810NM 1W CLUSTER (5X200MW) ISSUE 1
Received Dec 6, 2023 · Event occurred Jun 5, 2023
Report 3003899624-2023-00004 · MDR key 18279422
Device
Product problems
- Excessive Heating
- Excessive Heating
Patient
Unknown
- Burning Sensation
- Burning Sensation
Narrative
Additional Manufacturer Narrative
FAULTS CONFIRMED. BLUE WIRE SHORTED TO GROUND IN 1.5M CABLE. REPLACED COMPLETE CABLE. 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
ON THE LAST USE, THE MIDDLE SECTION OF THE 810NM 1W CLUSTER (5X200MW) ISSUE 1 WAS HOT TO TOUCH - NOT THE HEAD BUT THE MID SECTION OF THE LEAD.
Remedial action
- Repair