ENDOWRIST 470006

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 470006 manufactured by Intuitive Surgical, Inc..

Event Text Entries

[186306241] Became stuck in arm during the case and had to be pried out with a clamp and wheel fell off back of instrument when removed. Manufacturer response for large needle drive, large needle driver (per site reporter). No credit was given.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9897217
MDR Report Key9897217
Date Received2020-03-30
Date of Report2020-02-24
Date of Event2019-12-09
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 Mfg2019-12-12
Model Number470006
Lot NumberN10190610(0070)
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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