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

Catalog Number 7210387

Device Problem Power Problem (3010)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/24/2019

Event Type  malfunction  

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 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
• Type of Device: HANDPIECE
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 02148
• Manufacturer (Section G): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• Manufacturer Contact: pragya thikey ; 63 second ave; burlington, MA 01803 ; 7812212266
• MDR Report Key: 9235123
• MDR Text Key: 179294437
• Report Number: 1220948-2019-00145
• Device Sequence Number: 1
• Product Code: DWQ
• UDI-Device Identifier: 00840663106561
• UDI-Public: 00840663106561
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032387
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 7210387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/24/2019
• Initial Date FDA Received: 10/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1