VASERLIPO SYSTEM AND ACCESSORIES

Description of Event or Problem

A USER FACILITY REPORTED THAT THE FOOT PEDAL OF THEIR VASER SYSTEM DID NOT WORK UPON PREPARATION FOR A TREATMENT. THE VASER FOOT PEDAL WAS PHYSICALLY DAMAGED. THERE WAS A DELAY OF MORE THAN SIXTY MINUTES WITH THE PATIENT UNDER GENERAL ANESTHESIA AND THE PROCEDURE WAS ULTIMATELY ABORTED. BOTH THE DELAY OF OVER SIXTY MINUTES WHILE THE PATIENT IS UNDER GENERAL ANESTHESIA AND THE PROCEDURE BEING ABORTED, ARE CONSIDERED SERIOUS INCIDENTS PER SOLTA PROCEDURE.

Additional Manufacturer Narrative

NO PRODUCT WAS RETURNED, AS THE FOOTSWITCH IS NOT MANUFACTURED BY SOLTA. THEREFORE, NO FURTHER EVALUATION CAN BE PERFORMED. A DELAY IN A PROCEDURE DUE TO AN INOPERABLE FOOT PEDAL/SWITCH IS IDENTIFIED IN THE VASERLIPO SYSTEM RISK ASSESSMENT. NO NONCONFORMITIES OR ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT WHEN REVIEWING THE DEVICE HISTORY RECORD FOR THE VASER SYSTEM. THE 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 FOUND. AT THIS TIME, NO CAPA IS NECESSARY.