MAUDE Adverse Event Report: CYNOSURE LLC ELITE+

Catalog Number	105-7018-000
Medical Device Problem Code	Unexpected/Unintended Radiation Output (4028)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record confirms that the product passed and met all requirements before releasing.Cynosure field service engineer (fse) arrived on site and evaluated the device.Fse confirmed fiber was damaged and found alex pump chamber out of specification.Fiber breakage was observed near the handpiece.Fse expressed, "fiber breakage appears to be a mechanical breakage, which can be caused by provider bending or pulling it." to resolve the issue, fse replaced the fiber and alex pump chamber.During initial complaint given, site had relayed that no injury had occurred.On (b)(6) 2025, provider shared that they experienced a burn on the lateral side of their neck from the spark that occurred.Although no photos were provided, the provider confirmed that the burn was minor and did not require medical intervention and has nearly fully healed.Cynosure clinical determined cause of event to be inconclusive.Per cynosure clinical "settings used for this treatment were 11 j/cm² and 40 ms, which fall below the recommended minimums in the guidelines.This may help explain the patient's report of not feeling any sensation at the beginning of the session." the clinical settings used in this case have been reviewed and discussed with the treatment provider to help improve outcomes in similar future cases.Due to provider changing the fiber on their own, it may have contributed to the damage on the fiber.This is a device malfunction since the damaged fiber caused an accidental radiation occurrence (aro) and therefore reportable.
Event or Problem Description
Site reported that the elite+ was not working so provider switched out the fiber from the 20mm handpiece.After switching the fiber, provider heard a pop and energy was shot towards her.

• Brand Name: ELITE+
• Common Device Name: ELITE+
• 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: 22794757
• Report Number: 1222993-2025-00023
• Device Sequence Number: 12833867
• Product Code: GEX
• UDI-Device Identifier: 00841494100063
• UDI-Public: (01)00841494100063(11)180824
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K141425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/13/2025

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: Health Professional
• Device Catalogue Number: 105-7018-000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2018
• 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
• Patient Sex: Female