VASERLIPO SYSTEM AND ACCESSORIES
Received Jun 30, 2023 · Event occurred Jun 5, 2023
Report 3011423170-2023-00064 · MDR key 17238798
Device
Product problems
- Output Problem
- Output Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A USER FACILITY IN SPAIN REPORTED THAT THE PATIENT WAS UNDER ANESTHESIA FOR A VASERLIPO PROCEDURE. THE PROVIDER PERFORMED THE VASER SELF-TEST, WHICH PASSED. SUBSEQUENTLY, UPON PERFORMING THE VASER HANDPIECE TEST IT DID NOT PASS. ANOTHER HANDPIECE WAS NOT AVAILABLE FOR USE. THE TREATMENT WAS CANCELLED.
Additional Manufacturer Narrative
THOUGH REQUESTED, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. THE INVESTIGATION IS UNDERWAY.
Additional Manufacturer Narrative
NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE CUSTOMER DESPITE MULTIPLE REQUESTS. NO PRODUCT HAS BEEN RETURNED FOR EVALUATION. NO SOLTA SERIAL/LOT NUMBER WAS REPORTED FOR THIS EVENT. THEREFORE, REVIEW OF MANUFACTURING RECORDS CANNOT BE COMPLETED. THE TREND ANALYSIS, RISK ANALYSIS AND DIRECTIONS FOR USE REVIEW ARE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. TRENDING WILL BE PERFORMED TO MONITOR THIS ISSUE. DELAYED PROCEDURE DUE TO INOPERABLE HANDPIECE AND SYSTEM 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 CORRECTIVE ACTION IS NECESSARY AT THIS TIME.