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

Patient Problems Erythema (1840); Pain (1994); Partial thickness (Second Degree) Burn (2694)

Event Date 05/12/2023

Event Type  Injury  

Event Description

Using ronin x6 headlight for perineal case lasting 3.5h.Roughly 2.5h into case, noted buttocks red and warm to touch, placed saline soaked gauze over areas of redness, then 30 min later, attempted to replace gauze only to note that small blisters were forming.Appearance of blisters concerning for skin burn.Unclear source of burn.Preop zosyn had been given for surgical prophylaxis.Headlight used in conjunction with loupes, with distance from loupes to focal point 15" and distance from end of light to focal point 13", most likely at the highest brightness setting and largest aperture.Redness and blisters only found in exposed skin and not under drapes.Patient previously prepped preop with betadine, but no areas identified with wet betadine in dependent areas affected by burn.No burns resembling retractors or arcing.After burn discovered, headlight pointed towards a gloved hand and noted to be hotter than would be expected.Antibiotic ointment applied over blisters.Burn noted to progress severely and extensively later that evening as large second degree burn blisters superimposed on 1st degree burn.Burn more significant over right side of buttocks than left side.Wound care physician and team involved with application of antibiotic ointment and topical steroids.Prolonged hospitalization for burn wound care and pain control.Manufacturer performed testing on this specific headlight on (b)(6) 2023 and found to be within specifications with no evidence of malfunction.Thermocoupling testing by manufacturer showed a temperature rise of 5.4 degrees celsius.Manufacturer states that the headlight is designed to emit near zero light in the uv spectrum.Headlight has not been tested in pediatric or neonatal populations.No "pediatric" or "neonatal" settings, nor maximum duration of use recommended by manufacturer.Third party testing of headlight still in progress.Other fda reports of concerns of heat associated with ronin x6 identified online under medsun reports.Patient referred for dermatologic and rheumatological testing to determine if any underlying condition increasing risk of skin sensitivity to heat/light.

• Brand Name: RONIN X6 SURGICAL HEADLAMP/HEADLIGHT
• Type of Device: HEADLAMP, OPERATING, BATTERY-OPERATED
• Manufacturer (Section D): RONIN SURGICAL CORP.
• MDR Report Key: 17566282
• MDR Text Key: 321526628
• Report Number: MW5144689
• Device Sequence Number: 1
• Product Code: HPP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: RONIN BATTERY (B)(6).
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 1 MO
• Patient Sex: Female
• Patient Weight: 5 KG
• Patient Ethnicity: Hispanic