VASERLIPO SYSTEM AND ACCESSORIES

Description of Event or Problem

ADDITIONAL INFORMATION WAS RECEIVED. THE SYSTEM WAS TESTED PRIOR TO USE. THE MACHINE WAS SWITCHED ON AND ALL SWITCHES/BUTTONS WERE CHECKED AND WORKED. HOWEVER, DURING THE PROCEDURE, THE BUTTON'S CHANGE MODE DID NOT FUNCTION. THE TOTAL TIME OF THE VASER DELIVERY WAS ABOUT 8 MINUTES. THE PROCEDURE WAS COMPLETED USING SUCTION FROM AN ANESTHETIC MACHINE.

Additional Manufacturer Narrative

FIELD SERVICE CONFIRMED THE COMPLAINT OF THE MODE BUTTON BEING BROKEN. IT IS UNKNOWN WHAT CAUSED THE BROKEN BUTTON. FIELD SERVICE REPLACED THE MODE BUTTON AND VASER CABLE. AFTER THE REPAIR, THE SYSTEM PASSED FUNCTIONAL AND ELECTRICAL SAFETY TESTS. DELAYED PROCEDURE DUE TO INOPERABLE HANDPIECE AND SYSTEM IS IDENTIFIED IN VASERLIPO SYSTEM RISK ASSESSMENT. NO NONCONFORMITIES OR ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT 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 AS TO HOW THE BUTTON WAS BROKEN. THE ROOT CAUSE OF THE DELAY WAS ATTRIBUTED TO THE BROKEN BUTTON. AT THIS TIME, NO CAPA IS NECESSARY.

Additional Manufacturer Narrative

THE INVESTIGATION IS UNDERWAY.

Description of Event or Problem

A USER FACILITY REPORTED THE MODE BUTTON WAS BROKEN AND WOULD NOT TOGGLE PROPERLY BETWEEN MODES DURING A VASERLIPO PROCEDURE. THIS RESULTED IN A DELAY OF MORE THAN 60 MINUTES WITH THE PATIENT UNDER GENERAL ANESTHESIA. HOWEVER, THE PROCEDURE WAS ABLE TO BE COMPLETED WITH ANOTHER METHOD.