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	10/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The technician addressed the issue by evaluating the device error logs and reviewing system operations.The vectus handpiece's fiber cable and di filter components were replaced to resolve the device's issue.Routine system maintenance, calibration, verification of shutter functions, and output checks were then performed to confirm that device was 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.
Additional Manufacturer Narrative
The technician addressed the issue by evaluating the device error logs and reviewing system operations.The elite+ handpiece's fiber cable and di filter components were replaced to resolve the customer's issue with the device.Routine system maintenance, calibration, verification of shutter functions, and output checks were then performed to confirm that device was 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.

• Brand Name: ELITE+
• Common Device Name: ELITE+
• Manufacturer (Section D): CYNOSURE; 5 carlisle road; westford MA 01886
• MDR Report Key: 8117728
• Report Number: 1222993-2018-00030
• Device Sequence Number: 268032
• 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,Followup
• Report Date (Section B): 11/29/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2018
• Supplement Date Received by Manufacturer: 10/31/2018
• Initial Report FDA Received Date: 11/29/2018
• Supplement Report FDA Received Date: 12/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1