THOR PHOTOMEDICINE LTD

Additional Manufacturer Narrative

PROBE EXCEEDED TEMPERATURE TESTS AFTER 10 MINS (44.5 C). THOR RECOMMENDED THE REPLACEMENT OF THE PROBE HEAD IN ORDER TO RECTIFY THIS, THIS REPAIR WAS REFUSED BY THE CUSTOMER BUT OTHER REPAIR / SERVICING WAS CARRIED OUT. LETTER SENT TO CUSTOMER RE.PROBE TEMPERATURES AND ADVICE REGARDING DUTY CYCLE. 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

810NM 1W CLUSTER PROBE HEATS UP TO THE POINT IT IS UNCOMFORTABLE TO LEAVE IT ON THE SKIN WHEN TREATING.