MAUDE Adverse Event Report: LUTRONIC CORPORATION DERMAV

Catalog Number	1011600210
Medical Device Problem Code	Unexpected/Unintended Radiation Output (4028)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while provider was using the intellitrak, the handpiece was lifted off the tissue and went to the next row.It was confirmed that there was no patient or provider injury.A trained cynosure lutronic field service engineer (fse) went to the customer site for device evaluation.During this time, the reported issue of intermittent misfiring was verified.The intillitrak tip was found to be defective and to correct the issue a new tip was ordered for the customer.This event is a reportable event since this is an aro (accidental radiation occurrence) due to device firing unintentionally on its own.

• Brand Name: DERMAV
• Common Device Name: DERMAV
• Manufacturer (Section D): LUTRONIC CORPORATION; lutronic center; 219 sowon-ro; deogyang-gu, goyang-si 10534 ; KS 10534
• MDR Report Key: 22954452
• Report Number: 1222993-2025-00032
• Device Sequence Number: 8453736
• Product Code: GEX
• UDI-Device Identifier: 08809447655277
• UDI-Public: 8809447655277
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/03/2025
• Report Date (Section F): 09/03/2025

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
• Device Catalogue Number: 1011600210
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/06/2025
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 09/03/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/03/2025
• 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: 09/03/2025