VASERLIPO SYSTEM AND ACCESSORIES (CANNULA)

Additional Manufacturer Narrative

THE PRODUCT HAS BEEN REQUESTED FOR EVALUATION. INVESTIGATION IS UNDERWAY.

Description of Event or Problem

A USER FACILITY REPORTED TO A DISTRIBUTOR THAT THE VENTX CANNULA SEPARATED FROM THE BASE. THE EVENT OCCURRED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. AS A DIRECT CONSEQUENCE TO THE BROKEN CANNULA, THE PROCEDURE WAS DELAYED BY APPROXIMATELY 60 MINUTES. THE SURGICAL INTERVENTION WAS ULTIMATELY COMPLETED USING A REPLACEMENT CANNULA. IN ACCORDANCE WITH INTERNAL SAFETY GUIDELINES, THE CASE HAS BEEN ASSESSED AS SERIOUS DUE TO THE EXTENDED DURATION OF GENERAL ANESTHESIA REQUIRED AS A DIRECT CONSEQUENCE OF THE BROKEN CANNULA.

Additional Manufacturer Narrative

ALTHOUGH ATTEMPTS WERE MADE, NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER AND NO PRODUCT WAS RETURNED FOR EVALUATION. DELAY IN PROCEDURE DUE TO CANNULA BREAKING DURING A PROCEDURE IS IDENTIFIED IN THE VASERLIPO SYSTEM RISK ASSESSMENT. THE TREND ANALYSIS, RISK ANALYSIS AND DIRECTIONS FOR USE REVIEW ARE 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. AT THIS TIME, NO CORRECTIVE ACTION IS NECESSARY.