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	08/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No injuries were reported.Cynosure field site engineer (fse) arrived on site and evaluated the device.Fse was unable to duplicate the reported issue.Fse also tried to use different intellitrak tips with the laser, but spot sizes couldn't be recognized, and tips cannot be used.Fse relayed to cynosure tech support that the handpiece need to be replaced.Due to the site reporting an unintended discharge of laser energy, this event is an aro (accidental radiation occurrence) and therefore reportable.
Event or Problem Description
It was reported that the dermav would continue to fire after provider lifted handpiece off the patient.Site tried to change the tips, but still experiencing the same issue.

• Brand Name: DERMAV
• Common Device Name: DERMAV
• 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 ; 5 carlisle road; westford,, MA 01886
• MDR Report Key: 22922424
• Report Number: 3021199089-2025-00013
• Device Sequence Number: 21430056
• Product Code: GEX
• UDI-Device Identifier: 08809447655277
• UDI-Public: 8809447655277
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K203788
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/29/2025

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: 1011600210
• 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: 08/29/2025
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown