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

Catalog Number	7210387
Medical Device Problem Code	Failure to Conduct (1114)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received the device for evaluation.The housing and power cord were visually inspected and were found to be acceptable.The handpiece status light flashed green when the device was connected to the control unit indicating an issue with the handpiece.The drive shaft did not rotate when the window lock button was pressed.However, the drive shaft rotated properly when the run button was pressed.Upon disassembly of the housing, water was observed inside the core tube.The window lock reed switch on the switch pc board was also found to be malfunctioning.The root cause of the defect was determined to be a damage to the pc board due to water exposure.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.
Event or Problem Description
During pre-use check, the resector on the handpiece did not rotate.

• 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: 8056680
• Report Number: 1220948-2018-00098
• Device Sequence Number: 2190113
• Product Code: DWQ
• UDI-Device Identifier: 00840663107391
• UDI-Public: 00840663107391
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/09/2018

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: 7210387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2018
• Initial Report FDA Received Date: 11/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1