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	07/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received the device for evaluation.When the run or the window lock button was pressed, drive fork did not rotate.Upon disassembly, the endbell's o-rings were observed to be damaged from incorrect assembly likely by someone at the user facility.Rtv under button appeared to have been removed and replaced.Endbell wires were observed to have mostly removed from their pins.We observed water ingress inside the core tube and board wires appeared to have been re-soldered.Upon removal of the drive fork, we observed quad rings and ball bearing instead of slip bearing which is inconsistent with how we built this device.The device appeared to have been disassembled by someone at the customer location with an attempt to repair.However, we were unable to confirm if the parts were swapped before or after the malfunction had occurred.Hence, at this time, we could not conclusively determine the cause of the failure due to device tampering by the user facility.Based on the condition this device was received, the surgeon would not be able to use this device for the phlebectomy procedure.However, we are reporting this incident as we do not have adequate information on how this device was handled before or after the event at the user facility.The issue was detected during pre-use check.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: 8923139
• Report Number: 1220948-2019-00112
• Device Sequence Number: 253486
• 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): 08/22/2019

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: 08/12/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2019
• Initial Report FDA Received Date: 08/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1