BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE DUODENOVIDEOSCOPE

    MDR report key: 19270038 · Received May 8, 2024

    Report

    Report Number
    9610595-2024-09363
    Event Type
    Malfunction
    Date Received
    May 8, 2024
    Report Date
    June 7, 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 LEGAL MANUFACTURER¿S FINAL INVESTIGATION. THE FOREIGN MATERIAL FOUND HAS BEEN ATTRIBUTED TO INSUFFICIENT CLEANING. THE CUSTOMER PROVIDED THE FOLLOWING DETAILS REGARDING DEVICE HANDLING: CUSTOMER PERFORMED CLEANING, DISINFECTING, OR STERILIZING PROCESSES ON THE DEVICE BEFORE SENDING IT IN FOR REPAIR. THE CUSTOMER DID NOT KNOW IF THEY HAD PERFORMED THE SPECIFIC CLEANING STEPS REQUESTED. 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 YEAR SINCE THE SUBJECT DEVICE WAS MANUFACTURED. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE REPORTABLE MALFUNCTION WAS CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, THE EVALUATION COULD NOT SPECIFY WHAT THE FOREIGN MATERIAL WAS NOR THE ROOT CAUSE OF THE REMAINING FOREIGN MATERIAL SINCE IT WAS UNKNOWN WHETHER REPROCESSING WAS PRACTICED IN ACCORDANCE WITH IFU. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE: TJF-Q290V, OPERATION MANUAL, CHAPTER 3 "PREPARATION AND INSPECTION" DESCRIBES HOW TO DETECT THE SUBJECT EVENTS AND CHAPTER 5 "REPROCESSING OF THE ENDOSCOPE (AND RELATED REPROCESSING ACCESSORIES)" DESCRIBES HOW TO PREVENT THE SUBJECT EVENTS. 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 RESIDUAL LIQUID OR FOREIGN MATERIAL COMING OUT OF THE CHANNEL TUBE AND SUCTION CYLINDER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758983 EVIS LUCERA ELITE DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT AIZU OLYMPUS CO., LTD. TJF-Q290V

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown