BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIPOSONIX SYSTEM

    MDR report key: 3818047 · Received May 8, 2014

    Report

    Report Number
    3004106598-2014-00002
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    March 12, 2014
    Report Date
    April 16, 2014
    Manufacturer
    SOLTA MEDICAL INC.
    Product Code
    OHV
    PMA / PMN Number
    K112626
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TIP WAS RETURNED AND THE SYSTEM DATA WHICH CORRESPONDED TO THE TREATMENT WAS REVIEWED. THE SYSTEM LOGS INDICATED THAT THROUGHOUT THE ENTIRE TREATMENT SESSION, THE SYSTEM WAS OPERATING WITHIN ALL NORMAL PARAMETERS AND THE ONLY WARNINGS ISSUED WERE FOR DECOUPLING EVENTS AND CAP LOW WARNINGS. THE CAP LOW WARNING STOPS THE SYSTEM FROM DELIVERING ENERGY AND RESULTS IN A SAFE CONDITION. THIS WARNING IS RELATED TO WATER LOSS IN THE RTC (REPLACEABLE TREATMENT CARTRIDGE). DECOUPLING CONDITIONS RESULT IN THE SYSTEM TRANSITIONING TO A SAFE STATE THROUGH SHUT DOWN OF THE ENERGY PULSE. DECOUPLING OCCURS WHEN THE RTC IS LIFTED FROM THE SKIN DURING TREATMENT. THEREFORE, DISPLAY OF THESE SYSTEM MESSAGES DURING TREATMENT IS UNRELATED TO THE ADVERSE PATIENT EVENT. BASED ON THE INFORMATION COLLECTED THROUGH INVESTIGATION, DEVICE OPERATOR ERROR CANNOT BE RULED OUT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIGH INTENSITY FOCUSED ULTRASOUND (HIFU) TREATMENT ON THE FLANKS. IT WAS REPORTED THE PATIENT HAD THE APPROPRIATE AMOUNT OF SUBCUTANEOUS ADIPOSE TISSUE BEYOND THE FOCAL DEPTH OF TREATMENT. POST PROCEDURE, A RECTANGULAR SHAPED BLISTER (ABOUT HALF THE SIZE OF THE TREATMENT TIP PRESENTED ON THE LEFT FLANK. AFTER 2-3 DAYS THE SURFACE SKIN HAD PEELED OFF (COMPLETELY REMOVED) NEEDING STITCHES, RESULTING IN A SCAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278147 LIPOSONIX SYSTEM LIPOSONIX OHV SOLTA MEDICAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other