LIMELIGHT
Received Apr 29, 2024
Report 2954354-2024-00006 · MDR key 19209963
Device
Generic name
Lamp, Infrared, Therapeutic Heating
Manufacturer
Cutera, Inc.Product problems
- Improper or Incorrect Procedure or Method
- Improper or Incorrect Procedure or Method
Patient
NA · Female
- Scar Tissue
- Full thickness (Third Degree) Burn
- Scar Tissue
- Full thickness (Third Degree) Burn
Narrative
Description of Event or Problem
INCIDENT REPORT: BURN FOLLOWING LIMELIGHT PROCEDURE SOURCE: CLINIC IN JAPAN. PATIENT INFORMATION: ADULT FEMALE. BURN DIMENSIONS: 3 CM X 1 CM. BURN CARE: INFORMATION NOT PROVIDED. BURN OUTCOME: BURN HEALED BY EPIDERMAL REGENERATION RESULTING IN A DEPRESSED SCAR (3 CM X 1 CM). AFFECTED AREA: FACE. PROCEDURE: LIMELIGHT. INDICATION FOR TREATMENT: NOT PROVIDED. PATIENT AGE: NOT SPECIFIED. PROCEDURE DATE: NOT SPECIFIED. THE CLINIC REPORTED AN ADVERSE EVENT IN WHICH THE PATIENT EXPERIENCED A BURN ON THE FACE AFTER UNDERGOING A LIMELIGHT PROCEDURE. FURTHER DETAILS REGARDING THE INDICATION FOR TREATMENT, PATIENT AGE, AND PROCEDURE DATE WERE NOT PROVIDED BY THE CLINIC. THERE IS NOT A DEVICE PERFORMANCE COMPLAINT ASSOCIATED WITH THE CLINICAL CASE. THE PATIENT UNDERWENT A SERIES OF 90 ENERGY PULSES DIRECTED AT THE FACIAL AREA. A BURN OCCURRED FOLLOWING A SINGLE PULSE, RESULTING IN A BURN SHAPED LIKE THE COOLING/TREATMENT WINDOW. THIS SUGGESTS THAT THE OPERATOR MOMENTARILY LOST CONTACT BETWEEN THE SKIN AND THE COOLING/TREATMENT WINDOW DURING ENERGY DELIVERY. SUCH LOSS OF CONTACT COMPROMISES EFFECTIVE COOLING OF THE UNDERLYING TISSUE DURING ENERGY ADMINISTRATION.