MAUDE Adverse Event Report: CYNOSURE LLC ICON

Model Number	105-2500-000
Medical Device Problem Code	Unexpected/Unintended Radiation Output (4028)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient injury was involved.The device history record confirms that the product passed and met all requirements before releasing.Upon evaluation it was determined that the footswitch hose at rear system connection was damaged.Technician resolved the issue by removing the damaged portion of the hose.Due to the site reporting the device releasing radiation after foot was released from the foot pedal, this event is an aro (accidental radiation occurrence) and therefore reportable.
Event or Problem Description
It was reported that icon released 4 extra pulses of radiation after the user released their foot off the foot pedal.

• Brand Name: ICON
• Common Device Name: ICON
• Manufacturer (Section D): CYNOSURE LLC; 5 carlisle road; westford MA 01886
• MDR Report Key: 11423870
• Report Number: 1222993-2021-00006
• Device Sequence Number: 3243539
• Product Code: GEX
• UDI-Device Identifier: 00841494100018
• UDI-Public: (01)00841494100018(11)170920
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Type of Report: Initial
• Report Date (Section B): 03/05/2021

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 Model Number: 105-2500-000
• Device Catalogue Number: 105-2500-000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 03/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1