BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTEC SU-365. 365¿ BARE HOLMIUM FIBER

    MDR report key: 6518759 · Received April 25, 2017

    Report

    Report Number
    3004135191-2017-00044
    Event Type
    Malfunction
    Date Received
    April 25, 2017
    Date of Event
    January 25, 2017
    Report Date
    April 25, 2017
    Manufacturer
    FORTEC MEDICAL
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS INVESTIGATED THE REPORTED EVENT CONTACTING THE INITIAL REPORTER TO OBTAIN FURTHER INFORMATION. DESPITE REASONABLE ATTEMPTS (3) BY EMAIL TO THE INITIAL REPORTER, NO ADDITIONAL INFORMATION HAD BEEN RECEIVED OTHER THAN THE INFORMATION ON THE MEDWATCH REPORT. A REVIEW OF THE LUMENIS VERSAPULSE POWERSUITE LASER'S DHR CONFIRMED THAT THE SUBJECT DEVICE MET ALL TEST SPECIFICATIONS WITHOUT DEVIATION PER THE DHR DURING THE MANUFACTURING PROCESS. A REVIEW OF HISTORICAL INSTALLATION RECORDS FOUND THAT THE LUMENIS VERSAPULSE POWERSUITE LASER WAS INSTALLED AT THE USER FACILITY IN 2006. A REVIEW ALSO FOUND THAT LUMENIS HAS NOT SERVICED THE SUBJECT DEVICE IN AT LEAST THE PAST TWO YEARS. ALTHOUGH NO INFORMATION WAS PROVIDED BY THE USER FACILITY ABOUT THE SERVICE HISTORY OF THE DEVICE, LUMENIS CANNOT RULE OUT THAT SERVICE BY UNAUTHORIZED THIRD PARTY SERVICE PROVIDERS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. TO THE BEST OF LUMENIS' KNOWLEDGE, THE SUBJECT DEVICE REMAINS IN USE AT THE USER FACILITY. A NONLUMENIS FORTEC 365 BARE HOLMIUM FIBER WAS DEPLOYED DURING THE PROCEDURE. LUMENIS CONCLUDED A NON-LUMENIS FIBER MAY WORK ON ITS LASERS BUT THE COMPANY DOES NOT RECOMMEND SUCH USE. BASED ON THE INFORMATION ABOVE AND THE FACT THAT A SECOND FIBER OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE, THE MOST PROBABLE ROOT CAUSE OF THE EVENT WAS USE OF A NONQUALIFIED, NON-LUMENIS 365 FIBER. LUMENIS WILL FORWARD A COPY OF THE ORIGINAL MEDWATCH TO THE FIBER MANUFACTURER. FIBER INFORMATION: FORTEC SMARTSCOPE 200U BARE HOLMIUM FIBER. (B)(4).

    Description of Event or Problem · 1

    A USER FACILITY RISK MANAGER REPORTED ON A USER FACILITY MEDWATCH REPORT ((B)(4)) THAT DURING A PROCEDURE IN WHICH A LUMENIS POWERSUITE LASER WAS DEPLOYED, "THE SURGEON WAS UNHAPPY WITH THE PERFORMANCE OF THE FORTEC MEDICAL SU-365, 365 MICRON BARE HOLMIUM FIBER. THE SURGEON NOTED THAT THE FIBER BECAME FRAYED AT THE END DURING THE PROCEDURE. THE SURGEON WAS SO UNHAPPY THAT HE WANTED TO CUT THE FIBER IN ORDER TO CONTINUE THE CASE. THE NURSING STAFF ADVISED AGAINST CUTTING THE FIBER AND THE SURGEON AGREED TO USE ANOTHER SU-365 TO FINISH THE CASE. THERE WAS NO HARM TO THE PATIENT AND THE PROCEDURE WAS COMPLETED WITHOUT DELAY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300243 FORTEC SU-365. 365¿ BARE HOLMIUM FIBER POWERED LASER SURGICAL INSTRUMENT GEX FORTEC MEDICAL FORTEC SU-365. 365¿ BARE HOLMIUM FIBER UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1