da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON JUNE 10, 2008, INTUITIVE SURGICAL WAS NOTIFIED OF A PT DEATH PER LITIGATION DOCUMENTATION WHICH REPORTS THE FOLLOWING: IN 2007, FIVE DAYS AFTER UNDERGOING A DA VINCI RADICAL PROSTATECTOMY PROCEDURE, A PT UNDERWENT EMERGENCY EXPLORATORY LAPAROTOMY AND INTER ALIA. BOWEL NECROSIS WITH SEPTICEMIA WAS OBSERVED AND SAID TO BE THE RESULT OF AN INTEROPERATIVE MESENTERY TEAR. SIX CENTIMETERS OF CONTINUOUS STITCH WAS APPLIED TO REPAIR THE AFFECTED AREA, HOWEVER, THE PT EXPIRED.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED SEVERAL WEEKS AFTER A DA VINCI S PROSTATECTOMY SURGICAL PROCEDURE, THE PT EXPIRED. NO ADDITIONAL INFO WAS PROVIDED.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON 10/01/2015, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA VOLUNTARY REPORT MW5056296 WITH THE FOLLOWING EVENT DESCRIPTION: THIS IS A LATE REPORT AS WE WERE UNAWARE WE COULD HAVE REPORTED EARLIER TO FDA. MY MOTHER, (B)(6), AT TIME OF DEATH, WAS UNDERGOING A MITRAL VALUE [SIC] REPAIR WITH THE SURGEON, DR. (B)(6), USING THE DAVINCI ROBOT. THIS OCCURRED AT (B)(6) ON (B)(6) 2006. ACCORDING TO THE PHYSICIAN, THE ROBOT NICKED HER HEART WHICH RESULTED IN BLEEDING OUT AND EMERGENCY OPEN HEART SURGERY. SHE NEVER RECOVERED AND DEVELOPED SEPSIS INFECTION 4 DAYS LATER. WE WERE INFORMED LATER THAT OUR MOM WAS THE ONLY THE 3RD PATIENT FOR HEART VALVE SURGERY ON THIS ROBOT. WE ALSO ARE AWARE THAT ANOTHER WOMAN DIED SUBSEQUENTLY BY THE SAME ROBOT AND PHYSICIAN. THE DOCTOR LEFT TOWN AFTER THIS. (WE NEVER FILED A LAWSUIT DUE TO (B)(6) LAWS ON DAMAGES.) I AM WRITING THIS TO INFORM THE FDA AND TO NOTIFY YOU OF AN ADVERSE EVENT FOR YOUR STATS OF THIS DAVINCI ROBOT. MY HOPE IS THAT NO ONE WILL HAVE TO DIE FROM THIS ROBOT IN THE FUTURE IN THE CARDIAC REALM OF USE FOR DAVINCI. THANK YOU. (B)(6). ON 10/02/2015, ISI CONTACTED THE INITIAL REPORTER (THE PATIENT'S DAUGHTER) AND OBTAINED THE FOLLOWING INFORMATI

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI DIAGNOSTIC LAPAROSCOPY AND CHOLECYSTECTOMY PROCEDURE FOLLOWED BY A PLANNED OPEN PANCREATICODUODENECTOMY SURGICAL PROCEDURE ON (B)(6) 2006. THE PATIENT REPORTEDLY EXPIRED ON AN UNSPECIFIED DATE. ISI WAS PROVIDED WITH THE (B)(6) 2006 OPERATIVE REPORT AS WELL AS HER SUBSEQUENT OPERATIVE SUMMARIES AND HER HOSPITAL DISCHARGE SUMMARY. ACCORDING TO THE MEDICAL RECORDS, THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY FOR FURTHER CARE ON (B)(6) 2006 AND THEN WAS DISCHARGED ON (B)(6) 2006. NO FURTHER MEDICAL RECORDS WERE PROVIDED AFTER THIS DISCHARGE DATE. THE OPERATIVE REPORT DATED (B)(6) 2006 INDICATED THAT THE PATIENT UNDERWENT A ROBOTIC ASSISTED LAPAROSCOPY AND CHOLECYSTECTOMY, OPEN PANCREATICODUODENECTOMY, PORTAL VEIN RESECTION AND RECONSTRUCTION. THE PREOPERATIVE DIAGNOSIS WAS NOTED AS PANCREATIC HEAD MASS AND CYSTIC NEOPLASM AND THE POSTOPERATIVE DIAGNOSIS WAS PANCREATIC CARCINOMA. THE SURGICAL PROCEDURE BEGAN WITH A ROBOTIC ASSISTED DIAGNOSTIC LAPAROSCOPY TO IDENTIFY THE BODY AND NECK OF THE PANCREAS. THE PROCEDURE THEN PROCEEDED WITH A CHOLECYSTECTOMY. ONCE T

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE ON (B)(6) 2005. THE LEGAL DOCUMENT ALLEGES THAT AS A DIRECT AND PROXIMATE RESULT OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY, OR ITS IMPROPER AND / OR UNLAWFUL USE, THE PATIENT SUFFERED INJURIES. REPORTEDLY, THE PATIENT EXPIRED IN (B)(6) 2010. NO OTHER INFORMATION WAS PROVIDED.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IN A PUBLISHED CITRON RESEARCH ARTICLE TITLED INTUITIVE SURGICAL: ANGEL WITH BROKEN WINGS, OR THE DEVIL IN DISGUISE? ON JANUARY 17, 2013, IT WAS STATED IN AN EMBEDDED LINK ON PAGE 22 THAT IN DECEMBER 2003 THE WIDOW OF A (B)(6) TEACHER FILED A LAWSUIT AFTER A DOCTOR AT [HOSPITAL] ACCIDENTLY CUT HIS AORTA AND THE VENA CAVA WHILE USING THE DA VINCI SURGICAL ROBOT TO REMOVE A CANCEROUS KIDNEY. THE LAWSUIT ALLEGED THAT THE HOSPITAL ALLOWED DOCTORS INEXPERIENCED WITH THE ROBOT TO PERFORM THE SURGERY. THE CLAIM FURTHER CHARGED THAT THE HOSPITAL WAS MORE INTERESTED IN USING ITS NEW DEVICE THAN IN ENSURING HER HUSBAND'S SAFETY. ACCORDING TO THE LEGAL FINDINGS IN THIS CASE, THE COMPLAINT WAS FILED ON (B)(6) 2003 AND THE ONLY NAMED DEFENDANT WAS THE HOSPITAL. THE ALLEGATIONS STEM FROM THE CLAIM THAT THE DECEDENT UNDERWENT A TOTAL NEPHRECTOMY PROCEDURE. THE COMPLAINT ALSO ALLEGED THAT ISI HAD ESTIMATED 18 ROBOTIC SURGERIES WERE NECESSARY TO BE PROFICIENT WITH THE SYSTEM AND THAT ISI CERTIFIED THE DOCTOR AFTER ONLY THREE TRAINING SESSIONS. THE COMPLAINT STATED THAT THE DECEDENT SUFFERED FROM A SEVERED AORTA AND VENA CAVA. IN ADDITION, IT WAS ALLEGED THAT A LAP PAD WAS LEFT INSIDE OF THE DECEDEN