FDA Adverse Event Death Summary report: N

DA VINCI S SURGICAL SYSTEM

MDR report key: 1002352 · Received February 22, 2008

Report

Report Number: 2955842-2008-00073
Event Type: Death
Date Received: February 22, 2008
Date of Event: January 24, 2008
Report Date: February 22, 2008
Manufacturer: INTUITIVE SURGICAL, INC.
Product Code: NAY
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: LA, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

IN 2008, INTUITIVE SURGICAL HAS REQUESTED ADDITIONAL INFORMATION RELATED TO THIS EVENT FROM THIS SITE. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. THE HOSPITAL 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 INSTANCE OF THIS EVENT HAVE BEEN REPORTED TO ISI.

Description of Event or Problem · 1

IN 2008, AFTER A SINGLE VESSEL SMALL THORACOTOMY DA VINCI S PROCEDURE, THE PATIENT EXPIRED WHILE WEANING OFF OF BYPASS. PRIOR TO THE PROCEDURE, THE PATIENT APPEARED TO HAVE A HEPARIN REACTION AND EXPERIENCED A HYPOTENSIVE EVENT WITH A SYSTOLIC PRESSURE OF 39MM. THE SITE INITIATED A CARDIOPULMONARY BYPASS RUN AND COMPLETED THE PROCEDURE WITHOUT EVENT. WEAN FROM BYPASS WAS UNSUCCESSFUL AS PATIENT EXHIBITED STONE HEART CHARACTERISTICS. NO MALFUNCTION OF THE DAVINCI S SYSTEM WAS ALLEGED BY THE HOSPITAL, AND THE INFORMATION PROVIDED INDICATES THAT THIS EVENT IS RELATED TO THE INHERENT RISKS ASSOCIATED WITH BYPASS AND THE PATIENT'S MEDICAL HISTORY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	DA VINCI S SURGICAL SYSTEM	ENDOSCOPIC INSTRUMENT CONTROL SYSTEM	NAY	INTUITIVE SURGICAL, INC.	IS2000 A5.1P4

Patients

Seq	Age	Sex	Outcome	Treatment
1	73 YR		Death	ACCESSORIES\| DA VINCI S SURGICAL SYSTEM INSTRUMENTS