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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM

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INTUITIVE SURGICAL,INC. DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM Back to Search Results
Model Number IS2000 A5.1P7
Event Date 07/19/2010
Event Type  Death  
Manufacturer Narrative

A review of the site's system log found that no system error codes were generated during the surgical procedure. At this time it is undetermined as to what caused damage to patient's duodenum. Requests for additional information have been made; however no additional information has been received. A follow-up medwatch report will be submitted if additional information is received.

 
Event Description

On (b)(4) 2012 isi received a legal summons and complaint indicating on (b)(6) 2010, the patient underwent a da vinci s partial nephrectomy procedure at (b)(6) medical center. During the surgical procedure the patient sustained perforation of the duodenum. Between (b)(6) 2010, the patient developed an abscess, infection and sepsis. The patient deceased on (b)(6) 2010.

 
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Brand NameDA VINCI S SURGICAL SYSTEM
Type of DeviceENDOSCOPIC INSTRUMENT CONTROL SYSTEM
Manufacturer (Section D)
INTUITIVE SURGICAL,INC.
sunnyvale CA
Manufacturer (Section G)
INTUITIVE SURGICAL, INC.,
1266 kifer rd, bldg 101
sunnyvale CA 9408 6
Manufacturer Contact
jane clay
1266 kifer rd, bldg 101
sunnyvale , CA 94086
MDR Report Key2736219
Report Number2955842-2012-00425
Device Sequence Number1
Product CodeNAY
Report Source Manufacturer
Source Type Other
Reporter Occupation Other
Type of Report Initial
Report Date 08/13/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/07/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberIS2000 A5.1P7
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Hospital
Date Manufacturer Received08/13/2012
Was Device Evaluated By Manufacturer? No
Date Device Manufactured12/01/2008
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 09/07/2012 Patient Sequence Number: 1
Treatment
DA VINCI S INSTRUMENTS AND ACCESSORIES
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