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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 IS12000 A4.3P9
Event Date 09/27/2010
Event Type  Death  
Event Description

It was alleged that during a da vinci s partial nephrectomy procedure at (b)(6) hospital, the patient sustained cuts and lacerations, causing injury to the aorta, left renal artery, splenic vein and proximal renal vein. It is also alleged that during the surgical procedure the patient sustained perforation of the pancreas. The surgeon decided to convert the partial nephrectomy procedure to a radical nephrectomy procedure. A specialist was called in to assist with identification and repair of the damage organs and vessels. It is alleged that between (b)(6) 2010 as results of the various injuries and in particular the unrepaired and untreated injury to the pancreas, hemorrhagic debris and fluid accumulated in the contiguous residual cavity, causing and/or contributing to the development of a right pleural effusion and pericardial effusion. On september 28th, 2012, isi became aware that the patient expired on (b)(6) 2010.

 
Manufacturer Narrative

At this time it is undetermined as to what caused the patient's death. Several attempts have been made to gather additional information regarding this event from this site without success. A follow-up medwatch report will be submitted if additional information is received.

 
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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
tabitha reed
1266 kifer rd, bldg 101
sunnyvale , CA 94086
MDR Report Key2798286
Report Number2955842-2012-00613
Device Sequence Number1
Product CodeNAY
Report Source Manufacturer
Source Type Other
Reporter Occupation Other
Type of Report Initial
Report Date 09/28/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/22/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberIS12000 A4.3P9
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location Hospital
Date Manufacturer Received09/28/2012
Was Device Evaluated By Manufacturer? No
Date Device Manufactured09/01/2008
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: 10/22/2012 Patient Sequence Number: 1
Treatment
DAVINCI S SYSTEMS INSTRUMENT AND ACCESSORIES
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