TRIVEX SYSTEM CONTROL UNIT WITH BUILT IN PUMP 7210387

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-28 for TRIVEX SYSTEM CONTROL UNIT WITH BUILT IN PUMP 7210387 manufactured by Lemaitre Vascular, Inc..

Event Text Entries

[122304380] We have received the device for evaluation. The device did not operate at all when we tested the device during our evaluation. Further inspection found that a wire had detached from the pcb and a seal housing was found to be out of alignment with the heatsink tank. The seal housing was not tightly coupled to the motor which allowed the seal housing/motor to rotate enough to cause the wire to break. We believe this was an assembly error isolated to just this handpiece. There was no injury to the patient as the result of this incident. However, surgeon had to abandon the phlebectomy surgery as a result of this incident.
Patient Sequence No: 1, Text Type: N, H10


[122304381] Blade rotated intermittently during the procedure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1220948-2018-00074
MDR Report Key7918715
Date Received2018-09-28
Date of Report2018-09-26
Date of Event2018-08-29
Date Mfgr Received2018-08-29
Device Manufacturer Date2017-07-17
Date Added to Maude2018-09-28
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 CONTROL UNIT WITH BUILT IN PUMP
Generic NameHANDPIECE
Product CodeDWQ
Date Received2018-09-28
Returned To Mfg2018-09-06
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 2018-09-28

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