BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OES CYSTONEPHROFIBERSCOPE

    MDR report key: 16766397 · Received April 18, 2023

    Report

    Report Number
    3002808148-2023-03882
    Event Type
    Malfunction
    Date Received
    April 18, 2023
    Report Date
    May 30, 2023
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FAJ
    UDI-DI
    04953170411144
    PMA / PMN Number
    K032092
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO AN OLYMPUS REPAIR FACILITY, AND AN EVALUATION OF THE DEVICE WAS PERFORMED. DURING THE EVALUATION, IT WAS DISCOVERED THAT THE FORCEPS CHANNEL PORT WAS DEFORMED; THE FORCEPS CAP WAS NOTED TO BE BROKEN. THE CUSTOMER'S ORIGINALLY REPORTED ISSUE OF AIR/WATER LEAKAGE WAS NOT CONFIRMED. THE FOLLOWING ADDITIONAL FINDINGS WERE ALSO NOTED: LIGHT GUIDE BUNDLE, OPERATION UNIT, UP/DOWN PLATE, AND EYEPIECE ALL FLOODED, LIGHT GUIDE BUNDLE YELLOWING, INSUFFICIENT ANGULATION, AND VENT METAL CORROSION. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    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; HOWEVER, THE EVENT LIKELY OCCURRED DUE TO PHYSICAL STRESS. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    A DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THEIR OES CYSTONEPHROFIBERSCOPE EXHIBITED AIR/WATER LEAKAGES. UPON INSPECTION AND TESTING OF THE RETURNED UNIT, IT WAS DISCOVERED THAT THE FORCEPS CHANNEL PORT WAS DEFORMED. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTIONS BOTH ORIGINALLY REPORTED AS WELL AS FOUND DURING EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1601009 OES CYSTONEPHROFIBERSCOPE CYSTONEPHROFIBERSCOPE FAJ SHIRAKAWA OLYMPUS CO., LTD. CYF-5A 04953170411144

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown