MAUDE Adverse Event Report: CYNOSURE LLC ELITE+

Catalog Number	100-7018-010
Medical Device Problem Code	Unexpected/Unintended Radiation Output (4028)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2026
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 at site and evaluated the device.The engineer was not able to duplicate the reported issue.However, he completed a thorough device inspection and evaluation and found that the cable fiber had a damage but the site had attached a new fiber.The device was also subjected to a full device evaluation including full functionality testing with passing results.The energy levels and settings were checked and verified to be working within its specifications, and the device was determined to be functioning as intended.A member of the cynosure clinical team followed up with the treatment provider and confirmed that there was no patient injury.It is unknown what exactly contributed to the reported spark and accidental laser output.Based on the site's report of an unintended discharge of laser energy, this event is considered an accidental radiation.Occurrence (aro) and represents a device malfunction that is reportable under 21 cfr part 803 in accordance with u.S.Food and drug administration mdr requirements.
Event or Problem Description
It was reported that an elite+ cable was sparking and producing popping sounds while firing laser on its own during treatment.No patient injury was reported.

• 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
• MDR Report Key: 25450491
• Report Number: 1222993-2026-00036
• Device Sequence Number: 18310259
• Product Code: GEX
• UDI-Device Identifier: 00841494100063
• UDI-Public: (01)00841494100063(11)230615
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/15/2026

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: Health Professional
• Device Catalogue Number: 100-7018-010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2023
• 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