BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TRIA NAVIGATION SYSTEM

    MDR report key: 2081194 · Received April 21, 2011

    Report

    Report Number
    1723170-2011-00804
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    July 21, 2009
    Report Date
    July 21, 2009
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PASSIVE REDUCED VOLUME OBSERVED AFTER WARM UP, THE VOLUME DECREASING OVER TIME. FAILED AAK TEST AT .86MM WITH LINE SEPARATION OF 2.89MM. THE PSU IS OUT OF CALIBRATION.

    Description of Event or Problem · 1

    SITE REPORTED THAT THE TRIA SYSTEM'S CAMERA WAS OUT OF CALIBRATION. THIS EVENT DID NOT OCCUR DURING SURGERY AND NO PT WAS PRESENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1