VASERLIPO SYSTEM

Additional Manufacturer Narrative

THE DEVICE HAS BEEN REQUESTED. THE INVESTIGATION IS UNDERWAY.

Description of Event or Problem

A USER FACILITY REPORTED THAT THE VASERLIPO SYSTEM DISPLAY SCREEN WAS BLACK. HOWEVER, THE USER COULD HEAR THAT THE SYSTEM TURNED ON. THIS OCCURRED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA FOR OVER 60 MINUTES AND RESULTED IN THE PROCEDURE BEING ABORTED. SINCE THE PROCEDURE WAS CANCELED AND THE DELAY UNDER GENERAL ANESTHESIA WAS NOTED ABOVE 60 MINUTES, THE CASE MEETS THE REPORTABILITY REQUIREMENTS AND IS DEEMED AS A SERIOUS INCIDENT.

Additional Manufacturer Narrative

FIELD SERVICE CONFIRMED THE ISSUE. IT WAS FOUND THAT THE SYSTEM HAD LOOSE WIRES ON THE SPEAKER BOARD. SERVICE TIGHTENED THE WIRES IN THEIR CORRECT POSITION AND PERFORMED A COMPLETE FUNCTIONAL VERIFICATION PER SPECIFICATIONS. DELAYED PROCEDURE DUE TO NO DISPLAY 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, THIS ISSUE WAS CAUSED BY LOOSE WIRES ON THE SPEAKER BOARD. AT THIS TIME, NO CAPA IS NECESSARY.