MAUDE Adverse Event Report: LUTRONIC CORPORATION XERF 2.0

Catalog Number	1101300310
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	03/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient was burned during a test treatment with xerf.Xerf handpiece was also leaking icd out of the tip and cannisters were registering empty even when half full.On (b)(6) 2026, a trained cynosure lutronic field service engineer (fse) went to the site and performed a device evaluation.Fse observed device was connected to extended outlet adapter with multiple devices connected.Advised site to move device from adapter to a direct outlet connection.Fse then inspected the handpiece and did not find any damage visibly or internally.Fse inserted cryo into the device and saw it immediately leaking from the handpiece.To resolve the issue, fse replaced the handpiece.Fse notes that the client was not fully trained.A member of the cynosure lutronic clinical team contacted the site to further investigate the event.Site shared that the initial training scheduled for (b)(6) 2026 was not completed due to technical issues.A retraining session was completed on (b)(6) 2026.Although additional information was requested, there was no additional information made available from the customer site despite multiple requests from cynosure lutronic clinical.As a result, exact treatment settings remain unknown.Based on the limited information available, the cause of the reported side effect cannot be determined.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.

• 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
• MDR Report Key: 24844316
• Report Number: 1222993-2026-00022
• Device Sequence Number: 8946532
• Product Code: GEI
• UDI-Device Identifier: 08809447657981
• UDI-Public: (01)08809447657981(11)251203
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/10/2026
• Report Date (Section F): 04/10/2026

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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/13/2026
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/10/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/10/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/10/2026