FDA.reportPublic FDA data

MAUDE MDR 7839630

MDR report key
7839630
Report number
1220948-2018-00063
Event key
0
Event type
3
Date of event
2018-05-08
Date received
2018-08-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. PRAGYA THIKEY
Address
63 SECOND AVE BURLINGTON MA 01803 US
Phone
781-781-7812
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1TRIVEX SYSTEM CONTROL UNIT WITH BUILT IN PUMPHANDPIECELEMAITRE VASCULAR, INC.DWQ7210387Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-08-3101. D

Event Narratives#

N

Patient 1

WE HAVE RECEIVED THE DEVICE FOR EVALUATION. HOWEVER, WE WERE UNABLE TO REPLICATE THE REPORTED DEFECT. DEVICE WAS FOUND TO OPERATE PROPERLY WHEN THE RUN OR THE WINDOW LOCK BUTTON WAS PRESSED. UPON DISASSEMBLY OF THE HOUSING, WE FOUND MOISTURE IN THE INNER ASSEMBLY. ALTHOUGH WE ARE INCONCLUSIVE ABOUT THE ROOT CAUSE OF THE DEFECT, IT IS POSSIBLE THAT THE RESECTOR DID NOT MAKE PROPER CONNECTION WITH THE CONTROL UNIT SITUATED AT THE HOSPITAL. THERE WAS NO IMPACT ON THE PATIENT'S HEALTH AS THE RESULT OF THIS INCIDENT. PROCEDURE WAS COMPLETED USING A DIFFERENT HANDPIECE.

D

Patient 1

DURING PRE-USE CHECK, THE BLADES OF THE RESECTOR FAILED TO ROTATE.