BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 19107847 · Received April 15, 2024

    Report

    Report Number
    9610595-2024-07912
    Event Type
    Malfunction
    Date Received
    April 15, 2024
    Report Date
    June 7, 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.H6 MED DEVICE PROBLEM CODE WAS CORRECTED AS IT WAS INCORRECTLY SELECTED IN THE INITIAL MDR.A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE.THE LEGAL MANUFACTURER COULD NOT IDENTIFY THE FOREIGN MATERIAL/ FOREIGN MATERIAL CAME OUT OF THE BIOPSY CHANNEL.BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THAT THE FOLLOWING LED TO THE MALFUNCTION:¿ FOREIGN MATERIAL POSSIBLY REMAINED IN THE NOZZLE SINCE THE REPROCESSING WAS DEVIATED FROM THE INSTRUCTION MANUAL.¿ THE FOREIGN MATERIAL WAS POSSIBLY NOT REMOVED ALTHOUGH THE REPROCESSING WAS CONDUCTED PROPERLY DUE TO THE PHYSICAL DAMAGE ON THE DEVICE FROM THE OBTAINED INFORMATION.THIS ISSUE IS ADDRESSED IN THE INSTRUCTIONS FOR USE (IFU):¿ THE DETECTION METHOD IN GIF/CF/PCF-290 SERIES OPERATION MANUAL CHAPTER 3 PREPARATION AND INSPECTION.¿ THE PREVENTIVE MEASURE IN GIF/CF/PCF-290 SERIES REPROCESSING MANUAL CHAPTER 5 REPROCESSING THE ENDOSCOPE (AND RELATED REPROCESSING ACCESSORIES).OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF 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 REPORTED THAT A BLACK FOREIGN OBJECT EXITED THE TUBE OF THE GASTROINTESTINAL VIDEOSCOPE DURING CLEANING. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778429 EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-XP290N

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown