BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE COLONOVIDEOSCOPE

    MDR report key: 19041856 · Received April 4, 2024

    Report

    Report Number
    9610595-2024-07036
    Event Type
    Malfunction
    Date Received
    April 4, 2024
    Date of Event
    March 17, 2024
    Report Date
    April 24, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    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 CORRECTION OF THE INITIAL MDR AND THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. CORRECTED FIELDS: G2 (OTHER AND OTHER REPORT SOURCE WERE MISSING FROM THE INITIAL). A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER SEVEN (7) YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. A DEFINITIVE ROOT CAUSE WAS NOT IDENTIFIED, HOWEVER BASED ON THE RESULTS OF THE INVESTIGATION, THE PROBABLE CAUSE OF THE "WHITE CRYSTALLIZED CONTAMINATION IN THE AUXILIARY WATER CHANNEL." MALFUNCTIONS WOULD LIKELY BE RELATED TO THE REPROCESSING THAT WAS NOT CONDUCTED PROPERLY DUE TO LEAKAGE FROM THE BIOPSY CHANNEL. THE EVENT CAN BE PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: IFU STATES THE DETECTION METHOD IN ¿GIF/CF/PCF-290 SERIES OPERATION MANUAL CHAPTER 3 PREPARATION AND INSPECTION¿. IFU STATES THE PREVENTIVE 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 DURING THE DEVICE INSPECTION, THAT THE COLONOVIDEOSCOPE HAD WHITE CRYSTALLIZED CONTAMINATION WITHIN THE AUXILIARY JET CHANNEL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2017604 EVIS LUCERA ELITE COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. CF-HQ290L

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown