BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 24218064 · Received January 29, 2026

    Report

    Report Number
    9610595-2026-09987
    Event Type
    Malfunction
    Date Received
    January 29, 2026
    Report Date
    January 29, 2026
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    UDI-DI
    04953170305276
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE RESULTS OF THE INVESTIGATION, OLYMPUS CONFIRMED FOREIGN MATERIAL CAME OUT OF THE DEVICE, AND THE TYPE OF THE MATERIAL WAS IDENTIFIED AS SILICONE WHICH LIKELY CAUSED DEPOSITS OF WHITE FOREIGN MATERIAL WITHIN THE AIR/WATER CHANNEL AND CYLINDER. HOWEVER, THE DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE. A CAPA HISTORY REVIEW WAS PERFORMED AND NO RELATED CAPAS WERE FOUND. 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 THE INVESTIGATIONS OF CAPA, 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. THE CUSTOMER REQUEST IS NOT CONFIRMED. HOWEVER, ADDITIONAL FINDINGS WERE IDENTIFIED DURING DEVICE INSPECTION THAT ARE SUBJECT TO INVESTIGATION. THE MOST PROBABLE CAUSE OF THE ADDITIONAL FAILURE(S) IS CAUSE NOT ESTABLISHED, WHICH INDICATES THAT THE INVESTIGATION FINDINGS DO NOT LEAD TO A CLEAR CONCLUSION ABOUT THE CAUSE OF THE REPORTED ADVERSE EVENT. THE MOST PROBABLE CAUSE OF THE FAILURES RELATED TO WHITE FOREIGN MATERIAL 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). NO FURTHER ESCALATION IS REQUIRED.

    Description of Event or Problem · 0

    IT WAS OBSERVED DURING THE DEVICE EVALUATION THAT THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED FOREIGN OBJECTS WITHIN THE AIR/WATER CHANNEL AND CYLINDER . THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278485 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-HQ190 04953170305276

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown