MAUDE Adverse Event Report: LUTRONIC CORPORATION XERF 2.0

Catalog Number	F1101300330
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A member of the cynosure lutronic clinical team reached out to the site to investigate the event.Despite multiple attempts to obtain additional information, the site did not provide any additional information.Due to lack of communication with the site, cynosure lutronic clinical team could not provide clinical support.Xerf tip has not yet been returned for a device evaluation, but a photo was provided during initial communication.Surface damage was observed on the tip.Once tip has been returned and evaluated, a cynosure field service engineer (fse) will be able to identify root cause.The event is reportable per fda medical device reporting title 21 cfr part 803 since a malfunction occurred and could 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 sparking occurred on a patient face and patient felt "popping sensation" during a treatment using xerf 2.0.Treatment was immediately stopped and effector tip was replaced.Settings used for treatment included deep mode, cryo 1, level 6.

• Brand Name: XERF 2.0
• Common Device Name: XERF 2.0
• 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: 25116707
• Report Number: 3021199089-2026-00027
• Device Sequence Number: 10346915
• Product Code: GEI
• UDI-Device Identifier: 08809447657981
• UDI-Public: (01)08809447657981(11)250905
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K180945
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2026

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: Other
• Device Catalogue Number: F1101300330
• 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: 04/10/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/07/2026
• Supplement Report FDA Received Date: 06/26/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Female