MAUDE Adverse Event Report: LUTRONIC CORPORATION CLARITY II

Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on (b)(6) 2026 that during training on (b)(6) 2026 cryogen started spilling from the handpiece resulting in a raised red patch on the leg.A trained cynosure lutronic field service engineer (fse) went to the customer site for a device evaluation.During this time, the reported issue was observed.The nozzle inside the handpiece was found to be loose and was tightened to correct the issue.It is undetermined how this nozzle became loose.After the nozzle was tightened, the device pressure was tested with passing results.A member of the cynosure lutronic clinical was originally told by the treatment site that the patient (who was reported to be a staff member) "had a blister on the treatment area but is fine".Additional contact attempts to the treatment site were made to obtain information about how the patient was healing as well as requesting additional photos of healing, however, these information requests went unanswered.Images of the blister were not provided for evaluation.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.

• Brand Name: CLARITY II
• Common Device Name: CLARITY II
• Manufacturer (Section D): LUTRONIC CORPORATION; lutronic center; 219 sowon-ro; deogyang-gu,, goyang-si 10534 ; KS 10534
• MDR Report Key: 24403338
• Report Number: 1222993-2026-00009
• Device Sequence Number: 18198757
• Product Code: GEX
• UDI-Device Identifier: 08809447653723
• UDI-Public: (01)08809447653723(11)251202
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/20/2026
• Report Date (Section F): 02/20/2026

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/21/2026
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 01/21/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/20/2026
• 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: 02/20/2026