MalfunctionILY
810NM 1W CLUSTER (5X200MW)
Received Dec 7, 2023 · Event occurred Mar 8, 2022
Report 3003899624-2023-00007 · MDR key 18280664
Device
Product problems
- Use of Device Problem
- Excessive Heating
- Use of Device Problem
- Excessive Heating
Patient
Unknown
- Burning Sensation
- Burning Sensation
Narrative
Additional Manufacturer Narrative
RESISTORS OF CLUSTER PROBE WERE LOWERED, TEMPERATURES WERE CHECKED, STANDARD CALIBRATION WAS PERFORMED. NO CORRECTIVE ACTION WAS 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.
Description of Event or Problem
CLUSTER PROBE BECOMES HOT WHEN USED. NO ANNUAL SERVICE.
Remedial action
- Modification/Adjustment
- Inspection