MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. TRIVEX SYSTEM CONTROL UNIT WITH BUILT IN PUMP; HANDPIECE

Catalog Number	7210387F
Medical Device Problem Codes	Failure to Conduct (1114); Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have not received the device for evaluation since the device is still in the possession of the hospital.Hence, we could not conclusively determine the root cause of the defect.On 8/8/2018, the sales rep.Visited the hospital and tested the reported complaint device.She confirmed that the blades of the handpiece did not rotate at all when the handpiece was connected in the control unit.The issue was detectable when pressing either the run or the window lock button.Other handpieces operated normally when connected to the same control unit.There was no impact on the patient's health as the result of this incident.The issue was detected during the pre-use check and the procedure was completed using a different handpiece in stock.The device was non-functional and therefore the malfunction was detected prior to the case.There has been no serious injury (section 2.13) nor would the malfunction result in a death or serious injury if it was to reoccur i.E the device never functioned at any point of the case and therefore the patient was never exposed or potentially exposed, to the device.However, we have decided to report the incident since our evaluation was based on the reported defect from our sales rep.And the user at the hospital rather than our hands-on evaluation with this defective device itself.
Event or Problem Description
During pre-use check, the blades of the resector did not spin.

• Brand Name: TRIVEX SYSTEM CONTROL UNIT WITH BUILT IN PUMP
• Common Device Name: HANDPIECE
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 02148
• MDR Report Key: 7769047
• Report Number: 1220948-2018-00054
• Device Sequence Number: 13760829
• Product Code: DWQ
• UDI-Device Identifier: 00840663107391
• UDI-Public: 00840663107391
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 08/09/2018

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2018
• Initial Report FDA Received Date: 08/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1