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
It was reported that site had encountered f152 communication fault errors while using picosure pro and that the foot pedal would fire even after foot was off the pedal.Error with 1064nm handpiece (hp) was showing too high or too low energy, with site having to recalibrate it multiple times for it to operate.Error with 755nm zoom hp had the screen glitching and required site to recalibrate and restart repeatedly.Error with 532nm hp needed to be recalibrated 10 times before site was able to use it.
Additional Manufacturer Narrative
Cynosure lutronic technology (clt) clinical team contacted the site to investigate the event.Clt clinical determined the event to be inconclusive since root cause is unknown at this time.Site confirmed that no injuries had occurred.The appearance of the error message is an expected system response that prevents further operation of the device and informs the user to seek assistance from technical support/service.A device evaluation has not yet been scheduled.When the device has been evaluated, an investigation will be updated as needed.Although a device evaluation has not yet been completed, review of the device history record confirms that the product passed and met all requirements before releasing.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: 25472404
• Report Number: 1222993-2026-00043
• Device Sequence Number: 13245079
• Product Code: GEX
• UDI-Device Identifier: 00841494100537
• UDI-Public: (01)00841494100537(11)220610
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/11/2026

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: 05/15/2026
• Initial Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2022
• 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