ENDOWRIST 480422

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-30 for ENDOWRIST 480422 manufactured by Intuitive Surgical, Inc..

Event Text Entries

[185503842] Exposed blade. Manufacturer response for vessel sealer, vessel sealer (per site reporter). No credit was given.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9897216
MDR Report Key9897216
Date Received2020-03-30
Date of Report2020-02-24
Date of Event2019-12-11
Report Date2020-02-24
Date Reported to FDA2020-02-24
Date Reported to Mfgr2020-03-30
Date Added to Maude2020-03-30
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameENDOWRIST
Generic NameSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
Product CodeNAY
Date Received2020-03-30
Returned To Mfg2019-12-16
Model Number480422
Catalog Number480422
Lot NumberL91191001
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Age1 DA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerINTUITIVE SURGICAL, INC.
Manufacturer Address1266 KIFER ROAD SUNNYVALE CA 94086 US 94086


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-30

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