BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 2998308 · Received March 11, 2013

    Report

    Report Number
    1723170-2013-00170
    Event Type
    Malfunction
    Date Received
    March 11, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 11, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    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

    SYSTEM UNCRATED TO SET UP. CAMERA EXTERNAL CABLE HAD BEEN PURPOSELY CUT TO ALLOW CRATING OF THE SPRING ARM ASSY. THE LINEAR LEMO PLUG HAD GOTTEN JAMMED IN THE CART MAST AT THE APPROXIMATE AREA OF THE CARTS DOCKING MECHANISM. UTILIZING A LONG THIN OBJECT TO INSERT IN THE MAST TO FREE THE LEMO AND THEN ABLE TO EXTRACT. A SECONDARY AREA OF THE CABLE HAD BEEN DAMAGE IN WHAT APPEARS TO BE A PINCHING TYPE ACTION, CUTTING THE CABLE BUT NOT SEVERING. UNKNOWN WHEN THIS DAMAGE OCCURRED. CONNECT KNOWN GOOD CABLE BETWEEN PSU AND CART. POWER SYSTEM ON. INITIALLY PSU NOT TURNING ON WHEN SYSTEM POWERED UP. SCU WAS FOUND TO BE IN THE OFF POSITION. SYSTEM RUNNING FULLY FUNCTIONAL 3 HRS PLUS. ALLOW SYSTEM TO RUN >12HRS AND MONITOR FOR STABILITY. SYSTEM REMAINS STABLE.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY A MEDTRONIC REP AT THE SITE THAT THEIR WAS A PINCHED CABLE TO THE CAMERA. THE CAMERA, SCU, AND EXTERNAL CONNECTION CABLE BETWEEN THE TWO WERE TESTED AND FOUND TO BE FULLY FUNCTIONAL. THE REPORTED EVENT WAS NOT ABLE TO BE REPLICATED BY MEDTRONIC PERSONNEL. DUE TO A BACK-ORDER OF THE CAMERA CABLE, THE ENTIRE SYSTEM WAS REPLACED AT THE SITE AND ISSUE WAS RESOLVED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THE NAVIGATION SYSTEM WAS HAVING INTERMITTENT TRACKING ISSUES. THE CAMERA PERFORMED WELL FOR THE FIRST HALF OF THE SURGERY ONLY TO BECOME UNRESPONSIVE HALF WAY THROUGH. THERE WAS NO FAULT LIGHT ON THE CAMERA, BUT IT HAD RED STATUS AND WOULD NOT TRACK ANYTHING. THE REP TRIED CYCLING POWER AND IT MADE NO CHANGE. THE SURGEON CHOSE TO COMPLETE THE SURGERY WITHOUT THE USE OF NAVIGATION. NO NEGATIVE IMPACT TO THE PATIENT OUTCOME WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101269 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR