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

Model Number 7210387

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Patient Involvement (2645)

Event Date 04/09/2020

Event Type  malfunction  

Manufacturer Narrative

We have not received the device for evaluation.Hence, we could not conclusively determine the root cause of the malfunction at this time.The malfunction was detected during preuse check.There has been no serious injury ( 21 cfr 803.3 ) nor would the malfunction result in a death or serious injury if it was to reoccur since the resector could not be used for the procedure.However, we have decided to report the incident since our evaluation was based on the reported defect from the user at the hospital, rather than our hands-on evaluation with this defective device itself.

Event Description

Device failed to operate during pre-use check.

• Brand Name: TRIVEX SYSTEM RESECTOR HANDPIECE
• Type of Device: HANDPIECE
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington, ma
• Manufacturer Contact: pragya thikey ; 63 second ave; burlington, ma ; 2212266152
• MDR Report Key: 10039085
• MDR Text Key: 191261566
• Report Number: 1220948-2020-00058
• Device Sequence Number: 1
• Product Code: DWQ
• UDI-Device Identifier: 00840663106561
• UDI-Public: 00840663106561
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K032387
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7210387
• Device Catalogue Number: 7210387
• Device Lot Number: YB02469
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/29/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1