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	Burn(s) (1757)
Date of Event	06/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical intervention was required.The device was evaluated on site and technician was not able to replicate the reported issue.During evaluation, the technician noted the handpiece would not consistently fire after releasing the trigger button.The technician was unable to find the root cause therefore the handpiece was replaced.New handpiece performs as intended within device specification.The device history record confirms that the device passed and met all requirements before releasing.Since the customer site reported the laser unintentionally firing upon a staff member's upper lip, this event is then reportable to the fda as an aro (accidental radiation occurrence) related injury.
Event or Problem Description
It was reported that the vectus released an unintended radiation occurrence and burned a site staff member's upper lip.

• Brand Name: VECTUS
• Common Device Name: VECTUS
• Manufacturer (Section D): CYNOSURE LLC; 5 carlisle road; westford, ma
• MDR Report Key: 10263239
• Report Number: 1222993-2020-00016
• Device Sequence Number: 14214170
• Product Code: GEX
• UDI-Device Identifier: 00841494100124
• UDI-Public: (01)00841494100124(11)180117
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120622
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/13/2020

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2020
• Initial Report FDA Received Date: 07/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1