DUO HEADLIGHT AND CARRYING CASE
Received Sep 8, 2025 · Event occurred Jul 21, 2025
Report 3006697299-2025-00108 · MDR key 22992997
Device
Product problems
- Overheating of Device
- Overheating of Device
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A FACILITY REPORTED THAT DURING SURGERY, THE DUO HEADLIGHT AND CARRYING CASE (90600) WAS OVERHEATING ON THE DOCTOR'S HEAD, AND THE PLASTIC HAD MELTED. IT WAS ALSO REPORTED THAT THE BUTTON FOR CHANGING THE LIGHT SNOB DOES NOT WORK. THE WERE NO REPORTS OF INJURIES, DEATH, OR SURGICAL DELAYS AS ANOTHER "LED DUO" WAS USED TO COMPLETE THE SURGERY. IT WAS NOTED THAT THE SURGEON WAS NOT BURNED BECAUSE THE PHYSICIAN REMOVED THE DEVICE PROMPTLY.
Additional Manufacturer Narrative
THE DUO HEADLIGHT AND CARRYING CASE (90600) WAS RETURNED FOR EVALUATION: THE DEVICE HISTORY RECORD (DHR) COULD NOT BE COMPLETED DUE TO NO LOT NUMBER OR SERIAL NUMBER BEING PROVIDED. FAILURE ANALYSIS: THE DUO HEADLIGHT AND CARRYING CASE WAS RECEIVED IN USED CONDITION. THIS ISSUE IS NOT DUE TO OVERHEATING, BUT RATHER TO THE IMPROPER USE OF THE PLASTIC CAP. IT IS POSSIBLE THAT THE PLASTIC CAP WAS PLACED ON THE LUMINAIRE LIGHT WHILE THE DEVICE WAS ALREADY ON, CAUSING THE CAP TO MELT. THE IRIS ADJUSTING WHEEL HAS COME LOOSE FROM THE LUMINAIRE, AND THE LIGHT FIELD OF THE LUMINAIRE IS HAZY AND HAS AN OUT-OF-SPEC BRIGHTNESS, WHICH IS CONSIDERED MISUSE. THE LUMINAIRE MUST BE REPLACED. THE CONNECTOR BOARD MUST BE REPLACED AS PART OF THE LUMINAIRE REPLACEMENT. THE DEVICE MUST BE CHECKED TO VERIFY THAT IT MEETS THE MANUFACTURER'S SPECIFICATIONS. ROOT CAUSE ANALYSIS: THE REPORTED COMPLAINT WAS NOT CONFIRMED. THE EVALUATION DID IDENTIFY THAT THE PLASTIC CAP HAD MELTED. THIS OCCURRED BECAUSE THE CAP WAS PLACED ON THE HEADLIGHT WHILE IT WAS ON.