MAUDE Adverse Event Report: CYNOSURE LUTRONIC TECHNOLOGY CORPORATION DERMAV

Catalog Number	1011600210
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a red flash and loud noise occurred during 1064nm vascular treatment using dermav.Spark and soot were noted.Cynosure lutronic technology (clt) clinical team contacted the site to investigate the event.Site informed clt clinical that the patient experienced a burn.Although additional information was requested, there was no additional information made available from the customer site despite multiple requests from clinical.Burns are an expected side effect from such treatment.A trained cynosure field service engineer (fse) went to the site to perform a device evaluation.Fse checked the energy output on both 1064 and 532 wavelengths, confirming they were within specifications and in normal range.Burn shots also appeared normal.Fse then verified all settings and tested the unit thoroughly with no issues found.This event is reportable under fda medical device reporting requirements (21 cfr part 803), as it involves an observed device malfunction that could potentially cause or contribute to a serious injury if the issue were to recur.

• Brand Name: DERMAV
• Common Device Name: DERMAV
• Manufacturer (Section D): CYNOSURE LUTRONIC TECHNOLOGY CORPORATION; 219 sowon-ro; deogyang-gu, goyang-si 10534 ; KS 10534
• MDR Report Key: 25446585
• Report Number: 1222993-2026-00042
• Device Sequence Number: 15856534
• Product Code: GEX
• UDI-Device Identifier: 08800291820200
• UDI-Public: (01)08800291820200(11)241015
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 06/09/2026
• Report Date (Section F): 06/09/2026

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/13/2026
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 06/09/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/09/2026
• 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: 06/09/2026