BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II DUODENOVIDEOSCOPE

    MDR report key: 19722003 · Received July 11, 2024

    Report

    Report Number
    9610595-2024-13839
    Event Type
    Malfunction
    Date Received
    July 11, 2024
    Report Date
    July 31, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDT
    UDI-DI
    04953170367311
    PMA / PMN Number
    K143153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER EIGHT (8) YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. ALTHOUGH WE CONFIRMED THE SUGGESTED EVENTS ON THE PHOTOS PROVIDED, WE COULD NOT IDENTIFY THE FOREIGN MATERIAL BASED ON THE FACTS OBTAINED FROM THE INVESTIGATION, THE INSPECTION THE FOREIGN MATERIAL DETECTED BY INCOMING INSPECTION HAD THE CHARACTERISTICS AS THE WHITE FOREIGN MATERIAL HANDLED BY OMSC CAPA-201632. ACCORDING TO CAPA-201632, THE WHITE FOREIGN MATERIAL COULD BE CAUSED BY ANTI-GAS PRODUCT INCLUDING SIMETHICONE. IF THE CUSTOMER USED SIMETHICONE, THERE WAS RISK THAT FOREIGN MATERIAL REMAINED IN THE CHANNEL EVEN IF REPROCESSING WAS CONDUCTED IN ACCORDANCE WITH IFU. OLYMPUS DOES NOT RECOMMEND THE USE OF SIMETHICONE AND THERE IS A CAUTION IN IFU. THE REPORTED FAULT WAS LIKELY A RESULT OF INSUFFICIENT REPROCESSING AND WEAR AND TEAR. THE EVENTS CAN BE DETECTED AND PREVENTED IN ACCORDANCE WITH THE FOLLOWING SECTIONS OF THE INSTRUCTIONS FOR INSTRUCTIONS FOR USE: IFU STATES THE DETECTION METHOD IN EVIS EXERA II TJF TYPE Q180V OPERATION MANUAL CHAPTER 3 PREPARATION AND INSPECTION. IFU STATES THE PREVENTIVE MEASURE IN EVIS EXERA II TJF TYPE Q180V REPROCESSING CHAPTER 5 REPROCESSING THE ENDOSCOPE (AND RELATED REPROCESSING ACCESSORIES). OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE DUODENOVIDEOSCOPE EXHIBITED AIR/WATER CYLINDER HAS FOREIGN OBJECTS AND AIR/WATER-TUBE HAS FOREIGN OBJECTS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2380809 EVIS EXERA II DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT AIZU OLYMPUS CO., LTD. TJF-Q180V 04953170367311

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown