BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOUND VASER SYSTEM

    MDR report key: 3212741 · Received July 2, 2013

    Report

    Report Number
    1725012-2013-00001
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 4, 2013
    Manufacturer
    SOLTA MEDICAL
    Product Code
    MUU
    PMA / PMN Number
    K022051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE AMPLIFIER WAS RETURNED AND TESTED AND NO PROBLEMS WERE FOUND. THE LABELING REVIEW INDICATES: ASSISTED NECK CONTOURING PROTOCOL (18 CM LONG) OR 2.2 CM DIAMETER (12MM LONG) PROCESS, 20%-40% AMPLITUDE, VASER MODE. BEGIN WITH THE SHORT 2.2 PROBE IF POSSIBLE. TWENTY PERCENT AMPLITUDE IF FACE/NECK IS VERY SOFT. THIRTY PERCENT AMPLITUDE FOR MODERATE/AVERAGE FAT. MOVE TO 40% AMPLITUDE IF FACE IS FIBROUS. NEVER EXCEED 40% WITH THE 2.2 MM PROBES, THEY MAY BREAK. APPLY VASER UNTIL TARGETED THAT IS EMULSIFIED, LIKELY 2-3 MINUTES TOTAL PER SIDE DEPENDING ON VOLUMES, WITH AN ADDITIONAL 2-3 MINUTES UNDER THE CHIN DEPENDING ON HOW THE VASER WAS APPLIED ON THE SLIDES. TOTAL VASER TIME 6-10 MINUTES DEPENDING ON PT AND INFUSED VOLUMES. TRY TO ACHIEVE THE TARGETED 6-10 MINUTES OF VASER TIME TO MINIMIZE ASPIRATION TRAUMA. PROCEDURE SUGGESTIONS STATES: USE SUFFICIENT AND APPROPRIATE AMOUNTS OF WETTING SOLUTION. MAKE SURE THAT THE PT SOLUTION IS UNIFORMLY AND EVENLY DISTRIBUTED IN THE INTENDED FRAGMENTATION VOLUME. A GENTLE FIRMNESS AND FULLNESS IS THE TARGETED AREA IS DESIRABLE. ALLOW SUFFICIENT TIME FOR VASOCONSTRICTIVE REQUIREMENTS (USUALLY 8-10 MINUTES MINIMUM FOR 1:1,000,000 CONCENTRATIONS). APPLY WETTING SOLUTION SLIGHTLY BEYOND THE MARKED BOUNDARIES AND IN ALL POTENTIAL PORT LOCATIONS. THE TARGETED RATIO OF WETTING SOLUTION IN TO TOTAL ASPIRATE OUT IS IN THE RANGE 1.5: TO 2:1. INITIAL CONSERVATIVE APPLICATION TIMES CAN BE BASED ON ONE MINUTE OF ULTRASONIC APPLICATION (CONTINUOUS OR VASER MODE) FOR EVERY 200 ML OF WETTING SOLUTION INFUSED AT A SITE. IN THIS CASE THE PHYSICIAN TREATED AT 50% AMPLITUDE, VASER MODE WHICH IS HIGHER THAN THE RECOMMENDED SETTINGS. ADDITIONALLY, MAY NOT HAVE INFILTRATED SUFFICIENT FLUID FOR THE AMOUNT OF TIME TREATMENT WAS APPLIED.

    Description of Event or Problem · 1

    IT WAS REPORTED, THAT A PT UNDERGOING A LIPO PROCEDURE EXPERIENCED A THERMAL-RELATED AND POSSIBLY A FULL THICKNESS INJURY. THE PHYSICIAN WAS PERFORMING A LIPO PROCEDURE ON THE FACE WORKING FROM AN INCISION SITE IN AN AREA ABOVE AND BELOW THE MANDIBLE LINE (PTS CHIN). APPROX 1.5 MINUTES INTO THE PROCEDURE THE PHYSICIAN NOTICED REDNESS UNDER THE CHIN AND THE FORMATION OF A BLISTER ON THE OPPOSITE SIDE OF THE INCISION FROM THE INSERTION OF THE PROBE. THE PHYSICIAN STATED THE PROBE FELT VERY WARM AT THIS POINT AND WAS CONCERNED THAT HE MAY NOT HAVE INFILTRATED SUFFICIENT FLUID FOR THE AMOUNT OF TIME HE HAD APPLIED. HE TREATED THE SITE WITH BACITRACIN AND HYDROCORTISONE AND IT APPEARS TO BE RESOLVING NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302721 SOUND VASER SYSTEM INSTRUMENT, ULTRASONIC SURGICAL MUU SOLTA MEDICAL VASER-2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 2.2 MM PROBE