BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III DUODENOVIDEOSCOPE

    MDR report key: 19151455 · Received April 22, 2024

    Report

    Report Number
    9610595-2024-08348
    Event Type
    Malfunction
    Date Received
    April 22, 2024
    Report Date
    May 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

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION, BASED ON 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. BASED ON THE RESULTS OF THE INVESTIGATION, DISCOLORATION (FOREIGN MATERIAL) INSIDE THE LG-LENS WAS CONFIRMED. AND THE DEVICE DID NOT MEET THE STANDARD SPECIFICATIONS. SINCE THE ADHESION LOCATION OF FOREIGN MATERIAL WAS NOT EXTERNAL SURFACE OF THE DEVICE, THE FOREIGN MATERIAL COULD NOT BE REMOVED BY REPROCESSING. THE PROBABLE CAUSE, WAS THAT THE LG-LENS GLUE WAS PEELED OFF, DUE TO PHYSICAL STRESS BY HITTING/DROPPING THE DISTAL END, CHEMICAL STRESS BY CHEMICAL SOLUTIONS OR THE LIKE. SUBSEQUENTLY, HUMIDITY INVADED THE LG-LENS AND CAUSED CORROSION. THE ROOT CAUSE COULD NOT BE IDENTIFIED. THE INSTRUCTION MANUAL IDENTIFIES, THE FOLLOWING RELATED VERBIAGE. WHICH COULD HAVE DETECTED THE PHENOMENON: INSTRUCTIONS FOR USE (IFU) STATES, THE DETECTION METHOD IN TJF-Q190V, OPERATION MANUAL, 3.3: INSPECTION OF 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 THAT DURING THE DEVICE INSPECTION, THE DUODENOVIDEOSCOPE EXHIBITED DISCOLORATION INSIDE OF LIGHT GUIDE LENS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2259592 EVIS EXERA III DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT AIZU OLYMPUS CO., LTD. TJF-Q190V 04953170405563

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown