BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA II BRONCHOVIDEOSCOPE

    MDR report key: 4143971 · Received October 3, 2014

    Report

    Report Number
    2951238-2014-00384
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 19, 2014
    Manufacturer
    OLYMPUS AMERICA, INC.
    Product Code
    EOQ
    PMA / PMN Number
    K023984
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT HAS NOT YET BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. IF ANY ADDITIONAL INFORMATION IS RECEIVED AT A LATER TIME THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT AFTER 10 MINUTES INTO A DIAGNOSTIC LAVAGE PROCEDURE, THREE PIECES OF UNSPECIFIED MATERIAL WERE OBSERVED IN THE PATIENT'S LUNGS. THE USER FACILITY ALLEGED THAT THE THREE PIECES WERE FROM THE BRONCHOSCOPE. TWO OF THE THREE PIECES WERE SUCCESSFULLY RETRIEVED USING A DIFFERENT BRONCHOSCOPE AND A BIOPSY FORCEPS. IT IS UNKNOWN IF THE THIRD PIECE WAS LEFT INSIDE THE PATIENT. HOWEVER, THE USER FACILITY INDICATED THAT THE THIRD PIECE WAS NOT ACCOUNTED FOR DURING THE SUBSEQUENT PROCEDURE. OLYMPUS WAS INFORMED THAT THE PATIENT EXPERIENCED SEVERE TRAUMA, AND MODERATE BLEEDING IN THE LUNGS. THE INTENDED PROCEDURE WAS NOT SUCCESSFULLY COMPLETED. THE CURRENT CONDITION OF THE PATIENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617580 EVIS EXERA II BRONCHOVIDEOSCOPE BRONCHOSCOPE EOQ OLYMPUS AMERICA, INC. BF-P180 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention