MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. TRIVEX SYSTEM RESECTOR HANDPIECE

Model Number	7210387F
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have not received the device for "evalution".Hence, we could not conclusively determine the root cause of the malfunction at this time.
Event or Problem Description
During pre-use check, the handpiece failed to operate properly.The blade rotated intermittently even when the run button was not pressed.

• Brand Name: TRIVEX SYSTEM RESECTOR HANDPIECE
• Common Device Name: HANDPIECE
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington, ma
• MDR Report Key: 9714615
• Report Number: 1220948-2020-00019
• Device Sequence Number: 19592305
• Product Code: DWQ
• UDI-Device Identifier: 00840663107391
• UDI-Public: 00840663107391
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K032387
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/16/2020

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: Health Professional
• Device Model Number: 7210387F
• Device Catalogue Number: 7210387F
• Device Lot Number: YB02303
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2020
• Initial Report FDA Received Date: 02/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1