BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASERLIPO SYSTEM AND ACCESSORIES

    MDR report key: 18235320 · Received November 30, 2023

    Report

    Report Number
    3011423170-2023-00100
    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 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 AND BACK BRA ROLL, WAIST, AND ARMS. RENUVION (J-PLASMA) WAS ALSO BEING PERFORMED IN THE SAME TREATMENT AREA. ONCE VASER LIPOSUCTION WAS COMPLETED, RENUVION (J-PLASMA) WAS APPLIED WITH 2KJ ENERGY FOR EVERY 100CM2 AREA. THE PATIENT HAD A HISTORY OF ABDOMINOPLASTY BUT HAD NOT UNDERGONE OTHER TREATMENTS WITHIN THE SAME SYMPTOM AREA WITHIN THE PRIOR 90 DAYS. THE PATIENT WAS BEING TREATED FOR LIPODYSTROPHY OF CIRCUMFERENTIAL TRUNK AND BILATERAL UPPER EXTREMITIES AS WELL AS FOR A POOR SCAR FROM PRIOR ABDOMINOPLASTY ON THE UMBILICUS AND CENTRAL LOWER ABDOMEN. THE PROCEDURE PERFORMED INCLUDED: 1. VASER 360 LIPOSUCTION OF ABDOMEN, WAIST, BILATERAL BACK BRA ROLLS, BILATERAL UPPER EXTREMITIES. 2. UMBILICOPLASTY 3. SCAR REVISION OF CENTRAL ABDOMINAL SCAR 8 CM 4. RENUVION. 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 50) AND CONTINUOUS MODE (C) WAS USED FOR DEEP SUBCUTANEOUS (AT AMPLITUDE OF 60). NO SYSTEM ERRORS OCCURRED DURING THE TREATMENT AND NOTHING OUT OF THE ORDINARY WAS OBSERVED DURING THE TREATMENT. THE TOTAL VASER DELIVERY TIME WAS 24 MINUTES (ABDOMEN 10 MIN, 2 MIN EACH FRONT ARMPIT, 6 MIN WAIST/BRA ROLLS). 5,500L (500 MG OF LIDOCAINE, 250 MG OF TXA, AND 1ML OF 1:1000 EPINEPHRINE PER LITER) TUMESCENT FLUID WAS USED (2L ABDOMEN, 1L EACH WAIST BRA ROLL, 1L SPLIT ARMS) AND 4000ML LIPO ASPIRATE (3250 ML FAT) WAS REMOVED. THE TREATMENT WAS COMPLETED USING VASER WITH NO VENTX. A SKIN PORT WAS USED WITH A WET TOWEL BARRIER TO PROTECT THE SKIN FROM THE PROBE CONTACT. THE SKIN PORT WAS 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. ONCE THE DESIRED CONTOUR AND THICKNESS WAS ACHIEVED, RENUVION WAS THEN DONE IN THE AREAS. THE SKIN WAS FELT THROUGHOUT BOTH THE VASER AND RENUVION AND DID NOT FEEL ANY SIGNIFICANT WARMTH. 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. ERYTHEMATOUS AREA WITH BURN IS VISIBLE ON WAIST. ONE CRUSTED WOUND IS VISIBLE. THE OUTCOME IS UNKNOWN AT THIS TIME.

    Description of Event or Problem · 0

    THE PROVIDER REPORTS THAT AT THIS TIME THE PATIENT DOES NOT HAVE PERMANENT SCARRING, BUT IS DISPLAYING HYPOPIGMENTATION IN THE AREA. UPON REASSESSMENT OF THE CASE BY THE SOLTA 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
    1771920 VASERLIPO SYSTEM AND ACCESSORIES SYSTEM, SUCTION, LIPOPLASTY FOR REMOVAL QPB SOLTA MEDICAL, INC. 110-0032

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female RENUVION (J-PLASMA), MICROAIRE PAL LIPO SYSTEM.