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

Catalog Number	7210387
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received the complaint device for evaluation.However, we were unable to confirm the reported incident.We have inspected the housing and powercable of the handpiece and found them to be acceptable.Device operated properly on all settings and functions.However, upon disassembly, we observed moisture inside the core tube that had penetrated into the adhesive of the pc board.We also observed corrosion on the heat sink and motor.We have implemented a corrective and preventive action (capa) to address this issue.Based on our investigation, we have updated the design of the handpiece water seals, which will better prevent water and steam from entering into the inner components of the handpiece.There was no injury to the patient as the result of this incident.Surgeon replaced the handpiece to complete the remaining procedure.
Event or Problem Description
During procedure, the resector of the handpiece stopped spinning.However, after few attempts, surgeon was able to get the device to work properly.

• 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: 9235123
• Report Number: 1220948-2019-00145
• Device Sequence Number: 3094896
• Product Code: DWQ
• UDI-Device Identifier: 00840663106561
• UDI-Public: 00840663106561
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/24/2019

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: 10/14/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2019
• Initial Report FDA Received Date: 10/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1