BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II BRONCHOVIDEOSCOPE

    MDR report key: 7352833 · Received March 20, 2018

    Report

    Report Number
    8010047-2018-00476
    Event Type
    Malfunction
    Date Received
    March 20, 2018
    Date of Event
    February 15, 2018
    Report Date
    May 23, 2018
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EOQ
    PMA / PMN Number
    PK050220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE DEVICE EVALUATION RESULT. THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) BUT WAS RETURNED TO OLYMPUS (B)(4) FOR EVALUATION. THE EVALUATION CONFIRMED THAT THE ADHESIVE ON THE BENDING SECTION RUBBER WAS WORN AND THE UNIVERSAL CORD WAS SLIGHTLY DEFORMED. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE DEVICE EVALUATION RESULT. 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 SAMPLE COLLECTED FROM THE INSTRUMENT CHANNEL AND THE DISTAL END OF THE DEVICE. THE TESTING RESULT CLEARED THE (B)(4) GUIDELINE. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OMSC. BUT WAS RETURNED TO OLYMPUS (B)(4). THE SUBJECT DEVICE WAS SENT TO A THIRD PARTY LABORATORY FOR ADDITIONAL MICROBIOLOGICAL TESTING. IN THE ADDITIONAL TEST, UNSPECIFIED BACTERIA (102 CFU/10 ML) WERE DETECTED FROM THE INSTRUMENT CHANNEL OF THE SUBJECT DEVICE. THE TEST RESULT DIDN¿T CLEAR THE GERMAN GUIDELINE. ALSO, THE USER FACILITY REPORTED THAT THEY DIDN'T HAVE THE CLEANING BRUSH FOR THE INSTRUMENT CHANNEL. OMSC REVIEWED THE MANUFACTURING HISTORY OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING A CULTURING TEST BY THE FACILITY, THE INSTRUMENT CHANNEL OF THE SUBJECT DEVICE TESTED POSITIVE FOR PSEUDOMONAS AERUGINOSA (100 CCFU). THE SUBJECT DEVICE HAD BEEN DISINFECTED USING AN OLYMPUS AUTOMATED ENDOSCOPE REPROCESSR MODEL MINIETD2 (NOT AVAILABLE IN THE U.S.) WITH PERACETIC ACID. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195120 EVIS EXERA II BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORP. BF-Q180

    Patients

    Seq Age Sex Outcome Treatment
    1