BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTEC SMARTSCOPE 200U BARE HOLMIUM FIBER

    MDR report key: 5605540 · Received April 25, 2016

    Report

    Report Number
    3004135191-2016-00018
    Event Type
    Malfunction
    Date Received
    April 25, 2016
    Date of Event
    September 22, 2015
    Report Date
    April 22, 2016
    Manufacturer
    FORTEC MEDICAL.
    Product Code
    GEX
    PMA / PMN Number
    K011703
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS INVESTIGATED THE REPORTED EVENT CONTACTING THE INITIAL REPORTER TO OBTAIN FURTHER INFORMATION. NO PATIENT INFORMATION WAS PROVIDED. A LUMENIS TECHNICAL ENGINEER EXAMINED THE SUBJECT DEVICE POWERSUITE LASER COMPLETING PERFORMANCE TESTS OF ALL SPECIFICATIONS AND CONCLUDING THE DEVICE OPERATED TO MANUFACTURER'S SPECIFICATIONS. THE INITIAL REPORTER STATED THAT THE FIBER THAT THEY WERE USING WAS ON FIRE NEAR THE PROXIMAL END OF THE FIBER, WHERE STRAIN ENDS. THIS IS APPROX 3-4 INCHES FROM PROXIMAL END OF FIBER. A NON-LUMENIS FORTEC SMARTSCOPE 200U BARE HOLMIUM FIBER WAS DEPLOYED DURING THE PROCEDURE. LUMENIS CONCLUDED THAT THE SUBJECT DEVICE LUMENIS LASER WAS NOT THE CAUSE OF THE REPORTED EVENT. LUMENIS CONCLUDED A NON-LUMENIS FIBER MAY WORK ON ITS LASERS BUT THE COMPANY DOES NOT RECOMMEND SUCH USE. USE OF A NON-QUALIFIED ACCESSORY IS THE DETERMINE CAUSE OF THE EVENT REPORTED. LUMENIS WILL FORWARD A COPY OF THE ORIGINAL MEDWATCH TO THE SUBJECT DEVICE MANUFACTURER. SUBJECT PRODUCT INFORMATION: FORTEC SMARTSCOPE 200U BARE HOLMIUM FIBER. CORRECT MANUFACTURER INFORMATION: FORTEC MEDICAL, (B)(4).

    Additional Manufacturer Narrative · 1

    AS PART OF A REMEDIAL ACTIVITY, LUMENIS CONDUCTED A RETROSPECTIVE REVIEW OF ALL ITS COMPLAINT FILES FROM JANUARY 2015 - MAY 2017 WHICH SUGGEST THAT FIBER CONNECTORS HAD OVERHEATED. AN INVESTIGATION OF THE REPORTED EVENT FOUND THAT THE REPORTED MALFUNCTION OF THE FIBER CONNECTOR OVERHEATING WAS SIMILAR TO A DEVICE MALFUNCTION THAT RESULTED IN A POTENTIALLY HARMFUL SITUATION (MDR# 3004135191-2017-00024). ALTHOUGH NO INJURY WAS REPORTED AND NO MEDICAL INTERVENTION WAS REQUIRED TO PRECLUDE PERMANENT IMPAIRMENT, AND ALTHOUGH THERE IS NO EVIDENCE THAT A LUMENIS PRODUCT HAD MALFUNCTIONED IN THIS EVENT, LUMENIS IS STILL REPORTING THIS EVENT AS A PRODUCT PROBLEM/MALFUNCTION SINCE A LUMENIS LASER SYSTEM WAS A CONTRIBUTORY PART OF THE ADVERSE EVENT.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT DURING A PROCEDURE DURING WHICH A LUMENIS POWERSUITE LASER WAS DEPLOYED, THE "FIBER/SYSTEM CAUGHT FIRE AT THE FIBER METAL CONNECTION TO THE MACHINE." NO REPORT OF PATIENT HARM WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261735 FORTEC SMARTSCOPE 200U BARE HOLMIUM FIBER POWERED LASER SURGICAL INSTRUMENT GEX FORTEC MEDICAL. FORTEC SMARTSCOPE 200U UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other