MAUDE Adverse Event Report: LUTRONIC CORPORATION CLARITY II; Powered laser surgical instrument

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
The customer reported that when using clarity ii device foot pedal, the device began firing continuously from the hand piece.The device had to be shut down to stop the hand piece from firing.It was reported that there were no injuries that occurred during this incident.There was no injury reported associated with this incident.The clinical team made multiple contact attempts to obtain additional info about the reported event, including patient details as well as treatment and parameter details, however, these information requests went unanswered.A trained field service engineer went to the customer site for evaluation.During this time the reported issue of continuous firing was duplicated.To correct this issue, the device firmware was updated and the hand piece had the ferrite grounding coil installed.The field service engineer recommended the customer replace this hand piece with an updated and ground hand piece version.When the repairs were complete, the device was tested and passed all energy and functional tests as expected.

• Brand Name: CLARITY II
• Common Device Name: Powered laser surgical instrument
• 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 carlisle road; westofrd, MA 01886 ; 9783940763
• MDR Report Key: 21333929
• Report Number: 3021199089-2025-00001
• Device Sequence Number: 3772317
• Product Code: GEX
• UDI-Device Identifier: 08809447652610
• UDI-Public: 08809447652610
• 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: User Facility
• Initial Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 02/07/2025

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
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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