BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGHTSHEER DUET

    MDR report key: 7156323 · Received December 31, 2017

    Report

    Report Number
    3004135191-2017-00242
    Event Type
    Malfunction
    Date Received
    December 31, 2017
    Date of Event
    November 23, 2017
    Report Date
    December 31, 2017
    Manufacturer
    LUMENIS, LTD.
    Product Code
    GEX
    PMA / PMN Number
    K053628
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS INVESTIGATED THE REPORTED EVENT CONTACTING THE FOREIGN DISTRIBUTOR TO OBTAIN; PATIENT TREATMENT SETTINGS, PATIENT INFORMATION, PATIENT PHOTOS, AND SUN EXPOSURE, WHICH WERE PROVIDED. BASED ON INFORMATION RECEIVED FROM THE DISTRIBUTOR IN INCIDENT FORM NO PERMANENT IMPERMANENT IS EXPECTED. DISTRIBUTOR REPORTED THAT DISPOSABLE TIPS IS SUSPECTED TO BE THE CONTRIBUTORY CAUSES OF THE REPORTED EVENT. A LUMENIS HEALTHCARE PROFESSIONAL EVALUATED THE REPORTED EVENT DETAILS CONCLUDING THE REPORTED TREATMENT SETTINGS WERE APPROPRIATE BASED ON COMMON MEDICAL PRACTICE, DEVICE LABELING, AND DEVICE TRAINING FOR THE REPORTED PATIENT SKIN TYPE. FURTHERMORE, THE EXPERT CONCLUDED:"PICTURES FROM PATIENT DISPLAY SUPERFICIAL PARTIAL BURNS (NOT THE SIZE OF THE TIP BUT LIMITED TO EITHER A LINE OR A DOT). AS MENTIONED IN THE REPORTS BY THE TREATMENT SITE, NONE HAVE LED TO PERMANENT IMPAIRMENT." THE SUSPECTED CAUSE OF THE REPORTED EVENTS TO BE DISPOSABLE TIPS. LUMENIS IS CURRENTLY INVESTIGATING THE REPORTED EVENT. BASED ON THE INFORMATION PROVIDED, IT IS UNCERTAIN IF THE MALFUNCTION WOULD LIKELY LEAD TO SERIOUS INJURY SHOULD IT RECUR, AND IN AN ABUNDANCE OF CAUTION LUMENIS HAS CHOSEN TO REPORT THIS EVENT AS A MALFUNCTION UNTIL DETERMINATION CAN BE MADE. 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 FOREIGN DISTRIBUTOR REPORTED THAT ONE (1) PATIENT SUSTAINED A SUPERFICIAL BURNS TO AN ARMS ANATOMICAL AREA FOLLOWING TREATMENT WITH A LIGHTSHEER DUET 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
    935305 LIGHTSHEER DUET SOLID STATE AESTHETIC LASER DELIVERY DEVICE GEX LUMENIS, LTD. LIGHTSHEER DUET

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR