MAUDE Adverse Event Report: CYNOSURE LLC PICOSURE

Model Number	100-7012-010
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Burn(s) (1757); Scar Tissue (2060); Skin Discoloration (2074)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient experienced a burn and hyperpigmentation on the leg following a treatment using picosure.
Additional Manufacturer Narrative
Blister was formed following patient's burn.Burn, hyperpigmentation and blisters are expected side effects.Clinical confirms user error was involved.Physician treated the patient with 2-3 passes using the flat optic.Per labeling: each area should be treated only once with tight interlocking, but not overlapping pulses.It was also noted that the device was displaying error message f402 which indicates energy out of range during treatment.The appearance of the error message is an expected system response that informs the user to seek assistance from technical support/service.Upon evaluation, device laser was found operating within specification.The device history record confirms that the product passed and met all requirements before releasing.During a two weeks post treatment follow up, a scar was observed.Due to the patient experiencing a permanent injury, this event is therefore reportable.

• Brand Name: PICOSURE
• Common Device Name: PICOSURE
• 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: 15099152
• Report Number: 1222993-2022-00031
• Device Sequence Number: 20190515
• Product Code: GEX
• UDI-Device Identifier: 00841494100001
• UDI-Public: (01)00841494100001(11)180730
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 100-7012-010
• Device Catalogue Number: 105-7012-000
• 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: 06/14/2022
• Initial Report FDA Received Date: 07/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2018
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male