VASERLIPO SYSTEM AND ACCESSORIES
Received May 17, 2023 · Event occurred Apr 18, 2023
Report 3011423170-2023-00048 · MDR key 16947136
Device
Generic name
System, Suction, Lipoplasty For Removal
Manufacturer
Solta Medical, IncModel number
110-0022Product problems
- Smoking
- Suction Problem
- Smoking
- Suction Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
FIELD SERVICE CONFIRMED THE SUCTION MOTOR NON-OPERATIONAL. ACCORDING TO THE VASERLIPO SAFETY RISK ASSESSMENT (260-0113HZ REV. 14), INSUFFICIENT SUCTION ISSUES CAN CAUSE DELAY IN TREATMENT. FINAL TEST VERIFICATION SPECIFICATIONS ARE ACCEPTABLE. NO NON-CONFORMITIES OR ANOMALIES FOUND RELATED TO THIS COMPLAINT WHEN REVIEWING THE DEVICE HISTORY RECORD. THE LOT HISTORY, TREND ANALYSIS, RISK ANALYSIS AND DIRECTIONS FOR USE WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. NO CORRECTIVE ACTION IS NECESSARY AT THIS TIME.
Additional Manufacturer Narrative
FIELD SERVICE CONFIRMED THAT THE SUCTION MOTOR WAS DEFECTIVE. THE SUCTION MOTOR AND THE TUBING FROM THE VACUUM VALVE TO THE OCCLUDE VALVE WERE REPLACED. THE UNIT WAS REASSEMBLED AND PASSED POST, SUCTION, AND PERI PUMP TESTING. THE CANNULA OR PROBE DOES NOT STORE ANY TREATMENT DATA; THUS, THERE IS NO INFORMATION TO GATHER FROM ITS RETURN, AS IT WAS FOUND INTACT. THE SYSTEM HAS NO SYSTEM/DATA LOGS THAT CAN BE REVIEWED. FURTHER INVESTIGATION IS UNDERWAY.
Description of Event or Problem
A USER FACILITY REPORTED A SMELL OF SMOKE AND NO SUCTION DURING A VASERLIPO PROCEDURE. THE PROCEDURE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA.