BEUDAMED
    FDA Adverse Event Other Summary report: N

    WAYPOINT STEREOTACTIC SYSTEM

    MDR report key: 3049517 · Received April 3, 2013

    Report

    Report Number
    3005677147-2013-00003
    Event Type
    Other
    Date Received
    April 3, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 26, 2013
    Manufacturer
    FHC, INC.
    Product Code
    HAW
    PMA / PMN Number
    K092192
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FHC STEREOTACTIC TECHNOLOGY DEPARTMENT EVALUATED THE PAK PLANS FROM THE SURGERY AND DETERMINED THAT THE EQUIPMENT USED FOR PLANNING (WAYPOINT NAVIGATOR) PERFORMED AS REQUIRED. FHC WILL BE ATTENDING THE NEXT SURGERY WITH THIS SURGEON TO ENSURE PROPER TRAINING AND UNDERSTANDING OF THE SOFTWARE FUNCTIONALITY AS WELL AS CONFIRM THAT THE SOFTWARE IS WORKING AS INTENDED.

    Description of Event or Problem · 1

    FHC STEREOTACTIC TECHNOLOGY DEVELOPMENT REP REPORTED A POSSIBLE PROBLEM WITH THE WAYPOINT NAVIGATOR WHEN USED TO PLAN A TRAJECTORY FOR A SURGERY. THE SURGEON IDENTIFIED THAT THE LEFT STN TRAJECTORY WAS HIGH AND OVER A CENTIMETER OFF FROM THE INTENDED TARGET. THE SURGERY WAS PERFORMED USING THIS TRAJECTORY AND THUS LED TO MISPLACEMENT OF THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137468 WAYPOINT STEREOTACTIC SYSTEM WAYPOINT NAVIGATOR HAW FHC, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK