BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 3822013 · Received May 20, 2014

    Report

    Report Number
    1723170-2014-00527
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    June 19, 2013
    Report Date
    April 30, 2014
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS UNKNOWN. THIS EVENT IS BEING REPORTED AS A RESULT OF A RETROSPECTIVE REVIEW OF SIMILARLY REPORTED EVENTS THAT WERE INITIALLY DEEMED NOT REPORTABLE TO THE FDA. THE AWARE DATE OF THE NEED TO PERFORM THIS RETROSPECTIVE REVIEW IS CORRECTLY DOCUMENTED AS (B)(4) 2014. A MEDTRONIC REPRESENTATIVE WHO PERFORMED ONSITE TESTING OF THE SYSTEM REPORTED THAT THE STRAIGHT SUCTION WAS BENT AND WOULD NOT VERIFY. THE NEW SUCTION WAS REPLACED BY THE SITE, BUT THE SUSPECT SUCTION WAS DISPOSED OF AND NOT RETURNED TO THE MANUFACTURER FOR FURTHER ANALYSIS. THE REP ALSO FOUND THAT THE EXAM WITH THE REGISTRATION ON IT WAS A CORONAL EXAM (NAVIGATION PROTOCOL RECOMMENDS AXIAL). THE SITE HAD TRIED TO LOAD AN AXIAL EXAM LATER WHICH SHOWED WITHOUT THE REGISTRATION. SHE PERFORMED AN IN SERVICE FOR THE STAFF ON HOW TO IDENTIFY AND REGISTER ON AXIAL EXAMS.

    Description of Event or Problem · 1

    A SITE NURSE REPORTED THEY COULD NOT VERIFY THE STRAIGHT SUCTION IN THE NAVIGATE TASK DURING A FESS (FUNCTIONAL ENDOSCOPIC SINUS SURGERY) PROCEDURE. WHENEVER THEY ATTEMPTED TO VERIFY THE STRAIGHT SUCTION, THE 90 CURVED SUCTION WOULD BE DISPLAYED AND WOULD NEVER CHANGE TO THE STRAIGHT SUCTION. THEY WERE ABLE VERIFY THE TRACER PROBE AND THE 90 DEGREE SUCTION WITHOUT ANY ISSUES. THEY CONNECTED THE STRAIGHT SUCTION TO A DIFFERENT INSTRUMENT TRACKER; NO RESOLUTION. CHECKED THAT THE STRAIGHT SUCTION WAS ADDED TO THE PROCEDURE. THERE DID NOT APPEAR TO BE METAL INTERFERENCE IN THE FIELD. THEY RESTARTED THE APPLICATION BUT WERE UNABLE TO LOAD THE SAME PATIENT EXAM THAT WAS PREVIOUSLY REGISTERED ON; THERE WERE 15 EXAMS ASSOCIATED WITH THE PATIENT. THEY DISCONTINUED THE PROCEDURE AFTER 45 MINUTES OF TROUBLESHOOTING. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299956 FUSION NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. FUSION

    Patients

    Seq Age Sex Outcome Treatment
    1