MAUDE Adverse Event Report: CYNOSURE LLC ELITE+

Model Number	100-7018-010
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	11/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Site reported that patient experienced a blister on the upper lip following a laser treatment using elite+.Topical ointments were prescribed to address patient's impacted area.During treatment, operator may have accidently switched from yag to alex and fired a single pulse to the upper lip on a patient who was skin type vi.Per labeling, alex treatment parameters are recommended for skin type i-iii and not recommended on tanned skin.The device was evaluated, and technician verified that the unit did not switch wavelengths without a request.Technician performed a variety of system tests with each test passing.Evaluation validated that the unit did not error or fault during testing.The device history record confirms that the product passed and met all requirements before releasing.Blisters are expected side effects from laser treatments, however this event is reportable because the patient received care from medical intervention of prescribed topical ointments.
Event or Problem Description
Patient required medical intervention following a laser procedure.

• Brand Name: ELITE+
• Common Device Name: ELITE+
• Manufacturer (Section D): CYNOSURE LLC; 5 carlisle road; westford MA 01886
• MDR Report Key: 9521572
• Report Number: 1222993-2019-00036
• Device Sequence Number: 458925
• Product Code: GEX
• UDI-Device Identifier: 00841494100063
• UDI-Public: (01)00841494100063(11)180301
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K141425
• 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): 12/26/2019

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: Other
• Device Model Number: 100-7018-010
• Device Catalogue Number: 105-7018-000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2019
• Initial Report FDA Received Date: 12/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other