THOR PHOTOMEDICINE LTD

Additional Manufacturer Narrative

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

OLD DD2 MACHINE, THE LASER CLUSTER PROBE IS GETTING EXTREMELY HOT AROUND THE WHOLE OF THE LASER HEAD