BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTH S8

    MDR report key: 8814558 · Received July 22, 2019

    Report

    Report Number
    1723170-2019-04179
    Event Type
    Malfunction
    Date Received
    July 22, 2019
    Date of Event
    June 26, 2019
    Report Date
    March 10, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00643169722187
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING REVEALED THAT THE NAVIGATION SYSTEM PASSED A SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 9735820, SERIAL/LOT #: (B)(4), UBD: UNKNOWN, UDI# UNKNOWN. A SYSTEM CHECKOUT HAS NOT BEEN COMPLETED AS ON 2019-09-17. THE SYSTEM CONTROL UNIT (SCU) WAS RETURNED TO MEDTRONIC FOR ANALYSIS. WHEN CONNECTED TO A KNOWN GOOD SYSTEM, THE RETURNED SCU WAS FULLY FUNCTIONAL. A CHECK OF THE EVENT LOG DID NOT REVEAL ANY ADVERSE EVENTS. NO PROBLEM WAS FOUND. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    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 SYSTEM EVENT HAVING OCCURRED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE CAMERA HAD AN AMBER LIGHT. THE MEDTRONIC REPRESENTATIVE CHECKED THE CABLE GOING INTO THE BACK OF THE CAMERA, THE MIDDLE OF THE CAMERA, AND INTO THE POE INJECTOR WITHOUT RESOLUTION. POE WAS SHOWING GREEN STATUS. THE NDI TOOLBOX WAS CHECKED AND THE SCU WAS NOT PRESENT. CAMERA STATUS SHOWED CONFIGURATION ALERT AND SAID SCU CONNECTION FAILURE. THE ETHERNET CABLE WAS RESEATED FROM THE SCU TO THE COMPUTER ON BOTH SIDES WITHOUT RESOLUTION. THEY POWERCYCLED THE SCU WITHOUT RESOLUTION. NO AMBER LIGHT WAS SHOWING ON THE ETHERNET PORT OF THE SCU WHERE YOU CONNECT IT. A REPLACEMENT SCU WAS REQUESTED. NO PATIENT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604214 STEALTH S8 INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9735665 00643169722187

    Patients

    Seq Age Sex Outcome Treatment
    1