BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III DUODENOVIDEOSCOPE

    MDR report key: 19068747 · Received April 8, 2024

    Report

    Report Number
    9610595-2024-07343
    Event Type
    Malfunction
    Date Received
    April 8, 2024
    Report Date
    May 13, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDT
    UDI-DI
    04953170405563
    PMA / PMN Number
    K220587
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE DEVICE EVALUATION AND THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE WAS EVALUATED BY OLYMPUS, AND THE FOLLOWING WAS OBSERVED: RESIDUAL WHITE FOREIGN MATERIAL NOTED INSIDE THE AIR/WATER TUBE. RESIDUAL WHITE FOREIGN MATERIAL NOTED INSIDE THE AIR/WATER CYLINDER. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, ALTHOUGH FOREIGN MATERIAL WAS CONFIRMED IN THE AIR/WATER TUBE AND THE AIR/WATER CYLINDER, THE SPECIFIC MATERIAL COULD NOT BE IDENTIFIED. HOWEVER, FOREIGN MATERIAL WAS LIKELY NOT REMOVED DUE TO INSUFFICIENT REPROCESSING CAUSED BY LEAKAGE FROM THE FORCEPS ELEVATOR. ALTHOUGH, THE ROOT CAUSE OF THE FOREIGN MATERIAL REMAINING IN THE DEVICE COULD NOT BE DETERMINED. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE (IFU) WHICH STATE: "OPERATION MANUAL: CHAPTER 3 PREPARATION AND INSPECTION ¿ DETECTION METHODS"; "REPROCESSING MANUAL: CHAPTER 5 REPROCESSING THE ENDOSCOPE ¿ PREVENTION METHODS". OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE DUODENVIDEOSCOPE HAD A FOREIGN MATERIAL EXCITING FROM THE AIR/WATER NOZZLE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS CONFIRMED BY THE CUSTOMER THAT THE DEVICE WAS CLEANED, DISINFECTED, AND STERILIZED BEFORE RETURNING TO OLYMPUS FOR INSPECTION. THE AIR/WATER NOZZLE WAS FLUSHED WITH WATER AND AIR DURING THE MANUAL CLEANING PROCESS. IT WAS ALSO CONFIRMED THAT THE REPROCESSING ACCESSORIES WERE NOT DAMAGED, AND THAT THE REPROCESSING STEPS WERE FOLLOWED ACCORDING TO OLYMPUS RECOMMENDATIONS. THERE WERE NO MEDICATIONS ADMINISTERED VIA THE DEVICE USED DURING THE PROCEDURE. THE CUSTOMER WAS UNABLE TO IDENTIFY THE WHITE FOREIGN MATERIAL FOUND IN THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2423716 EVIS EXERA III DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT AIZU OLYMPUS CO., LTD. TJF-Q190V 04953170405563

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown