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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC, DA VINCI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM
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INTUITIVE SURGICAL, INC, DA VINCI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Injury (2348)
Event Type  Injury  
Event Description
Attorneys have alleged that their clients suffered injuries associated with da vinci surgical procedures. These claims do not involve deaths. These allegations were first received by intuitive surgical during the time period of (b)(4) 2013 to (b)(4) 2014. For those claims where procedure dates are provided, the dates range from (b)(6) 2004 through (b)(6) 2014.
 
Manufacturer Narrative
This medwatch report reflects 1,387 initial events and 19 supplemental events summarized as part of (b)(4). If additional information is received, follow up reports will be submitted to the fda. This report does not admit that the report or information submitted under this report constitutes an admission that the device, intuitive surgical or intuitive surgical employees, caused or contributed to the reportable event.
 
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Brand NameDA VINCI SURGICAL SYSTEM
Type of DeviceENDOSCOPIC INSTRUMENT CONTROL SYSTEM
Manufacturer (Section D)
INTUITIVE SURGICAL, INC,
950 kifer rd.
sunnyvale CA 94086
Manufacturer Contact
tabitha reed
950 kifer rd.
sunnyvale, CA 94086
4085232420
MDR Report Key3651923
MDR Text Key4320437
Report Number2955842-2014-01197
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Attorney
Type of Report Initial
Report Date 02/27/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was Device Evaluated by Manufacturer? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 02/27/2014 Patient Sequence Number: 1
Treatment
DA VINCI SYSTEM INSTRUMENTS AND ACCESSORIES
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