BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 2013560 · Received February 3, 2011

    Report

    Report Number
    1723170-2011-00080
    Event Type
    Malfunction
    Date Received
    February 3, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 6, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS CURRENTLY IN PROGRESS.

    Description of Event or Problem · 1

    A MEDTRONIC REP REPORTED THAT THE PASSIVE BIOPSY NEEDLE HAD A BREAK IN TRACKING WHEN BEING USED. THE REP MADE SURE THE TWO PASSIVE SPHERES ON THE NEEDLE WERE DRY AND FREE OF DEBRIS. HE REPORTED THAT THERE WERE TWO OVERHEAD LIGHTS ON AND DIRECTLY OVER THE SURGICAL FIELD. THE SURGEON COMPLETED THE SURGERY WITH THE USE OF THE STEALTHSTATION. THERE WAS NO NEGATIVE IMPACT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTHSTATION S7 SYSTEM STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. S7 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR