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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC. ENDOWRIST;DAVINCI SI SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number 410322
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/31/2019
Event Type  malfunction  
Event Description
From staff: provider was doing a robotic hysterectomy and using vessel sealer. At one point in the case the blade become exposed, and the robot had a recoverable fault. Provider immediately stopped use of the instrument, and the scrub removed it from use. No harm was done.
 
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Brand NameENDOWRIST;DAVINCI SI
Type of DeviceSYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
1266 kifer rd
sunnyvale CA 94086
MDR Report Key8300755
MDR Text Key134885140
Report Number8300755
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 Other Health Care Professional
Type of Report Initial
Report Date 02/01/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number410322
Device Catalogue Number410322
Device Lot NumberM10170816
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/01/2019
Event Location Hospital
Date Report to Manufacturer02/04/2019
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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