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 that during a da Vinci-assisted sliding hiatal hernia procedure, after sealing and cutting of an unspecified branch of the aorta, bleeding occurred and the patient ultimately expired.The surgeon reported that the Vessel Sealer Curved (VSC) instrument seal and cut cycle worked as expected with no error messages. However, when the jaws of the VSC were opened, the sealed branch started to hemorrhage. The procedure continued robotically for approximately one hour in attempts to fully stop the bleeding which was able to be controlled at multiple points after the initial seal. The estimated blood loss during the robotic portion was approximately 2 liters when a mass transfusion protocol was initiated and the procedure was converted to a thoracotomy but the surgeon was unable to control the bleeding. The aorta was then cross-clamped and the bleeding stopped; however, the patient expired in the operating room. The surgeon reports there were no error messages or robotic-related complications that occurred during the procedure. Specifically, the VSC worked as expected with no error messages or complications with sealing during use.

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 THAT DURING A DA VINCI-ASSISTED UNSPECIFIED COLORECTAL PROCEDURE, THE INFERIOR MESENTERIC ARTERY (IMA) WAS SEALED WITH THE VESSEL SEALER CURVED (VSC) INSTRUMENT AND BLEEDING OCCURRED AFTER SEALING AND CUTTING. THE PATIENT LATER EXPIRED ON POSTOPERATIVE DAY 3. THE SURGEON REPORTED THAT WHEN THE JAWS WERE OPENED, BLEEDING WAS IMMEDIATE. THE IMA HAD AN OPEN LUMEN AND SHOWED NO SIGNS OF SEALING. THE VSC CONTINUED TO BE USED TO SEAL THE IMA TWO MORE TIMES ALONG DIFFERENT POINTS DURING THE PROCEDURE; BLEEDING OCCURRED AFTER EACH SEAL. THE VESSEL HAD TO BE RE-SEALED MORE PROXIMALLY TOWARD THE AORTA TO MOBILIZE THE TISSUE TO CREATE AN OSTOMY. THE SEALING TONES WERE REPORTED AS APPROPRIATE AND NO ERROR MESSAGES WERE PRODUCED WHILE SEALING. THE ESTIMATED BLOOD LOSS WAS 300ML. AFTER THE ROBOTIC PORTION WAS COMPLETED AND DURING CLOSURE, THE PATIENT CODED. RESUSCITATION MEASURES WERE SUCCESSFUL, AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. THE PATIENT EXPIRED THREE DAYS LATER AFTER THE FAMILY DECIDED TO WITHDRAW CARE. THE SURGEON RELATED THE VSC INABILITY TO SUCCESSFULLY SEAL MULTIPLE TIMES THROUGHOUT THE PROCEDURE TO CHALLENGING TISSUE INTEGRITY DUE TO EDEMA. THE

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 THAT DURING A DA VINCI-ASSISTED MEDIAN ARCUATE LIGAMENT SYNDROME RELEASE (MALS) PROCEDURE, THE PATIENT EXPERIENCED INTRAOPERATIVE BLEEDING FROM THE AORTA AND ULTIMATELY EXPIRED. THE VESSEL SEALER CURVED (VSC) INSTRUMENT WAS BEING USED FOR BLUNT DISSECTION AND CAUTERY WHEN SIGNIFICANT BLEEDING OCCURRED FROM THE AORTA. THE PROCEDURE WAS EMERGENTLY CONVERTED TO AN OPEN APPROACH. WHEN AN ASSISTING VASCULAR SURGEON CROSS CLAMPED THE AORTA DURING REPAIR ATTEMPTS, THE PATIENT¿S PULSE WAS LOST AND CHEST COMPRESSIONS WERE STARTED. WITH NO RETURN OF A PULSE, THE CROSS CLAMPS ON THE AORTA WERE REMOVED AND BLEEDING CONTINUED WITH THE CHEST COMPRESSIONS. THE PATIENT EXPIRED IN THE OPERATING ROOM. THE SURGEON STATED THAT THE CAUSE OF THE AORTIC INJURY WAS UNKNOWN. THE SURGEON REPORTED THAT THROUGHOUT THE PROCEDURE, IT WAS NOTICED THAT THE VSC PRODUCED INCREASED THERMAL SPREAD AND INCREASED BLEEDING AFTER ENERGY ACTIVATION WHEN COMPARED TO THE VESSEL SEALER EXTEND. IT WAS ALSO STATED THAT THE VSC JAW MOVEMENT WOULD OPEN A LITTLE SLOWLY AT FIRST, THEN WOULD SPRING OPEN QUICKLY, WITH INCREASED BLEEDING FROM THE FAST JAW OPENING. NO ADDITIONAL INFORMATION WAS PROVIDED.

Ion Endoluminal System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING AN ION TRANSBRONCHIAL LUNG BIOPSY PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX REQUIRING PLACEMENT OF A CHEST TUBE AND HOSPITALIZATION. THE TARGETED LESION WAS A LEFT UPPER LOBE INFERIOR NODULE ABUTTING THE MOST INFERIOR PART OF THE LINGULA BEHIND THE HEART. PER THE PHYSICIAN, THERE WERE SUBOPTIMAL ANGLES AND THE DEPTH PERCEPTION WAS NOT GOOD. FINE NEEDLE ASPIRATIONS (FNA) PASSES AND FORCEPS WERE USED. THE PHYSICIAN REPORTED THAT THEY INSERTED THE FORCEPS FURTHER THAN INTENDED AND LIKELY CAUSED THE PNEUMOTHORAX. A LARGE PNEUMOTHORAX WAS IDENTIFIED DURING THE ION PROCEDURE; THEREFORE, A 14 FRENCH CHEST TUBE WAS PLACED AND THE PROCEDURE WAS ABORTED. THE PATIENT WAS HOSPITALIZED 4 DAYS THEN DISCHARGED HOME IN STABLE CONDITION. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. THE DIAGNOSIS WAS MAC-NTM (MYCOBACTERIUM AVIUM COMPLEX NONTUBERCULOUS MYCOBACTERIA).

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 THAT AFTER A DA VINCI-ASSISTED SINGLE-PORT UNSPECIFIED ¿HEAD AND NECK¿ SURGICAL PROCEDURE, THE PATIENT DEVELOPED A POSTOPERATIVE HEMORRHAGE AND ULTIMATELY EXPIRED. THE SURGEON INFORMED THE INTUITIVE CLINICAL SALES REPRESENTATIVE THAT THE ROBOTIC PROCEDURE WAS COMPLETED WITHOUT ANY INTRAOPERATIVE COMPLICATIONS; HOWEVER, THE PATIENT DEVELOPED POST-OPERATIVE COMPLICATIONS DUE TO UNSPECIFIED BLEEDING FROM THE NON-SPECIFIC PROCEDURE. NO ADDITIONAL EVENT INFORMATION WAS PROVIDED. THE SURGEON STATED THAT THE ADVERSE EVENT ¿HAD NOTHING TO DO WITH THE DA VINCI SP SYSTEM¿. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE SURGEON WERE MADE; HOWEVER, NO RESPONSE WAS RECEIVED.

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 THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE, AN INADVERTENT PERFORATION OF THE PULMONARY ARTERY OCCURRED WHILE USING A THIRD-PARTY LAPAROSCOPIC STAPLER INSTRUMENT, RESULTING IN SIGNIFICANT HEMORRHAGE AND THE PATIENT ULTIMATELY EXPIRED. THE EXACT VOLUME OF BLOOD LOSS IS UNKNOWN. THE SURGEON DOES NOT BELIEVE THAT THE DA VINCI SYSTEM, INSTRUMENTS, OR ACCESSORIES CAUSED OR CONTRIBUTED TO THE EVENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT THE CUSTOMER HAS INDICATED THAT THEY WILL NOT GRANT PERMISSION FOR FURTHER ACCESS TO THE EVENT INFORMATION.