BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA III BRONCHOVIDEOSCOPE

    MDR report key: 20057298 · Received August 23, 2024

    Report

    Report Number
    9610595-2024-16931
    Event Type
    Injury
    Date Received
    August 23, 2024
    Date of Event
    July 15, 2024
    Report Date
    March 31, 2025
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    EOQ
    UDI-DI
    04953170335174
    PMA / PMN Number
    K121959
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) INSPECTED ALL METHODS OF REPROCESSING TO MAKE SURE PROPER PROCEDURES WERE BEING ADHERED TO AS PER THE REPROCESSING INSTRUCTIONS FOR USE FOR THE SCOPE, AND IT WAS NOTED THAT THE CUSTOMER WAS FOLLOWING THE GUIDELINES OF THE IFU WITH A MINOR CORRECTION NEEDED TO ENSURE BRONCHOSCOPES ARE NOT HAVING FLUID FLUSHED THROUGH THE CHANNELS DURING MANUAL CLEANING AS THE IFU ONLY CALLS FOR ASPIRATION OF FLUID THROUGH THE CHANNELS. HIGH LEVEL DISINFECTION (HLD) WAS OBSERVED TO BE DONE PROPERLY VIA A DSD EDGE AUTOMATIC ENDOSCOPIC REPROCESSOR (AER) AND THE CUSTOMER DRIES CHANNELS POST HIGH-LEVEL DISINFECTION WITH A CHANNEL DRYING MACHINE FOR 10 MINUTES PER SCOPE. THE SCOPES ARE THEN PLACED INTO A DRYING CABINET IN A ROOM WITH A COOL TEMPERATURE. THE ESS COMPLETED AN IN-SERVICE ON THE BRONCHOVIDEOSCOPE AND THE CLEANING, DISINFECTION, AND STERILIZATION OF THE DEVICE WAS REVIEWED. A REPAIR REDUCTION IN-SERVICE WAS ALSO COMPLETED, AND THE FACILITY REPAIR TRENDS AND WAYS TO AVOID AND PREVENT COMMON REPAIRS WAS REVIEWED. THE CUSTOMER WAS ALSO INFORMED OF WAYS TO PREVENT THE ACCUMULATION OF MOLD WITHIN THE ENDOSCOPE BY ENSURING THE SCOPES DO NOT SIT IN THE MOISTENED AER BASIN POST HLD PROCESS FOR EXTENDED PERIODS OF TIME. THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2429304-2024-0000385.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE RESULTS OF THIRD-PARTY CULTURE TESTING, DEVICE EVALUATION, AND THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. THE FOLLOWING WAS NOTED: AN EXCESSIVE AMOUNT OF LINT WAS IDENTIFIED AT THE OPENING OF BIOPSY CHANNEL. ALSO, ADDITIONAL LINT AND SCRAPE MARKS WERE OBSERVED THROUGHOUT THE ENTIRETY OF THE BIOPSY CHANNEL. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. ALTHOUGH THE CUSTOMER DID NOT CONDUCT CULTURE TESTING, IT WAS SUGGESTED THAT THE DEVICE WAS CONTAMINATED WITH FUNGI OR FILAMENTOUS FUNGI. OLYMPUS SENT THE DEVICE FOR THIRD-PARTY CULTURE TESTING. SAMPLES WERE OBTAINED FROM THE INSERTION SECTION AND BIOPSY/SUCTION CHANNEL, AND NO GROWTH WAS OBSERVED. BASED ON THE RESULTS OF THE INVESTIGATION, MINOR DEVIATION WAS OBSERVED DURING MANUAL CLEANING OF THE DEVICE (CLEANING DETERGENT WAS FED IN THE ASPIRATION PROCESS AFTER BRUSHING THE INSTRUMENT CHANNEL). HOWEVER, NO OBVIOUS DEVIATION FROM THE INSTRUCTIONS FOR USE (IFU) WAS OBSERVED, WHICH COULD HAVE LED TO THE REPORTED EVENT. MOREOVER, THE ROOT CAUSE OF LINT REMAINING IN THE INSTRUMENT CHANNEL WAS UNABLE TO BE IDENTIFIED. THERE WAS NO CORRELATION OBSERVED BETWEEN THE SUBJECT DEVICE AND THE CAUSE OF THE CONTAMINATION. THEREFORE, A RELATIONSHIP BETWEEN THE SUBJECT DEVICE AND THE REPORTED INFECTION COULD NOT BE DETERMINED. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE (IFU) IN SECTION: ¿AN INSUFFICIENTLY REPROCESSED ENDOSCOPE AND/OR ACCESSORY MAY POSE AN INFECTION CONTROL RISK TO THE PATIENTS AND/OR OPERATORS WHO TOUCH THEM.¿ THIS SUPPLEMENTAL REPORT INCLUDES AN UPDATE TO D9 AND H3 FROM THE INITIAL MEDWATCH. ALSO, INFORMATION HAS BEEN ADDED TO H4. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT DEVELOPED AN INFECTION INVOLVING MOLD AFTER AN UNSPECIFIED PROCEDURE USING THIS BRONCHOFIBROSCOPE. THE CUSTOMER IS STARTING AN INVESTIGATION TO FIND OUT IF THE CAUSE OF THE INFECTION IS RELATED TO THE BRONCHOSCOPE OR IF IT IS AN ENVIRONMENTAL ISSUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NO FURTHER INFORMATION WAS RECEIVED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232559 EVIS EXERA III BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ AIZU OLYMPUS CO., LTD. BF-H190 04953170335174

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other