BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE

    MDR report key: 18906322 · Received March 14, 2024

    Report

    Report Number
    3002808148-2024-02439
    Event Type
    Malfunction
    Date Received
    March 14, 2024
    Date of Event
    February 1, 2024
    Report Date
    May 30, 2024
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    PSV
    UDI-DI
    04953170243233
    PMA / PMN Number
    K070983
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THE DEVICE WAS USED 4-5 TIMES ON PATIENTS AFTER THE CUSTOMER TOOK THE SECOND GERM TEST. AFTER THE POSITIVE CULTURE, THE DEVICE WAS QUARANTINED. THE DEVICE WAS REPROCESSED ONCE BEFORE SAMPLING. THE LAST REPROCESSING WAS ON 31 JAN 2024. THE SAMPLE WAS TAKEN IMMEDIATELY AFTER PREPARATION. THE DEVICE WAS LAST USED ON A PROCEDURE BEFORE SECOND SAMPLING ON (B)(6) 2024. THE SUSPECT DEVICE HAS BEEN RETURNED TO OLYMPUS FOR EVALUATION AND THE INVESTIGATION IS ONGOING. THE PHYSICAL DEVICE EVALUATION HAS BEEN COMPLETED. PRIOR TO THE DEVICE EVALUATION, THE DEVICE WAS SENT OUT FOR ADDITIONAL MICROBIOLOGICAL TESTING. THE LEGAL MANUFACTURE REVIEWED THE CUSTOMER PROVIDED THE CLEANING DISINFECTION AND STERILIZATION (CDS) PROCESSES WHERE NO OBVIOUS DEVIATIONS FROM INSTRUCTIONS FOR USE (IFU) WERE IDENTIFIED. THE HYGIENE MICROBIOLOGICAL INVESTIGATION REPORT INDICATED THE CHANNELS OF THE SCOPE WERE CULTURED AND NO POSITIVE CULTURES WERE DETECTED. THE RESULTS OBTAINED COMPLY WITH THE TARGET LEVEL FOR AN ENDOSCOPE SUBJECTED TO HIGH LEVEL DISINFECTION AND RINSED WITH STERILE WATER. THE DEVICE EVALUATION FOUND NO ADDITIONAL REPORTABLE MALFUNCTIONS ASIDE FROM THE ALLEGATION REPORTED IN B5. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS. THIS REPORT IS RELATED TO MFRS: 02166(1/4), 02361 (2/4), AND 02355 (3/4).

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION, BASED ON THE LEGAL MANUFACTURE'S (LM) REVIEW OF THE CUSTOMER CLEANING DISINFECTION AND STERILIZATION (CDS) PROCESSES AND THE LMS FINAL INVESTIGATION. CORRECTION TO H11: OF THE INITIAL REPORT. THE DEVICE WAS EVALUATED, WHERE NO ABNORMALITIES WERE FOUND, THAT COULD HAVE LED TO THE REPORTED EVENT. THE LM REVIEWED: THE CUSTOMER PROVIDED THE CDS PROCESSES. WHERE NO OBVIOUS DEVIATIONS, FROM INSTRUCTIONS FOR USE (IFU) WERE IDENTIFIED. 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 MICRO ORGANISMS 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 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

    IT WAS REPORTED THAT, DURING REPROCESSING, THE BRONCHOVIDEOSCOPE TESTED POSITIVE FOR 20 COLONY FORMING UNITS (CFUS)/19.5 ML OF KLEBSIELLA PNEUMONIAE ON (B)(6) 2024 AND GREATER THAN 120 CFUS/ 20ML OF KLEBSIELLA PNEUMONIAE ON (B)(6) 2024. 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
    2465031 EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE ULTRASONIC BRONCHOFIBERVIDEOSCOPE PSV SHIRAKAWA OLYMPUS CO., LTD. BF-UC180F 04953170243233

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown