inforMED
InjuryILY

LIGHTFORCE

Received Apr 29, 2026 · Event occurred Apr 30, 2025

Report 9616086-2026-00011 · MDR key 25025925

Device

Generic name

Lts-2501-c-s8 (cts-duo) System

Model number

SYS-000812-000-01

Product problems

  • Temperature Problem

Patient

NA · Unknown

  • Burn(s)

Narrative

Additional Manufacturer Narrative

THE CUSTOMER REPORTED THAT THE PATIENT EXPERIENCED SOME THERMAL BURN. NO FURTHER INFORMATION WAS RECEIVED AFTER SEVERAL ATTEMPTS WERE MADE TO OBTAIN MORE INFORMATION. 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.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE PATIENT EXPERIENCED SOME THERMAL BURN.