BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M22

    MDR report key: 6424964 · Received March 22, 2017

    Report

    Report Number
    3004135191-2017-00035
    Event Type
    Injury
    Date Received
    March 22, 2017
    Date of Event
    February 17, 2017
    Report Date
    June 22, 2017
    Manufacturer
    LUMENIS, LTD.
    Product Code
    GEX
    PMA / PMN Number
    K083733
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS INVESTIGATED THE REPORTED EVENT BY CONTACTING THE USER FACILITY DIRECTLY. ATTEMPTS HAVE BEEN MADE BY PHONE TO OBTAIN; PATIENT TREATMENT SETTINGS, PATIENT INFORMATION, PATIENT PHOTOS, AND SUN EXPOSURE. NO INFORMATION HAS BEEN PROVIDED BY THE USER FACILITY. AN EXAMINATION OF THE SUBJECT DEVICE BY A LUMENIS TECHNICAL EXPERT CONCLUDED THAT UPON ARRIVAL THE TECHNICAL EXPERT FOUND THE IPL HANDPIECE TO BE DELIVERING APPROX. 20% HIGHER ENERGY THAN THE DISPLAY SCREEN SETTINGS. FOLLOWING PREVENTATIVE MAINTENANCE AND PERFORMING ENERGY CALIBRATIONS, THE TECHNICAL EXPERT STATED THAT THE SUBJECT DEVICE MET ALL LUMENIS MANUFACTURE SPECIFICATIONS AND WAS RETURNED BACK TO SERVICE AT THE USER FACILITY. LUMENIS IS CONTINUING ITS INVESTIGATION. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, THE COMPLAINT RECORD WILL BE UPDATED ACCORDINGLY, AND A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    A LUMENIS QUALITY ENGINEER REVIEWED THE REPORTED EVENT DETAILS AND CONCLUDED BY STATING, "ALTHOUGH THE HANDPIECE ENERGY DEVIATED FROM THE DESIRED VALUE, IT WAS WITHIN THE SAFETY REQUIREMENT OF +/- 20% ENERGY DEVIATION." ADDITIONALLY, THE QUALITY ENGINEER CONSULTED WITH A LUMENIS CLINICAL AFFAIRS MANAGER WHO STATED, "SUCH DEVIATION ALTHOUGH OUTPUTTING HIGHER ENERGY IS WITHIN THE SAFETY LIMITS, FURTHERMORE THE USER IS REQUIRED TO MAKE A TEST PATCH TO ENSURE NO ADVERSE EVENT HAPPENING." THE QUALITY ENGINEER CONCLUDED THAT THE SUBJECT DEVICE OPERATED WITHIN LUMENIS SPECIFICATIONS AND THAT THE REPORTED EVENT IS NOT DUE TO A SYSTEM MALFUNCTION. A REVIEW OF DEVICE LABELING FOUND THE FOLLOWING CAUTION: "THE ENERGY OUTPUT OF A TREATMENT HEAD DECREASES OVER TIME. THUS, IF CALIBRATION IS PERFORMED AFTER A LONG TIME INTERVAL, THE ENERGY EMITTED AFTER THE CALIBRATION MAY BE HIGHER THAN BEFORE THE CALIBRATION, FOR THE SAME SETTING. MAKE SURE TO PERFORM A TEST PATCH BEFORE STARTING TREATMENT."

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT ONE (1) PATIENT SUSTAINED A BURN OF UNKNOWN SEVERITY TO AN UNKNOWN ANATOMICAL AREA FOLLOWING IPL TREATMENT WITH A LUMENIS M22 LASER. NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION HAS BEEN RECEIVED EXCEPT FOR THE INITIAL REPORT FROM THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206969 M22 INTENSE PULSE LIGHT DELIVERY DEVICE GEX LUMENIS, LTD. M22

    Patients

    Seq Age Sex Outcome Treatment
    1 Congenital Anomaly| O