MAUDE Adverse Event Report: CYNOSURE ELITE+

Model Number	100-7018-010
Medical Device Problem Code	Unexpected/Unintended Radiation Output (4028)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Technician visited the customer site to evaluate the device and determined that the rear panel interconnect board required replacement.So to resolve the customer's device issue, the technician performed the replacement on the device.To ensure that the device was operating without any further issues, technician performed a demonstration for the customer to show that the handpiece's trigger button was operating as intended.The energy output was verified to be operating within specification.There was no patient injury related to this event.This event is reportable as an accidental radiation occurrence (aro) due to the device's unintended discharge of energy.
Event or Problem Description
The device's handpiece continued to discharge energy after releasing the trigger button.

• Brand Name: ELITE+
• Common Device Name: ELITE+
• Manufacturer (Section D): CYNOSURE; 5 carlisle road; westford MA 01886
• MDR Report Key: 8564971
• Report Number: 1222993-2019-00007
• Device Sequence Number: 2349848
• Product Code: GEX
• UDI-Device Identifier: 00841494100063
• UDI-Public: (01)00841494100063(11)180402
• 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: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/30/2019

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: 100-7018-010
• Device Catalogue Number: 105-7018-000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2018
• Initial Report FDA Received Date: 04/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1