VASERLIPO SYSTEM AND ACCESSORIES

Additional Manufacturer Narrative

THE TREATING PHYSICIAN REPORTED NO ISSUES WITH THE VASER AMPLIFIER DURING THESE EVENTS. SOLTA MEDICAL REQUESTED THE PRODUCT BACK FOR EVALUATION. THE VASER AMPLIFIER, VENTX CONSOLE, POWERX SYSTEM, AND HANDPIECES WERE RETURNED FOR EVALUATION. THOROUGH VISUAL AND FUNCTIONAL TESTS WERE PERFORMED FOR THESE PRODUCTS. THE VASER AMPLIFIER, VENTX CONSOLE, POWERX SYSTEM PASSED VISUAL AND FUNCTIONAL TESTING. THE HANDPIECES PASSED BOTH GROUND AND IMPEDANCE TESTING. NO ISSUES WERE FOUND WHEN TESTING THESE ITEMS BOTH INDIVIDUALLY AND IN COMBINATION AT VARIOUS POWER VOLTAGES. THE PHYSICIAN RETURNED VASER PROBES FOR EVALUATION. VISUAL INSPECTION FOUND THAT SOME OF THE PROBES HAD EXCESSIVE WEAR. VASER PROBES ARE REPOSABLE ITEMS. ACCORDING TO INSPECTION GUIDELINES IN THE REPROCESSING USER GUIDE, IF THE PROBE IS HEAVILY WORN, THE PROBE SHOULD NOT BE USED AND MUST BE REPLACED PRIOR TO USE. IT IS UNKNOWN IF THESE PROBES WERE USED DURING THESE EVENTS. VASER AMPLIFIERS ARE EQUIPPED WITH AUDIBLE AND VISUAL INDICATORS (ALERT/WARNING) FOR SYSTEM FAULT CONDITIONS. THE AUDIBLE ALERT/WARNING SIGNAL INDICATOR IS AN URGENT WARNING TONE WHICH CAN OCCUR IF THE SYSTEM DETECTS CONDITIONS OUTSIDE OF SAFETY PARAMETERS PRIOR TO AND DURING TREATMENT. ACCORDING TO THE PHYSICIAN, THERE WERE NO SYSTEM ERRORS AND NOTHING OUT OF THE ORDINARY OCCURRED DURING TREATMENT. AN INDEPENDENT MEDICAL REVIEW WAS PERFORMED BY A BOARD-CERTIFIED PHYSICIAN WITH EXTENSIVE VASER EXPERIENCE ON THE INFORMATION AVAILABLE REGARDING THESE EVENTS. THE REVIEW OF THESE EVENTS FOUND IT DID NOT APPEAR THAT THE PATIENT BURNS WERE ATTRIBUTABLE TO THE VASER AMPLIFIER. BASED ON THE MEDICAL REVIEW, THESE EVENTS WERE NOT CAUSED BY VASER, BUT COULD HAVE POSSIBILITY BEEN DUE TO OVERLY AGGRESSIVE SUPERFICIAL LIPOSUCTION BY THE USER THAT DAMAGED THE BLOOD SUPPLY TO THE SKIN, PRODUCED HEMORRHAGE INTO THE SKIN AND CAUSED AREAS OF FULL THICKNESS SKIN NECROSIS. SOLTA SALES VISITED THE PHYSICIAN MULTIPLE TIMES AFTER THESE EVENTS WERE REPORTED. SOLTA SALES COMMUNICATED POSSIBLE TECHNIQUE RELATED ISSUES, LIKE OVERLY AGGRESSIVE SUPERFICIAL LIPOSUCTION TO THE PHYSICIAN. THIS PHYSICIAN WAS TRAINED BY SOLTA AND ATTENDED ADDITIONAL COURSES WITH AN EXPERIENCED VASER USER ABOUT VASER TECHNIQUES. NO NONCONFORMITIES OR ANOMALIES WERE 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. POST-MARKET ANALYSIS SHOWED THE RISK OF PATIENT BURNS FROM A LIPOSUCTION PROCEDURE WHEN USING VASER IS IMPROBABLE. BASED ON THE AVAILABLE INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED, AND NO CONCLUSIONS CAN BE DRAWN. AT THIS TIME, NO CAPA IS NECESSARY.

Additional Manufacturer Narrative

THE VASER AND ACCESSORIES WERE RETURNED FOR INVESTIGATION. THE DOCTOR''S VASER, POWERX, AND VENTX SYSTEMS, ALONG WITH 2 VASER HANDPIECES, VASERSMOOTH HANDPIECE, AND POWERX HANDPIECE WERE TESTED FOLLOWING RELEASED PRODUCTION TESTING AND PASSED. THEY ARE ALL OPERATING WITHIN SPECIFICATION. THE THREE CUSTOMER PROBES WERE WORN AND SHOWED SIGNS OF EXCESSIVE WEAR PER THE INSTRUCTIONS FOR USE. 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. THE INVESTIGATION IS ONGOING.

Additional Manufacturer Narrative

THE PRODUCT HAS BEEN REQUESTED FOR EVALUATION. THE INVESTIGATION IS UNDERWAY.

Description of Event or Problem

A USER FACILITY REPORTED BURNS TO THE ABDOMEN 2 DAYS POST VASERLIPO TREATMENT. AVAILABLE PICTURES WERE REVIEWED BY THE MEDICAL REVIEWER. BURNED AREAS ARE VISIBLE ON ABDOMINAL AND PELVIC AREAS. SECONDARY INTERVENTION (OINTMENTS, MEDICATIONS, ETC.) REQUIRED TO TREAT THIS EVENT INCLUDES BURN CREAMS AND OZONE TREATMENT. IT IS REPORTED THAT THE PATIENT IS STILL UNDER TREATMENT AND THAT PERMANENT DAMAGE/ SCARRING IS EXPECTED. NO OTHER TREATMENTS (BESIDES THE ONE REPORTED) BEING PERFORMED IN SAME AREA WHERE SYMPTOMS WERE REPORTED. THE PATIENT HAS NOT UNDERGONE ANY OTHER TREATMENTS IN THE SAME SYMPTOM AREA WITHIN THE PAST 90 DAYS. THE SYSTEM WAS TESTED BEFORE THE PROCEDURE AND THE VASER PASSED THE SELF-TEST. IN THE AREA WHERE THE INJURY OCCURRED, THE SYSTEM WAS IN VASER (V) MODE AND THE HIGHEST AMPLITUDE LEVEL USED WAS 10%. NO SYSTEM ERRORS OCCURRED NOR WAS ANYTHING OUT OF THE ORDINARY NOTICED DURING TREATMENT. THE TOTAL TIME OF VASER DELIVERY WAS 6 MIN MAXIMUM WITH 1 MIN PER AREA. 6000 ML TO 8000 ML TUMESCENT FLUID WAS USED WITH ABOUT 2000 ML TO 3000 ML PER AREA. 5 L OF LIPO ASPIRATE WAS REMOVED AFTER FRAGMENTATION. THE PROCEDURE WAS COMPLETED USING THE VASER. IT IS NOTED THAT A POWER ASSISTED LIPO DEVICE WAS NOT USED. A SKIN PORT WAS USED AND WAS NOT DAMAGED OR MISALIGNED. A WET TOWEL BARRIER WAS UTILIZED TO PROTECT THE SKIN FROM THE PROBE CONTACT. A 1-2 RING PROBE(S) WAS USED FOR THE TREATMENT. THE PROBE/CANNULA DID NOT BREAK OFF OR BREAK INTO MULTIPLE SEPARATE PIECES.