BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 002-1100 15W THERMAL THERAPY

    MDR report key: 5475433 · Received March 2, 2016

    Report

    Report Number
    1723170-2016-00283
    Event Type
    Malfunction
    Date Received
    March 2, 2016
    Date of Event
    February 2, 2016
    Report Date
    November 10, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    GEX
    PMA / PMN Number
    K081656
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRELIMINARY ENGINEERING INVESTIGATION OF RETURNED SUSPECT DEVICE FINDS THAT THE CONICAL TIP LASER DIFFUSING FIBER (LDF) IS BROKEN RIGHT AT THE TAPER AND IS HANGING BY A SMALL PIECE. THE COOLING CATHETER SYSTEM APPEARS TO HAVE BEEN CUT AS ONLY A PORTION WAS RETURNED WITH A FLAT OPENING AT THE DISTAL END. NO EVIDENCE OF CHARRING ON EITHER LDF OR CCS. INVESTIGATION INTO THE RETURNED COMPONENTS IS ON-GOING.

    Additional Manufacturer Narrative · 1

    THE HARDWARE INVESTIGATION OF THE RETURNED VISUALASE COOLING LASER APPLICATOR SYSTEM (VCLAS) CONCLUDED THAT THE REPORTED EVENT WAS RELATED TO A PHYSICAL DAMAGE ISSUE. THE REPORTED EVENT WAS CONFIRMED. THIS ISSUE WAS DOCUMENTED IN A MEDTRONIC NAVIGATION HARDWARE ANOMALY TRACKING DATABASE.

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. RETURN REQUESTED. REPLACEMENT .6MM CORE FIBER 15MM TIP SHIPPED TO SITE. NO PARTS HAVE BEEN RECEIVED BY MANUFACTURER FOR ANALYSIS. NO FURTHER ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED A THERMAL THERAPY SYSTEM UROKIT 600 T-15 COOLING CATHETER TIP DISCONNECTED FROM THE MAIN SHEATH OF THE CATHETER. NO FURTHER DETAILS REGARDING THE DAMAGE, OR HOW IT OCCURRED, WERE PROVIDED. AS REPORTED, THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131084 SYSTEM 002-1100 15W THERMAL THERAPY POWERED LASER SURGICAL INSTRUMENT GEX MEDTRONIC NAVIGATION, INC. (LOUISVILLE)

    Patients

    Seq Age Sex Outcome Treatment
    1