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

Catalog Number	7210387
Medical Device Problem Code	Failure to Conduct (1114)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received the device for evaluation.The handpiece was returned to us with the drive shaft disassembled from the motor unit.The end bell that secures the seal housing to the core tube was also missing.The pcb wires to the end bell were cut and the drive shaft pin and retainer cup were also missing along with seal housings' internal components and bearings.Based on the condition this device was received, the surgeon would not be able to use this device for the phlebectomy procedure.Based on the limited available information we have at this time, we are reporting this incident as we do not have adequate information about how this device was handled after the event at the user facility.The issue was detected during pre-use check and the device was not used in the patient.
Event or Problem Description
During pre-use check, the blades of the resector did not spin.

• Brand Name: TRIVEX SYSTEM RESECTOR HANDPIECE
• Common Device Name: HANDPIECE
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 02148
• MDR Report Key: 8405620
• Report Number: 1220948-2019-00022
• Device Sequence Number: 13775101
• Product Code: DWQ
• UDI-Device Identifier: 00840663106561
• UDI-Public: 00840663106561
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K032387
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/08/2019

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 Catalogue Number: 7210387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2019
• Initial Report FDA Received Date: 03/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1