BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III DUODENOVIDEOSCOPE

    MDR report key: 19320528 · Received May 15, 2024

    Report

    Report Number
    9610595-2024-09849
    Event Type
    Malfunction
    Date Received
    May 15, 2024
    Date of Event
    April 29, 2024
    Report Date
    June 14, 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

    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. NEW INFORMATION ADDED TO THE FOLLOWING FIELDS: H3, H4, H6. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER SIX (6) YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BECAUSE WE COULD NOT IDENTIFY THE STAIN OR FOREIGN MATERIAL. SINCE THE MATERIAL ADHERED TO THE OUTER SURFACE OF THE SCOPE, IT WAS NOT REMOVED BY REPROCESSING. WE PRESUMED THAT HUMIDITY INVADED THE LIGHT GUIDE LENS, WHICH LED TO CORROSION OCCURRING FROM APPLIED PHYSICAL STRESS TO THE DISTAL END, SUCH AS HITTING AND DROPPING, OR THE LIGHT GUIDE LENS GLUE PEELED OFF BY CHEMICAL STRESS, SUCH AS CHEMICAL SOLUTIONS USED FOR THE DEVICE. HOWEVER, WE COULD NOT CONFIRM THE SUGGESTED EVENT OR SPECIFY THE OCCURRENCE OR CAUSE OF THE SUGGESTED EVENT. THE EVENTS CAN BE DETECTED AND PREVENTED IN ACCORDANCE WITH THE FOLLOWING SECTIONS OF THE INSTRUCTIONS FOR INSTRUCTIONS FOR USE: ¿IFU STATES THAT DETECTION METHOD IN TJF-Q190V OPERATION MANUAL 3.3 INSPECTION OF THE ENDOSCOPE.¿ 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 WHITE FOREIGN MATERIAL ON THE ADHESIVE AROUND THE LIGHT GUIDE LENS, IN THE AIR WATER TUBE, AND IN THE AIR WATER CYLINDER. ADDITIONALLY, THE INSIDE OF THE LIGHT GUIDE LENS HAD A STAIN. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1548051 EVIS EXERA III DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT AIZU OLYMPUS CO., LTD. TJF-Q190V 04953170405563

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown