MAUDE Adverse Event Report: LUTRONIC CORPORATION XERF

Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	08/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the treatment parameters used were found to be within the recommended clinical guidelines.Images provided on 08/13/2025 were reviewed and discussed with cynosure lutronic medical director.Cynosure medical director states, "the redness observed in the images suggests a partial thickness burn and the patient is at risk for scarring and/or hyper/hypopigmentation." the medical director completed a review of the additional images supplied between 08/14/2025-08/27/2025 and stated "it appears that there may be a small full thickness burn on the left jawline." a trained cynosure lutronic field service engineer (fse) evaluated the device.During this time, the device was subjected to multiple tests including full functionality testing with passing results.The device was found to be working to device published specifications.However, images of the device tip were reviewed and observed a mark which appears to be a burn mark.It is unknown what caused this visual discrepancy.At this time, it is unknown what contributed to the reported malfunction and burning observed in the patient images or the damage to the tip observed in the provided image.It is unknown what caused this observed defect to the tip.The defect was observed but unable to be verified if it contributed to the reported burning.Since a reported malfunction and serious injury occurred, we are reporting this event.
Event or Problem Description
It was reported that during corporate training, a staff member experienced a burn on the face during a xerf rf electrocoagulation and hemostasis treatment.

• Brand Name: XERF
• Common Device Name: XERF
• Manufacturer (Section D): LUTRONIC CORPORATION; lutronic center; 219 sowon-ro; deogyang-gu, goyang-si 10534 ; KS 10534
• Manufacturer (Section G): LUTRONIC CORPORATION; lutronic center; 219, sowon-ro; deogyang-gu,, goyang-si 10534 ; KS 10534
• Manufacturer Contact: nirav desai ; 5 carlisle rd; westford, MA 01886
• MDR Report Key: 23026091
• Report Number: 3021199089-2025-00012
• Device Sequence Number: 9819843
• Product Code: GEI
• UDI-Device Identifier: 08809447657981
• UDI-Public: 08809447657981
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K251327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/11/2025

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
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female