MAUDE Adverse Event Report: CYNOSURE LLC VECTUS

Model Number	105-3500-000
Medical Device Problem Code	Unexpected/Unintended Radiation Output (4028)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Site confirmed there was no patient injury involved.Service was unable to duplicate issue.The device history record confirms that the product passed, and met all requirements before releasing.Due to the site reporting the device firing on its own, this event is an aro (accidental radiation occurrence), and therefore, reportable.
Event or Problem Description
Customer reported that the device's handpiece fired on its own.No foot pedal was plugged in.

• Brand Name: VECTUS
• Common Device Name: VECTUS
• Manufacturer (Section D): CYNOSURE LLC; 5 carlisle road; westford MA 01886
• MDR Report Key: 10690818
• Report Number: 1222993-2020-00018
• Device Sequence Number: 304019
• Product Code: GEX
• UDI-Device Identifier: 00841494100124
• UDI-Public: (01)00841494100124(11)180117
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: K120622
• 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): 10/16/2020

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: 105-3500-000
• Device Catalogue Number: 105-3500-000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2020
• Initial Report FDA Received Date: 10/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1