MAUDE Adverse Event Report: LUTRONIC CORPORATION CLARITY II

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
Additional Manufacturer Narrative
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.
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.

• Brand Name: CLARITY II
• Common Device Name: LARITY II
• 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 rd; westford, MA 01886
• MDR Report Key: 24208953
• Report Number: 3021199089-2026-00004
• Device Sequence Number: 17520207
• Product Code: GEX
• UDI-Device Identifier: 08809447653723
• UDI-Public: 08809447653723
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K183566
• 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
• Type of Report: Initial
• Report Date (Section B): 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
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/29/2026
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown