BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON

    MDR report key: 512461 · Received February 6, 2004

    Report

    Report Number
    MW1031130
    Event Type
    Malfunction
    Date Received
    February 6, 2004
    Date of Event
    February 4, 2004
    Report Date
    February 6, 2004
    Manufacturer
    MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    POWER CORD ON THE STEALTHSTATION TREON WAS PARTIALLY CUT THROUGH BY THE METALLIC STRAIN RELIEF ON THE CORD RETRACTING MECHANISM. THIS RESULTED IN A SHORT BETWEEN THE POWER LINE HOT AND THE CHASSIS OF THE MACHINE. POTENTIAL FOR ELECTRIC SHOCK, FIRE, OR LOSS OF POWER TO CRITICAL EQUIPMENT. NO INJURY REPORTED. BEGINNING OF SURGERY WAS DELAYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTHSTATION TREON SURGICAL NAVIGATION SYSTEM HAW MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES STEALTHSTATION TREON *

    Patients

    Seq Age Sex Outcome Treatment
    1 *