MAUDE Adverse Event Report: LUTRONIC CORPORATION CLARITY II LASER SYSTEM; POWERED LASER SURGICAL INSTRUMENT

Model Number	CLARITY II
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	08/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Field service engineer evaluated the device.Functional tests were performed but the issue could not be replicated.An o-ring was replaced as part of preventative maintenance.The patient received a minor burn which is an expected side effect of a laser treatment.Therefore it is not considered a serious injury.This report is being submitted as a malfunction report due to the possibility of recurrence.
Event or Problem Description
Patient was being treated for laser hair removal on her chin with 1064nm ndyag laser.While laser was firing, cryogen function stopped firing.This resulted in minor 1st degree thermal burn and was treated with silvadene cream.

• Brand Name: CLARITY II LASER SYSTEM
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUTRONIC CORPORATION; 219 sowon-ro, deogyang-gu; goyang-si, geonggi-do 10534 ; KS 10534
• Manufacturer (Section G): LUTRONIC CORPORATION; 219 sowon-ro; deogyang-gu; goyang-si, geonggi-do 10534 ; KS 10534
• Manufacturer Contact: haewon park ; 19 fortune dr.; billerica, MA 01821 ; 8885887644
• MDR Report Key: 15472808
• Report Number: 3021199089-2022-00002
• Device Sequence Number: 11471192
• Product Code: GEX
• UDI-Device Identifier: 08809447652542
• UDI-Public: (01)08809447652542
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Modification/Adjustment,Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 09/22/2022

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: Health Professional
• Device Model Number: CLARITY II
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2022
• Initial Report FDA Received Date: 09/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American