MAUDE Adverse Event Report: CYNOSURE LLC PICOSURE PRO

Model Number	100-7051-010
Medical Device Problem Code	Radiation Output Problem (4026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the picosure was continuously firing during treatment.
Additional Manufacturer Narrative
No patient injury was reported.The device history record confirms that the product passed and met all requirements before releasing.Upon device evaluation, it was determined that the foot pedal hose was pinched and blocked by chair wheels or machine while treatment was performed.Foot pedal is worked by air and when the operator released the pedal, the device continued to fire since the hose was pinched.Due to the site reporting an unintended discharge of laser energy, this event is an aro (accidental radiation occurrence) and therefore reportable.

• Brand Name: PICOSURE PRO
• Common Device Name: PICOSURE PRO
• Manufacturer (Section D): CYNOSURE LLC; 5 carlisle road; westford MA 01886
• Manufacturer Contact: kelli pennie ; 5 carlisle road; westford, MA 01886 ; 9783672425
• MDR Report Key: 15536345
• Report Number: 1222993-2022-00036
• Device Sequence Number: 8132998
• Product Code: GEX
• UDI-Device Identifier: 00841494100537
• UDI-Public: (01)00841494100537(11)220520
• Combination Product (Y/N): Y
• 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): 10/04/2022

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 Model Number: 100-7051-010
• Device Catalogue Number: 105-7051-000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 10/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2022
• 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: Female