VASERLIPO SYSTEM AND ACCESSORIES
Received Jul 10, 2024 · Event occurred Jun 21, 2024
Report 3011423170-2024-00184 · MDR key 19713554
Device
Product problems
- Decrease in Suction
- Battery Problem
- Communication or Transmission Problem
- Noise, Audible
- Decrease in Suction
- Battery Problem
- Communication or Transmission Problem
- Noise, Audible
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
FIELD SERVICE VISITED THE SITE FOR EVALUATION. WHILE ONSITE, THEY CONFIRMED ONE WIRELESS FOOTSWITCH WAS FUNCTIONAL, AND THE SECOND COULDN'T BE TESTED DUE TO DEAD BATTERIES. FIELD SERVICE COULD NOT CONFIRM CUSTOMER'S REPORT OF NOISE OR ISSUES WITH THE SUCTION PUMP. THE SYSTEM TESTED WITHIN SPECIFICATIONS. THE SYSTEM IS WORKING AS INTENDED. AS A PRECAUTION, SERVICE WILL REPLACE THE PUMP. THE CONCLUSIONS FROM THE PREVIOUS REPORT REMAIN UNCHANGED.
Description of Event or Problem
ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE EVENTS THAT OCCURRED DURING THE VASERLIPO SURGERY. THE USER FACILITY ALSO REPORTED ZERO SUCTION WITH THE VACUUM PUMP. PRIOR TO TREATMENT, AN OFF-GRINDING AND CLICKING NOISE WAS COMING FROM BOTTOM OF THE VENTX CONSOLE. NO PAL (POWER ASSISTED LIPO) DEVICE WAS USED.
Description of Event or Problem
A USER FACILITY REPORTED THAT THE FOOT PEDALS STOPPED WORKING DURING A VASERLIPO PROCEDURE, WHICH RESULTED IN A DELAY OF MORE THAN 60 MINUTES WITH THE PATIENT UNDER GENERAL ANESTHESIA. THE BATTERIES WERE REPLACED AND ONE OF THE TWO FOOTPEDALS (BLUE) BEGAN WORKING. THE CUSTOMER THEN ATTACHED THE WIRED FOOTPEDAL TO THE VASER. THE CUSTOMER WAS HAVING DIFFICULTY PAIRING THE FOOTPEDALS BUT EVENTUALLY THEY WERE ABLE TO PAIR THEM AND COMPLETED THE SURGERY.
Additional Manufacturer Narrative
THE CUSTOMER WAS HAVING DIFFICULTY PAIRING THE FOOTPEDALS BUT EVENTUALLY THEY WERE ABLE TO PAIR THEM AND COMPLETED THE SURGERY. THE CUSTOMER DECLINED TO HAVE THE FOOTPEDAL RETURNED FOR EVALUATION. DELAYED PROCEDURE DUE TO INOPERABLE FOOT PEDAL/SWITCH IS IDENTIFIED IN VASERLIPO SYSTEM RISK ASSESSMENT. BASED ON THE AVAILABLE INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED AND NO CONCLUSIONS CAN BE FOUND. 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.