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 2018-10-30 for TRIVEX SYSTEM RESECTOR HANDPIECE 7210387 manufactured by Lemaitre Vascular, Inc..

Event Text Entries

[125655887] We have received the device for evaluation. We observed that the run button and the hermetic header assembly had been removed from the bezel and housing. All of the wires that connect the motor and other components to the endbell connector pins had been disconnected. Based on the condition the device was received, it is likely the device was manipulated with some attempt to repair. The resector would not rotate and the surgeon would not be able to use this device for the phlebectomy procedure. Based on the limited available information we have at this time, we are reporting this incident as we do not have adequate information about how the device was handled after the event at the user facility. There was no injury to the patient as the result of this incident since the issue was detected during pre-use check. The procedure was completed by stab phlebectomy procedure since they do not have any other handpieces in stock.
Patient Sequence No: 1, Text Type: N, H10


[125655888] During pre-use check, the blades of the resector did not spin.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1220948-2018-00092
MDR Report Key8021530
Date Received2018-10-30
Date of Report2018-10-30
Date of Event2018-09-30
Date Mfgr Received2018-09-30
Device Manufacturer Date2017-12-29
Date Added to Maude2018-10-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
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 Received2018-10-30
Returned To Mfg2018-10-30
Catalog Number7210387
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerLEMAITRE VASCULAR, INC.
Manufacturer Address63 SECOND AVE BURLINGTON MA 02148 US 02148


Patients

Patient NumberTreatmentOutcomeDate
10 2018-10-30

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