGN OBJECTS WAS TRACED TO COMPONENT FAILURE INDICATING EXPECTED OR RANDOM COMPONENT FAILURE WITHOUT ANY DESIGN OR MANUFACTURING ISSUE. 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 COLONOVIDEOSCOPE EXHIBITED FOREIGN MATERIAL ON J-TUBE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816486 EVIS EXERA III COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. CF-HQ190I

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown