BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 1406014 · Received June 19, 2009

    Report

    Report Number
    8010047-2009-00122
    Event Type
    Malfunction
    Date Received
    June 19, 2009
    Date of Event
    May 21, 2009
    Report Date
    May 21, 2009
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FFY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY RETURNED A BALLOON TO OLYMPUS FOR EVALUATION, WHICH IS CURRENTLY IN TRANSIT. THE CAUSE OF THE USER'S EXPERIENCE CANNOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF SIGNIFICANT ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE PROVIDED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A DIAGNOSTIC EBUS (ENDOSCOPIC BRONCHIAL ULTRASOUND) PROCEDURE, THE USERS COULD NOT GET PROPER IMAGING TO OBTAIN A BIOPSY DUE TO THE BALLOONS LEAKING. THE USERS REPORTEDLY ATTEMPTED USE OF SEVERAL BALLOONS WITHOUT SUCCESS. THE USERS ELECTED TO ABORT THE EBUS PROCEDURE AND PROCEEDED TO AN OPERATIVE BIOPSY CERVICAL MEDIASTINOSCOPY. THERE WAS REPORTEDLY NO PATIENT INJURY OTHER THAN AN UNPLANNED INCISION. THE PATIENT WAS DISCHARGED FROM THE FACILITY IN A STABLE CONDITION ON THE SAME DAY OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS SINGLE-USE BALLOON FFY OLYMPUS MEDICAL SYSTEMS CORPORATION MAJ-1351 92H

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS EVIS EXERA ULTRASONIC| BRONCHOFIBERVIDEOSCOPE