69 LED CLUSTER PROBE WAVELENGTH = 660NM & 850NM ISSUE 1

Description of Event or Problem

THE RINGS AROUND THE PROBES GET VERY HOT ESPECIALLY WHEN DOING THE SMALL PROBE ON STEM CELLS AND IT CONCERNS ME THAT IT SHOULD NOT BE GETTING THIS HOT.

Additional Manufacturer Narrative

TEMPERATURE TESTING COMPLETED FOR 69 CLUSTER AND RESULTS WITHIN SPECIFICATION. NO ACTION REQUIRED. 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.