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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC. ENDOWRIST NEEDLE DRIVER SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/28/2019
Event Type  malfunction  
Event Description
Robotic needle driver "broke" while in use and in patient. Complete instrument recovered, and no harm done.
 
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Brand NameENDOWRIST NEEDLE DRIVER
Type of DeviceSYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
1266 kifer rd
building 101
sunnyvale CA 94086
MDR Report Key8435608
MDR Text Key139303464
Report Number8435608
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 Risk Manager
Type of Report Initial
Report Date 03/11/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/11/2019
Event Location Hospital
Date Report to Manufacturer03/20/2019
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? No
Type of Device Usage

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