BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III COLONOVIDEOSCOPE

    MDR report key: 19635753 · Received June 28, 2024

    Report

    Report Number
    9610595-2024-13052
    Event Type
    Malfunction
    Date Received
    June 28, 2024
    Date of Event
    June 16, 2024
    Report Date
    July 31, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    UDI-DI
    04953170305214
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 6 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION AND THE INFORMATION PROVIDED, IT COULD NOT BE DETERMINED WHAT THE FOREIGN MATERIAL WAS. IT WAS CONFIRMED THAT CUSTOMER USES SIMETHICONE VIA BIOPSY CHANNEL. THERE WAS NO DAMAGE TO THE AREA WHERE THE FOREIGN MATERIAL WAS DETECTED, AND THERE WERE NO DEVIATIONS FROM THE CLEANING DISINFECTION AND STERILIZATION (CDS) STEPS PROVIDED IN THE INSTRUCTIONS FOR USE (IFU). THEREFORE, THE CAUSE OF THE MATERIAL REMAINING 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 PREVENTATIVE MEASURES 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 DURING THE DEVICE INSPECTION, THAT THE COLONOVIDESCOPE AIR / WATER TUBE AND AIR / WATER CYLINDER HAD WHITISH FOREIGN MATERIAL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2206063 EVIS EXERA III COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. PCF-H190I 04953170305214

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown