BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHTSHEER DUET

    MDR report key: 2399438 · Received January 5, 2012

    Report

    Report Number
    1720381-2012-00002
    Event Type
    Injury
    Date Received
    January 5, 2012
    Date of Event
    December 5, 2011
    Report Date
    January 5, 2012
    Manufacturer
    LUMENIS INC.
    Product Code
    GEX
    PMA / PMN Number
    K053628
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AN EXAMINATION OF THE SUBJECT DEVICE BY A LUMENIS TECHNICAL EXPERT CONCLUDED THE DEVICE OPERATED TO MANUFACTURE SPECIFICATIONS. SUBJECT DEVICE MALFUNCTION IS NOT THE SUSPECTED ROOT CAUSE OF THE EVENT REPORTED. A LUMENIS HEALTHCARE PROFESSIONAL EVALUATED THE REPORTED EVENT DETAILS AND PATIENT PHOTOGRAPHS CONCLUDING THE PROBABLE ROOT CAUSE OF THE REPORTED EVENT TO BE DEBRIS BUILD UP ON THE TREATMENT TIP AS A RESULT OF INSUFFICIENT CLEANING BY THE DEVICE OPERATOR IN CONTRADICTION TO DEVICE LABELING AND COMMON MEDICAL PRACTICE. ADDITIONALLY, THE HEALTHCARE PROFESSIONAL NOTED THAT DEVICE OPERATOR FAILURE TO PERFORM A TEST PATCH PRIOR TO TREATMENT MOST LIKELY CONTRIBUTED TO THE EVENTS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE PATIENTS SUSTAINED BLISTERS TO THE CHIN, SIDE OF FACE AND LIP AREA RESPECTIVELY FOLLOWING TREATMENT WITH A LUMENIS LIGHTSHEER DUET LASER ET HANDPIECE. IT WAS FURTHER REPORTED THAT NO TEST PATCH WAS PERFORMED PRIOR TO TREATMENT. NO INFORMATION REGARDING A REPORT OF SERIOUS INJURY OR ANY MEDICAL INTERVENTION TO PRECLUDE SERIOUS INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTSHEER DUET SOLID STATE AESTHETIC LASER DELIVERY DEVICE GEX LUMENIS INC. LIGHTSHEER DUET

    Patients

    Seq Age Sex Outcome Treatment
    1 Other