VASERLIPO SYSTEM AND ACCESSORIES

Additional Manufacturer Narrative

SEVERAL ATTEMPTS WERE MADE TO HAVE THE HANDPIECE RETURNED FOR EVALUATION BUT WERE UNSUCCESSFUL. IT APPEARS NO RESPONSE WILL BE FORTHCOMING. DELAYED PROCEDURE, DUE TO THE PROBE/CANNULA BREAKING, IS IDENTIFIED IN THE VASERLIPO SYSTEM RISK ASSESSMENT. 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 NON-CONFORMITIES OR ANOMALIES FOUND RELATED TO THIS COMPLAINT WHEN REVIEWING THE DEVICE HISTORY RECORD FOR THE SERIAL/LOT NUMBER. BASED ON THE AVAILABLE INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED AND NO CONCLUSIONS CAN BE DRAWN. NO CORRECTIVE ACTION IS REQUIRED.

Description of Event or Problem

A USER FACILITY REPORTED THAT A VASER PROBE HAD BROKEN OFF INTO THEIR VASER HANDPIECE DURING A PROCEDURE AND THEY WERE UNABLE TO REMOVE A BROKEN PROBE PIECE FROM THE HANDPIECE. NO OTHER PROBE COULD BE CONNECTED TO THE HANDPIECE AND NO WORKING BACK-UP HANDPIECE WAS AVAILABLE. THIS DAMAGE OCCURRED WITH THE PATIENT UNDER GENERAL ANESTHESIA. THE VASER COULD NO LONGER BE USED AND THE PROCEDURE WAS COMPLETED BY PERFORMING TRADITIONAL LIPOSUCTION. THE DELAY DURING THE PROCEDURE WAS LONGER THAN 60 MINUTES.