BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS UES-40 ELECTROSURGICAL UNIT

    MDR report key: 1853665 · Received September 30, 2010

    Report

    Report Number
    8010047-2010-00188
    Event Type
    Malfunction
    Date Received
    September 30, 2010
    Report Date
    September 1, 2010
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVAL. THE EVAL DID NOT DUPLICATE EITHER A BURNING ODOR OR SMOKE, HOWEVER THE DEVICE WAS NOTED TO DISPLAY AN ERROR 02 MESSAGE AND THE OSCILLATION PRINTED CIRCUIT BOARD WAS DETERMINED TO HAVE BEEN DAMAGED. THE OSCILLATION BOARD WAS FORWARDED TO THE ORIGINAL EQUIPMENT MFR FOR ADDITIONAL INVESTIGATION. THE DEVICE WAS SERVICED AND RETURNED TO THE USER FACILITY. THE SOURCE OF THE DAMAGE WAS LIKELY OPERATING THE DEVICE BEYOND RECOMMENDED ENERGY DELIVERY INTERVAL. THE UES-40 INSTRUCTIONS FOR USE ADVISES USERS, "CAUTION: THE MAXIMUM OUTPUT TIME SHOULD BE 10 SECONDS AND THERE SHOULD BE AN INTERVAL OF 30 SECONDS BETWEEN OUTPUTS." IF FURTHER SIGNIFICANT ADDITIONAL INFO IS OBTAINED, THE REPORT WILL BE UPDATED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION. THIS REPORT IS BEING SUBMITTED AS AN MDR IN AN ABUNDANCE OF CAUTION. OLYMPUS AMERICA INC. IS FILLING MDRS ON BEHALF OF (B)(4) AND OLYMPUS MEDICAL SYSTEMS CORP. (B)(4).

    Description of Event or Problem · 1

    USER FACILITY REPORTED THAT DURING AN UNSPECIFIED TYPE OF PROCEDURE, THE SUBJECT DEVICE REPORTEDLY HAD A BURNING SMELL AND SMOKE WAS COMING FROM THE UNIT. THERE WAS NO PT HARM. THE PROCEDURE WAS REPORTEDLY COMPLETED WITH USE OF ANOTHER COMPANY'S ELECTROSURGICAL GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS UES-40 ELECTROSURGICAL UNIT ELECTROSURGICAL UNIT KNS OLYMPUS MEDICAL SYSTEMS CORPORATION UES-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1