VASERLIPO SYSTEM AND ACCESSORIES

Additional Manufacturer Narrative

A FIELD SERVICE EVALUATION DID NOT IDENTIFY ANY DEVICE ISSUES. THE SELF-TEST PASSED, AND THE REPORTED PROBLEM WAS NOT DUPLICATED. UPON CUSTOMER REQUEST, THE FIELD SERVICE TECHNICIAN RETURNED FOR FURTHER DEVICE EVALUATION AND AGAIN DID NOT DETECT ANY SYSTEM CONCERNS. THE SELF-TEST PASSED, AND THE REPORTED PROBLEM WAS NOT DUPLICATED. THE HANDPIECE WAS TESTED FOR TEN MINUTES IN WATER AND NO ISSUES WERE FOUND. AS A PRECAUTION AND REQUEST FROM THE CUSTOMER, FIELD SERVICE REPLACED THE ULTRASOUND BOARD. THE SELF-TEST WAS AGAIN PERFORMED, AND THE HANDPIECE WAS TESTED AGAIN IN WATER FOR FIVE MINUTES, WITH PASSING RESULTS. FIELD SERVICE PRODUCT EVALUATION DID NOT CONFIRM THE FAILURE MODE. 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. FINAL TEST VERIFICATION SPECIFICATIONS ARE ACCEPTABLE. 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 ARE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. DELAYED PROCEDURE DUE TO INOPERABLE HANDPIECE AND SYSTEM IS IDENTIFIED IN VASERLIPO SYSTEM RISK ASSESSMENT. BASED ON THE AVAILABLE INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED, AND NO CONCLUSIONS CAN BE FOUND. NO CORRECTIVE ACTION IS NECESSARY AT THIS TIME.

Description of Event or Problem

IT WAS REPORTED THAT DURING A VASER LIPO PROCEDURE A PATIENT EXPERIENCED A PROCEDURE DELAY OF GREATER THAN SIXTY MINUTES WHILE UNDER GENERAL ANESTHESIA DUE TO A SYSTEM SELF-TEST FAILURE. THE VASER SYSTEM WAS INOPERABLE WITH A RED TRIANGLE ERROR SIGNAL DURING THE TREATMENT, WHICH WAS A SURGERY ON BACK, FLANKS, ARMS, AND SUBMENTUM. A VENTX AND MICROAIRE PAL (POWER ASSISTED LIPO) WERE USED DURING THE PROCEDURE. NO PATIENT INJURY OCCURRED; HOWEVER, THE EVENT IS CONSIDERED A SERIOUS INJURY PER SOLTA PROCEDURE DUE TO THE PROCEDURE DELAY OVER 60 MINUTES WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER VASER LIPO DEVICE FROM A DIFFERENT CLINIC NEARBY.