MAUDE Adverse Event Report: CYNOSURE LLC PICOSURE

Catalog Number	105-7012-000
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
Additional Manufacturer Narrative
There was no additional information provided by the customer site despite multiple requests from cynosure clinical for patient-treatment details.The device history record confirms that the product passed and met all requirements before releasing.Cynosure field site engineer (fse) arrived at site and evaluated the device.Cynosure fse reports arm on the output shutter was bent and allowed the system to fire externally without faulting.To resolve the issue, cynosure fse replaced the output shutter.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
It was reported that the picosure device was firing continuously without operator touching the foot pedal.

• 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: 19929028
• Report Number: 1222993-2024-00042
• Device Sequence Number: 8082711
• Product Code: GEX
• UDI-Device Identifier: 00841494100001
• UDI-Public: (01)00841494100001(11)170328
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/07/2024

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: 105-7012-000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2024
• Initial Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2017
• 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