MAUDE Adverse Event Report: RONIN SURGICAL CORP. RONIN X6 OR HEADLIGHT; HEADLAMP, OPERATING, BATTERY-OPERATED

Model Number	RK0350
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	09/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
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.

• Brand Name: RONIN X6 OR HEADLIGHT
• Common Device Name: HEADLAMP, OPERATING, BATTERY-OPERATED
• Manufacturer (Section D): RONIN SURGICAL CORP.
• MDR Report Key: 23054567
• Report Number: MW5176076
• Device Sequence Number: 9664742
• Product Code: HPP
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: RK0350
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/15/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 13 MO
• Patient Sex: Female
• Patient Weight: 11 KG
• Patient Ethnicity: Hispanic