BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OES CYSTONEPHROFIBERSCOPE

    MDR report key: 17225829 · Received June 29, 2023

    Report

    Report Number
    3002808148-2023-06542
    Event Type
    Malfunction
    Date Received
    June 29, 2023
    Date of Event
    May 29, 2023
    Report Date
    June 29, 2023
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FAJ
    UDI-DI
    04953170286964
    PMA / PMN Number
    K032092
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1) ESTABLISHMENT NAME: (B)(6) HOSPITAL (B)(6) MEDICAL CENTER. THE DEVICE WAS RETURNED TO OLYMPUS AND THE CUSTOMER'S ALLEGATION WAS CONFIRMED. OTHER EVALUATION FINDINGS INCLUDE THE FOLLOWING: A CHIPPED RUBBER BOND, A PEELED OPERATION UNIT CONNECTION INDEX, AN OPERATING PART LIQUID LEAKAGE, AN UPWARD/DOWNWARD PLATE LEAK, AND A PEELED GRIP COVER PAINT. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THERE WAS NO INDICATION THAT THE EVENT WAS CAUSED BY A MISUSE OR THAT THE EVENT WAS RELATED TO DESIGN OF THE DEVICE. REPAIR HISTORY WAS REVIEWED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED EVENT. ALTHOUGH EVALUATION CONFIRMED THE RECEIVING SIDE OF THE TUBE MOUNTING PART WAS DETACHED, A DEFINITIVE ROOT CAUSE OF THE DEFECT COULD NOT BE IDENTIFIED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE AT A LATER DATE, THIS REPORT WILL BE SUPPLEMENTED. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THAT THE T-TUBE ATTACHMENT PART OF THE OES CYSTONEPHROFIBERSCOPE WAS DISCONNECTED. THIS WAS FOUND WHILE THE DEVICE WAS BEING CLEANED. THERE WAS NO DELAY TO THE INTENDED PROCEDURE, AND NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254533 OES CYSTONEPHROFIBERSCOPE CYSTONEPHROFIBERSCOPE FAJ SHIRAKAWA OLYMPUS CO., LTD. CYF-5A 04953170286964

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown