BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYRUS G400 ELECTROSURGICAL GENERATOR

    MDR report key: 3919081 · Received June 16, 2014

    Report

    Report Number
    2951238-2014-00243
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    GYRUS ACMI INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER TIME THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING SURGERY WITH A DAVINCI ROBOTICS, THE PATIENT SUSTAINED A MINOR BURN. AT A TIME THE ERROR LOG ON THE DEVICE WERE INSPECTED AND NO ERRORS WERE FOUND. THE DEVICE WAS BEING USED WITH A NON OLYMPUS APPROVED DEVICE. OLYMPUS FOLLOWED UP WITH THE USER FACILITY VIA TELEPHONE AND EMAIL TO OBTAIN MORE DETAILED INFORMATION ABOUT THE REPORTED EVENT BUT WITH NO RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352911 GYRUS G400 ELECTROSURGICAL GENERATOR ELECTROSURGICAL GENERATOR GEI GYRUS ACMI INC. G400 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other