BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBERSCOPE "HYF-XP"

    MDR report key: 15601956 · Received October 13, 2022

    Report

    Report Number
    9610595-2022-02930
    Event Type
    Malfunction
    Date Received
    October 13, 2022
    Date of Event
    June 6, 2022
    Report Date
    December 21, 2022
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    HIH
    UDI-DI
    04953170340178
    PMA / PMN Number
    K891451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT YET RETURNED TO OLYMPUS FOR EVALUATION. THE DEVICE WAS SENT TO AN INDEPENDENT LABORATORY FOR CONFIRMATION CULTURE TESTING. THE DEVICE TESTED POSITIVE FOR <1 COLONY FORMING UNITS (CFUS) OF UNSPECIFIED REVIVABLE MICRO-ORGANISMS. THE RESULTS COMPLY WITHIN THE TARGET LEVELS DEFINED IN THE INSTRUCTIONS FOR AN ENDOSCOPE. THE DEVICE WAS HIGH-LEVEL DISINFECTED AND RINSED WITH STERILE WATER. AS OF THIS REPORT THE CUSTOMER HAS NOT PROVIDED THE CLEANING STERILIZATION AND DISINFECTION (CDS) PROCESSES PERFORMED AT THE USER FACILITY. 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 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. 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. THE FOLLOWING IS INCLUDED IN THE DEVICE IFU: ¿CHAPTER 6 COMPATIBLE REPROCESSING METHODS AND CHEMICAL AGENTS. CHAPTER 7 CLEANING, DISINFECTION, AND STERILIZATION PROCEDURES¿. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, DURING ROUTINE TESTING, THE OES HYSTEROFIBERSCOPE TESTED POSITIVE FOR AN UNEXPECTED MICROBIOLOGICAL CONTAMINATION. THE SCOPE WAS SAMPLED ONCE. DURING THE SAMPLING, THE SCOPE TESTED POSITIVE FOR 1 COLONY FORMING UNITS (CFUS) OF COAGULASE-NEGATIVE STAPHYLOCOCCUS HOMINIS. ALL CHANNELS WERE TESTED. SAMPLING OCCURRED AT REPROCESSING, BEFORE USE. 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
    2273145 FIBERSCOPE "HYF-XP" HYSTEROFIBERSCOPE HIH AIZU OLYMPUS CO., LTD. HYF-XP 04953170340178

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown