BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III DUODENOVIDEOSCOPE

    MDR report key: 14013871 · Received April 5, 2022

    Report

    Report Number
    8010047-2022-05670
    Event Type
    Malfunction
    Date Received
    April 5, 2022
    Report Date
    June 21, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    UDI-DI
    04953170405563
    PMA / PMN Number
    K202661
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INSPECTION AND TESTING FOUND IT WAS NOT POSSIBLE TO DETERMINE WHEN THE SCOPE WAS CONTAMINATED WITH FOREIGN MATERIAL. IN ADDITION, THE DISTAL END WAS DEFORMED AND CORRODED, THE ADHESIVE ON THE BENDING SECTION COVER WAS CRACKED, THE PAINT WAS PEELING FROM THE AIR/WATER NUT, AND THE PLUG UNIT HOUSING WAS DAMAGED. THE INVESTIGATION IS ONGOING; THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME. HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. CORRECTION TO THE INITIAL MEDWATCH. THE AWARE DATE SHOULD BE 03-FEB-2021. INVESTIGATION ACTIVITIES HAVE BEEN OPENED TO MANAGE THE ACTIONS RELATED TO THIS REPORT AND ANY REQUIRED MDR REPORTING. 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, THE ROOT CAUSE IS UNABLE TO BE DETERMINED. HOWEVER, THE LIKELY CAUSE IS DUE TO UNINTENDED FOREIGN MATERIAL ADHERED TO THE DISTAL END OF THE DEVICE DURING TRANSPORTATION. IT ALSO LIKELY CORROSION ACCELERATED DUE TO THE PRESENCE OF LIQUID AND ITS PRODUCT WAS DETECTED AS FOREIGN MATERIAL. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THERE WAS DAMAGE AND RUST STAINS WERE PRESENT WHEN THE DUODENOVIDEOSCOPE WAS RETURNED FROM BEING REPAIRED. THE DEVICE WAS RETURNED TO AN OLYMPUS SERVICE CENTER FOR EVALUATION. DURING INSPECTION AND TESTING, FOREIGN MATERIAL WAS FOUND ON THE DISTAL END. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION (FOREIGN MATERIAL). THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2049785 EVIS EXERA III DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. TJF-Q190V 04953170405563

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown