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	06/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During a device evaluation, the engineer confirmed that an internal screw had become dislodged and interfered with the trigger assembly.This resulted in the trigger malfunctioning.The loose hardware (screw) was removed, locked in position with loctite and handpiece passed all function tests.The device history record confirms that the product passed and met all requirements before releasing.Due to the malfunction of the device firing on its own, this event is an aro (accidental radiation occurrence) and therefore reportable.
Event or Problem Description
It was reported that a device malfunction caused the finger switch on the handpiece to jam and eventually fire, resulting in damage to the patient's bed.No injury was reported.

• Brand Name: VECTUS
• Common Device Name: VECTUS
• Manufacturer (Section D): CYNOSURE LLC; 5 carlisle road; westford MA 01886
• MDR Report Key: 12204832
• Report Number: 1222993-2021-00024
• Device Sequence Number: 11883707
• Product Code: GEX
• UDI-Device Identifier: 00841494100124
• UDI-Public: (01)00841494100124(11)190122
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 07/21/2021

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: 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: 06/24/2021
• Initial Report FDA Received Date: 07/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1