TRIVEX SYSTEM RESECTOR HANDPIECE 7210387

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-09 for TRIVEX SYSTEM RESECTOR HANDPIECE 7210387 manufactured by Lemaitre Vascular, Inc..

Event Text Entries

[127075626] 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.
Patient Sequence No: 1, Text Type: N, H10


[127075627] During pre-use check, the resector on the handpiece did not rotate.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1220948-2018-00098
MDR Report Key8056680
Date Received2018-11-09
Date of Report2018-11-09
Date of Event2018-10-08
Date Mfgr Received2018-10-10
Date Added to Maude2018-11-09
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. PRAGYA THIKEY
Manufacturer Street63 SECOND AVE
Manufacturer CityBURLINGTON MA 01803
Manufacturer CountryUS
Manufacturer Postal01803
Manufacturer Phone7812212266
Manufacturer G1LEMAITRE VASCULAR, INC.
Manufacturer Street63 SECOND AVE
Manufacturer CityBURLINGTON MA 01803
Manufacturer CountryUS
Manufacturer Postal Code01803
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameTRIVEX SYSTEM RESECTOR HANDPIECE
Generic NameHANDPIECE
Product CodeDWQ
Date Received2018-11-09
Returned To Mfg2018-10-18
Catalog Number7210387
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerLEMAITRE VASCULAR, INC.
Manufacturer Address63 SECOND AVE BURLINGTON MA 02148 US 02148


Patients

Patient NumberTreatmentOutcomeDate
10 2018-11-09

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