BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S8 SYSTEM

    MDR report key: 7981463 · Received October 18, 2018

    Report

    Report Number
    1723170-2018-05239
    Event Type
    Malfunction
    Date Received
    October 18, 2018
    Date of Event
    September 20, 2018
    Report Date
    October 18, 2018
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00643169722187
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING REVEALED THAT THE POWER OVER ETHERNET (POE) SHOWED RED LIGHT. THE POE INJECTOR WAS REPLACED. THE IMAGING SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. A CABLE WAS RETURN TO THE MANUFACTURER FOR ANALYSIS. NO FAILURE WAS FOUND DURING FUNCTIONAL TESTING AND VISUAL EXAMINATION. THE CABLE WAS TESTED AND IT DID NOT HAVE ANY OPENS OR SHORTS THE POE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. ANALYSIS FOUND THAT WHEN POWERED ON AND POWER WAS PROVIDED TO THE CAMERA, THE POE INJECTORS LED WAS GREEN AND OVER TIME TURNED RED. IF THE POE WAS UNPLUGGED FROM THE WALL POWER AND COOLED, THE POE WOULD PROVIDE POWER ONCE WALL POWER WAS RE-APPLIED. THE REPORTED EVENT WAS RELATED TO A ELECTRICAL ISSUE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED INTRA-OPERATIVELY FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT DURING A SCOLIOSIS CASE, THE CAMERA ON THE NAVIGATION SYSTEM SUDDENLY LOST POWER AND THE SOFTWARE DISPLAYED "LOCALIZED NOT CONNECTED." THE SYSTEM WAS REBOOTED AND THE CAMERA CAME BACK ONLINE BUT LOST POWER. THE CAMERA WAS NOT MOVED AT ALL DURING THIS TIME. THE MANUFACTURER REPRESENTATIVE (REP) PRESENT TOOK THE SYSTEM OUT OF THE ROOM. THE BULKHEAD IN THE CAMERA ARM DID NOT APPEAR TO HAVE ANY DAMAGE, THE CONNECTIONS TO THE POWER OVER ETHERNET (POE) INJECTOR WERE ALL SECURE. THE CAMERA WAS NOT MOVED ONCE REBOOTING AND WOULD FUNCTION, BUT THEREAFTER, THE POE INJECTOR LIGHT WOULD GO RED AND THE CAMERA WOULD LOSE POWER. THE SITE USED A DIFFERENT NAVIGATION DEVICE TO COMPLETE THE CASE. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF ABOUT 5 MINUTES DUE TO THIS ISSUE AND NO KNOWN IMPACT ON THE PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822530 STEALTHSTATION S8 SYSTEM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9735665 00643169722187

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR