BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 8930852 · Received August 26, 2019

    Report

    Report Number
    1723170-2019-04635
    Event Type
    Malfunction
    Date Received
    August 26, 2019
    Date of Event
    August 2, 2019
    Report Date
    August 26, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00613994450944
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9733582, SERIAL/LOT #: UNKNOWN. NO PARTS HAVE BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS. 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. IT WAS REPORTED THAT THE SYSTEM¿S CAMERA WAS NOT FUNCTIONING. A MEDTRONIC REPRESENTATIVE (REP) WAS CALIBRATING THE ¿SONOCAL¿ AND THEN THE CAMERA SHUT DOWN. IT THEN CAME BACK UP AND WAS CONSTANTLY BEEPING AND FLASHING A GREEN LIGHT. IT WAS DISPLAYING ¿LOCALIZER NOT CONNECTED.¿ THE REP OPENED THE NORTHERN DIGITAL INC. (NDI) TOOLBOX AND NOTHING WAS DISPLAYED. TECHNICAL SERVICES (TS) HAD THE REP LOOK AT THE POLARIS SPECTRA SYSTEM CONTROL UNIT (SCU) LIGHTS AND THEY WERE FUNCTIONING AND ILLUMINATED AS INTENDED. TS HAD THE REP BYPASS THE INPUT/OUTPUT (I/O) HUB TO CHECK TO SEE IF THE CABLE WAS DAMAGED AND IT WAS FUNCTIONING AS INTENDED AS WELL. TS THEN HAD THE REP RESEAT THE LIMO CABLE TO THE SCU AND THE ISSUE WAS RESOLVED. TS HAD THE REP RESTART THE SYSTEM TO MAKE SURE IT WAS FUNCTIONING, AND IT WAS FUNCTIONING AS INTENDED. IT WAS NOTED THAT THE PROBABLE CAUSE WAS A LOOSE OR TWISTED INTERNAL SCU TO POSITIONING SENSOR UNIT (PSU) CABLE; ULTIMATELY THERE WAS A WIRE THAT BECAME LOOSE WHEN THE SYSTEM WAS BEING TRANSPORTED TO DIFFERENT PARTS OF THE OPERATING ROOM (OR). THERE WAS NO PATIENT INVOLVED WITH THIS EVENT. IT WAS NOTED THAT THE SYSTEM HAS BEEN USED SEVERAL TIMES SINCE WITH NO ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722728 STEALTHSTATION S7 SYSTEM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733856 00613994450944

    Patients

    Seq Age Sex Outcome Treatment
    1