BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 19311260 · Received May 14, 2024

    Report

    Report Number
    9610595-2024-09735
    Event Type
    Malfunction
    Date Received
    May 14, 2024
    Date of Event
    April 21, 2024
    Report Date
    June 5, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 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 5 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. THE LEGAL MANUFACTURER 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 CAME OUT OF THE DEVICE, BUT THE TYPE OF THE MATERIAL OR ROOT CAUSE CANNOT BE IDENTIFIED. IN ADDITION, NO PHYSICAL DAMAGE OF THE DEVICE WAS CONFIRMED AT WHERE THE FOREIGN MATERIAL REMAINED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE: INSTRUCTIONS STATES THE DETECTION METHOD IN GIF/CF/PCF-290 SERIES OPERATION MANUAL CHAPTER 3 PREPARATION AND INSPECTION INSTRUCTIONS STATES THE PREVENTATIVE MEASURES IN GIF/CF/PCF-290 SERIES REPROCESSING MANUAL CHAPTER 5 REPROCESSING THE ENDOSCOPE 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 GASTROINTESTINAL VIDEOSCOPE EXHIBITED A BLOCKAGE IN THE ASPIRATION CHANNEL AND AIR/WATER CHANNEL ALONG WITH FOREIGN WHITE MATERIAL IN THE JET TUBE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548348 EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-HQ290

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown