BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III COLONOVIDEOSCOPE

    MDR report key: 23861216 · Received December 21, 2025

    Report

    Report Number
    9610595-2025-41552
    Event Type
    Malfunction
    Date Received
    December 21, 2025
    Date of Event
    November 22, 2025
    Report Date
    February 18, 2026
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    UDI-DI
    04953170305115
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION/INSPECTION. BASED ON THE RESULTS OF THE INVESTIGATION, THE FOREIGN MATERIAL COULD NOT BE IDENTIFIED. IT IS LIKELY THE RESULT OF INSUFFICIENT REPROCESSING; HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE. ONE OR MORE FAILURE MODE(S) IDENTIFIED HAS BEEN PREVIOUSLY INVESTIGATED THROUGH THE PRODUCT TECHNICAL INVESTIGATION (PTI) PROCESS AND THEREFORE DOES NOT REQUIRE ANY FURTHER INVESTIGATION. SEE CODING TABLE FOR THE PTI REFERENCE NUMBER ASSOCIATED WITH THESE FAILURE MODES. 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 AND COMPLAINT HISTORY REVIEW WAS NOT PERFORMED ON A27 - APPROPRIATE TERM/CODE NOT AVAILABLE, AS WHITE RESIDUE IN THE AIR/WATER CHANNEL HAS BEEN TRENDED AND ESCALATED IN CAPA-201632. A CAPA HISTORY REVIEW WAS PERFORMED ON 22 NOV 2025 FOR THE FAILURE MODES LISTED BELOW AND THE FOLLOWING RELATED CAPAS WERE/WAS FOUND. THIS REVIEW WAS PERFORMED FOR CF-HQ190L AND ADDITIONAL SEARCHED TERMS WHITE FOREIGN BODY WHITE RESIDUE IN A/W CHANNEL LG SIDE (A27 - APPROPRIATE TERM/CODE NOT AVAILABLE & G04134 - TUBE) WHERE CAPA-201632 WAS IDENTIFIED TO BE RELATED. REFERENCE CAPA-201632 REMAINS OPEN AT THIS TIME AND COUNTERMEASURES MAY CHANGE THROUGHOUT THE CAPA PROCESS. PLEASE REFERENCE THE CAPA FOR UP-TO-DATE DETAILS ON COUNTERMEASURES. WHITE RESIDUE INSIDE CHANNEL - A SAMPLE OF THE FM COULD NOT BE RETAINED FOR TESTING. THE COMPLAINT WAS CONFIRMED, THE DEVICE LEAKING FROM INSTRUMENT CHANNEL AND HAVE LOW ANGULATION. THE MOST PROBABLE CAUSE OF THE COMPLAINT IS DUE D02 - CAUSE TRACED TO COMPONENT FAILURE WHICH IS EXPECTED OR RANDOM COMPONENT FAILURE WITHOUT ANY DESIGN OR MANUFACTURING ISSUE. DUE TO C0703 - LEAKAGE/SEAL AND C070606 - WEAR PROBLEM. NO FURTHER ESCALATION IS REQUIRED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE A CORRECTION TO A PREVIOUSLY SUBMITTED REPORT. CORRECTED FIELD: H11. THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. BASED ON THE RESULTS OF THE INVESTIGATION, THE FOREIGN MATERIAL COULD NOT BE IDENTIFIED. IT IS LIKELY THE RESULT OF INSUFFICIENT REPROCESSING; HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. 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 FLEX VIDEO SCOPE EXHIBITED WHITE RESIDUES ON THE AIR/WATER CHANNEL BOTH SIDES. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1874587 EVIS EXERA III COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. CF-HQ190L 04953170305115

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown