BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OES CYSTONEPHROFIBERSCOPE

    MDR report key: 15697187 · Received October 29, 2022

    Report

    Report Number
    9610595-2022-03450
    Event Type
    Malfunction
    Date Received
    October 29, 2022
    Date of Event
    September 11, 2022
    Report Date
    January 13, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FAJ
    UDI-DI
    04953170339417
    PMA / PMN Number
    K032092
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE DEVICE EVALUATION AND THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE WAS EVALUATED WHERE NO ABNORMALITIES WERE FOUND THAT COULD HAVE LED TO THE POSITIVE CULTURE. DEFECTS WERE NOTED WHERE: - PEELING OF THE CURVED RUBBER ADHESIVE. - INSERT DEFLECTION. - SCRATCH OF OREDOME. - LACK OF IMAGE GUIDE BUNDLE. HOWEVER, THESE DEFECTS ALONE ARE NOT CONSIDERED SEVERE ENOUGH TO CAUSE A POTENTIAL ADVERSE EVENT. 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, A ROOT CAUSE COULD NOT BE DETERMINED. GROWTH OF MICROORGANISMS WERE FOUND THROUGH CULTURE TESTING BY THE USER AFTER REPROCESSING. HOWEVER, WHEN OLYMPUS CULTURE TESTED AFTER REPROCESSING IN ACCORDANCE WITH INSTRUCTIONS FOR USE (IFU) BEFORE REPAIR, THE RESULTS CONFORMED TO THE REGULATION'S RECOMMENDATION. THE INSTRUCTION MANUAL OF CYF-5 DESCRIBES THE REPROCESSING METHODS IN THE FOLLOWING CHAPTERS: CHAPTER "COMPATIBLE REPROCESSING METHODS AND CHEMICAL AGENTS". CHAPTER "CLEANING, DISINFECTION, AND STERILIZATION PROCEDURES". OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE CLEANING, DISINFECTION, AND STERILIZATION (CDS) WAS PERFORMED BY THE CUSTOMER. MANUAL CLEANING USED ANIOS CLEAN EXCEL D AS THE DETERGENT AND MODEL # 100-1824/50 BRUSHES WERE USED. MANUAL DISINFECTION WAS DONE USING ANIOS OXIZYM-HL AS THE DETERGENT. THE SCOPE WAS STORED HORIZONTALLY. OLYMPUS WAS USED FOR REPAIR AND MAINTENANCE. THE SCOPE WAS NOT STERILIZED PER PROCEDURE. AFTER THE DEVICE WAS RETURNED TO OLYMPUS, IT WAS SENT OUT FOR ADDITIONAL TESTING. THE MICROBIOLOGICAL ANALYSIS REPORT INDICATED THE CHANNELS OF THE SCOPE WERE CULTURED AND THE RESULTS OBTAINED COMPLY WITH THE TARGET LEVEL FOR AN ENDOSCOPE SUBJECTED TO HIGH LEVEL DISINFECTION AND RINSED WITH STERILE WATER. THIS EVENT IS UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIVING ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE CYSTONEPHROFIBERSCOPE TESTED POSITIVE FOR AN UNEXPECTED CONTAMINATION. THE ISSUE WAS FOUND DURING REGULAR EXAMINATION IN THE HOSPITAL. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN STATE OF HEALTH OF ANY PERSON, TO WHICH THIS MEDICAL DEVICE COULD HAVE BEEN A CONTRIBUTORY CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2881899 OES CYSTONEPHROFIBERSCOPE CYSTONEPHROFIBERSCOPE FAJ AIZU OLYMPUS CO., LTD. CYF-5 04953170339417

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown