BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3092300 · Received May 3, 2013

    Report

    Report Number
    1723170-2013-00315
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 5, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS AND SHOWED SIGNS OF PHYSICAL DAMAGE. THE STARBURST END OF THE ARM WILL NOT TIGHTEN. ALL OF THE COLOR HAS BEEN STERILIZED OFF THE OF THE ARM. THE REPORTED EVENT WAS CONFIRMED. THE DEVICE WAS REPLACED AND THERE WERE NO FURTHER ISSUES.

    Description of Event or Problem · 1

    A HOSPITAL STAFF MEMBER REPORTED THAT THE ARTICULATING ARM WILL NOT LOCK. THIS EVENT WAS REPORTED OUTSIDE THE OPERATING ROOM, NO PATIENT WAS PRESENT AT THE TIME OF THE ALLEGED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195262 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1