MAUDE Adverse Event Report: LUTRONIC CORPORATION CLARITY II

Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Unexpected/Unintended Radiation Output (4028)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Site reported clarity ii's foot pedal is firing unintentionally and "the only way they can stop it is to turn the machine off." no injuries were reported.Cynosure field service engineer (fse) arrived at site and evaluated the device.Fse was able to duplicate the continuous misfiring.Fse states, "the unit has out of date firmware and does not have a ferrite coil or grounded handpiece assembly." to resolve the reported issue, fse replaced the handpiece with proper ground version, added a ferrite coil and performed the necessary firmware updates.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
• MDR Report Key: 21334192
• Report Number: 1222993-2025-00001
• Device Sequence Number: 3772323
• Product Code: GEX
• UDI-Device Identifier: 08809447652610
• UDI-Public: 08809447652610
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/07/2025
• Report Date (Section F): 02/06/2025

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
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/08/2025
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 02/05/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/07/2025
• 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: 02/06/2025