BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE

    MDR report key: 5536858 · Received March 30, 2016

    Report

    Report Number
    2951238-2016-00340
    Event Type
    Injury
    Date Received
    March 30, 2016
    Report Date
    March 18, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    PSV
    PMA / PMN Number
    PK070983
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS FORWARDED TO AN INDEPENDENT LABORATORY FOR FURTHER MICROBIOLOGY TESTING. THE EXACT CAUSE OF THE REPORTED ISSUE COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME AS THE EVALUATION IS STILL IN PROGRESS. AS PART OF OUR INVESTIGATION INTO THIS REPORT, OLYMPUS DISPATCHED AN ENDOSCOPY SUPPORT SPECIALIST (ESS) TO THE FACILITY TO OBSERVE THEIR REPROCESSING PRACTICES. ESS VISITED THE FACILITY ON (B)(6) 2016 TO REVIEW THE REPROCESSING STEPS AND FOUND NO DEVIATIONS TO THE REPROCESSING PROCEDURE. DURING THE IN-SERVICE VISIT, IT WAS FOUND THAT ONE OF THE SINKS IN THE ENDOSCOPY ROOM HAD TESTED POSITIVE FOR AN UNSPECIFIED FUNGUS. ESS AND A FIELD SERVICE ENGINEER (FSE) OBSERVED THAT THE PUR WATER PRE-FILTER HAD AN OPEN VALVE THAT WAS BYPASSING WATER FROM GOING THROUGH IT. THE ESS AND FSE ENSURED THE FACILITY CORRECTED THE POSITION OF THE VALVE PRIOR TO LEAVING.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO MAKE A CORRECTION ON THE PROCODE FROM IYN TO PSV.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SENT TO AN INDEPENDENT LABORATORY FOR MICROBIOLOGY TESTING AND TESTED NEGATIVE GROWTH. THE SCOPE WAS THEN FORWARDED TO OLYMPUS FOR DEVICE EVALUATION. A VISUAL EXAMINATION OF THE INTERNAL CHANNELS OF THE SCOPE WAS EXAMINED WITH OLYMPUS TELESCOPE AND BOROSCOPE TEST EQUIPMENT AND NO SIGNS OF FOREIGN MATERIAL WERE OBSERVED. THE DEVICE PASSED LEAK TEST. NO OTHER ABNORMALITIES WERE NOTED. THE SCOPE WAS SERVICED AND RETURNED TO THE FACILITY.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT THE DEVICE CULTURE TESTED POSITIVE FOR AN UNSPECIFIED FUSARIUM GROWTH AFTER IT HAD BEEN REPROCESSED IN THE OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR (AER). THE OCCURRENCE IS FROM A BRONCHIAL ASPIRATION PROCEDURE THAT TOOK PLACE AROUND MID-(B)(6) 2016. A PATIENT'S CULTURE RESULT WAS ALSO POSITIVE FOR AN UNSPECIFIED "FUNGAL GROWTH". THE SCOPE WAS REMOVED FROM CLINICAL SERVICE ON (B)(6) 2016. THE FACILITY IS INVESTIGATING THE CAUSE OF THE FUNGAL GROWTH AND HAS CULTURED THE REPROCESSING AREAS, INCLUDING WORK SURFACES AND FAUCETS IN ORDER TO RULE OUT ANY OTHER CONTRIBUTING FACTORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190404 EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE ULTRASONIC BRONCHOFIBERVIDEOSCOPE PSV OLYMPUS MEDICAL SYSTEMS CORP. BF-UC180F N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other