BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II DUODENOVIDEOSCOPE

    MDR report key: 19634182 · Received June 28, 2024

    Report

    Report Number
    9610595-2024-13028
    Event Type
    Malfunction
    Date Received
    June 28, 2024
    Date of Event
    June 16, 2024
    Report Date
    August 6, 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
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    TESTS HAVE SHOWED THAT THE DEVICE WAS OUT OF SPECIFICATION. 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 NINE (9) YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE INVESTIGATION RESULTS, SIMETHICONE WAS USED IN THE BIOPSY CHANNEL AT THE USER FACILITY. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED, BUT IT IS LIKELY THAT THE FOREIGN MATERIAL WAS NOT REMOVED BECAUSE REPROCESSING WAS IMPROPERLY CONDUCTED DUE TO LEAKAGE FROM THE FORCEPS ELEVATOR. ADDITIONALLY, THE LIGHT GUIDE LENS GLUE WAS DAMAGED BY PHYSICAL (STRESS SUCH AS HITTING OR DROPPING THE DISTAL END) AND CHEMICAL STRESS FROM SOLUTIONS. THIS DAMAGE ALLOWED HUMIDITY TO INVADE THE LIGHT GUIDE LENS, LEADING TO CORROSION. THE SUGGESTED EVENTS ARE DETECTABLE/PREVENTABLE BY HANDLING THE DEVICE IN ACCORDANCE WITH THE FOLLOWING INSTRUCTIONS FOR USE (IFU). INSTRUCTIONS FOR USE (IFU) STATES THE DETECTION METHOD IN EVIS EXERA II TJF TYPE Q180V OPERATION MANUAL CHAPTER 3 PREPARATION AND INSPECTION. INSTRUCTIONS FOR USE (IFU) STATES THE PREVENTATIVE MEASURES IN EVIS EXERA II TJF TYPE Q180V REPROCESSING CHAPTER 5 REPROCESSING THE ENDOSCOPE (AND RELATED REPROCESSING ACCESSORIES). INSTRUCTIONS FOR USE (IFU) STATES THE DETECTION METHOD IN EVIS EXERA II TJF TYPE Q180V OPERATION MANUAL CHAPTER 3 PREPARATION AND INSPECTION. 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 DUODENOVIDEOSCOPE EXHIBITED A DISCOLORATION INSIDE THE LIGHT GUIDE LENS AND FOREIGN MATERIAL IN THE AIR/WATER TUBE AND THE AIR/WATER CYLINDER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820216 EVIS EXERA II DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT AIZU OLYMPUS CO., LTD. TJF-Q180V 04953170367311

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown