MAUDE Adverse Event Report: LUTRONIC CORPORATION CLARITY II

Catalog Number	1110200230
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Cryogenic Burn (4539)
Date of Event	12/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a while conducting training a clarity ii device was continuously spraying cryogen.The patient was reportedly burned by the cryogen.A trained cynosure lutronic field service engineer (fse) went to the customer site for a device evaluation.During this time, the fse observed the reported icd leak.To correct the issue the fse replaced the handpiece and completed all required verifications.The reported icd leak issue was corrected.A member of the cynosure lutronic clinical team made multiple contact attempts to inquire on how the patient was healing, however, there was no additional information provided.Since a device malfunction occurred, we are reporting this event.

• 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: 24215809
• Report Number: 1222993-2026-00005
• Device Sequence Number: 21173995
• Product Code: GEX
• UDI-Device Identifier: 08809447653723
• UDI-Public: (01)08809447653723(11)250522
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 01/29/2026
• Report Date (Section F): 01/29/2026

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: 1110200230
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/31/2025
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 01/29/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/29/2026
• 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: 01/29/2026