DUO HEADLIGHT 2 BAY SYSTEM - US
Received May 27, 2026 · Event occurred Apr 16, 2026
Report 3006697299-2026-00049 · MDR key 25308714
Device
Product problems
- Nonstandard Device
- Overheating of Device
- Intermittent Energy Output
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A FACILITY REPORTED THAT THE DUO HEADLIGHT 2 BAY SYSTEM - US (90620US) WAS FLICKERING DURING SURGERY, AND AFTER EXAMINING THE DEVICE, IT WAS DISCOVERED THAT THE FAN WAS NOT "STAYING, CAUSING THE LAMP TO OVERHEAT AND THUS CAUSING THE INTENSITY TO FLICKER." THERE WAS NO INJURY, DEATH, OR SURGICAL DELAY REPORTED.
Additional Manufacturer Narrative
THE DUO HEADLIGHT 2 BAY SYSTEM - US (90620US) WAS RETURNED FOR EVALUATION: THE DEVICE HISTORY RECORD (DHR) WAS NOT AVAILABLE FOR REVIEW, AS THE LOT NUMBER WAS NOT PROVIDED. FAILURE ANALYSIS: THE DUO HEADLIGHT 2 BAY SYSTEM - US (90620US) WAS IN USED CONDITION. EVALUATION DUPLICATED THE PROBLEM AND IDENTIFIED THAT THE FAN AND POWER SUPPLY WIRE HARNESS REQUIRED REPLACEMENT, AND WERE REPLACED. THE DUO HEADLIGHT PASSED ALL TESTS. ROOT CAUSE ANALYSIS: THE REPORTED COMPLAINT WAS CONFIRMED. THIS IS MOST LIKELY DUE TO ROUTINE USE AND WEAR. NO MANUFACTURING, WORKMANSHIP, OR MATERIAL DEFICIENCY HAS BEEN IDENTIFIED.