MAUDE Adverse Event Report: CYNOSURE LLC PICOSURE

Model Number	100-7012-010
Medical Device Problem Code	Unexpected/Unintended Radiation Output (4028)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient impact involved in this event.During device evaluation, technician was able to duplicate the reported issue.While in ready mode, laser displayed a warning message.Technician further evaluated the device and found that the air switch on i/o board was over-sensitive.A new i/o board was installed to resolve issue.Technician then performed functional check and confirmed laser was operating as intended after replacing i/o board.The device history record confirms that the product passed and met all requirements before releasing.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
The customer reported that the picosure handpiece had continued to deliver an unintended discharge of laser energy after the trigger button was released.

• Brand Name: PICOSURE
• Common Device Name: PICOSURE
• Manufacturer (Section D): CYNOSURE LLC; 5 carlisle road; westford, ma
• MDR Report Key: 9889673
• Report Number: 1222993-2020-00013
• Device Sequence Number: 2910375
• Product Code: GEX
• UDI-Device Identifier: 00841494100001
• UDI-Public: (01)00841494100001(11)190610
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K173199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/27/2020

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: 100-7012-010
• Device Catalogue Number: 100-7012-010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2020
• Initial Report FDA Received Date: 03/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1