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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. ENDOWRIST SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT

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INTUITIVE SURGICAL, INC. ENDOWRIST SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number 470347
Device Problem Physical Resistance/Sticking (4012)
Patient Problem Insufficient Information (4580)
Event Date 05/19/2020
Event Type  malfunction  
Event Description
During a robotic case, the tip up fenestrated grasper was used without problem throughout the case. When the surgeon asked for the instrument to be removed, staff reported "the wrist of the instrument became immovable and would not straighten out. " this kept the instrument from being pulled out of the cannula and out of the patient. The surgeon, surgical technologist (st), & registered nurse first assistant (rnfa) attempted to mechanically and manually straighten out the grasper portion at the wrist, but were unable to at first. Intuitive technical support was engaged and informed of the issues. Intuitive provided suggestions which the rnfa attempted. Eventually, staff was able to manipulate the robot arm and cannula in order to slide the arm and instrument out. Manufacturer response for system, surgical, computer controlled instrument, endowrist (per site reporter) intuitive representative picked up device stating it could take up to 6 months for results of analysis.
 
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Brand NameENDOWRIST
Type of DeviceSYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
1266 kifer road
sunnyvale CA 94086
MDR Report Key10566179
MDR Text Key207923114
Report Number10566179
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 09/18/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number470347
Device Lot NumberN101902017
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/19/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/18/2020
Event Location Hospital
Date Report to Manufacturer09/22/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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