VASERLIPO SYSTEM

Description of Event or Problem

ADDITIONAL INFORMATION WAS PROVIDED FOR THE PATIENT EVENT. THE PATIENT HAD RECEIVED VASER TREATMENT IN THEIR LOWER BACK, WAIST, HIPS, AND UPPER AND LOWER ABDOMEN. THREE DAYS FOLLOWING THE PROCEDURE THE PATIENT OBSERVED A BURN IN THEIR UPPER AND LOWER ABDOMEN AREA. THE PATIENT WAS TREATED WITH COPPER PEPTIDE CREAM, SILVADENE, AND PLACED IN A HYPERBARIC OXYGEN CHAMBER. THE WOUND WAS THEN DRESSED WITH A DILUTED DAKIN SOLUTION. PATIENT IS CURRENTLY IN STABLE CONDITION BUT A PERMANENT SCAR IS EXPECTED. AVAILABLE PICTURES OF THE INJURY WERE REVIEWED AND IT WAS OBSERVED THERE WERE OPEN WOUNDS, CRUSTS AND POST INFLAMMATORY HYPER PIGMENTATION VISIBLE ON UPPER AND LOWER ABDOMEN AREAS. TOTAL VASER DELIVERY TIME WAS 11 MINUTES AND 50 SECONDS WITH THE HIGHEST AMPLITUDE OF 70% IN VASER MODE AND 2667CC OF TUMESCENT FLUID WAS ADMINISTERED. A SKIN PORT WAS USED DURING THE PROCEDURE ALONG WITH A TOWEL BARRIER TO PROTECT THE SKIN FROM PROBE CONTACT. AFTER THE VASER DELIVERY, THE PATIENT RECEIVED STANDARD LIPOSUCTION AND RENUVION AT 65% POWER WITH 5 PASSES TO EACH INSERTION SITE IN THE ABDOMINAL AREA. NO OTHER PROCEDURES WERE PERFORMED IN THE SAME SYMPTOM AREA WITHIN 30 DAYS PRIOR. THE SYSTEM WAS NOT TESTED PRIOR TO THE PROCEDURE AND NO SYSTEM ISSUES WERE PRESENT. THE PROCEDURE WAS COMPLETED USING THE VASER SYSTEM.

Additional Manufacturer Narrative

THE PRODUCT HAS BEEN RETURNED AND IT''S ANTICIPATED EVALUATION WILL BE PERFORMED SHORTLY. THE INVESTIGATION IS ONGOING.

Additional Manufacturer Narrative

CORRECTION: B3: DATE OF EVENT FROM 27-MAY-2023 TO 30-MAY-2023. THE VASERLIPO SYSTEM WAS RETURNED FOR EVALUATION AND SERVICE WAS UNABLE TO CONFIRM ANY FUNCTIONAL ISSUE WITH THE UNIT. THE SYSTEM POWERED ON AND PASSED IT''S SELF-TESTS. THE POWER, CURRENT, VOLTAGE AND FREQUENCY OUTPUTS WERE ALL WITHIN SPECIFIED PARAMETERS. THE SAFE AND EFFECTIVE USE OF THIS MEDICAL DEVICE DEPENDS ON A LARGE DEGREE ON FACTORS SOLELY UNDER THE CONTROL OF THE OPERATOR. IT IS IMPORTANT THAT ALL OPERATORS OF THE VASERLIPO SYSTEM READ, UNDERSTAND, AND FOLLOW THE OPERATING INSTRUCTIONS SUPPLIED WITH EQUIPMENT. USE OF THIS DEVICE IS LIMITED TO THOSE PHYSICIANS WHO, BY MEANS OF FORMAL PROFESSIONAL TRAINING OR SANCTIONED CONTINUING MEDICAL EDUCATION (INCLUDING SUPERVISED OPERATIVE EXPERIENCE), HAVE ATTAINED PROFICIENCY IN SUCTION LIPOPLASTY. A REVIEW OF THE MANUFACTURING RECORDS SHOWED ALL REQUIREMENTS WERE MET. THE LOT HISTORY, TREND ANALYSIS, RISK ANALYSIS AND/OR DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. REVIEW OF MANUFACTURING RECORDS SHOW FINAL MANUFACTURING TEST VERIFICATION SPECIFICATIONS ARE ACCEPTABLE. NO NON-CONFORMITIES OR ANOMALIES FOUND RELATED TO THIS COMPLAINT WHEN REVIEWING THE DEVICE HISTORY RECORD FOR THE SERIAL/LOT NUMBER. BASED ON THE AVAILABLE INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED AND NO CONCLUSIONS CAN BE DRAWN. THIS EVENT WAS MOST LIKELY UNRELATED TO THE VASER DEVICE. NO CORRECTIVE ACTION IS REQUIRED.

Additional Manufacturer Narrative

THE PRODUCT HAS BEEN REQUESTED TO BE RETURNED FOR EVALUATION. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

A USER FACILITY REPORTED TO A SOLTA SERVICE REPRESENTATIVE THAT A PATIENT EXPERIENCED A BURN DURING A VASER PROCEDURE. NO FURTHER DETAILS OF THE EVENT WERE PROVIDED AND THE PATIENT'S CURRENT STATUS IS UNKNOWN. ADDITIONAL INFORMATION IS BEING SOUGHT AFTER.