MAUDE Adverse Event Report: CYNOSURE LLC PICOSURE PRO

Catalog Number	105-7051-010
Medical Device Problem Code	Unexpected/Unintended Radiation Output (4028)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No injury was reported.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.Fse found the device on the foot pedal cord.Fse explains that this caused the foot pedal to malfunction.Logs were reviewed and it confirmed the system was unable to detect all handpieces due to foot pedal being pressed.During test fire, there was no error code and all hand pieces connected without any issues.Due to the site reporting unintended discharges of laser energy, this event is an aro (accidental radiation occurrence) and therefore reportable.
Event or Problem Description
Site reported picosure pro was firing laser for a few seconds even after foot pedal was released.Device rebooted itself and atleast five (5) error messages appeared.Site then shut down the device manually and waited a few minutes before turning it on again.The device then could not recognize any of the handpieces.Site restarted the device again and was now working but still reported issues with foot pedal firing continuously.

• Brand Name: PICOSURE PRO
• Common Device Name: PICOSURE PRO
• 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: 22580097
• Report Number: 1222993-2025-00016
• Device Sequence Number: 7232916
• Product Code: GEX
• UDI-Device Identifier: 00841494100537
• UDI-Public: (01)00841494100537(11)230601
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K210226
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 07/23/2025

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
• Operator of Device: Other
• Device Catalogue Number: 105-7051-010
• 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: 06/23/2025
• Initial Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2023
• 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