BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA COLONOVIDEOSCOPE

    MDR report key: 19034552 · Received April 3, 2024

    Report

    Report Number
    9610595-2024-06973
    Event Type
    Malfunction
    Date Received
    April 3, 2024
    Report Date
    April 23, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    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. ADDITIONAL INFORMATION ADDED TO FIELD H3, H6. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 11 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 CAME OUT OF THE DEVICE, BUT THE TYPE OF THE MATERIAL OR ROOT CAUSE CANNOT BE IDENTIFIED. THE FOREIGN MATERIAL RESIDUE POINT WAS CONFIRMED TO BE FREE FROM DEFORMATION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE: EVIS LUCERA PCF TYPE 260 SERIES, OPERATION MANUAL, CHAPTER 3 ¿PREPARATION AND INSPECTION¿ DESCRIBES HOW TO DETECT THE SUBJECT EVENT. EVIS LUCERA PCF TYPE 260 SERIES, REPROCESSING MANUAL, CHAPTER 3 ¿CLEANING, DISINFECTION, AND STERILIZATION PROCEDURES¿ DESCRIBES HOW TO PREVENT THE SUBJECT EVENT. 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 DURING THE DEVICE INSPECTION, THAT THE COLONOVIDEOSCOPE EXHIBITED FOREIGN OBJECTS IN THE NOZZLE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1544923 EVIS LUCERA COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. PCF-Q260AI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown