MAUDE Adverse Event Report: LUTRONIC CORPORATION XERF

Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A trained cynosure lutronic field service engineer (fse) went to the treatment provider site for a device evaluation.During this time, the device calibration was tested and found to be working within published specifications.However, customer provided images of the first effector tip that was used observed visual damage.It is undetermined what caused this damage.The tip was requested for additional evaluation, however, has not been returned.A member of the cynosure lutronic clinical team made contact with the treatment provider and determined that the treatment parameters used for both effector tips were within the normal ranges outlined in the quickstart guide (qsg).The patient was evaluated by the treatment clinic's medical director and received preventative treatment, it was confirmed that the patient has recovered following treatment.As a precaution to reduce the probability of reoccurrence, the importance of post treatment care and clinical guidelines were reviewed carefully with the treatment provider.At this time, it is unknown what contributed to the reported malfunction and burning observed damage to the effector tip that was 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.The event is reportable per fda medical device reporting title 21 cfr part 803 since a malfunctioned occurred and would likely cause or contribute to a serious injury if the malfunction were to recur.
Event or Problem Description
It was reported that during treatment, after approximately 450 pulses the device released an unexpected sound and spark from the effector tip.The treatment was interrupted and a burn mark on the edge of the effector tip was observed where the spark was reported to have occurred causing a reported burn on the patients skin.The effector was replaced and treatment continued.

• Brand Name: XERF
• Common Device Name: ERF
• 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: 24332414
• Report Number: 3021199089-2026-00006
• Device Sequence Number: 18589657
• Product Code: GEX
• UDI-Device Identifier: 08809447657981
• UDI-Public: 08809447657981
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K050254
• 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): 02/13/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/13/2026
• 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
• Patient Age: 43 YR
• Patient Sex: Female