ENDOWRIST 470400-09 470400

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-31 for ENDOWRIST 470400-09 470400 manufactured by Intuitive Surgical, Inc.

MAUDE Entry Details

Report Number2955842-2020-10255
MDR Report Key9908705
Report SourceOTHER
Date Received2020-03-31
Date of Report2020-03-09
Date of Event2020-03-09
Date Mfgr Received2020-03-09
Device Manufacturer Date2019-02-18
Date Added to Maude2020-03-31
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 ContactDAVID WANG
Manufacturer Street3410 CENTRAL EXPRESSWAY
Manufacturer CitySANTA CLARA CA 95051
Manufacturer CountryUS
Manufacturer Postal95051
Manufacturer Phone4085232100
Manufacturer G1INTUITIVE SURGICAL, INC
Manufacturer Street3410 CENTRAL EXPRESSWAY
Manufacturer CitySANTA CLARA CA 95051
Manufacturer CountryUS
Manufacturer Postal Code95051
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameENDOWRIST
Generic NameBIPOLAR GRASPER, LONG
Product CodeNAY
Date Received2020-03-31
Model Number470400-09
Catalog Number470400
Lot NumberN10190219 0026
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerINTUITIVE SURGICAL, INC
Manufacturer Address3410 CENTRAL EXPRESSWAY SANTA CLARA CA 95051 US 95051


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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