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

Model Number IS2000 A5.1P2

Event Date 01/11/2008

Event Type  Death   Patient Outcome  Death

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.

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.

• Brand Name: DA VINCI S SURGICAL SYSTEM
• Type of Device: ENDOSCOPIC 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 Key: 967285
• MDR Report Key: 997372
• Event Key: 956455
• Report Number: 2955842-2008-00056
• Device Sequence Number: 1
• Product Code: NAY
• 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 Received: 02/12/2008
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: Health Professional
• Device MODEL Number: IS2000 A5.1P2
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: No
• Was The Report Sent To Manufacturer?: No
• Date Manufacturer Received: 01/17/2008
• Was Device Evaluated By Manufacturer?: No
• Date Device Manufactured: 07/01/2007
• 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	Treatment Date
DA VINCI S SURGICAL SYSTEM INSTRUMENTS
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