BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASERLIPO SYSTEM AND ACCESSORIES

    MDR report key: 17637628 · Received August 28, 2023

    Report

    Report Number
    3011423170-2023-00077
    Event Type
    Injury
    Date Received
    August 28, 2023
    Date of Event
    August 2, 2023
    Report Date
    August 2, 2023
    Manufacturer
    SOLTA MEDICAL, INC
    Product Code
    QPB
    PMA / PMN Number
    K190551
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONCLUSIONS FROM THE PREVIOUS REPORT SUBMISSION REMAIN UNCHANGED.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED A PATIENT EXPERIENCED A BURN ON THE ABDOMEN POST VASER TREATMENT. IT WAS REPORTED NO SYSTEM ERRORS AND NOTHING OUT OF THE ORDINARY OCCURRED DURING TREATMENT. THE HIGHEST ENERGY USED WAS 70% ON VASER MODE. IT WAS REPORTED ANOTHER POWER ASSISTED LIPOSUCTION (PAL) DEVICE BESIDES VENTX WAS USED. THE PAL DEVICE WAS NOT SPECIFIED BY CUSTOMER. THE SYSTEM AND HANDPIECE WERE RETURNED FOR EVALUATION. EVALUATION OF THE VASER DEVICE DID NOT FIND ANY OPERATIONAL ERROR WITH THIS SYSTEM. THE SYSTEM POWERED UP AND OPERATED AS INTENDED. SERVICE CHECKED INTERNAL WIRING. POWER SUPPLY VOLTAGES WERE NORMAL, AND THE AMPLIFIER WAS IN OPERATIONAL SPECIFICATION. EVALUATION OF THE HANDPIECE ALSO DID NOT FIND ANY ERRORS OR DEFECTS. THE HANDPIECE ATTACHED AND OPERATED AS INTENDED. THE HANDPIECE PASSED ALL FUNCTIONAL, WAVEFORM, AND CONTINUITY TESTING. VASERLIPO SYSTEM RISK ASSESSMENT LISTS PATIENT BURNS AS A POSSIBLE COMPLICATION OF TREATMENT. A FINAL REVIEW OF THE MANUFACTURING RECORDS SHOWED ALL REQUIREMENTS WERE MET. FINAL TEST VERIFICATION SPECIFICATIONS ARE ACCEPTABLE. NO NON-CONFORMITIES OR ANOMALIES FOUND RELATED TO THIS COMPLAINT WHEN REVIEWING THE DEVICE HISTORY RECORD. THE LOT HISTORY, TREND ANALYSIS, RISK ANALYSIS AND DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. THIS EVENT IS MOST LIKELY UNRELATED TO THE 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.

    Description of Event or Problem · 0

    THE TREATING PHYSICIAN REPORTED THE PATIENT OUTCOME FOR THIS CASE. HE IS UNSURE ABOUT THE OUTCOME BUT DID SEE THE PATIENT LAST WEEK AND HAS VASTLY IMPROVED. HE STATES THAT THE PATIENT HAD SOME MINOR DISCOLORATION BUT SHOULD NOT HAVE SCARRING.

    Description of Event or Problem · 0

    A USER FACILITY ORIGINALLY REPORTED A BURN TO THE PATIENT'S ABDOMEN 5 DAYS POST VASERLIPO TREATMENT. IT IS REPORTED THAT THE SKIN OVER THE ABDOMEN WAS RED AND WARM TO THE TOUCH, DRY, AND INTACT. ALASTIN REFORM AND RECOVER SKIN PRODUCT WAS APPLIED TO THE SKIN. THE PATIENT'S CURRENT STATUS IS REPORTED AS STABLE AND SEEMING TO IMPROVE BUT UNSURE IF ANY PERMANENT DAMAGE OR SCARRING WILL BE PRESENT. AVAILABLE PICTURES WERE REVIEWED BY THE MEDICAL REVIEWER AND BURNED AREAS ARE VISIBLE ON THE LOWER AND UPPER ABDOMEN, MAINLY ON THE UMBILICAL AND PUBIC REGIONS. NO OTHER TREATMENTS (BESIDES THE ONE REPORTED) WERE BEING PERFORMED IN THE SAME AREA WHERE SYMPTOMS WERE REPORTED, NOR HAS THE PATIENT UNDERGONE ANY OTHER TREATMENTS IN THE SAME SYMPTOM AREA WITHIN THE PAST 90 DAYS. THE PATIENT HAS NOT HAD PRIOR AESTHETIC TREATMENTS ON THIS AREA. THE SYSTEM WAS TESTED PRIOR TO THE PROCEDURE, AND IT POWERED ON WITH THE CORRECT SETTINGS. IN THE AREA WHERE THE INJURY OCCURRED, THE SYSTEM WAS IN VASER MODE WITH AN AMPLITUDE LEVEL OF NO MORE THAN 70%. IT IS REPORTED THAT NO SYSTEM ERRORS OCCURRED, NOR WAS ANYTHING OUT OF THE ORDINARY NOTICED DURING TREATMENT. THE TOTAL TIME OF VASER DELIVERY WAS 10 MINUTES. 2100CC OF TUMESCENT FLUID WAS USED AND 1400CC OF LIPO ASPIRATE WAS REMOVED AFTER FRAGMENTATION. THE TREATMENT WAS COMPLETED USING THE VASER. A VENTX WAS NOT USED BUT AN UNSPECIFIED POWER ASSISTANCE DEVICE WAS. A SKIN PORT WAS ALSO USED AND IT WAS NOT DAMAGED OR MISALIGNED. A WET TOWEL BARRIER WAS UTILIZED TO PROTECT THE SKIN FROM THE PROBE. A 3-RING PROBE WAS USED FOR THIS TREATMENT AND HAS BEEN USED ON PREVIOUS TREATMENTS. THE SURGEON IS UNCLEAR AS TO THE REASON FOR THIS EVENT, AS THE TREATMENT WAS STANDARD. THE SURGEON IS NOT CONVINCED THE INJURY IS A BURN AND THINKS IT COULD BE DEVASCULARIZATION OF THE SKIN DUE TO A COMBINATION OF VASER AND HIS STANDARD BASKET CANNULA EVEN-ING OUT. THE SURGEON INDICATED THE PATIENT SEEMS TO BE SLOWLY RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1316258 VASERLIPO SYSTEM AND ACCESSORIES SYSTEM, SUCTION, LIPOPLASTY FOR REMOVAL QPB SOLTA MEDICAL, INC VHP

    Patients

    Seq Age Sex Outcome Treatment
    1 Female PAL (POWER ASSISTED LIPO)