TRIVEX SYSTEM RESECTOR HANDPIECE 7210387F

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-14 for TRIVEX SYSTEM RESECTOR HANDPIECE 7210387F manufactured by Lemaitre Vascular, Inc..

Event Text Entries

[185004555] We have not received the device for "evalution". Hence, we could not conclusively determine the root cause of the malfunction at this time.
Patient Sequence No: 1, Text Type: N, H10


[185004556] During pre-use check, the handpiece failed to operate properly. The blade rotated intermittently even when the run button was not pressed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1220948-2020-00019
MDR Report Key9714615
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-02-14
Date of Report2020-02-16
Date of Event2020-01-17
Date Mfgr Received2020-01-17
Date Added to Maude2020-02-14
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
Manufacturer CountryUS
Manufacturer Phone2212266152
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTRIVEX SYSTEM RESECTOR HANDPIECE
Generic NameHANDPIECE
Product CodeDWQ
Date Received2020-02-14
Model Number7210387F
Catalog Number7210387F
Lot NumberYB02303
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerLEMAITRE VASCULAR, INC.
Manufacturer Address63 SECOND AVE BURLINGTON, MA US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-14

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