BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III BRONCHOVIDEOSCOPE

    MDR report key: 11751950 · Received April 30, 2021

    Report

    Report Number
    8010047-2021-05667
    Event Type
    Malfunction
    Date Received
    April 30, 2021
    Report Date
    June 21, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EOQ
    UDI-DI
    04953170335181
    PMA / PMN Number
    K121959
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS ONGOING. THE DEFINITIVE CAUSE OF THE USER¿S EXPERIENCE CANNOT BE DETERMINED AT THIS TIME. THIS REPORT WILL BE UPDATED UPON COMPLETION OF THE INVESTIGATION OR UPON RECEIPT OF ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER¿S INVESTIGATION. THE SERIAL NUMBER IS UNKNOWN. THEREFORE, THE MANUFACTURING DEVICE HISTORY RECORD COULD NOT BE REVIEWED. HOWEVER, ONLY DEVICES THAT HAVE PASSED INSPECTION ARE SHIPPED. THE LITERATURE REPORTED THE RESULT OF THE MICROBIOLOGICAL TEST USING OLYMPUS BRONCHOSCOPES (ENDOSCOPE) AND NON-OLYMPUS BRONCHOSCOPES (ENDOSCOPE). AS A RESULT OF THE MICROBIOLOGICAL TESTING, THE MICROBES WERE DETECTED FROM THE SUBJECT DEVICE. THERE WAS NO REPORT OF INFECTION ON THIS LITERATURE. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED BECAUSE THE SUBJECT DEVICE WAS NOT RETURNED FOR EVALUATION. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE.

    Description of Event or Problem · 1

    IT IS REPORTED IN THE LITERATURE ARTICLE TITLED "EFFECTIVENESS OF REPROCESSING FOR FLEXIBLE BRONCHOSCOPES AND ENDOBRONCHIAL ULTRASOUND BRONCHOSCOPES" MICROBIAL GROWTH WAS FOUND IN 14 FULLY REPROCESSED BRONCHOSCOPES ACROSS SIX DIFFERENT MODELS. THE AIM OF THE STUDY WAS TO EVALUATE THE EFFECTIVENESS OF REAL-WORLD BRONCHOSCOPE REPROCESSING USING A SYSTEMATIC, MULTIFACETED APPROACH. THE STUDY CLEARLY STATES THERE WERE NO HUMAN SUBJECTS INVOLVED. RESEARCHERS EXAMINED 24 CLINICALLY USED BRONCHOSCOPES. AFTER MANUAL CLEANING, 100% OF BRONCHOSCOPES HAD RESIDUAL CONTAMINATION. MICROBIAL GROWTH WAS FOUND IN 14 FULLY REPROCESSED BRONCHOSCOPES (58%), INCLUDING MOLD, STENOTROPHOMONAS MALTOPHILIA, AND ESCHERICHIA COLI/SHIGELLA SPECIES. VISIBLE IRREGULARITIES WERE OBSERVED IN 100% OF BRONCHOSCOPES, INCLUDING RETAINED FLUID; BROWN, RED, OR OILY RESIDUE; SCRATCHES; DAMAGED INSERTION TUBES AND DISTAL ENDS; AND FILAMENTOUS DEBRIS IN CHANNELS. REPROCESSING PRACTICES WERE SUBSTANDARD AT TWO OF THREE SITES. CONCLUSIONS: DAMAGED AND CONTAMINATED BRONCHOSCOPES WERE IN USE AT ALL SITES. INADEQUATE REPROCESSING PRACTICES MAY HAVE CONTRIBUTED TO BIOBURDEN FOUND ON BRONCHOSCOPES. HOWEVER, EVEN WHEN GUIDELINES WERE FOLLOWED, HIGH-LEVEL DISINFECTION WAS NOT EFFECTIVE. A SHIFT TOWARD THE USE OF STERILIZED BRONCHOSCOPES IS RECOMMENDED. IN THE MEANTIME, QUALITY MANAGEMENT PROGRAMS AND UPDATED REPROCESSING GUIDELINES ARE NEEDED. THIS CASE REPORTS THE TWO BF-1TH190 SCOPES THAT TESTED POSITIVE FOR MICROORGANISMS IN THE STUDY AFTER BEING FULLY REPROCESSED. (CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE FOUR BF-P190 SCOPES TESTING POSITIVE FOR MICROORGANISMS AFTER BEING FULLY REPROCESSED. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE TWO BF-UC180F SCOPES TESTING POSITIVE FOR MICROORGANISMS AFTER BEING FULLY REPROCESSED. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE FOUR BF-1TQ180 SCOPES TESTING POSITIVE FOR MICROORGANISMS AFTER BEING FULLY REPROCESSED. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE ONE BF-XP190 TESTING POSITIVE FOR MICROORGANISMS AFTER BEING FULLY REPROCESSED. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE ONE BF-P180 SCOPE TESTING POSITIVE FOR MICROORGANISMS AFTER BEING FULLY REPROCESSED.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652227 EVIS EXERA III BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORP. BF-1TH190 04953170335181

    Patients

    Seq Age Sex Outcome Treatment
    1