BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUODENOVIDEOSCOPE

    MDR report key: 19073991 · Received April 9, 2024

    Report

    Report Number
    9610595-2024-07432
    Event Type
    Malfunction
    Date Received
    April 9, 2024
    Report Date
    May 9, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDT
    UDI-DI
    04953170229459
    PMA / PMN Number
    K954451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION, BASED ON THE DEVICE EVALUATION AND 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 (10) YEARS, SINCE THE SUBJECT DEVICE WAS MANUFACTURED. THE LEGAL MANUFACTURER REVIEWED: THE CUSTOMER PROVIDED THE CLEANING DISINFECTION AND STERILIZATION (CDS) PROCESSES. AND NO OBVIOUS DEVIATIONS, FROM INSTRUCTIONS FOR USE (IFU) WERE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, OLYMPUS WAS UNABLE TO DETERMINE, WHAT FOREIGN MATERIAL WAS INVOLVED. HOWEVER, IT WAS CONFIRMED, THAT THE FOREIGN MATERIAL REMAINED IN THE KNOB WIRE. THERE WAS NO PHYSICAL DAMAGE TO THE LOCATION OF THE FOREIGN MATERIAL. THEREFORE, THE CAUSE OF THE MATERIAL REMAINING IN THE DEVICE COULD NOT BE DETERMINED. THE EVENT CAN BE DETECTED AND PREVENTED IN ACCORDANCE, WITH THE FOLLOWING INSTRUCTIONS FOR USE: INSTRUCTIONS FOR USE STATES: THAT DETECTION METHOD IN TJF TYPE 150, OPERATION MANUAL, CHAPTER 3: PREPARATION AND INSPECTION. INSTRUCTIONS FOR USE STATES: THAT PREVENTIVE MEASURE IN TJF TYPE 150, REPROCESSING MANUAL, 3.5: MANUAL CLEANING. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE DUODENOVIDEOSCOPE EXHIBITED FOREIGN OBJECTS IN THE KNOB WIRE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607380 DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT AIZU OLYMPUS CO., LTD. TJF-150 04953170229459

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown