BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE

    MDR report key: 17794698 · Received September 21, 2023

    Report

    Report Number
    3002808148-2023-10184
    Event Type
    Malfunction
    Date Received
    September 21, 2023
    Report Date
    October 18, 2023
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    PSV
    UDI-DI
    04953170399831
    PMA / PMN Number
    K183525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION BASED ON ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER. THE CLEANING, DISINFECTION, AND STERILIZATION (CDS) WAS PERFORMED BY THE CUSTOMER. THE CUSTOMER CONFIRMED THAT THERE WERE NO DEVIATIONS OR DEFICIENCIES CONCERNING REPROCESSING OF THE SCOPE. ADDITIONALLY, THE CUSTOMER CONFIRMED THAT THERE WERE NO SUSPECTED PATIENT INFECTIONS DUE TO THE FACILITY FINDINGS. BLOOD TESTING OF THE THREE PATIENTS CONFIRMED NO INFECTION. THE CUSTOMER SUSPECTED THE CONTAMINATION WAS DRIED BLOOD FROM A PATIENT. THE CUSTOMER PROVIDED THE CLEANING, DISINFECTION, AND STERILIZATION PROCESS STATING THAT PRECLEANING WAS PERFORMED IMMEDIATELY AFTER THE PROCEDURE BY A RINSE IMMEDIATELY IN THE TREATMENT ROOM FOLLOWED BY PRECLEANING WITHIN 2 HOURS WITH THE FOLLOWING STEPS: LEAK TEST (WITH OLYMPUS MU-1 LEAK TESTER), BRUSH CHANNELS, FLUSH WITH OLYMPUS ADAPTER, WIPE THE OUTSIDE, AND THEN FLUSH CHANNELS AGAIN WITH A WATER GUN. THE DETERGENT USED WAS ENDOHIGH DETERGENT. THE BRUSHES USED WERE SINGLE USE MEDI-GLOBE INTERDENTAL BRUSHES AND OLYMPUS INTERDENTAL BRUSHES WERE SOMETIMES USED 2-3 TIMES. THE AUTOMATED ENDOSCOPE REPROCESSOR (AER) USED WAS WASSENBURG WD440 PT WITH ENDOHIGH DETERGENT AND ENDOHIGH GTA DISINFECTANT. THE MINIMUM EFFECTIVE CONCENTRATION IS CHECKED DURING MAINTENANCE AND VALIDATION TWICE PER YEAR. THE DEVICE WAS DRIED AND STORED IN THE WASSENBURG DRYER UNTIL USE. OLYMPUS IS THE MAINTENANCE COMPANY.

    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 AND BECAUSE THE SUBJECT DEVICE WAS NOT RETURNED, A ROOT CAUSE COULD NOT BE DETERMINED. THE REPORTED EVENT WAS NOT CONFIRMED AS THE SCOPE WAS NOT MICROBIOLOGICALLY TESTED AND CULTURE RESULT REPORTS WERE NOT SHARED. THE FOLLOWING DESCRIPTIONS FOR REPROCESSING ARE INCLUDED IN THE DEVICE IFU: CHAPTER 3 COMPATIBLE REPROCESSING METHODS CHAPTER 4 REPROCESSING WORKFLOW FOR ENDOSCOPES AND ACCESSORIES CHAPTER 5 REPROCESSING THE ENDOSCOPE (AND RELATED REPROCESSING ACCESSORIES) CHAPTER 6 REPROCESSING THE ACCESSORIES CHAPTER 7 REPROCESSING ENDOSCOPES AND ACCESSORIES USING AN AER/WD OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE WILL NOT BE RETURNED TO OLYMPUS FOR EVALUATION. THE USER FACILITY REPORTED THAT AFTER THE CONTAMINATION ON THE LENS WAS REMOVED WITH A COTTON SWAB AND ALCOHOL, THE IMAGE WAS RESTORED. THE INVESTIGATION IS ONGOING AND FOLLOW-UP WITH THE USER FACILITY IS CURRENTLY BEING PERFORMED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THAT THE EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE HAD A POOR IMAGE. IT WAS LATER DISCOVERED THAT THE SOURCE OF THE POOR IMAGE WAS CONTAMINATION FOUND ON THE LENS. THE DEVICE WAS USED IN THREE PATIENT PROCEDURES PRIOR TO BEING TAKEN OUT OF USE. THERE WERE NO REPORTS OF PATIENT HARM. RELATED PATIENT IDENTIFIERS: (B)(6) FOR THE FIRST PATIENT BELIEVED TO BE THE SOURCE OF THE CONTAMINATION. (B )(6) FOR THE OTHER POTENTIALLY AFFECTED PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88935 EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE BRONCHOFIBERVIDEOSCOPE PSV SHIRAKAWA OLYMPUS CO., LTD. BF-UC190F 04953170399831

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown