BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA II BRONCHOVIDEOSCOPE

    MDR report key: 4180126 · Received October 15, 2014

    Report

    Report Number
    2951238-2014-00460
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 22, 2014
    Manufacturer
    OLYMPUS MED SYSTEMS CORP
    Product Code
    EOQ
    PMA / PMN Number
    K050220
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. IF ADDITIONAL INFO OR IF THE DEVICE IS RECEIVED AT A LATER TIME THIS REPORT WILL BE SUPPLEMENTED. PLEASE CROSS REFERENCE WITH MANUFACTURE REPORT NUMBERS, 2951238-2014-00458 AND 2951238-2014-00459.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT THREE PTS WERE EXAMINED WITH THE SAME BRONCHOSCOPE ON THREE DIFFERENT BIOPSY PROCEDURES, AND THE PTS' BIOPSY SAMPLES TESTED POSITIVE FOR STENOTROPHOMONAS MALTOPHILIA. THE CURRENT CONDITION OF THE PTS ARE UNK. AS PART OF OUR INVESTIGATION OF THIS REPORT, AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) VISITED THE USER FACILITY TO ASSESS THEIR REPROCESSING PRACTICES AND TO PROVIDE REPROCESSING TRAINING IF NECESSARY. THE ESS REPORTED THAT THERE WAS NO PROBLEM NOTED DURING THE REPROCESSING OF THE ENDOSCOPE AT THE USER FACILITY DURING THE SITE VISIT. OLYMPUS CONTACTED THE USER FACILITY VIA TELEPHONE AND IN WRITING TO OBTAIN MORE DETAILED INFO REGARDING THE REPORTED EVENT BUT WITH NO RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653972 EVIS EXERA II BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ OLYMPUS MED SYSTEMS CORP BF-1T180 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other