MAUDE Adverse Event Report: CYNOSURE, INC. DBA ELLMAN SURGITRON 4.0 DUAL RF S5 IEC

Catalog Number	IEC5P-ST (MOD2)
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	01/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Following the rf procedure, the patient visited the er for post treatment care and was evaluated by a specialist.The specialist concluded that there was no retinal damage found or any vision loss, rather the patient just had blurred vision.There was no medication prescribed by the specialist and indicated the patient's condition should improve within a timeframe of 2 weeks - 6 months.Patient does not have a pre-existing history of eye related issues.There is no permanent injury anticipated from this incident as the specialist had not seen any signs of retinal eye damage and expected a recovery for the patient.It was deemed inconclusive as to how the patient experienced this impact.
Event or Problem Description
Patient had blurred vision following an rf treatment procedure on the face.

• Brand Name: SURGITRON 4.0 DUAL RF S5 IEC
• Common Device Name: SURGITRON 4.0 DUAL RF S5 IEC
• Manufacturer (Section D): CYNOSURE, INC. DBA ELLMAN; 400 karin lane; hicksville NY 11801
• MDR Report Key: 7267649
• Report Number: 2428235-2018-00001
• Device Sequence Number: 1917668
• Product Code: GEI
• UDI-Device Identifier: 00841494106706
• UDI-Public: (01)00841494106706(11)170424
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K123366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/13/2018

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 Catalogue Number: IEC5P-ST (MOD2)
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2018
• Initial Report FDA Received Date: 02/13/2018
• 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
• Patient Age: 45 YR