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	07/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer site complained of unintended discharges of energy coming from the device's handpiece during startup.Device was examined, bent shutter observed.Shutter was replaced and laser has been checked with no errors.There was no patient injury involved in this incident.Picosure's operator manual states, "all personnel in the treatment room, including patient, will wear protective eyewear to prevent eye damage from this intense light." warnings from the om includes: "always wear the appropriate protective eyewear.Failure to wear the appropriate protective eyewear can result in serious eye injury." this event is an aro (accidental radiation occurrence) because of the alleged complaint of unintended discharge of laser energy.
Event or Problem Description
The device's handpiece discharged unintended energy during start up.

• Brand Name: PICOSURE
• Common Device Name: PICOSURE
• Manufacturer (Section D): CYNOSURE LLC; 5 carlisle road; westford MA 01886
• MDR Report Key: 8830875
• Report Number: 1222993-2019-00013
• Device Sequence Number: 2588110
• Product Code: GEX
• UDI-Device Identifier: 00841494100001
• UDI-Public: (01)00841494100001(11)170511
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K160480
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/26/2019

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: No Information
• Device Model Number: 100-7012-010
• Device Catalogue Number: 105-7012-000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2019
• Initial Report FDA Received Date: 07/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1