BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBERSCOPE "HYF-XP"

    MDR report key: 18637347 · Received February 3, 2024

    Report

    Report Number
    9610595-2024-02381
    Event Type
    Malfunction
    Date Received
    February 3, 2024
    Date of Event
    January 9, 2024
    Report Date
    March 19, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    HIH
    UDI-DI
    04953170411571
    PMA / PMN Number
    K891451
    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 LEGAL MANUFACTURE'S (LM) REVIEW OF THE CUSTOMER COMPLETED CLEANING DISINFECTION AND STERILIZATION (CDS) CHECKLIST, RESULTS OF THIRD-PARTY TESTING, THE DEVICE EVALUATION AND THE LMS FINAL INVESTIGATION. THE LM REVIEWED THE CUSTOMER PROVIDED THE CDS PROCESSES WHERE NO OBVIOUS DEVIATIONS FROM INSTRUCTIONS FOR USE (IFU) WERE IDENTIFIED. OLYMPUS PROVIDED THE FOLLOWING RESULT OF THE CULTURE TEST, PERFORMED AT THE THIRD-PARTY LABS: SAMPLING DATE: FEB 06, 2024 SAMPLING FROM: ALL CHANNELS CFU: >1CFU BACTERIAL IDENTIFICATION: N/A THE DEVICE WAS EVALUATED WHERE NO ABNORMALITIES WERE FOUND THAT COULD HAVE LED TO THE POSITIVE CULTURE. 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 THE IFU BEFORE REPAIR, THE RESULTS CONFORMED TO THE REGULATION'S RECOMMENDATION. THE INSTRUCTION MANUAL OF THE SUBJECT DEVICE 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 SUSPECT DEVICE HAS BEEN RETURNED TO OLYMPUS FOR EVALUATION AND THE INVESTIGATION IS ONGOING. THE PHYSICAL DEVICE EVALUATION HAS NOT BEEN COMPLETED. PRIOR TO THE DEVICE EVALUATION, THE DEVICE WAS SENT OUT FOR ADDITIONAL MICROBIOLOGICAL TESTING. THE MICROBIOLOGICAL ANALYSIS RESULTS ARE PENDING. THE CUSTOMER PROVIDED THE CLEANING STERILIZATION AND DISINFECTION (CDS) PROCESSES PERFORMED AT THE USER FACILITY. THE DETERGENT USED WAS ANIOS¿CLEAN EXCEL D. THE INSTRUMENT/SUCTION CHANNEL, SUCTION CYLINDER, INSTRUMENT CHANNEL PORT AND DISTAL END WERE BRUSHED. THE DISINFECTANT USED WAS ANIOS¿CLEAN EXCEL D. THE DEVICE WAS STORED IN HORIZONTAL STORAGE. ADDITIONALLY, THE CUSTOMER CONFIRMED THAT THERE WERE NO SUSPECTED PATIENT INFECTIONS DUE TO THE FACILITY FINDINGS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS.

    Additional Manufacturer Narrative · 0

    CORRECTION TO H10 OF THE FIRST SUPPLEMENTAL REPORT. OLYMPUS PROVIDED THE FOLLOWING RESULT OF THE CULTURE TEST, PERFORMED AT THE THIRD-PARTY LABS: SAMPLING DATE: (B)(6) 2024. SAMPLING FROM: ALL CHANNELS. CFU: <1CFU. BACTERIAL IDENTIFICATION: N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING REPROCESSING, THE HYSTEROFIBERSCOPE TESTED POSITIVE FOR 1 COLONY FORMING UNITS (CFU) OF STAPHYLOCOCCUS HOMINIS ON (B)(6) 2023. THE DEVICE WAS TESTED POSITIVE AGAIN ON (B)(6) 2024, FOR 5 COLONY FORMING UNITS (CFUS) OF NEISSERIA SPP. ALL CHANNELS WERE SAMPLED. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN STATE OF HEALTH OF ANY PERSON, TO WHICH THE SCOPE COULD HAVE BEEN A CONTRIBUTORY CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278560 FIBERSCOPE "HYF-XP" HYSTEROFIBERSCOPE HIH AIZU OLYMPUS CO., LTD. HYF-XP 04953170411571

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown