MAUDE Adverse Event Report: CYNOSURE LLC ICON

Catalog Number	105-2500-000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	04/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer was contacted for additional details regarding this reported event, but would not provide any additional information to further review the incident.Icon is a delivery system that can be connected to multiple handpieces for various types of treatments.It is unknown which handpiece was used and what type of treatment was performed during the event.On 12 july 2021, cynosure field service engineer (fse) was contacted for an error 14 code displaying on icon.Error 14 is code for discrepancy with multiple handpieces.During evaluation, fse confirmed they could not calibrate the maxys handpiece since calibration port shroud was missing.To resolve the error code, fse contacted cynosure technical support (ts) for calibration port shroud replacement.It is unknown if the error 14 issue is related to the patient event.Root cause as to why the patient sustained a burn/scarring is unknown since there is insufficient information at this time.Cynosure will continue to monitor such complaints.Burns are an expected side effect from such treatment.As scarring post treatment was reported from the event, this is considered a permanent injury and therefore reportable.
Event or Problem Description
Cynosure legal received documents disclosing a lawsuit on (b)(6) 2025 regarding an event where a patient was burned following an icon treatment that was performed on (b)(6) 2021.Within the documents received, permanent scarring from burns were mentioned.Cynosure team reviewed its complaint database and no records of this event had been previously 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 ; 9783940763
• MDR Report Key: 21437804
• Report Number: 1222993-2025-00005
• Device Sequence Number: 19984469
• Product Code: GEX
• UDI-Device Identifier: 00841494100018
• UDI-Public: (01)00841494100018(11)170117
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K142376
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/21/2025

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: Health Professional
• Device Catalogue Number: 105-2500-000
• 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: 01/02/2025
• Initial Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2017
• 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: Disability
• Patient Sex: Unknown