VASERLIPO SYSTEM

Additional Manufacturer Narrative

FURTHER INFORMATION AND DEVICE EVALUATION HAS BEEN REQUESTED. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

A USER FACILITY REPORTED THAT THEY WERE UNABLE TO COMPLETE A VASER PROCEDURE ON A PATIENT BECAUSE THE VASER FOOTSWITCH STOPPED WORKING. THERE WAS A DELAY OF GREATER THAN 60 MINUTES WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE VASER DELIVERY ON THE FRONT OF THE PATIENT WAS COMPLETED BUT THE PROCEDURE HAD TO BE ABORTED PRIOR TO COMPLETION OF THE VASER PROCEDURE ON THE PATIENT¿S BACK. THERE WERE NO HEALTH CONSEQUENCES TO THE PATIENT, HOWEVER, THIS EVENT MEETS THE DEFINITION OF A SERIOUS INJURY PER SOLTA MEDICAL REVIEWER DUE TO THE ABORTED PROCEDURE AS WELL AS THE GREATER THAN ONE HOUR DELAY WHILE UNDER GENERAL ANESTHESIA.

Additional Manufacturer Narrative

SOLTA MADE MULTIPLE ATTEMPTS TO OBTAIN FURTHER INFORMATION ABOUT THE EVENT BUT WERE UNSUCCESSFUL, AND IT APPEARS NO RESPONSE WILL BE FORTHCOMING. NO PRODUCT WAS RETURNED FOR EVALUATION. THE SYSTEM DOES NOT HAVE ANY SYSTEM DATA LOGS OR EVENT DATA LOGS THAT CAN BE REVIEWED. DELAYED PROCEDURE DUE TO AN INOPERABLE FOOTSWITCH IS IDENTIFIED IN THE VASERLIPO SYSTEM RISK ASSESSMENT. 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 NONCONFORMITIES OR ANOMALIES WERE FOUND RELATED TO THIS EVENT WHEN REVIEWING THE DEVICE HISTORY RECORD. 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.