VASERLIPO SYSTEM

Additional Manufacturer Narrative

SOLTA REQUESTED THE DEVICE TO BE RETURNED FOR EVALUATION HOWEVER, THE CUSTOMER STATED THE DEVICE WAS WORKING PROPERLY IN OTHER PROCEDURES AND DECLINED TO HAVE IT EVALUATED. VASERLIPO SYSTEM RISK ASSESSMENT, LISTS PATIENT BURNS AS A POSSIBLE COMPLICATION 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. 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 NUMBER. 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

A USER FACILITY REPORTED THAT A VASER PROBE WAS GETTING HOT DURING SURGERY AND THE PATIENT EXPERIENCED BURNS THE NEXT DAY FOLLOWING A VASER PROCEDURE. THE CUSTOMER PERFORMED A VASER SELF-TEST ON THE AMPLIFIER PRIOR TO THE PROCEDURE, IN WHICH THE DEVICE PASSED TESTING WITH NO ISSUES. THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA AND THE TREATMENT AREA WAS PREPPED WITH 4-5L OF TUMESCENT FLUID. THE CUSTOMER UTILIZED A TOWEL BARRIER AND SKIN PORT TO PROTECT THE PATIENT¿S SKIN FROM UNINTENDED CONTACT WITH THE PROBE. VASER TREATMENT TO THE PATIENT WAS PERFORMED IN MULTIPLE AREAS INCLUDING THEIR FLANKS, BACK, INNER THIGHS, ARMS AND ABDOMEN. VASER ENERGY WAS DELIVERED TO THE PATIENT IN THE INJURY AREA FOR 6 MINUTES IN CONTINUOUS MODE WITH THE HIGHEST AMPLITUDE AT 50%. THE CUSTOMER DID KNOW ANY ENERGY LEVELS OR TIME FOR VASER DELIVERY IN OTHER AREAS. NO SYSTEM ERRORS HAD OCCURRED AND NOTHING UNUSUAL WAS NOTED DURING THE SURGERY. THE VASER PROBE HAD BEEN USED BEFORE ON OTHER PATIENTS PRIOR TO THIS PROCEDURE, AND THERE WAS NO VISIBLE PITTING OR WEAR. THE DAY FOLLOWING TREATMENT, THE PATIENT OBSERVED BURNS ON THE BILATERAL POSTERIOR OF THEIR ARM. THE PATIENT RECEIVED TREATMENT WITH RENUVION, A NON SOLTA DEVICE, IN THE SAME SYMPTOM AREA DURING THE SURGERY. THE PATIENT HAD NOT RECEIVED ANY OTHER TREATMENT IN THE SAME SYMPTOM AREA WITHIN 90 DAYS OF THE SURGERY. IT IS UNKNOWN IF THE PATIENT RECEIVED OTHER AESTHETIC TREATMENTS, IN THE PAST, IN THE SAME SYMPTOM AREA. THE PATIENT WAS TREATED WITH HYPERBARIC OXYGEN THERAPY AND DIMETHYL SULFOXIDE (DMSO), AS WELL AS A PRESCRIPTION FOR SILVADENE CREAM. THEIR CURRENT STATUS IS THAT THEY ARE HEALING HOWEVER, PERMANENT SCARRING IS EXPECTED. A SOLTA MEDICAL REVIEWER EXAMINED PHOTOS OF THE PATIENT WHICH SHOWED BURNED AREAS TO THEIR ARM AND FLANK ON ONE SIDE.

