BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III DUODENOVIDEOSCOPE

    MDR report key: 19149349 · Received April 19, 2024

    Report

    Report Number
    9610595-2024-08327
    Event Type
    Malfunction
    Date Received
    April 19, 2024
    Date of Event
    April 7, 2024
    Report Date
    May 15, 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
    003

    Narratives

    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 5 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THAT THE LIGHT GUIDE LENS GLUE WAS PEELED OFF DUE TO PHYSICAL STRESS BY HITTING/DROPPING THE DISTAL END, CHEMICAL STRESS BY CHEMICAL SOLUTIONS, OR SIMILAR FACTORS. IN ADDITION TO THAT, HUMIDITY INVADED THE LIGHT GUIDE LENS AND CAUSED CORROSION. HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED BASED ON THE RESULTS OF THE INVESTIGATION AND THE INFORMATION PROVIDED, IT IS LIKELY THAT THE FOREIGN MATERIAL WAS SIMETHICONE AND THAT MIGHT NOT HAVE BEEN REMOVED FROM THE DEVICE DUE TO THE DEVIATION FROM THE INSTRUCTIONS FOR USE (IFU) DURING DEVICE REPROCESSING. THERE WAS NO DAMAGE TO THE AREA WHERE THE FOREIGN MATERIAL WAS DETECTED. THEREFORE, THE CAUSE OF THE MATERIAL REMAINING IN THE DEVICE COULD NOT BE DETERMINED. THE INSTRUCTION MANUAL STATES THE DETECTION METHOD ASSOCIATED WITH THE EVENT STAIN INSIDE THE LIGHT GUIDE LENS IN "OPERATION MANUAL 3.3 INSPECTION OF THE ENDOSCOPE". THE INSTRUCTION MANUAL STATES THE DETECTION METHOD ASSOCIATED WITH THE EVENT FOREIGN MATERIAL IN DISTAL END, AIR/WATER CHANNEL AND CYLINDER IN "OPERATION MANUAL CHAPTER 3 PREPARATION AND INSPECTION ", AND PREVENTATIVE MEASURES IN " REPROCESSING MANUAL CHAPTER 5 REPROCESSING THE ENDOSCOPE". OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE DUODENOVIDEOSCOPE EXHIBITED FOREIGN MATERIAL IN THE DISTAL END, AIR/WATER TUBE AND AIR/WATER CYLINDER. IN ADDITION, THERE WAS STAIN INSIDE THE LIGHT GUIDE LENS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1082710 EVIS EXERA III DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT AIZU OLYMPUS CO., LTD. TJF-Q190V 04953170405563

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown