MAUDE Adverse Event Report: CYNOSURE LLC PICOSURE PRO

Catalog Number	105-7051-000
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
Event or Problem Description
Site contacted cynosure lutronic technical support for assistance with a lamp warning message on the picosure pro device.Site then relayed to technical support that a week ago, the device would not stop firing even after operator took her foot off the pedal.
Additional Manufacturer Narrative
Cynosure clinical determined that no patient injury had occurred.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 confirmed system needed a lamp change and replaced the lamps, o-ring, and ran calibration.Footswitch was checked and fse cleaned the connection on 5mm handpiece.Fse concludes system is working within published specification and ready for use again.Based on the site's report of an unintended discharge of laser energy, this event is considered an accidental radiation occurrence (aro) and represents a device malfunction that is reportable under 21 cfr part 803 in accordance with u.S.Food and drug administration mdr requirements.

• 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
• MDR Report Key: 25081191
• Report Number: 1222993-2026-00026
• Device Sequence Number: 10306595
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/05/2026

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: 105-7051-000
• 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: 04/11/2026
• Initial Report FDA Received Date: 05/05/2026
• 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