BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 2830672 · Received November 13, 2012

    Report

    Report Number
    1723170-2012-00626
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 15, 2012
    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

    NO PATIENT WAS PRESENT AT THE TIME OF THE ALLEGED MALFUNCTION. AN RMA WAS CREATED FOR THIS CASE AND A REPLACEMENT PART WAS SHIPPED ON (B)(4) 2012. THE SUSPECTED PART WAS RECEIVED BY THE MANUFACTURER AND EVALUATED. AS REPORTED, THE POSITION SENSOR UNIT (PSU) FAILED AN ACCURACY ASSESSMENT KIT (AAK) TEST AT .41 MM. THE PSU IS OUT OF CALIBRATION.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THE CAMERA FAILED THE ACCURACY ASSESSMENT KIT (AAK) TEST DURING INSPECTION. THIS EVENT WAS REPORTED OUTSIDE THE OPERATING ROOM. THERE WAS NO PATIENT PRESENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1