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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 A5.1P2
Event Date 01/11/2008
Event Type  Death  
Manufacturer Narrative

On january 18, 08, intuitive surgical spoke to the physician who performed the procedure. The physician stated the procedure was complex due to that pt's previous medical history and anatomy, however, the case was completed successfully with the da vinci s system and no malfunction of the system was alleged by the hosp. The physician indicated the pt died from sepsis due to a defect in the small bowel, however, it is unclear if the perforation in the bowel occurred during or after the surgical procedure. In 2008, intuitive surgical spoke to the attending nurse present during the procedure. The nurse stated that when the surgical staff removed the trocar at the end of the procedure, the pt's bowel appeared normal. Additionally, the surgical staff observed no issues during the surgery which could have caused or contributed to the pt's adverse outcome. The hosp has continued to use the da vinci s system to perform surgery on patients. As of 2008, no adverse events or product problems have been experienced with the site's da vinci s system. As of 2008, no similar instances of this event have been reported to intuitive surgical.

 
Event Description

On january 17, 2008, intuitive surgical was notified that following a da vinci s hysterectomy surgical procedure, the pt suffered from sepsis and expired four days post da vinci assisted surgery.

 
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Brand NameDA VINCI S SURGICAL SYSTEM
Type of DeviceENDOSCOPIC INSTRUMENT CONTROL SYSTEM
Manufacturer (Section F)
INTUITIVE SURGICAL, INC.
sunnyvale CA
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
sunnyvale CA
Manufacturer (Section G)
Manufacturer Contact
elymarie ablog
950 kifer rd.
sunnyvale , CA 94086-
(408) 523 -2205
Device Event Key967285
MDR Report Key997372
Event Key956455
Report Number2955842-2008-00056
Device Sequence Number1
Product CodeNAY
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 02/08/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/12/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberIS2000 A5.1P2
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was The Report Sent To Manufacturer? No
Date Manufacturer Received01/17/2008
Was Device Evaluated By Manufacturer? No
Date Device Manufactured07/01/2007
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 02/12/2008 Patient Sequence Number: 1
Treatment
DA VINCI S SURGICAL SYSTEM INSTRUMENTS
ACCESSORIES
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