BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II DUODENOVIDEOSCOPE

    MDR report key: 19485470 · Received June 7, 2024

    Report

    Report Number
    9610595-2024-11531
    Event Type
    Malfunction
    Date Received
    June 7, 2024
    Report Date
    July 3, 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
    AU
    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 7 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. DURING THE DEVICE EVALUATION, AN ADDITIONAL FINDING WAS IDENTIFIED: FOREIGN MATERIAL AROUND THE FORCEPS ELEVATOR. BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, IT IS LIKELY THAT THE STAIN INSIDE THE LIGHT GUIDE LENS OCCURRED BECAUSE THE ADHESION LOCATION OF THE FOREIGN MATERIAL WAS NOT ON THE EXTERNAL SURFACE OF THE DEVICE, MAKING IT UNREMOVABLE THROUGH REPROCESSING. THE LIGHT GUIDE LENS GLUE MAY HAVE PEELED OFF DUE TO PHYSICAL STRESS FROM IMPACT OR DROPPING THE DISTAL END, CHEMICAL STRESS FROM SOLUTIONS USED, OR SIMILAR FACTORS. SUBSEQUENTLY, HUMIDITY INVADED THE LIGHT GUIDE LENS, CAUSING CORROSION. ADDITIONALLY, REGARDING THE FOREIGN MATERIAL FOUND ON THE FORCEPS ELEVATOR, IT MAY HAVE REMAINED DUE TO IMPROPER REPROCESSING OR WEAR AND TEAR ON THE DEVICE. STAIN INSIDE THE LIGHT GUIDE-LENS EVENT CAN BE DETECTED BY FOLLOWING THE INSTRUCTIONS FOR USE (IFU): IFU STATES THE DETECTION METHOD IN EVIS EXERA II TJF TYPE Q180V OPERATION MANUAL CHAPTER 3 PREPARATION AND INSPECTION. FORCEPS ELEVATOR EVENT CAN BE PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE (IFU): 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. 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 DISCOLORATION INSIDE OF THE LIGHT GUIDE LENS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1285958 EVIS EXERA II DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT AIZU OLYMPUS CO., LTD. TJF-Q180V 04953170367311

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown