BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III COLONOVIDEOSCOPE

    MDR report key: 23191416 · Received October 1, 2025

    Report

    Report Number
    9610595-2025-23591
    Event Type
    Malfunction
    Date Received
    October 1, 2025
    Report Date
    October 1, 2025
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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: THE MOST PROBABLE CAUSE OF THE FAILURE IS KNOWN INHERENT RISK OF DEVICE, WHICH INDICATES THAT THE REPORTED ADVERSE EVENT IS KNOWN AND DOCUMENTED IN THE LABELING AND ALL REASONABLE MITIGATION STEPS HAVE BEEN TAKEN (INCLUDING BOTH SHORT OR LONG TERM KNOWN COMPLICATIONS OR ADVERSE REACTIONS). THE MOST PROBABLE CAUSE OF THE FAILURE IS CAUSE TRACED TO COMPONENT FAILURE INDICATING EXPECTED OR RANDOM COMPONENT FAILURE WITHOUT ANY DESIGN OR MANUFACTURING ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. A COMPLAINT HISTORY REVIEW FOR WHITE FOREIGN MATERIAL WAS REFERRED TO CAPA-201632. A CAPA HISTORY REVIEW WAS PERFORMED AND CAPA-201632 WAS IDENTIFIED TO BE RELATED TO THIS COMPLAINT THE WHITE FOREIGN MATERIAL DETECTED BY INCOME INSPECTION HAS BEEN HANDLED BY OMSC CAPA-201632. ACCORDING TO PREVIOUS INVESTIGATIONS, THE USE OF PRODUCTS THAT CONTAIN SILICONE CAN CAUSE DEPOSITS OF WHITE FOREIGN MATERIAL. SILICONE IS FOR EXAMPLE INCLUDED IN SIMETHICONE, A DEFOAMING AGENT, LUBRICANTS AND SO ON. IF THE CUSTOMER USED THEM, THERE WAS RISK THAT FOREIGN MATERIAL WAS REMAINED IN THE CHANNEL EVEN IF THE REPROCESSING WAS CONDUCTED IN ACCORDANCE WITH IFU. SIMETHICONE AND PETROLEUM/OIL/SILICONE-BASED LUBRICANTS ARE NON-WATER SOLUBLE AND THUS NOT RECOMMENDED FOR USE BY OLYMPUS. FCA PROCESS HAS BEEN INITIATED FOR WHITE FOREIGN MATERIAL (HHA NO.: FY25-087). IF ANY ACTION IS REQUIRED TO THE CUSTOMER, IT WILL BE CONDUCTED IN ACCORDANCE WITH FCA PROCESS. THE CAPA IS IN OPEN STATUS. THE CAPA OWNER WAS INFORMED ABOUT THIS COMPLAINT. 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 COLONO VIDEOSCOPE EXHIBITED A CLOGGED J-TUBE IN CONTROL UNIT AND FOREIGN MATERIAL IN THE J-TUBE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1673286 EVIS EXERA III COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. PCF-H190L

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown