VASERLIPO SYSTEM AND ACCESSORIES

Description of Event or Problem

A USER FACILITY REPORTED A BURN TO A PATIENT'S LEG RELATED TO A VASERLIPO PROCEDURE. IT IS UNKNOWN WHEN THE BURN WAS NOTICED. AVAILABLE IMAGES TAKEN FROM BEHIND THE PATIENT¿S LEG WERE REVIEWED BY THE MEDICAL REVIEWER. A LARGE WOUND IS VISIBLE ON THE BACK OF THE LEG, SHOWN IN DIFFERENT STAGES OF THE HEALING PROCESS. BASED ON THE IMAGES, THE CASE WAS REASSESSED AS SERIOUS. MORE INFORMATION HAS BEEN REQUESTED.

Additional Manufacturer Narrative

THE INVESTIGATION IS UNDERWAY.

Additional Manufacturer Narrative

NO PRODUCT WAS RETURNED FOR EVALUATION. THE CUSTOMER DID NOT RESPOND TO FOLLOW UP ATTEMPTS. THE VASERLIPO SYSTEM RISK ASSESSMENT LISTS PATIENT BURNS AS A POSSIBLE COMPLICATION OF THE TREATMENT. A REVIEW OF THE MANUFACTURING RECORDS SHOWED ALL REQUIREMENTS WERE MET. NO NONCONFORMITIES OR ANOMALIES WERE FOUND RELATED TO THIS EVENT 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. 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

MORE INFORMATION WAS RECEIVED. THE SYMPTOMS WERE NOTICED 15 DAYS POST VASERLIPO TREATMENT TO THE PATIENT'S RIGHT MEDIAL MALLEOLUS, RESULTING IN TISSUE LOSS AND PERMANENT SCARRING. THE PATIENT WAS TREATED ON THE CALVES AND KNEES. IT IS REPORTED THAT THE PATIENT IS TAKING CIMZIA AND LAROXYL. NO SECONDARY INTERVENTION (OINTMENTS, MEDICATIONS, ETC.) WAS REPORTED FOR TREATING THIS EVENT. NO OTHER TREATMENTS (BESIDES THE ONE REPORTED) WERE BEING PERFORMED IN 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 SYSTEM WAS NOT TESTED PRIOR TO THE PROCEDURE AS THE CUSTOMER AND THERE WERE NO ALARMS DURING THE PROCEDURE. IN THE AREA WHERE THE INJURY OCCURRED, THE SYSTEM WAS IN VASER (V) MODE. 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 19 MIN 21 SECONDS IN ALL ZONES, COMBINED. 2.5 L SERUM INFILTRATION WAS IN ALL AREAS. 1 LITER OF LIPO ASPIRATE, PER LOWER LIMB, WAS REMOVED AFTER FRAGMENTATION. THE TREATMENT WAS COMPLETED WITH USING VASER. A PAL MICROAIRE, SKIN PORT, AND 3 RING PROBE WERE USED. A WET TOWEL BARRIER WAS UTILIZED TO PROTECT THE SKIN FROM PROBE CONTACT. THE PROBE/CANNULA USED IN THIS TREATMENT HAS BEEN USED TO TREAT OTHER PATIENTS. NO PORTIONS OF THE PROBE/CANNULA BROKE OFF RESULTING IN TWO/OR MULTIPLE SEPARATE PIECES.

Additional Manufacturer Narrative

THE INVESTIGATION IS ONGOING.