BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE COLONOVIDEOSCOPE

    MDR report key: 19280468 · Received May 9, 2024

    Report

    Report Number
    9610595-2024-09460
    Event Type
    Malfunction
    Date Received
    May 9, 2024
    Report Date
    May 24, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 AND DEVICE EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 2 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, OLYMPUS CONFIRMED FOREIGN MATERIAL CAME OUT OF THE DEVICE, BUT THE TYPE OF THE MATERIAL OR ROOT CAUSE CANNOT BE IDENTIFIED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE CUSTOMER PROVIDED THE CLEANING DISINFECTION AND STERILIZATION (CDS) PROCESSES WHERE NO OBVIOUS DEVIATIONS FROM INSTRUCTIONS FOR USE (IFU) WERE IDENTIFIED. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: "IFU STATES THAT DETECTION METHOD IN GIF/CF/PCF-290 SERIES OPERATION MANUAL CHAPTER 3, PREPARATION AND INSPECTION; IFU STATES THAT PREVENTIVE MEASURE IN GIF/CF/PCF-290 SERIES REPROCESSING MANUAL CHAPTER 5, REPROCESSING THE ENDOSCOPE (AND RELATED REPROCESSING ACCESSORIES)". 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 EVALUATION, THERE WAS FOREIGN MATTER ON THE NOZZLE TIP, ILLUMINATION AND OBJECTIVE LENS OF THE COLONOVIDEOSCOPE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1358317 EVIS LUCERA ELITE COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. PCF-H290ZI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown