VASERLIPO SYSTEM

Additional Manufacturer Narrative

IN ADDITION TO THE MEASUREMENTS BEING OUT OF SPECIFICATION, SERVICE FOUND THAT THE ULTRASOUND PRINTED CIRCUIT BOARD WAS NOT WORKING AS IT SHOULD. MORE INVESTIGATION IS UNDERWAY FOR ROOT CAUSE ANALYSIS.

Additional Manufacturer Narrative

CORRECTION: B5 FROM: EVENT OCCURRED DURING PROCEDURE AND DMSO APPLIED SAME DAY - TO: EVENT OCCURRED POST-OP AND DMSO APPLIED 10 DAYS LATER. D1 FROM: VASER PRO AMPLIFIER - TO: VASERLIPO SYSTEM, D2 FROM: ULTRASONIC SURGICAL SYSTEM GENERATOR - TO: SYSTEM, SUCTION, LIPOPLASTY. D2 PRODUCT CODE FROM: MUU - TO: QPB. G4 PMA/510(K) FROM: K110306 - TO: K190551. THE VASERLIPO SYSTEM WAS RETURNED AND EVALUATED. THE MEASUREMENTS OF THE VASER DEVICE ARE ABOVE SPECIFICATION. A FAULTY VASER HANDPIECE CAN CAUSE A VASER TO FAIL. THE VASER HANDPIECE WAS TESTED AND FAILED THE TESTING. FINAL MANUFACTURING TEST VERIFICATION SPECIFICATIONS ARE ACCEPTABLE. NO NON-CONFORMITIES OR ANOMALIES FOUND RELATED TO THIS COMPLAINT WHEN REVIEWING THE DEVICE HISTORY RECORD. MORE INVESTIGATION IS UNDERWAY FOR ROOT CAUSE ANALYSIS.

Description of Event or Problem

CORRECTION: THE PATIENT WAS STARTED ON DMSO POST TREATMENT BY 10 DAYS. THE ISSUE WAS REPORTED POST-OP. A 1-MONTH POST OP PATIENT PHOTO WAS RECEIVED AND REVIEWED BY THE MEDICAL REVIEWER AND A LARGE, CRUSTED WOUND IS VISIBLE ON UPPER ARM (SIDE IS NOT CLEAR). ALSO, CRUSTED WOUNDS ARE VISIBLE ON BOTH INNER THIGHS.

Additional Manufacturer Narrative

THE DEVICE HAS BEEN REQUESTED. THE INVESTIGATION IS UNDERWAY.

Description of Event or Problem

A USER FACILITY REPORTED BURNS TO THE BILATERAL INNER THIGHS OF A PATIENT DURING A VASER LIPO PROCEDURE. THE PATIENT WAS STARTED ON DMSO ON THE DATE OF TREATMENT. THE PATIENT'S BURNS ARE NOTED AS HEALING AND THAT IT IS MOST LIKELY THAT THERE WILL BE SCARRING. AVAILABLE PHOTOGRAPHS OF THE PATIENT WERE REVIEWED BY THE MEDICAL REVIEWER. THE TIME OF THE PICTURES AND THE EXACT LOCATIONS (RIGHT OR LEFT) ARE NOT AVAILABLE. LARGE AREAS OF INFLAMMATION AND ERYTHEMA WERE VISIBLE ON BOTH THIGHS. A WOUND WITH A LARGE CRUST WAS VISIBLE ON ONE THIGH. TWO SMALLER CRUSTS AND WOUNDS ARE VISIBLE ON THE SECOND THIGH. OTHER PICTURES SHOWED POST INFLAMMATORY HYPERPIGMENTED AREAS. NO OTHER TREATMENTS (BESIDES VASER) WERE BEING PERFORMED IN SAME AREA WHERE SYMPTOMS WERE REPORTED. THE PATIENT HAD NOT UNDERGONE ANY OTHER TREATMENTS IN THE SAME SYMPTOM AREA WITHIN THE PAST 90 DAYS. IT WAS NOTED THAT THE DOCTOR DOESN'T TYPICALLY TEST THE SYSTEM PRIOR TO THE TREATMENTS. IN THE AREA WHERE THE INJURY OCCURRED, THE SYSTEM WAS IN VASER MODE AND THE HIGHEST AMPLITUDE LEVEL USED WAS AT 50%. NO SYSTEM ERRORS OCCURRED, NOR WAS ANYTHING OUT OF THE ORDINARY NOTICED DURING TREATMENT. THE TOTAL TIME OF THE VASER DELIVERY WAS LESS THAN 2 MINUTES PER SIDE. APPROXIMATELY 500-600CC/SIDE OF TUMESCENT FLUID WAS USED. TREATMENT WAS COMPLETED USING THE VASER. MICROAIRE WAS USED. A SKIN PORT WAS USED AND IT WAS NOTED THAT THERE WAS NO DAMAGE OR MISALIGNMENT. A WET TOWEL BARRIER WAS ALSO UTILIZED TO PROTECT THE SKIN FROM PROBE CONTACT. A 2 AND 3 RING PROBE WERE USED FOR THE TREATMENT. THIS WAS NOT THE FIRST TIME THE PROBE/CANNULA WERE USED, AND NO BREAKAGE WAS REPORTED.

Additional Manufacturer Narrative

CORRECTION TO DATE OF EVENT: FROM 12/2/2022 TO: 12/12/2022. IT WAS REPORTED A PATIENT EXPERIENCED A BURN ON THE BILATERAL INNER THIGHS POST VASER TREATMENT. IT WAS REPORTED THE HIGHEST AMPLITUDE USED WAS 50% ON VASER MODE. CUSTOMER REPORTED NO SYSTEM ERRORS OR ANYTHING OUT OF THE ORDINARY OCCURRED DURING TREATMENT. EVENT DETAILS, AND THE RETURNED DEVICES, WHICH INCLUDED A VASER AMPLIFIER AND FOUR VASER HANDPIECES WERE INVESTIGATED. IT IS POSSIBLE, BUT UNKNOWN, IF FACTORS, SUCH AS THE VASER AMPLIFIER MEASUREMENTS NOT WITHIN SPECIFICATIONS, USE OF NON-FUNCTIONAL HANDPIECE, AND THE POWER-ASSISTED LIPOSUCTION DEVICE CONTRIBUTED TO THIS EVENT. THE TESTING INSTRUCTIONS SET FORTH IN THE VASER USER GUIDE MAKE CLEAR THAT THE USER IS TO TEST THE VASER AMPLIFIER WITH THE VASER TEST SWITCH PRIOR TO EVERY SURGERY. THE PURPOSE OF THE VASER TEST SWITCH IS TO TEST THE VASER OR VASER PRO AMPLIFIER WITHOUT CONNECTION TO THE VASER HANDPIECE. IF THE SYSTEM DOES NOT FUNCTION, THIS SWITCH WILL ALLOW THE USER TO DETERMINE IF THE FAULT IS IN THE VASER AMPLIFIER OR IN THE HANDPIECE. 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/OR 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

CORRECTION TO DATE OF EVENT: OCCURRED 12/12/2022.