VASERLIPO SYSTEM AND ACCESSORIES

Additional Manufacturer Narrative

NO PRODUCT WAS RETURNED FOR EVALUATION, AS THE PROVIDER REPORTED THAT THEY REPAIRED THE SYSTEM THEMSELVES BY REMOVING AND CLEANING THE PUMP. THE RETURN FOR FURTHER EVALUATION OR REPAIR WAS DECLINED. ACCORDING TO THE VASERLIPO SYSTEM RISK ASSESSMENT, A DELAYED PROCEDURE DUE TO INOPERABLE SUCTION IS IDENTIFIED, AND THE USER MANUAL PROVIDES USERS WITH CLEANING GUIDANCE ON CLEANING THE CONSOLE AND FOOTSWITCHES. 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, THE PUMP ISSUES WERE RESOLVED BY CLEANING THE PUMP. NO CORRECTIVE ACTION IS NECESSARY AT THIS TIME.

Additional Manufacturer Narrative

SOLTA REQUESTED PICTURES OF THE DEVICE TUBING, BUT THE PROVIDED PICTURES WERE INSUFFICIENT TO DETERMINE IF CONTAMINATION WAS PRESENT DURING THE PROCEDURE. MORE DETAILED PHOTOS WERE REQUESTED BUT WERE NOT PROVIDED. THE CUSTOMER NOTIFIED SOLTA THAT THEY ARE DECLINING A SOLTA REPAIR AND THAT THEY HAVE REPAIRED THE DEVICE AS THE MOTOR WAS STUCK. UPON REQUESTING ADDITIONAL INFORMATION, THE PROVIDER STATED THAT THEIR BIOMEDICAL DEPARTMENT REMOVED THE MOTOR AND SAW DUST COLLECTION CAUSING THE MOTOR TO GET STUCK. UPON CLEANING OUT AND REINSTALLING THE MOTOR, THE UNIT FUNCTIONED NORMALLY. AS THE PROVIDER HAS DECLINED ADDITIONAL DEVICE EVALUATION OR REPAIR, NO FURTHER DEVICE INFORMATION IS AVAILABLE. THE INVESTIGATION IS UNDERWAY.

Description of Event or Problem

A USER FACILITY REPORTED A CLICKING SOUND WHEN ACTIVATING THE SUCTION ON THE VASERLIPO SYSTEM, BUT THE PUMP WOULD NOT RUN. THIS RESULTED IN A DELAY OF MORE THAN SIXTY MINUTES WITH THE PATIENT UNDER GENERAL ANESTHESIA. 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.