BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASERLIPO SYSTEM AND ACCESSORIES

    MDR report key: 18235424 · Received November 30, 2023

    Report

    Report Number
    3011423170-2023-00101
    Event Type
    Injury
    Date Received
    November 30, 2023
    Date of Event
    November 6, 2023
    Report Date
    November 6, 2023
    Manufacturer
    SOLTA MEDICAL, INC.
    Product Code
    QPB
    PMA / PMN Number
    K190551
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS UNDERWAY.

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN EVALUATED, AND NO PROBLEM WAS IDENTIFIED. THE EQUIPMENT MET ALL SPECIFICATIONS AND PASSED ALL TESTING. THIS EVENT NO LONGER MEETS REPORTABILITY REQUIREMENTS, AS A SERIOUS INJURY DID NOT OCCUR. THOUGH FURTHER INVESTIGATION IS UNDERWAY, NO ADDITIONAL REPORTS WILL BE SUBMITTED.

    Description of Event or Problem · 0

    A USER FACILITY REPORTED A BURN TO THE PATIENT¿S BILATERAL (RIGHT AND LEFT) WAIST FOUR DAYS AFTER A VASER TREATMENT. NO BURN WAS OBSERVED ON THE DAY OF THE SURGERY. THE TREATMENT AREA INCLUDED THE ABDOMEN, ANTERIOR ARMPIT, WAIST, BACK BRA ROLLS, AND ARMS. RENUVION WAS ALSO BEING PERFORMED IN THE SAME TREATMENT AREA. ONCE VASER LIPOSUCTION WAS COMPLETED, RENUVION WAS APPLIED WITH 2KJ ENERGY FOR EVERY 100CM2 AREA. THE PATIENT HAD NO HISTORY OF AESTHETIC PROCEDURES PERFORMED IN THE TREATMENT AREA. THE PATIENT WAS BEING TREATED FOR LIPODYSTROPHY OF CIRCUMFERENTIAL TRUNK AND BILATERAL UPPER EXTREMITIES AS WELL AS FOR BILATERAL GLUTEAL AUGMENTATION. THE PROCEDURE PERFORMED INCLUDED: 1. VASER 360 LIPOSUCTION OF ABDOMEN, BILATERAL WAIST, BILATERAL BACK BRA ROLLS, BILATERAL UPPER EXTREMITIES. 2. RENUVION TO ABOVE AREAS. 3. AUTOLOGOUS FAT GRAFT TO BILATERAL BUTTOCKS (600 ML RIGHT, 500 ML LEFT). GENERAL ENDOTRACHEAL ANESTHESIA WAS USED. MEDICATIONS INCLUDED 2G OF IV ANCEF AND 1 GRAM OF TXA. THE VASER DEVICE WAS NOT TESTED PRIOR TO USE. VASER MODE (V) WAS USED FOR SUPERFICIAL (AT AMPLITUDE OF 60%) AND CONTINUOUS MODE (C) WAS USED FOR DEEP SUBCUTANEOUS (AT AMPLITUDE OF 70%). NO SYSTEM ERRORS OCCURRED DURING THE TREATMENT AND NOTHING OUT OF THE ORDINARY WAS OBSERVED DURING THE TREATMENT. THE TOTAL VASER DELIVERY TIME INCLUDED 2 MINUTES TO EACH SIDE OF THE WAIST, 8 MINUTES TO THE ABDOMEN, AND 4 MINUTES TO BRA ROLLS. 5,600 ML TUMESCENT FLUID (3000MG OF LIDOCAINE TOTAL TUMESCENT SOLUTION AS WELL AS 1ML OF 1:1000 EPINEPHRINE PER LITER, AND 250MG OF TXA PER LITER) WAS APPLIED (2L ABDOMEN, 1L/EACH WAIST, BRA ROLL, 1L ARMS) AND 4500 ML LIPO ASPIRATE (3700 FAT) WAS REMOVED. LIPO ASPIRATE 600 ML WAS GRAFTED INTO THE RIGHT BUTTOCK AND 500 ML INTO THE LEFT BUTTOCK FOR A NET 2600 ML FAT LIPO ASPIRATE REMOVED. THE TREATMENT WAS COMPLETED USING VASER WITH NO VENTX. A SKIN PORT WAS USED ON ALL SITES WITH A WET TOWEL BARRIER TO PROTECT THE SKIN FROM THE PROBE CONTACT. THE SKIN PORTS WERE NOT DAMAGED OR MISALIGNED. A 2-RING PROBE WAS USED, AND IT REMAINED INTACT DURING THE SURGERY. IT HAD PREVIOUSLY BEEN USED TO TREAT OTHER PATIENTS. LIPOSUCTION WAS THEN PERFORMED WITH 4MM SMOOTH CURVED MERCEDES CANNULA USING THE MICROAIRE PAL LIPOSUCTION SYSTEM. A 3MM SMOOTH CANNULA WAS USED FOR SUPERFICIAL CONTOUR IN THE MIDLINE AND LATERAL TO THE RECTUS. ONCE THE LIPOSUCTION WAS COMPLETE, RENUVION WAS THEN DONE IN THE AREAS. THE SKIN WAS FELT THROUGHOUT BOTH THE VASER AND RENUVION AND DID NOT FEEL ANY SIGNIFICANT WARMTH. THE WELLS JOHNSON AUTOGRAFT INFUSER WAS USED TO REINSERT THE FAT USING MICROAIRE PAL AND A 4MM BASKET CANNULA. UNDER DIRECT VISUALIZATION, USING AN ULTRASOUND, FAT WAS REINJECTED INTO THE DEEP AND SUPERFICIAL SUBCUTANEOUS LAYER WITH CARE MADE TO DO NO INJECTION INTO THE MUSCLE ITSELF. THE RIGHT SIDE WAS SLIGHTLY SMALLER THAN THE LEFT PREOPERATIVELY SO 600ML WAS PLACED ON THE RIGHT SIDE AND 500 ML ON THE LEFT. SECONDARY INTERVENTION HAS NOT BEEN USED ON THE PATIENT. ON POST OP DAY SIX, THE REPORTER STATED IT WAS TOO EARLY TO TELL IF PERMANENT DAMAGE OR SCARRING WOULD OCCUR. THE AVAILABLE PICTURES TAKEN SIX DAYS POST PROCEDURE WERE REVIEWED BY THE SOLTA MEDICAL REVIEWER. ONE SIDE OF THE WAIST HAS A LARGER CRUSTED AREA WITH AN OPEN WOUND. ANOTHER SIDE HAS CRUSTED AREA. THE OUTCOME IS UNKNOWN AT THIS TIME.

    Description of Event or Problem · 0

    THE PROVIDER REPORTS THAT THE PATIENT DOES NOT HAVE PERMANENT SCARRING. UPON REASSESSMENT OF THE CASE BY THE (B)(6) MEDICAL REVIEWER, THIS EVENT IS NO LONGER CONSIDERED A SERIOUS INJURY. THEREFORE, THIS FILE NO LONGER MEETS REPORTABILITY REQUIREMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2180184 VASERLIPO SYSTEM AND ACCESSORIES SYSTEM, SUCTION, LIPOPLASTY FOR REMOVAL QPB SOLTA MEDICAL, INC. 110-0032

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Female RENUVION, MICROAIRE PAL LIPO SYSTEM