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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2025
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 broken at the distal end.Fse states, "fiber broken at distal end can indicate it was bent or pulled by the operator." to resolve the issue, fse replaced the fiber and confirmed laser was working within specification.Fse also instructed site on fiber handling precautions to avoid future damage.This is a device malfunction since the damaged fiber caused an accidental radiation occurrence (aro) and therefore reportable.
Event or Problem Description
Site reported elite+ was producing more energy than expected.On aug 13, 2025 site relayed to cynosure clinical that when they went to check the handpiece, the handpiece was pointed at the ground and it fired from the back of the handpiece where wire was broken.Although operator's glove was burned, operator did not experience an injury.

• 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: 22853156
• Report Number: 1222993-2025-00027
• Device Sequence Number: 18257138
• Product Code: GEX
• UDI-Device Identifier: 00841494100063
• UDI-Public: (01)00841494100063(11)230614
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/20/2025

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: 105-7018-000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2023
• 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: Unknown