BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS EVIS EXERA BRONCHOVIDEOSCOPE

    MDR report key: 2070573 · Received March 25, 2011

    Report

    Report Number
    8010047-2011-00061
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 25, 2011
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    EOQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED-UP WITH THE USER FACILITY TO GATHER ADDITIONAL INFORMATION REGARDING THIS REPORT. THE USER FACILITY REPORTED THAT THE IMAGE BECAME COMPLETELY WHITE WHEN THE SUBJECT DEVICE REACHED THE TISSUE. THE USERS HAD SWITCHED TO A DIFFERENT DEVICE AND COMPLETED THE PROCEDURE. THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION CONFIRMED THAT THE IMAGE WAS DISTORTED AND PARTIALLY VISIBLE. THERE WAS NO EVIDENCE OF FLUID INVASION IN THE SCOPE CONNECTOR, IN THE ELECTRICAL CONNECTOR UNIT OR IN THE CONTROL BODY. THE SCOPE PASSED THE LEAKAGE TEST AND THE FOG TEST. THE DIFFICULTY WAS ISOLATED TO THE ELECTRICAL CONNECTOR, AND WAS REPLACED. THE DEVICE WAS SERVICED AND RETURNED TO THE USER FACILITY. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A DIAGNOSTIC BRONCHOSCOPY PROCEDURE, THE DISPLAY ON THE SCREEN WAS COMPLETELY WHITE. THE INTENDED PROCEDURE WAS COMPLETED WITH A DIFFERENT OLYMPUS ENDOSCOPE. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS EVIS EXERA BRONCHOVIDEOSCOPE BRONCHOSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORPORATION BF-P160 NA

    Patients

    Seq Age Sex Outcome Treatment
    1