BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 19639503 · Received June 28, 2024

    Report

    Report Number
    9610595-2024-13086
    Event Type
    Malfunction
    Date Received
    June 28, 2024
    Report Date
    July 17, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    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. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 14 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. THE LEGAL MANUFACTURE WAS UNABLE TO CONFIRM WHETHER THE CUSTOMER'S REPROCESSING STEPS WERE DEVIATED FROM THE INSTRUCTIONS FOR USE. BASED ON THE RESULTS OF THE INVESTIGATION, OLYMPUS CONFIRMED FOREIGN MATERIAL REMAINED IN THE DEVICE, BUT THE TYPE OF THE MATERIAL OR ROOT CAUSE CANNOT BE IDENTIFIED. WE CONFIRMED THAT THE SECTION OF THE DEVICE WITH THE FOREIGN MATERIAL REMAINED HAD NO DEFORMATION THE EVENT CAN BE PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: GIF/CF/PCF TYPE 260 SERIES, CHAPTER 3 PREPARATION AND INSPECTION¿ DESCRIBES THE METHODS FOR DETECTION. THE INSTRUCTION MANUAL REPROCESSING MANUAL "EVIS LUCERA GIF/CF/PCF/SIF TYPE 260 SERIES, CHAPTER 3 CLEANING, DISINFECTION, AND STERILIZATION PROCEDURES¿ DESCRIBES THE METHODS FOR PREVENTION 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 GASTROINTESTINAL VIDEOSCOPE EXHIBITED THE NOZZLE HAD FOREIGN OBJECTS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819524 EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-PQ260

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown