BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMENIS PULSE 120H

    MDR report key: 6854257 · Received September 11, 2017

    Report

    Report Number
    3004135191-2017-00128
    Event Type
    Malfunction
    Date Received
    September 11, 2017
    Date of Event
    July 31, 2015
    Report Date
    September 10, 2017
    Manufacturer
    LUMENIS LTD.
    Product Code
    GEX
    PMA / PMN Number
    K140388
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF A REMEDIAL ACTIVITY, LUMENIS CONDUCTED A RETROSPECTIVE REVIEW OF ALL ITS SAFETY COMPLAINT FILES FROM JANUARY 2015 TO JULY 2017. AN INVESTIGATION OF THE REPORTED EVENT FOUND THAT THE REPORTED MALFUNCTION OF A NON LUMENIS FIBER CONNECTOR OVERHEATING WAS SIMILAR TO A DEVICE MALFUNCTION THAT RESULTED IN A POTENTIALLY HARMFUL SITUATION (MDR# 3004135191-2017-00024). BECAUSE THE COMPANY IS AWARE THAT THIS MALFUNCTION WAS ALLEGED TO HAVE CAUSED OR CONTINUED TO A SERIOUS INJURY THIS EVENT REPRESENTS A REPORTABLE MALFUNCTION. A LUMENIS TECHNICAL EXPERT EXAMINED THE SUBJECT DEVICE AND COMPLETED PERFORMANCE TESTS OF ALL SPECIFICATIONS CONCLUDING THE DEVICE OPERATED MANUFACTURER'S SPECIFICATIONS. THE LUMENIS TECHNICAL EXPERT NOTED: "CHECKED OPTICAL ALIGNMENT, TESTED WITH TEST FIBER, MICROSCOPE VIEWER AND CONFIRMED OPTICAL AXIS ON ALL FOUR BRICKS ARE WITHIN SPECIFICATION AND MEETS ALL FACTORY REQUIREMENTS. BEAM PROFILE IS IN THE CENTER OF TEST FIBER APERTURE. CHECKED POWER OUTPUT ON ALL USER PRESETS INCLUDING KIDNEY STONE SETTINGS AT ENERGY 0.5 FREQUENCY=80 HZ POWER=40WATTS.CE ALSO PERFORMED STANDARD POWER OUTPUT TEST WITH LONG TEST FIBER AT 5 WATTS.10 WATTS,30 WATTS,40 WATTS,60 WATTS,80 WATTS AND 100 WATTS AND CONFIRMED POWER OUTPUT IS WITHIN SPECIFICATION AND READY TO USE." ALTHOUGH NO SERIOUS INJURY HAD OCCURED, AND ALTHOUGH THERE IS NO EVIDENCE THAT A LUMENIS PRODUCT HAD MALFUNCTIONED IN THIS EVENT, LUMENIS IS REPORTING THIS EVENT SINCE A LUMENIS LASER SYSTEM WAS A CONTRIBUTORY PART OF THE EVENT.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT ONE (1) LUMENIS EMPLOYEE SUSTAINED BURNS TO THEIR FINGERS WHILE ATTEMPTING TO REMOVE A NON-LUMENIS LASER FIBER FROM A LUMENIS P120H SYSTEM DURING A DEMONSTRATION . IT WAS LATER REPORTED BY THE LUMENIS EMPLOYEE WHO SUSTAINED THE BURNS THAT NO MEDICAL ATTENTION WAS SOUGHT AT THE TIME OF THE INCIDENT, AND "THE BURN HAD BEEN OBSERVED OVER THE NEXT FEW DAYS, EVENTUALLY HEALING COMPLETELY ON ITS OWN".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636140 LUMENIS PULSE 120H HOLMIUMN (HO:YAG) SURGICAL LASERS AND DELIVERY DEVICE GEX LUMENIS LTD. LUMENIS P120H

    Patients

    Seq Age Sex Outcome Treatment
    1