LIGHTFORCE
Received May 6, 2026 · Event occurred Apr 7, 2026
Report 9616086-2026-00016 · MDR key 25107492
Device
Generic name
Lightforce Xli (40w) Therapy Laser System
Manufacturer
Litecure, Llc A Djo Llc CompanyModel number
SYS-000656-000-01Product problems
- Temperature Problem
Patient
41 YR · Unknown
- Burn(s)
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT THEY WERE PERFORMING A LASER TREATMENT AND NOTED A REDNESS ON THE HUMAN PATIENT, THEN IT STOPPED. THE HUMAN PATIENT REPORTED BACK AND THEY DEVELOPED A 3RD DEGREE BURN.
Additional Manufacturer Narrative
THE CUSTOMER REPORTED THAT THEY WERE PERFORMING A LASER TREATMENT AND NOTED A REDNESS ON THE HUMAN PATIENT, THEN IT STOPPED. THE HUMAN PATIENT REPORTED BACK AND THEY DEVELOPED A 3RD DEGREE BURN. NO FURTHER INFORMATION WAS RECEIVED. DEVICE NOT RETURNED FOR EVALUATION. THE ROOT CAUSE COULD NOT BE ESTABLISHED. ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT IF NEW INFORMATION BECOMES AVAILABLE.