BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III COLONOVIDEOSCOPE

    MDR report key: 23563180 · Received November 14, 2025

    Report

    Report Number
    9610595-2025-32295
    Event Type
    Malfunction
    Date Received
    November 14, 2025
    Date of Event
    November 6, 2025
    Report Date
    November 14, 2025
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    UDI-DI
    04953170305115
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS REPORTED BECAUSE ANGULATION KNOB IS VERY STIFF. THE PRODUCT WAS RETURNED TO THE OLYMPUS SERVICE TEAM. THE PRODUCT ANALYSIS CONFIRMED THAT: CONTROL KNOB MV: HEAVY, CONTROL KNOB OUT OF SPECIFICATION. CONTROL BODY: (AD) DRY A/W CHANNEL AND CYLINDER HAVE A WHITE DETERGENT SOLUTION. A SHR REVIEW WAS NOT CONDUCTED ON THIS PREVIOUSLY SERVICED DEVICE AS THE COMPLAINT IS NOT RELATED TO A DEATH, INFECTION, OR PATIENT INJURY. A LABELING REVIEW IS NOT REQUIRED AS THERE IS NO EVIDENCE TO SUGGEST THAT THE USER MAY NOT HAVE PROPERLY HANDLED/USED THE DEVICE IN ACCORDANCE WITH THE IFU. A RISK REVIEW WAS PERFORMED FOR A040607, A1803 BASED ON HISTORICAL DATA AND NO UNANTICIPATED RISKS, NEW FAILURES, AND/OR NEW HARMS WERE IDENTIFIED. A HISTORICAL REVIEW OF THE LAST 12 MONTHS OF COMPLAINTS WAS PERFORMED FOR A040607, AND NO TRENDS WERE IDENTIFIED. A CAPA HISTORY REVIEW WAS PERFORMED FOR A040607, A1803 AND NO RELATED CAPAS WERE FOUND. THE COMPLAINT WAS CONFIRMED; THE DEVICE CONTROL KNOB TORQUE FAILED. THE MOST PROBABLE CAUSE OF THE COMPLAINT IS D02 - CAUSE TRACED TO COMPONENT FAILURE EXPECTED OR RANDOM COMPONENT FAILURE WITHOUT ANY DESIGN OR MANUFACTURING ISSUE. NO FURTHER ESCALATION IS REQUIRED.

    Description of Event or Problem · 0

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION THE SUBJECT DEVICE HAD A WHITE DETERGENT SOLUTION IN THE AIR/WATER CHANNEL AND CYLINDERS. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2852522 EVIS EXERA III COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. CF-HQ190L 04953170305115

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown