BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M22

    MDR report key: 8018490 · Received October 30, 2018

    Report

    Report Number
    3004135191-2018-00135
    Event Type
    Malfunction
    Date Received
    October 30, 2018
    Report Date
    October 29, 2018
    Manufacturer
    LUMENIS LTD.
    Product Code
    GEX
    PMA / PMN Number
    K170060
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS INVESTIGATED THE REPORTED EVENT BY CONTACTING THE USER FACILITY BY THREE (3) EMAILS AND ONE (1) CALL TO OBTAIN; PATIENT TREATMENT SETTINGS, PATIENT INFORMATION, PATIENT PHOTOS, WHICH WERE PROVIDED. AN EXAMINATION OF THE SUBJECT DEVICE BY A LUMENIS TECHNICAL EXPERT CONCLUDED THAT VASCULAR FILTER WAS BURNED. VERIFIED BURNED FILTER AND IPL FLASH LAMP HAD A SMOKY FILM. HE CLEANED FLASH LAMP, CHECKED POWER OUTPUT AT SEVERAL LEVELS. IT WAS WELL WITHIN MANUFACTURES SPECS PER SERVICE MANUAL. POWER WAS INCREASED ABOUT 17% ON THE PREVIOUS SERVICE CALL. THIS WAS REPORTED TO THE USER ON THE DAY AFTER WO WAS COMPLETED AND THAT THE POWER REQUESTED SHOULD BE LOWERED BY ABOUT 20%. ACCORDING TO USER MANUAL OF M22 DEVICE THERE IS A SAFETY PRECAUTION REGARDING THE FILTERS BEFORE TREATMENT : "6.3.1.1 CAUTION - IT IS VERY IMPORTANT TO KEEP THE FILTER CLEAN AT ALL TIMES, OTHERWISE IT CAN HARM THE PATIENT AND CAUSE DAMAGE TO THE MODULE. REPLACE THE FILTER IF IT IS BROKEN OR IF THE COATING IS DAMAGED (I.E., SPOTS COVER MORE THAN 15% OF COATING SURFACE)." A LUMENIS CLINICAL TRAINING DIRECTOR AND HEALTHCARE PROFESSIONAL REVIEWED THE REPORTED EVENT DETAILS AND CONCLUDED THAT "CUSTOMER REPORTS 2ND DEGREE BURNS ON THE LEG POST IPL. PT IS A FITZ II. NO TEST SPOT PRIOR TO TREATMENT. TREATMENT SETTINGS OF NF AGE SPOT AND TELANGIECTASIAS USED. JOULSE NOT REPORTED. 515 AND 560 FILTER DOUBLE PULSE. TEST SPOTS IN SUN EXPOSED AREAS ARE RECOMMENDED. INCOMPLETE INFORMATION AT THIS TIME. PHOTO SHOW LARGE PIGMENTATION AREA IN THE SHAPE OF A LIGHT GUIDES. WHEN TREATING SMALL AREA'S OF PIGMENTATION CUTTING OUT AT TEMPLATE IS RECOMMEND TO AVOID LARGE "FOOT PRINTS" WHEN TREATING THESE TYPES OF LESIONS. SHE ADDS THAT POSSIBLE EFFECT WOULD BE POST INFLAMMATORY HYPER-PIGMENTATION. THE LUMENIS CLINICAL TRAINING DIRECTOR AND HEALTHCARE PROFESSIONAL FURTHER CONCLUDED THIS TO BE 'MINOR INJURY' (VERY LOW WITH A RANKING OF 5). WHILE THE INFORMATION RECEIVED TO DATE DOES NOT CONFIRM THAT THE INJURY WAS PERMANENT DAMAGE NOR DID THE INJURY REQUIRE MEDICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT, AND THE MALFUNCTION IS UNDER INVESTIGATION THE COMPANY IS REPORTING THIS EVENT IN AN ABUNDANCE OF CAUTION. AN INVESTIGATION HAS BEEN OPENED REGARDING THIS MALFUNCTION OF BURNT FILTERS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE COMPLAINT RECORD WILL BE UPDATED ACCORDINGLY, AND A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT ONE (1) PATIENT SUSTAINED A BURN OF UNKNOWN SEVERITY TO CHIN FOLLOWING IPL TREATMENT WITH LUMENIS M22 LASER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859119 M22 INTENSE PULSE LIGHT DELIVERY DEVICE GEX LUMENIS LTD. M22

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other