BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM 002-1100 15W THERMAL THERAPY

    MDR report key: 5100509 · Received September 24, 2015

    Report

    Report Number
    1723170-2015-01067
    Event Type
    Injury
    Date Received
    September 24, 2015
    Date of Event
    May 13, 2015
    Report Date
    April 27, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    GEX
    PMA / PMN Number
    K081656
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE CAPA INVESTIGATION, THE ROOT CAUSE FOR THIS EVENT WAS IDENTIFIED AS THE FOLLOWING: THE LASER MAY DELIVER LESS LASER POWER THAN THE AMOUNT SET BY THE USER, AND THIS MAY RESULT IN LASER FAILURES WHEN THERE IS A LESS THAN OPTIMAL INTERFACE BETWEEN THE LASER FIBER AND THE LENS SO THAT THE LENS FOCAL POINT IS NOT LOCATED AT THE END OF THE LASER FIBER. THIS MAY BE CAUSED BY EITHER A LARGER THAN DESIRED GAP BETWEEN THE LENS AND THE OPTICAL FIBER, OR THE FIBER END MAY BE TOO CLOSE TO THE LENS. EVIDENCE WAS INSUFFICIENT TO DIRECTLY LINK THE ISSUE TO A SINGLE ROOT CAUSE. THE CAPA TEAM IDENTIFIED TWO ADDITIONAL POSSIBLE CONTRIBUTING ROOT CAUSES: LASER DIFFUSING FIBER (LDF) WAS NOT CONNECTED PROPERLY OR WAS NOT SCREWED ON COMPLETELY BY THE USER. VARIABILITY MAY EXIST BETWEEN MANUFACTURED LOTS. SPECIFICALLY, THERE MAY BE INSTANCES OF FIBER PROTRUSION OR FIBER RECESSION. THIS COMPLAINT WILL BE FURTHER MONITORED THROUGH THE CAPA PROCESS.

    Additional Manufacturer Narrative · 1

    ON 05/14/2015 IN TROUBLE-SHOOTING, A MEDTRONIC REPRESENTATIVE, MD SR CLINICAL SPECIALIST, PERFORMED LASER POWER OUTPUT TEST ON THE 15W LASER IN USE DURING CASE. WHEN SET AT 15W, HE FOUND THE ACTUAL OUTPUT TO ONLY BE ~6.4W, LIKELY CAUSED BY LOW LASER OUTPUT. ON 05/15/2015 A MEDTRONIC REPRESENTATIVE, FOLLOWING-UP AT THE SITE, REPORTED THAT IN A 6 TRAJECTORY SPINAL TUMOR ABLATION CASE ON (B)(6) 2015 THEY WERE UNABLE TO SEE CLEAR HEATING ON THE T-MAP. THE MEDTRONIC REPRESENTATIVE WAS CONFIDENT THAT THE IMAGE PLANE WAS SET WELL (THEY COULD SEE THE WHOLE LENGTH OF THE COOLING CATHETER), HOWEVER, WHEN THE LASER WAS TURNED ON, THEY ONLY SAW BITS OF BLUE NOISE RATHER THAN A DEFINED BLUE ABLATION REGION BECOMING VISIBLE ON THE T-MAP. THE SURGEON LET THE LASER RUN FOR ~30 SECONDS BEFORE TURNING IT OFF. THE SURGEON WAS NOT COMFORTABLE CONTINUING TO ABLATE IF THE HEATING WAS NOT BEING SEEN CLEARLY. THEY MOVED THE LASER DIFFUSING FIBER (LDF) TO A SECOND TRAJECTORY/COOING CATHETER, ADJUSTED THE SCANNER PLANE AND AGAIN SAW THE SAME LDF MAL-DEFINED HEAT SIGNATURE. AGAIN, THE SURGEON STOPPED THE LASER AFTER ~30 SECONDS AND THEN CHOSE TO ABANDON THE WHOLE PROCEDURE. ON 06/05/2015 CONFIRMED BY A MEDTRONIC LASER INDUCED THERMAL THERAPY SPECIALIST WAS THAT IF THE 15-W LASER WAS ONLY PUTTING OUT ~50% OF THE ACTUAL POWER (AND THUS BELIEVED TO BE AN ISSUE WITH THE LASER'S PERFORMANCE), THEN THE RISK FOR UNINTENTIONAL ABLATION WAS EXTREMELY LOW ON 06/25/2015 A MEDTRONIC REPRESENTATIVE, FOLLOWING-UP AT THE SITE, REPORTED THAT AFTER REPLACING THE GENERATOR, THE SYSTEM HAS BEEN FUNCTIONING PROPERLY. ISSUE RESOLVED. ON 08/04/2015 A MEDTRONIC REPRESENTATIVE, FOLLOWING-UP, REPORTED ONCE THE SURGEON WAS NOT SEEING ANY BENEFITS HE DID STOP ABLATING THE PATIENT. THERE WAS NO DELAY IN THE SURGERY, THERE WAS NO AFFECT TO THE PATIENT AND SURGERY DID NOT REQUIRE RESCHEDULING.

    Additional Manufacturer Narrative · 1

    THE PART WAS SENT DIRECTLY TO THE CONTRACT MANUFACTURER FOR EVALUATION AND REPAIR. THE LASER WAS FUNCTIONALLY TESTED AND FOUND TO BE OUT OF TOLERANCE. THE LOWER OUTPUT WAS DUE TO A BURNT EMISSION PORT. THE HARDWARE INVESTIGATION FOUND THAT THE REPORTED EVENT WAS RELATED TO A HARDWARE ISSUE. THIS ISSUE WAS DOCUMENTED IN A MEDTRONIC NAVIGATION HARDWARE ANOMALY TRACKING DATABASE.

    Description of Event or Problem · 1

    A SITE PHYSICIAN REPORTED THAT, WHILE IN A LASER INDUCED THERMAL THERAPY PROCEDURE, WAS UNABLE TO GET A THERMAL MAP. NO ADDITIONAL DETAILS WERE PROVIDED. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE LASER INDUCED THERMAL THERAPY SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631736 SYSTEM 002-1100 15W THERMAL THERAPY POWERED LASER SURGICAL INSTRUMENT GEX MEDTRONIC NAVIGATION, INC. (LOUISVILLE)

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention