MAUDE Adverse Event Report: CYNOSURE LLC VECTUS

Catalog Number	105-3500-000
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	10/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record confirms that the product passed and met all requirements before releasing.Cynosure clinical reached out to the site and confirmed user error was involved.Provider inadvertently pulsed the laser near the edge of a tattoo, which resulted in an immediate thermal injury.Labeling instructs that treatment should not be performed within one (1) inch of, or directly on, any tattoo or permanent makeup to prevent skin damage and color changes, including the rare complication of paradoxical darkening.The guide also recommends covering the tattoo or permanent makeup with a moistened tongue depressor to block laser exposure if treatment is performed nearby.Cynosure medical director reviewed the incident and confirmed that patient had a full thickness injury with loss of epidermis, and epidermis exposed underlying subcutaneous tissue.Cynosure medical director states, "this should be kept clean and mildly moist with dressing changes 2 x day.A thin layer of aquaphor could be helpful.The wound will close slowly by secondary intention.There will likely be a scar.Once that is closed, apply topical scar treatment with silicone gel and massage." following up with a burn specialist was also recommended.The correct treatment technique, along with the medical director's recommendations have been reinforced with the site to prevent recurrence of similar incidents in the future.Burns are an expected side effect from such treatment.Since a full thickness burn occurred from this event, this is considered a serious injury and therefore reportable.
Event or Problem Description
Site reported provider accidentally lasered patient's tattoo on the leg during a laser hair removal treatment using vectus.

• Brand Name: VECTUS
• Common Device Name: VECTUS
• Manufacturer (Section D): CYNOSURE LLC; 5 carlisle road; westford MA 01886
• Manufacturer Contact: nirav desai ; 5 carlisle road; westford, MA 01886 ; 9783940763
• MDR Report Key: 23555064
• Report Number: 1222993-2025-00057
• Device Sequence Number: 10160305
• Product Code: GEX
• UDI-Device Identifier: 00841494100124
• UDI-Public: (01)00841494100124(11)180205
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K120622
• 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): 11/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Catalogue Number: 105-3500-000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/21/2018
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female