BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERAIII BRONCHOVIDEOSCOPE

    MDR report key: 14052090 · Received April 8, 2022

    Report

    Report Number
    8010047-2022-05947
    Event Type
    Malfunction
    Date Received
    April 8, 2022
    Date of Event
    February 26, 2022
    Report Date
    June 7, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EOQ
    UDI-DI
    04953170335181
    PMA / PMN Number
    K121959
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO THE INITIAL EVENT, THE CULTURE RESULTS REPORTED WERE OF THE ETD MINI AND NOT OF THE SUBJECT DEVICE. 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. BECAUSE THE SUBJECT DEVICE WAS NOT RETURNED AND CULTURE RESULTS OF THE DEVICE WERE NOT RECEIVED AND BASED ON THE RESULTS OF THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. THE FOLLOWING IS INCLUDED IN THE DEVICE IFU: "WARNING: AN INSUFFICIENTLY REPROCESSED ENDOSCOPE AND/OR ACCESSORY MAY POSE AN INFECTION CONTROL RISK TO THE PATIENTS AND/OR OPERATORS WHO TOUCH THEM." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE CLEANING, DISINFECTION, AND STERILIZATION (CDS) OF THE SCOPE WAS PERFORMED BY THE CUSTOMER. A DATABASE OF REPROCESSING PROTOCOLS HAD BEEN SUBMITTED TO OLYMPUS. THE ETD MINI WAS INSTALLED ON (B)(6) 2021. SINCE INSTALLATION, THERE HAD BEEN NO PREVENTATIVE MAINTENANCE OR REPAIRS PERFORMED. THE LAST CALIBRATION OF THE ETD MINI WAS DURING INSTALLATION ON (B)(6) 2021. THE SCOPE WAS PRECLEANED IN WATER WITH A BRUSH. IT WAS UNKNOWN IF THE SCOPE WOULD BE RETURNED TO OLYMPUS FOR EVALUATION. THE TAP WATER TESTED NEGATIVE. THE SUBJECT DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED FOR EVALUATION. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    CORRECTION TO THE INITIAL EVENT, THE CULTURE RESULTS REPORTED WERE OF THE ETD MINI AND NOT OF THE SUBJECT DEVICE.

    Description of Event or Problem · 0

    THE OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, A MICROBIOLOGICAL CULTURE WAS PERFORMED ON THE EVIS EXERA III BRONCHOVIDEOSCOPE. THE SCOPE TESTED POSITIVE FOR COAGULASE-NEGATIVE STAPHYLOCOCCI AFTER BEING WASHED IN AN ENDOTHERMO DISINFECTOR (ETD) MINI WASHER/DISINFECTOR. THE ETD MINI WASHER/DISINFECTOR HAD WORKED IMPROPERLY AND WAS INCORRECTLY DOSING WITHOUT AN ERROR ON THE MACHINE. DURING THE FIRST INSPECTION, THE MACHINE WAS ONLY TAKING HALF OF THE FLUID DOSAGE (DISINFECTANT AND DETERGENT). AFTER CALIBRATION, THE MACHINE WAS TAKING DOUBLE OF THE FLUID DOSAGE. AFTER A THIRD INSPECTION, THE MACHINE FUNCTIONED AS INTENDED. THE SCOPE WOULD BE DISINFECTED IN ANOTHER ETD AND RE-CULTURED. NO ADDITIONAL TEST RESULTS WERE PROVIDED. ADDITIONALLY, THE ETD MINI WAS CULTURED AND TESTED POSITIVE FOR ESCHERICHIA COLI AND COAGULASE-NEGATIVE STAPHYLOCOCCI ON (B)(6) 2022 AND TESTED POSITIVE AGAIN FOR ESCHERICHIA COLI AND COAGULASE-NEGATIVE STAPHYLOCOCCI ON (B)(6) 2022. THERE WAS NO CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN THE STATE OF HEALTH OF ANY PERSON, TO WHICH THE SCOPE COULD HAVE BEEN A CONTRIBUTORY CAUSE. THIS COMPLAINT IS RELATED TO PATIENT IDENTIFIER (B)(6) (ETD MINI, WD00501A).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187013 EVIS EXERAIII BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORP. BF-1TH190 04953170335181

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown