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

Catalog Number	7210387F
Medical Device Problem Code	Failure to Conduct (1114)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received the device for evaluation.When the handpiece was connected to the control unit, it flashed green indicating an issue with the handpiece.Upon disassembly, water was observed inside the core tube and under the pc board.The switch assembly area was found to be acceptable.When the motor was tested in a standalone mode, the lock reed switch was activated but the motor rotated hesitantly suggesting some drag inside the motor.This extra drag could have prevented the mdu drive shaft from rotating when the motor was operating under a load - with the mdu drive shaft and the resector connected at the user facility.The root cause of the issue was determined to be a motor damage due to water ingress.The seal failure was likely due to wear from repeated cleaning, use and sterilization that led to water ingress into the inner components of the handpiece that affected the motor functionality.We currently have a corrective and preventive action (capa) open to address this issue.There was no injury to the patient.The malfunction was detected prior to the case.The device never functioned at any point of the case and therefore the patient was never exposed to the device.
Event or Problem Description
During pre-use check, the resector on the handpiece did not spin at all when pressing either the run or the window lock button.

• 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: 8030752
• Report Number: 1220948-2018-00095
• Device Sequence Number: 1302585
• Product Code: DWQ
• UDI-Device Identifier: 00840663107391
• UDI-Public: 00840663107391
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 11/01/2018

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: 7210387F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2018
• Initial Report FDA Received Date: 11/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1