BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2050143 · Received April 1, 2011

    Report

    Report Number
    1723170-2011-00589
    Event Type
    Malfunction
    Date Received
    April 1, 2011
    Date of Event
    September 9, 2010
    Report Date
    September 9, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SOFTWARE INVESTIGATION FOUND THAT CLEANING OFF OLD EXAMS FROM THE HARD DRIVE HELPED WITH THE PERFORMANCE OF THE SYSTEM. THE OLDER COMPUTERS HAVE A SMALLER HARD DRIVE AND ARE MORE PRONE TO DIFFICULTIES DISPLAYED BY THE SOFTWARE WHEN THE HARD DRIVES GET TOO FULL. TECHNICAL SERVICES PROVIDED ADDITIONAL INSTRUCTION TO USER THAT RESOLVED ISSUE AT THE TIME OF EVENT.

    Description of Event or Problem · 1

    SITE REPORTED IN THE MIDDLE OF A NAVIGUS BIOPSY CASE AND STATED THE TREON SYSTEM IS REALLY SLOW AS IF THE CAMERA IS FROZEN. THE SITE REP REMOVED SOME OF THE PT EXAMS ON THE SYSTEM, RESTARTED THE APPLICATION AND RESET THE CAMERA WHICH ALLOWED THE SURGEON TO COMPLETE THE CASE WITHOUT ISSUE. THE WAS NO IMPACT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. TREON NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK