BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III COLONOVIDEOSCOPE

    MDR report key: 18160583 · Received November 17, 2023

    Report

    Report Number
    9610595-2023-17555
    Event Type
    Malfunction
    Date Received
    November 17, 2023
    Date of Event
    October 26, 2023
    Report Date
    February 12, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    UDI-DI
    04953170305115
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON 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. BASED ON THE RESULTS OF THE INVESTIGATION, THE ROOT CAUSE OF THE EVENT WAS UNABLE TO BE IDENTIFIED. IT WAS CONFIRMED THAT THERE WERE FOREIGN OBJECTS IN THE AIR/WATER CYLINDER, AIR/WATER CHANNEL, AND AUXILIARY WATER CHANNEL. THE EVENT LIKELY OCCURRED DUE TO A LEAK FAILURE. THE DETECTION METHOD IS DESCRIBED IN THE INSTRUCTION MANUAL GIF/CF/PCF-190 SERIES OPERATION MANUAL CHAPTER 3 PREPARATION AND INSPECTION. PREVENTION MEASURES ARE DESCRIBED IN THE INSTRUCTION MANUAL 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 EVALUATED AND THE EVALUATION FOUND, INSULATION RESISTANCE VALUE AT DISTAL END DID NOT MEET THE STANDARD VALUE DUE TO BURN ON PLASTIC DISTAL END COVER AND AIRWATER-CYLINDER HAD FOREIGN OBJECTS. IN ADDITION TO REPORTABLE FINDING MENTIONED IN REPORTABLE EVENT DESCRIPTION, THE DEVICE EVALUATION FOUND FOLLOWING NON-REPORTABLE FINDINGS: AIRWATER-CYLINDER AND SUCTION-CYLINDER HAD NO COLOR; THE PLUG UNIT AND THE CONNECTING TUBE HAD A SCRATCH; DUE TO WEAR OF ANGLE WIRE, THE PLAY OF UP/DOWN KNOB AND THE PLAY OF RIGHT/LEFT KNOB WERE OUT OF THE STANDARD VALUE; THE ADHESIVE ON BENDING SECTION COVER HAD VISIBLE THREAD AND THE UNIVERSAL CORD HAD A WRINKLE. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, THE DISTAL END OF COLONOVIDEOSCOPE WAS PEROUS. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND: A DRY WHITISH FOREIGN MATERIAL RESEMBLING POWDER WAS FOUND INSIDE THE AIRWATER-TUBE AND THE JET-TUBE. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673935 EVIS EXERA III COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. CF-HQ190L 04953170305115

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown