MAUDE Adverse Event Report: CYNOSURE LLC ELITE+

Model Number	100-7018-010
Medical Device Problem Code	Radiation Underexposure (3018)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient injury was reported.During a device evaluation, technician observed damages on the optics and confirmed that the energy was low and greater than 20% outside of specification.Device will be repaired.Since the energy was confirmed to be outside of the specification, this event is an aro (accidental radiation occurrence) and therefore reportable.
Event or Problem Description
It was reported that the handpiece was recalibrating continuously, and upon inspection device was found to be out of specification.

• Brand Name: ELITE+
• Common Device Name: ELITE+
• Manufacturer (Section D): CYNOSURE LLC; 5 carlisle road; westford MA 01886
• MDR Report Key: 11140049
• Report Number: 1222993-2021-00001
• Device Sequence Number: 11687086
• Product Code: GEX
• UDI-Device Identifier: 00841494100063
• UDI-Public: (01)00841494100063(11)181114
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: 141425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/08/2021

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: Other
• Device Model Number: 100-7018-010
• Device Catalogue Number: 105-7018-000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2020
• Initial Report FDA Received Date: 01/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1