MAUDE Adverse Event Report: CYNOSURE LLC ICON

Catalog Number	105-2500-000
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Cynosure clinical team contacted the site to investigate the event.Cynosure clinical confirmed that no injury had occurred.Site also informed cynosure clinical they were using the icon max g handpiece when the issue occurred.Maxg is a ipl handpiece and not a laser based handpiece.Although it was firing continuously, this is not an accidental radiation occurrence (aro) since it is not a laser-based handpiece.A trained cynosure field service engineer (fse) went to the site to perform a device evaluation.Fse verified the error happening.Fse replaced the foot pedal and air switch and then calibrated the handpiece and tested the system.Functional checks and energy tests were performed.Site confirming the device is working properly now.The event is reportable per fda medical device reporting title 21 cfr part 803 since an observed malfunction occurred and could likely cause or contribute to a serious injury if the malfunction were to recur.
Event or Problem Description
It was reported that the icon foot pedal continued to fire even without operator pressing it.No patient injury was reported.

• Brand Name: ICON
• Common Device Name: ICON
• Manufacturer (Section D): CYNOSURE LLC; 5 carlisle road; westford MA 01886
• Manufacturer Contact: nirav desai ; 5 carlisle road; westford, MA 01886
• MDR Report Key: 25364937
• Report Number: 1222993-2026-00049
• Device Sequence Number: 10654608
• Product Code: GEX
• UDI-Device Identifier: 00841494100018
• UDI-Public: (01)00841494100018(11)190813
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K142376
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/02/2026

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: 105-2500-000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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