BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERAII BRONCHOVIDEOSCOPE

    MDR report key: 8127335 · Received December 3, 2018

    Report

    Report Number
    8010047-2018-02348
    Event Type
    Injury
    Date Received
    December 3, 2018
    Date of Event
    October 15, 2018
    Report Date
    January 7, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EOQ
    PMA / PMN Number
    K050220
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) BUT WAS RETURNED TO OLYMPUS (B)(4). (B)(4) SENT THE DEVICE TO A THIRD PARTY LABORATORY FOR MICROBIOLOGICAL TESTING. AS A RESULT OF THE TESTING, NO MICROBE WAS DETECTED FROM THE SAMPLES COLLECTED FROM THE INSTRUMENT CHANNEL AND THE DISTAL END OF THE SUBJECT DEVICE. (B)(4) EVALUATED THE SUBJECT DEVICE AND CONFIRMED THAT THE THERE WERE SCRATCHES ON THE OBJECT LENS AND LIGHT GUIDE LENS, THE COATING OF THE INSERTION TUBE WAS PEELED PARTIALLY AND THE INSERTION TUBE WAS KINKED. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IN THIS REPORT HAS NOT BEEN RETURNED TO OMSC FOR EVALUATION. THERE WAS NO MALFUNCTION REPORT OF THE SUBJECT DEVICE. OMSC REVIEWED THE MANUFACTURE HISTORY OF THE DEVICE AND CONFIRMED NO IRREGULARITY. CONSIDERING THE INFORMATION PROVIDED FROM THE USER FACILITY, IT WAS UNCLEAR WHETHER THE REPORTED INFECTION WAS CAUSED BY THE PROCEDURE USING THE SUBJECT DEVICE OR ALREADY EXISTING BEFORE THE PROCEDURE. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT TOTAL SEVEN PATIENTS INFECTED WITH ENTEROBACTER KOBEI AFTER BRONCHOSCOPY. ON (B)(6) 2018, THE SAMPLES COLLECTED WITH FIRST THREE PATIENTS TESTED POSITIVE FOR ENTEROBACTER KOBEI AND CLOACAE. AFTER THE POSITIVE CULTURES, IT WAS REVEALED THAT ALL THREE PATIENTS HAD EXPERIENCED BRONCHOSCOPY USING THE SUBJECT DEVICE. THEN, AFTER MANUAL CLEANING FOLLOWED BY DISINFECTION USING A NON-OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR (BHT INNOVA E3), THE USER FACILITY CONDUCTED MICROBIOLOGICAL CULTURING TESTING ON SUBJECT DEVICE. IN THE TESTING, NO MICROBE WAS DETECTED FROM THE SAMPLE COLLECTED FROM THE SUBJECT DEVICE. ON (B)(6) 2018, IT WAS FOUND THAT ANOTHER FOUR PATIENTS INFECTED WITH THE SAME BACTERIA AT THE USER FACILITY. AT THAT TIME, THE USER FACILITY CONDUCTED CULTURING TESTING FOR THE SUBJECT AGAIN. IN THE TESTING, NO MICROBE WAS DETECTED FROM THE SAMPLES, WHICH WERE COLLECTED FROM THE SUBJECT DEVICE BEFORE AND AFTER THE REPROCESSING. THE USER FACILITY HAD CLEANED THE SUBJECT DEVICE USING A NON-OLYMPUS CLEANING BRUSH (LTA MEDICAL) AND REPROCESSED USING THE NON-OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR(AER) OR AN OLYMPUS AER MODEL ETD3 (NOT AVAILABLE IN THE USA). IT WAS REPORTED THAT ALL PATIENTS WERE TREATED AND THEY WERE GOING WELL. OMSC IS SUBMITTING SEVEN MEDICAL DEVICE REPORTS ACCORDING TO THE NUMBER OF THE INFECTED PATIENT. THIS IS 7 OF 7 REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    966487 EVIS EXERAII BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORP. BF-Q180

    Patients

    Seq Age Sex Outcome Treatment
    1 Other