BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III COLONOVIDEOSCOPE

    MDR report key: 19623778 · Received June 27, 2024

    Report

    Report Number
    9610595-2024-12905
    Event Type
    Malfunction
    Date Received
    June 27, 2024
    Date of Event
    May 24, 2024
    Report Date
    July 29, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    UDI-DI
    04953170416118
    PMA / PMN Number
    K192793
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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 1 YEAR 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. THERE WAS NO DAMAGE TO THE AREA WHERE THE FOREIGN MATERIAL WAS DETECTED, AND IT WAS UNKNOWN IF REPROCESSING WAS PERFORMED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: GIF/CF/PCF-190 SERIES OPERATION MANUAL CHAPTER 3 PREPARATION AND INSPECTION. GIF/CF/PCF-190 SERIES REPROCESSING MANUAL CHAPTER 5 REPROCESSING THE ENDOSCOPE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND THE DEVICE EVALUATION FOUND THE FOLLOWING: SWITCH#1 HAD SURFACE CUT; BORESCOPE INSTRUMENT CHANNEL DEEP SCRAPES AND CONTROL KNOB HAD MOVEMENT. THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE COLONOVIDEOSCOPE HAD SOME MATERIAL CAME OUT WHILE BRUSHING THE SCOPE, POSSIBLE FROM AN ENDOTHERAPY DEVICE. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480587 EVIS EXERA III COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. PCF-HQ190L 04953170416118

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown