BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 5460507 · Received February 25, 2016

    Report

    Report Number
    1723170-2016-00252
    Event Type
    Malfunction
    Date Received
    February 25, 2016
    Date of Event
    January 29, 2016
    Report Date
    February 25, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ON 02/02/3016, A MEDTRONIC REPRESENTATIVE, FOLLOWING-UP AT THE SITE, REPORTED THE STRAIGHT PROBE WAS THE INSTRUMENT UTILIZED IN THE DESCRIPTION OF THIS EVENT, NOT THE STRAIGHT SUCTION AS ORIGINALLY REPORTED. ON 02/10/2016, A MEDTRONIC REPRESENTATIVE PERFORMED A NAVIGATION SYSTEM CHECK-OUT, ALL AREAS PASSED. SYSTEM PERFORMED AS INTENDED. ON 02/24/2016, SOFTWARE LOG ANALYSIS WAS UNABLE TO DETERMINE PROBABLE CAUSE WITH THE INSUFFICIENT INFORMATION PROVIDED. THERE IS NOTHING IN THE LOGS TO INDICATE WHY THE ELEVATOR PROBE WAS SHOWING UP AS THE CURRENT PROBE. NO FURTHER ISSUES HAVE BEEN REPORTED. (B)(4).

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A TRANSSPHENOIDAL PROCEDURE, WHILE USING THE STRAIGHT PROBE, THE SURGEON UTILIZED A "RING COLLET" AND NOTED THE STRAIGHT PROBE DISPLAYED ON THE SCREEN CHANGED TO ELEVATOR. THE SURGEON THEN RE-VERIFIED THE STRAIGHT PROBE IN ORDER TO PROCEED. DELAY IN THERAPY WAS 45 SECONDS. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118087 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) S7

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR