MAUDE Adverse Event Report: LUTRONIC CORPORATION CLARITY II

Catalog Number	1100200230
Medical Device Problem Code	Continuous Firing (1123)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a preventative maintenance visit onsite, cynosure field service engineer observed continuous firing with clarity ii.No injuries were reported.
Additional Manufacturer Narrative
To correct the observed continuous firing issue the ferrite coil assembly was updated, the hp was replaced and the software was updated to gui version 1.09, system to version 1.08a, mfc to version 1.04 and hp to version 1.05 with replacement of hp assembly.Following required repairs and updates, the device was found to be working within published specifications.This event is reportable since this is an aro (accidental radiation occurrence) due to device firing unintentionally on its own.

• 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
• Manufacturer (Section G): LUTRONIC CORPORATION; lutronic center; 219 sowon-ro; deogyang-gu, goyang-si 10534 ; KS 10534
• Manufacturer Contact: nirav desai ; 3/5 carlise rd; westford, MA 01886 ; 9783940763
• MDR Report Key: 22195251
• Report Number: 3021199089-2025-00004
• Device Sequence Number: 9244224
• Product Code: GEX
• UDI-Device Identifier: 08809447652542
• UDI-Public: 08809447652542
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 06/12/2025

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: 1100200230
• 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: 06/12/2025
• 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
• Patient Sex: Unknown