RONIN X6 OR HEADLIGHT
Received Sep 15, 2025 · Event occurred Sep 3, 2025
Report MW5176076 · MDR key 23054567
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
13 MO · Female
- Partial thickness (Second Degree) Burn
- Partial thickness (Second Degree) Burn
Narrative
Description of Event or Problem
DURING A SURGICAL PROCEDURE IN THE OPERATING ROOM, THE RONIN X6 HEADLIGHT WAS USED. TWO SURGEONS WORE HEADLIGHTS THROUGHOUT THE APPROXIMATELY TWO-HOUR SURGERY. UPON COMPLETION OF THE PROCEDURE, IT WAS OBSERVED THAT THE PATIENT'S ABDOMEN--SPECIFICALLY THE AREA EXPOSED OUTSIDE THE STERILE DRAPE--APPEARED DISCOLORED AND SHOWED SIGNS OF SMALL BLISTERING. A CONSULTATION WITH THE PLASTIC SURGERY TEAM WAS CONDUCTED, AND THEY CONFIRMED THAT THE AFFECTED AREA SUSTAINED A BURN INJURY. PATIENT WAS A 13-MONTH-OLD CHILD. BIO ENGINEERING TESTED EVERY RONIN HEADLIGHT THAT WE HAVE ONSITE. NOTHING WAS FOUND TO BE WRONG WITH THE HEADLIGHTS. PEAK INTENSITY: 350,000 LUX ADJUSTABLE SPOT DIAMETER: 5.6" TO 1.5" AT 18" WORKING DISTANCE RUNTIME: 5+ HOURS (EXTENDED BATTERY), 2.5 HOURS (STANDARD BATTERY) WEIGHT: 6.2 OZ LUMINAIRE WIRELESS DESIGN WITH HAPTIC, AUDIBLE, AND VISUAL BATTERY INDICATORS.