BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASERLIPO SYSTEM AND ACCESSORIES

    MDR report key: 17635341 · Received August 28, 2023

    Report

    Report Number
    3011423170-2023-00076
    Event Type
    Injury
    Date Received
    August 28, 2023
    Date of Event
    June 14, 2023
    Report Date
    June 14, 2023
    Manufacturer
    SOLTA MEDICAL, INC
    Product Code
    QPB
    PMA / PMN Number
    K190551
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVALUATION DID NOT CONFIRM THE FAILURE MODE. FIELD SERVICE ATTENDED THE CUSTOMER SITE AND PERFORMED TESTING ON THE SYSTEM. FUNCTIONAL AND SAFETY ELECTRICAL TESTING PASSED, AND NO ISSUES WERE FOUND DURING THE EVALUATION. THE SYSTEM WAS WORKING AS PER SPECIFICATION. THE CANNULA AND/OR PROBE IS A PIECE OF METAL USED DURING THE PATIENT PROCEDURE. THIS PIECE OF METAL DOES NOT STORE ANY TREATMENT DATA AND THUS THERE IS NO INFORMATION TO GATHER FROM ITS RETURN. THE EXCEPTION TO THIS WOULD BE IF THE CANNULA AND/OR PROBE HAD BROKEN INTO PIECES OR WAS REPORTED TO HAVE A BURR THAT WAS INVOLVED IN THE PATIENT INJURY. FOR OTHER REPORTED EVENTS, THESE ITEMS ARE NOT A VIABLE SOURCE OF EVALUATION DATA. THE SYSTEM HAS NO SYSTEM/DATA LOGS THAT CAN BE REVIEWED. ACCORDING TO VASER SAFETY RISK ASSESSMENT (260-0113 REV 17) POST-OPERATIVE ECCHYMOSIS, EDEMA, AND BLISTERS ARE KNOWN POSSIBLE COMPLICATIONS OF TREATMENT. A REVIEW OF THE MANUFACTURING RECORDS SHOWED ALL REQUIREMENTS WERE MET. THE LOT HISTORY, TREND ANALYSIS, RISK ANALYSIS AND DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. FINAL TEST VERIFICATION SPECIFICATIONS ARE ACCEPTABLE. NO NON-CONFORMITIES OR ANOMALIES FOUND RELATED TO THIS COMPLAINT WHEN REVIEWING THE DEVICE HISTORY RECORD. IT WAS REPORTED THE CUSTOMER PERFORMED VASER TREATMENT WITH ANOTHER PROCEDURE CALLED RENUVION. BASED ON THE AVAILABLE INFORMATION, THIS EVENT WAS NOT CAUSED BY THE VASER DEVICE. BASED ON THE AVAILABLE INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED, AND NO CONCLUSIONS CAN BE DRAWN. NO CORRECTIVE ACTION IS NECESSARY AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THE PRODUCT HAS BEEN REQUESTED. THE INVESTIGATION IS UNDERWAY.

    Description of Event or Problem · 0

    A USER FACILITY REPORTED BRUISING AND BLISTERS TO THE PATIENT¿S FLANKS AND UPPER ABDOMEN 5 DAYS POST VASERLIPO PROCEDURE. AVAILABLE INFORMATION AND PICTURES WERE REVIEWED BY THE MEDICAL REVIEWER. NO TREATMENT WAS REPORTED. THE OUTCOME IS REPORTED AS HYPERPIGMENTATION. THE DATE OF THE PICTURES IS UNCLEAR. BRUISING AND BLISTERS ARE VISIBLE OVER FLANK AND UPPER LATERAL CHEST. UNCLEAR IF IT IS ONE SIDE OR BOTH SIDES. OTHER PICTURES SHOW HEALING OF BRUISES AND BLISTERS WITH INFLAMMATION AND HYPERPIGMENTED AREAS OVER THE FLANK AND UPPER LATERAL CHEST AREAS. IN A PICTURE NOTED AS THE LAST PICTURE, THE EVENT IS RECOVERED WITH ERYTHEMA AND HYPERPIGMENTATION REMAINING AT THE FLANK. THE PATIENT'S CURRENT STATUS IS REPORTED AS HEALED AFTER 6 WEEKS WITH HYPERPIGMENTATION. IT IS REPORTED THAT RENUVION, 60 % WITH 2L HELIUM WERE BEING PERFORMED IN SAME AREA WHERE SYMPTOMS WERE REPORTED. THE PATIENT HAD NOT UNDERGONE ANY OTHER TREATMENTS IN THE SAME SYMPTOM AREA WITHIN THE PAST 90 DAYS. PRIOR TO THIS EVENT, THE PATIENT HAD NEVER HAD PRIOR AESTHETIC TREATMENTS ON THIS AREA. THE SYSTEM WAS NOT TESTED BEFORE THE PROCEDURE. IN THE AREA WHERE THE INJURY OCCURRED, THE HIGHEST AMPLITUDE LEVEL USED WAS 50%. NO SYSTEM ERRORS OCCURRED, NOR WAS ANYTHING OUT OF THE ORDINARY DURING TREATMENT. THE TOTAL TIME OF VASER DELIVERY WAS 20 MIN WITH 10 MINUTES TO THE BACK AND 10 MINUTES TO THE FLANKS. FIVE LITERS OF TUMESCENT FLUID WAS USED. THE SURGERY WAS COMPLETED USING VASER WITH A VENTX. A SKIN PORT WAS USED, AS WELL AS A WET TOWEL BARRIER. A 5-RING PROBE WAS USED FOR TREATMENT AND IS REPORTED TO HAVE BEEN USED PREVIOUSLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1338486 VASERLIPO SYSTEM AND ACCESSORIES SYSTEM, SUCTION, LIPOPLASTY FOR REMOVAL QPB SOLTA MEDICAL, INC 110-0037

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown RENUVION, 60 % WITH 2L HELIUM.