MAUDE Adverse Event Report: CYNOSURE LLC PICOSURE

Catalog Number	100-7012-010
Medical Device Problem Code	Unexpected/Unintended Radiation Output (4028)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No injuries were reported.The device history record was also reviewed and confirmed passing and meeting all requirements prior to release.Cynosure field site engineer (fse) arrived on site and evaluated the device.Fse confirmed device had a broken output shutter.To resolve the issue, a replacement output shutter was ordered.Due to the site reporting an unintended discharge of laser energy, this event is an aro (accidental radiation occurrence) and therefore reportable.
Event or Problem Description
Site reported picosure laser firing without operator stepping on the footswitch.

• Brand Name: PICOSURE
• Common Device Name: PICOSURE
• 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: 23015574
• Report Number: 1222993-2025-00034
• Device Sequence Number: 18598183
• Product Code: GEX
• UDI-Device Identifier: 00841494100001
• UDI-Public: (01)00841494100001(11)161215
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/10/2025

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: 100-7012-010
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2016
• 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