Description of Event or Problem

ADDITIONAL INFORMATION FOR THE PATIENT SURGERY WAS RECEIVED. PATIENT FIRST RECEIVED VASER TREATMENT IN THEIR ARMS. A TOTAL OF 3.4L OF TUMESCENT FLUID WAS INFILTRATED THROUGHOUT THE AREA. VASER WAS THEN PERFORMED USING A 2 RING PROBE ON V MODE 50% FOR TOTAL TIME OF 18 MINUTES AND 56 SECONDS. LIPOSUCTION WAS THEN PERFORMED USING A 4 MM BASKET AND A 4 MM MERCEDES TIP CANNULA. FAT EQUALIZATION WAS PERFORMED IN THE AREAS IN WHICH LIPOSUCTION HAD BEEN CONDUCTED. RENUVION WAS THEN PERFORMED TO THE ARMS AND INNER THIGHS WITH A SETTING OF 2.5 L/MIN 100%. TOTAL ENERGY DELIVERED TO THESE AREAS WAS 15 J/CM². A 15 FRENCH BLAKE DRAIN WAS PLACED IN THE SACRAL AREA AND THE REMAINDER OF THE INCISIONS WERE CLOSED WITH A 5-0 FAST. THE PATIENT THEN RECEIVED VASER TREATMENT TO THEIR ABDOMEN AREA. A TOTAL OF 2.7L OF TUMESCENT SOLUTION WAS INFILTRATED THROUGHOUT THE AREAS. VASER WAS AGAIN PERFORMED USING A 3 RING PROBE ON V MODE 50% FOR TOTAL TIME OF 15 MINUTES AND 28 SECONDS. LIPOSUCTION WAS AGAIN PERFORMED USING A 4 MM BASKET CANNULA. A TOTAL OF 2200 CC OF LIPO ASPIRATE WAS REMOVED. FAT EQUALIZATION WAS AGAIN PERFORMED IN THE AREAS IN WHICH LIPOSUCTION HAD BEEN CONDUCTED. RENUVION WAS THEN PERFORMED TO THE INNER THIGHS AT 15 J/CM² INTO THE ABDOMEN AT 20 J/CM². THE GAS WAS EVACUATED AFTER THE RENUVION WAS PERFORMED. A 15 FRENCH BLAKE DRAIN WAS PLACED IN THE INGUINAL REGION. THE PATIENT REPORTED EVENTS ONE DAY POST PROCEDURE. THE PHYSICIAN NOTED SKINS ON HER POSTERIOR ARMS AND FLANKS LOOKED DUSKY AND POSSIBLY COMPROMISED. PATIENT WAS ADVISED TO USE DIMETHYL SULFOXIDE (DMSO) AND START HYPERBARIC OXYGEN (HBO) TREATMENT FOR ENHANCING THE THERAPY. THE PATIENT CONTINUED THERAPY WITH SKIN REPORTED IN BETTER CONDITION THREE DAYS AFTER SURGERY. VARIOUS TREATMENTS CONTINUED AFTER AND, THE PATIENT WAS RECOMMENDED TO HAVE DEBRIDEMENT AND WOUND VAC PLACED FOLLOWING WITH LASER TREATMENT. THIRTY-SEVEN DAYS FOLLOWING THE PROCEDURE, IT WAS REPORTED THAT BOTH ARMS WERE SUCCESSFULLY DEBRIDED, WITH PARTIALLY CLOSING ONE SIDE AND APPLYING THE WOUND VAC. IT WAS ALSO REPORTED THAT THE BURN WAS DEEP AND DOWN TO THE FASCIA IN THE ARMS. FOUR PICTURES OF THE PATIENT''S POSTERIOR ARM ARE AVAILABLE WITH NO DATE. OPEN WOUNDS ARE VISIBLE ON PATIENT''S ARMS (PICTURES HAVE NO LABEL TO CLARIFY LEFT OR RIGHT ARM). PICTURES HAVE BEEN TAKEN THROUGH THE COURSE OF TREATMENT, BUT THE EXACT TIME IS UNCLEAR. TWO PICTURES ARE AVAILABLE OF PATIENT''S LATERAL SIDES OF ARMS. SCARS ARE VISIBLE ON THE HIGHLIGHTED AREAS. (NO LABEL TO CLARIFY LEFT/ RIGHT ARM AND TIME).

Additional Manufacturer Narrative

THE CUSTOMER BELIEVES THE PRODUCT IS NOT FUNCTIONING PROPERLY BUT STILL HAS DECLINED TO RETURN IT FOR EVALUATION. THE RESULTS OF THE INVESTIGATION REMAIN UNCHANGED.