VASERLIPO SYSTEM AND ACCESSORIES
Received Dec 22, 2023
Report 3011423170-2023-00110 · MDR key 18387160
Device
Generic name
System, Suction, Lipoplasty For Removal
Manufacturer
Solta Medical, IncModel number
110-0032Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Burn(s)
- Burn(s)
Narrative
Additional Manufacturer Narrative
VASER SYSTEM WAS RETURNED FOR EVALUATION. SERVICE COULD NOT CONFIRM THE COMPLAINT AS THE CUSTOMER DESCRIBED. THE VASER IS FUNCTIONAL AND MEET WITH SPECIFICATION. THE VASER LENS IS DAMAGED AND WILL NEED TO BE REPLACED. NO OTHER ISSUES WERE FOUND. BOTH OF THE CUSTOMER'S VASER HANDPIECES ARE FUNCTIONAL AND PASSED THE SAFETY TESTS. VASER LIPO SYSTEM RISK ASSESSMENT LISTS PATIENT BURNS AS A POSSIBLE COMPLICATION OF TREATMENT. BASED ON THE AVAILABLE INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED, AND NO CONCLUSION CAN BE DRAWN. 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 REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. NO CORRECTIVE ACTION IS NECESSARY AT THIS TIME.
Additional Manufacturer Narrative
THE PRODUCT HAS NOT BEEN RETURNED FOR AN EVALUATION. THE INVESTIGATION IS UNDERWAY.
Description of Event or Problem
A USER FACILITY REPORTED A PATIENT BURN FOR A VASERLIPO TREATMENT. AT THIS TIME, THERE IS NO OTHER INFORMATION. INFORMATION IS BEING SOUGHT AFTER AND A REPORT WILL BE FILED WHEN MORE INFORMATION BECOMES AVAILABLE.