BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAPULSE POWERSUITE 100 W

    MDR report key: 6957817 · Received October 18, 2017

    Report

    Report Number
    3004135191-2017-00191
    Event Type
    Malfunction
    Date Received
    October 18, 2017
    Date of Event
    January 14, 2016
    Report Date
    October 18, 2017
    Manufacturer
    LUMENIS, LTD.
    Product Code
    GEX
    PMA / PMN Number
    K011703
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 JUNE 2017. AN INVESTIGATION OF THE REPORTED EVENT FOUND THAT ALTHOUGH THERE WAS NO PATIENT HARM AS A RESULT OF THE FOOTPEDAL STICKING, THE SAME MALFUNCTION MIGHT LEAD TO SERIOUS INJURY SHOULD IT RECUR. THE FOOT PEDAL HAD BEEN RETURNED TO MANUFACTURER FOR ANALYSIS, AND ALTHOUGH THE ALLEGED MALFUNCTION COULD NOT BE DUPLICATED, LUMENIS CANNOT RULE OUT THAT THE MALFUNCTION HAD HAPPENED. A REVIEW OF SUBJECT DEVICE RISK MANAGEMENT FILES SHOWS THIS IS AN ANTICIPATED RISK WHICH HAS BEEN QUANTIFIED AND FOUND TO BE NEGLIGIBLY SMALL. THE RISK HAS BEEN CHARACTERIZED AND DOCUMENTED AS ACCEPTABLE WITHIN A FULL RISK ASSESSMENT NO CORRECTIVE ACTION OR REMEDIAL ACTIONS WERE DEEMED NECESSARY. ALTHOUGH NO INJURY WAS REPORTED, THIS MALFUNCTION MIGHT LEAD TO SERIOUS INJURY SHOULD IT RECUR, AND IN AN ABUNDANCE OF CAUTION, LUMENIS IS REPORTING THIS MALFUNCTION.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT DURING A PROCEDURE IS WHICH A VERSAPULSE POWERSUITE 100W LASER SYSTEM WAS BEING USED, "THE FOOT PEDAL STUCK IN THE MIDDLE OF THE PROCEDURE, AND THE LASER HAD TO BE EMERGENCY SHUT OFF WHILE THE DOCTOR HELD THE FIBER IN THE AIR.". NO REPORT OF SERIOUS INJURY WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737044 VERSAPULSE POWERSUITE 100 W HOLMIUM (HO:YAG) AND DUAL WAVELENGTH (HO:YAG/ND:YAG) SURGICAL LASER GEX LUMENIS, LTD. VERSAPULSE POWERSUITE 100W

    Patients

    Seq Age Sex Outcome Treatment
    1