VASERLIPO SYSTEM AND ACCESSORIES

Additional Manufacturer Narrative

FIELD SERVICE CONFIRMED THE SUCTION PUMP WAS NON-OPERATIONAL. THE SUCTION PUMP WAS REPLACED. AFTER REPAIR, THE SYSTEM PASSED IRRIGATION PUMP OPERATION VERIFICATION, CHASSIS GROUND RESISTANCE, SUCTION PUMP OPERATION VERIFICATION AND FUNCTIONALITY. THE SYSTEM PERFORMED AS EXPECTED. ACCORDING TO THE VASERLIPO SAFETY RISK ASSESSMENT, INSUFFICIENT SUCTION ISSUES CAN CAUSE DELAY IN TREATMENT. 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. AT THIS TIME, NO CAPA IS NECESSARY.

Description of Event or Problem

A USER FACILITY REPORTED THAT THEIR VENTX DID NOT HAVE SUCTION DURING A PROCEDURE WHILE THE PATIENT WAS GENERAL ANESTHESIA. AS A RESULT, THE SURGERY WAS CANCELLED, AND THE PATIENT WAS AWAKENED AFTER 5 MINUTES OF TROUBLESHOOTING. THIS EVENT WAS ASSESSED AS SERIOUS DUE TO THE ABORTED PROCEDURE WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA.