BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE DUODENOVIDEOSCOPE

    MDR report key: 19590165 · Received June 21, 2024

    Report

    Report Number
    9610595-2024-12563
    Event Type
    Malfunction
    Date Received
    June 21, 2024
    Report Date
    July 14, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDT
    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. ADDITIONAL INFORMATION ADDED TO FIELD H3 AND H6. CORRECTION TO PREVIOUS NARRATIVE: THE LEGAL MANUFACTURER WAS UNABLE TO CONFIRM WHETHER REPROCESSING WAS CONDUCTED PROPERLY. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 3 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THAT FOREIGN MATERIAL NOZZLE WAS NOT IDENTIFIED. THERE WAS NO DEFORMATION OBSERVED AT FOREIGN RESIDUE POINTS. HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. THE INSTRUCTION MANUAL STATES THE DETECTION METHOD ASSOCIATED WITH THE EVENT IN "TJF-Q290V OPERATION MANUAL CHAPTER 3 PREPARATION AND INSPECTION", AND PREVENTATIVE MEASURES IN " TJF-Q290V 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. THE LEGAL MANUFACTURE REVIEWED THE CUSTOMER PROVIDED THE CLEANING DISINFECTION AND STERILIZATION (CDS) PROCESSES WHERE NO OBVIOUS DEVIATIONS FROM INSTRUCTIONS FOR USE (IFU) WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THERE WAS FOREIGN MATERIAL IN THE NOZZLE OF THE DUODENOVIDEOSCOPE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1157081 EVIS LUCERA ELITE DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT AIZU OLYMPUS CO., LTD. TJF-Q290V

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown