MalfunctionHPP
HEADLAMP, OPERATING, BATTERY-OPERATED
Received Oct 20, 2021 · Event occurred Jul 8, 2021
Report 12664630 · MDR key 12664630
Device
Generic name
Headlamp, Operating, Battery-operated
Manufacturer
Ronin Surgical CorporationModel number
X6Product problems
- Smoking
- Use of Device Problem
Patient
Not reported
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
DOCTOR WAS WEARING A RONIN X6 HEADLIGHT. DOCTOR LOOKED OUT TO THE FIELD ABOVE THE LOUPES AND THE LIGHT WAS POINTING AT THE SURGICAL GOWN. AFTER A MINUTE THE GOWN STARTED TO STEAM/SMOKE. THE LIGHT WAS THEN POINTED AWAY. NO BURN HOLE IN THE GOWN.