BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA LLL COLONOVIDEOSCOPE

    MDR report key: 12694464 · Received October 25, 2021

    Report

    Report Number
    8010047-2021-13605
    Event Type
    Malfunction
    Date Received
    October 25, 2021
    Report Date
    November 16, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    UDI-DI
    04953170305115
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INITIAL EVALUATION OF THE SCOPE CONFIRMED THE NOZZLE HAS CAVITY/GAP AND AS GLUE WAS APPLIED INCORRECTLY. ALSO, THE DRIED LIQUID DROPLETS WERE NOTED INSIDE THE CHANNEL. ADDITIONALLY, DISTAL END PLASTIC COVER IS SCRATCHED. THE CONNECTING TUBE IS SCRATCHED. THERE IS DEEP SCRATCHING ON THE SCOPE COVER NEAR THE CONTROL BODY. THE COIL PIPE PLATE IS DEFORMED AND THE LIGHT GUIDE TUBE COATING DAMAGED/SCRATCHED. IT WAS NOTED THE SCOPE WAS RETURNED TO OLYMPUS FOR REPAIR ON (B)(6) 2021. THE INVESTIGATION IS ONGOING; THEREFORE, THE ROOT CAUSE OF THE REPORTED ISSUE/MALFUNCTION CANNOT BE DETERMINED AT THIS TIME. HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP MEDICAL DEVICE 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. 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, WATER DROPLETS CAME OUT OF THE BIOPSY CHANNEL OF THE DEVICE RETURNED FROM REPAIR LIKELY DUE TO INADEQUATE DRYING INSIDE THE CHANNEL, OR THE TEMPERATURE AND/OR HUMIDITY CHANGE FROM STORAGE ENVIRONMENT, ETC. THERE WAS A GAP BETWEEN THE NOZZLE AND THE C-COVER, WHICH CANNOT BE CLEANED BY CORRECT REPROCESSING. THIS IS LIKELY DUE TO THE FACILITY STAFF WAS LESS TRAINED IN REPROCESSING AND/OR DEVICE HANDLING. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS (B)(4) WAS INFORMED BY THE CUSTOMER THAT THE WHEN THE EVIS EXERA III COLONO-VIDEOSCOPE WAS RECEIVED BACK FROM REPAIR, DURING RECEIPT INSPECTION "THE GLUE ON THE BACK OF THE SPRAY PIPE WAS OBSERVED TO BE DEFECTIVE AS IT IS COMPLETELY OPEN AND THERE IS A GAP BETWEEN THE DISTAL END CAP AND THE SPRAY PIPE WHERE DIRT AND MOISTURE NOW ENTERS WHICH CANNOT BE CLEANED". ADDITIONALLY, THE SCOPE IS ALSO NOT DRIED PROPERLY, THERE ARE ALL KINDS OF WATER DROPLETS IN THE BIOPSY CHANNEL." NO PATIENT INVOLVEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1588927 EVIS EXERA LLL COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. CF-HQ190L 04953170305115

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown