BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2081214 · Received April 21, 2011

    Report

    Report Number
    1723170-2011-00827
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    June 28, 2010
    Report Date
    June 28, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PER RMA, A REPLACEMENT CABLE WAS SENT TO SITE. UPON EVAL OF RETURNED CABLE SHOWS THE CAMERA CABLE IS NOT FRAYED AS REPORTED, BUT RATHER, THE LEMO CONNECTOR SHELL IS MISSING AND THE PINS ARE BENT. THE CABLE IS OTHERWISE FUNCTIONAL PASSING A CONTINUITY TEST WITH NO OPENS OR SHORTS DETECTED. THE OVERALL CONDITION OF THE SPRING ARM IS POOR WITH NICKS AND SCRATCHES ON ALL SURFACES.

    Description of Event or Problem · 1

    MEDTRONIC REP REPORTED THAT THE CAMERA CABLE IS FRAYED, CAUSING INTERMITTENT RED AND BLACK STATUS BETWEEN COMPUTER AND CAMERA. 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 TREON TREATMENT GUIDANCE SYSTEM STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. TREON NA

    Patients

    Seq Age Sex Outcome Treatment
    1