BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 1062787 · Received June 17, 2008

    Report

    Report Number
    8010047-2008-00103
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    May 13, 2008
    Report Date
    May 19, 2008
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT HAS NOT YET BEEN RETURNED TO OLYMPUS FOR INVESTIGATION. THE CAUSE OF THE USER'S EXPERIENCE CANNOT BE DETERMINED AT THIS TIME. IF THE DEVICE IS RETURNED TO OLYMPUS FOR INVESTIGATION AT A LATER DATE AND ADDITIONAL, RELEVANT INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL FOLLOW. 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 THE ELECTRO-SURGICAL UNIT DID NOT CAUTERIZE DURING A VEIN HARVESTING PROCEDURE RESULTING IN THE NEED TO CONVERT THE PROCEDURE TO AN OPEN VEIN SURGERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE. THERE WAS NO PT INJURY REPORTED. HOWEVER, THE PT WAS STILL IN THE HOSPITAL FOR UNKNOWN RELATED CONDITIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR