MAUDE Adverse Event Report: LUTRONIC CORPORATION XERF

Catalog Number	1101300310
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	03/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On 3/18/2026 a trained cynosure lutronic field service engineer went to the treatment clinic for a device evaluation.During this time the device was subjected to full functionality testing, verified device set up and confirmed power measurement.The device was found to be working within published specifications.Visual inspection of the effector tip used during treatment observed a small black dot on the tips surface, which was reported to not be present prior to treatment.An image was taken of this damage, and its location suggests carbonization occurred at the ntc line tip lot and manufacturing date was checked and it was confirmed to be produced before the implementation of the resistance inspection that was completed in september 2025.Once the tip has been returned and evaluated, root cause can be better verified.A member of the cynosure lutronic clinical team contacted the treatment clinic for additional information.It was determined that the treatment parameters used were within the recommended clinical guidelines of the quickstart guide (qsg).It is undetermined what caused the reported burning, it is possible that the effector tip may not have had full contact with the treatment area when the burn occurred, though this cannot be confirmed.Burning is an expected side effect from treatment.The event is reportable per fda medical device reporting title 21 cfr part 803 since a malfunction occurred and would likely cause or contribute to a serious injury if the malfunction were to recur.We are reporting this as an initial mdr and will submit a final mdr once investigation has been completed.
Event or Problem Description
It was reported that a patient experienced a burn on the face during treatment performed on (b)(6) 2026 with a xerf device.

• 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 road; westford, MA 01886
• MDR Report Key: 24781378
• Report Number: 3021199089-2026-00019
• Device Sequence Number: 9935456
• Product Code: GEI
• UDI-Device Identifier: 08809447657981
• UDI-Public: (01)08809447657981(11)250429
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/03/2026

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
• Device Catalogue Number: 1101300310
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2025
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 31 YR
• Patient Sex: Female