MalfunctionILY
104 LED CLUSTER PROBE WAVELENGTH = 660NM & 850NM ISS 1
Received Dec 6, 2023 · Event occurred Jan 10, 2023
Report 3003899614-2023-00005 · MDR key 18279533
Device
Generic name
104 Led Cluster Probe Wavelength = 660nm & 850nm Iss 1
Manufacturer
Thor Photomedicine LtdModel number
S2140Product problems
- Excessive Heating
- Excessive Heating
Patient
Unknown
- Burning Sensation
- Burning Sensation
Narrative
Additional Manufacturer Narrative
THE PROBE HEAD REQUIRED CLEANING. AFTER CLEANING, PROBE WORKED WITHIN SPECIFICATIONS. THIS MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORT BASED ON ENHANCEMENTS MADE TO THE COMPANY'S COMPLAINT HANDLING PROCESSES. THIS EVENT IS BEING FILED IN ACCORDANCE WITH A CAPA WHICH HAS BEEN OPENED TO MANAGE THE ACTIONS RELATED TO REMEDIATION OF COMPLAINT FILES AND ANY REQUIRED MDR REPORTING.
Description of Event or Problem
LED CLUSTER PROBE IS GETTING TOO HOT TO USE.