BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III COLONOVIDEOSCOPE

    MDR report key: 19199229 · Received April 28, 2024

    Report

    Report Number
    9610595-2024-08814
    Event Type
    Malfunction
    Date Received
    April 28, 2024
    Date of Event
    April 9, 2024
    Report Date
    May 30, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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. ADDITIONAL INFORMATION ADDED TO FIELD H3 AND 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 3 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION AND THE INFORMATION PROVIDED, THE FOREIGN MATERIAL COULD BE SIMETHICONE. IT IS LIKELY THAT THE FOREIGN MATERIAL REMAINED IN THE DEVICE DUE TO THE DEVIATION FROM INSTRUCTIONS FOR USE (IFU) IN REPROCESSING STEPS. NO PHYSICAL DAMAGE OF THE DEVICE WAS CONFIRMED AT WHERE THE FOREIGN MATERIAL REMAINED. HOWEVER, THE ROOT CAUSE OF THE MATERIAL REMAINED IN THE DEVICE COULD NOT BE DETERMINED.THE INSTRUCTION MANUAL STATES THE DETECTION METHOD ASSOCIATED WITH THE EVENT IN "GIF/CF/PCF-190 SERIES OPERATION MANUAL CHAPTER 3 PREPARATION AND INSPECTION" AND THE PREVENTION METHOD IN "GIF/CF/PCF-190 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 COLONOVIDEOSCOPE EXHIBITED FOREIGN MATERIAL FOUND INSIDE THE AIR/WATER CYLINDER, AIR/WATER TUBE AND JET TUBE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030365 EVIS EXERA III COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. PCF-H190L

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown