BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 002-1100 15W THERMAL THERAPY

    MDR report key: 4590310 · Received March 11, 2015

    Report

    Report Number
    1723170-2015-00264
    Event Type
    Malfunction
    Date Received
    March 11, 2015
    Date of Event
    October 24, 2014
    Report Date
    June 2, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    GEX
    PMA / PMN Number
    K081656
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT MADE AVAILABLE FROM THE SITE. OPERATOR OF DEVICE IS A HEALTH PROFESSIONAL, SPECIALLY TRAINED TO USE THE LASER INDUCED THERMAL THERAPY SYSTEM. BIOTEX, INC. INVESTIGATION FINDS THAT THE ERROR IN LASER DIFFUSING FIBER (LDF) PLACEMENT (NOT THE APPROPRIATE 2 MILLIMETER PULLBACK) CAUSED THE LDF TO BURN AND MELT THE CATHETER TIP. ON 10/27/2014 A VISUALASE REPRESENTATIVE, FOLLOWING-UP, REPORTED THE CATHETER WAS DISPOSED OF IN A BIOHAZARD CONTAINER AT THE HOSPITAL AND IS NOT AVAILABLE FOR TESTING. MEDTRONIC NAVIGATION IS FILING THIS REPORT HAVING RECENTLY ACQUIRED THE 510K RELATED TO THE VISUALASE DEVICES AND TRANSFERRING RESPONSIBILITY FOR COMPLAINT HANDLING AND MDR REPORTING ON FEBRUARY 9, 2015. UPON CONDUCTING A RETROSPECTIVE REVIEW OF EXISTING COMPLAINT RECORDS, PREVIOUSLY HANDLED THROUGH THE QUALITY SYSTEM AT BIOTEX, INC., (B)(4) (PRIOR OWNER OF THE 510K), IT WAS DETERMINED THAT THIS EVENT MEETS THE CRITERIA MEDTRONIC WOULD CONSIDER REPORTABLE TO FDA. THE AWARE DATE USED IS THE AWARE DATE WITHIN THE BIOTEX QUALITY SYSTEM; HOWEVER, MEDTRONIC NAVIGATION REVIEWED THIS COMPLAINT FOR MDR REPORTABILITY AND DATA TRANSFER BEGINNING ON 02/12/2015.

    Additional Manufacturer Narrative · 1

    A SOFTWARE ENGINEERING REVIEWED THE RETURNED LOG FILES AND DETERMINED THE SOFTWARE INVESTIGATION FOUND THE SOFTWARE BEHAVIOR DESCRIBED IS THE INTENDED BEHAVIOR OF THE SOFTWARE. SOFTWARE IS FUNCTIONING AS DESIGNED. THE LOG FILES INDICATED LEAKAGE FROM THE CATHETER. ALTHOUGH A SPECIFIC CAUSE OF THE CATHETER WAS UNCONFIRMED AS THE PART WAS NOT RETURNED TO THE MANUFACTURER, AN INVESTIGATION INTO CATHETERS WITH SIMILAR REPORTED MALFUNCTIONS WAS COMPLETED AND WAS DOCUMENTED IN A MEDTRONIC NAVIGATION HARDWARE ANOMALY TRACKING DATABASE.

    Description of Event or Problem · 1

    A VISUALASE REPRESENTATIVE REPORTED THAT, WHILE IN A PROCEDURE, AFTER APPROXIMATELY 60 SECONDS, A BLACK ARTIFACT APPEARED ON THE THERMAL MONITORING. LASER WAS TURNED OFF AND IT WAS NOTED THAT THE FIBER HAD NOT BEEN PULLED BACK THE APPROPRIATE 2 MILLIMETERS. PLACEMENT WAS THEN CORRECTED AND THE PROCEDURE CONTINUED WITHOUT ISSUE. THE CATHETER HAD THE APPEARANCE OF BLACK CHAR ON THE TIP AFTER REMOVAL FROM THE PATIENT. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE THERMAL THERAPY SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168875 SYSTEM 002-1100 15W THERMAL THERAPY POWERED LASER SURGICAL INSTRUMENT GEX MEDTRONIC NAVIGATION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1