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 TWO DAYS AFTER A SUCCESSFUL DA VINCI SI TONGUE BASE RESECTION PROCEDURE AND WHILE STILL ADMITTED, THE PATIENT EXPERIENCED BLEEDING FROM THE OPERATIVE AREA AND EXPIRED. IT WAS REPORTED THAT THE PATIENT DID EXPERIENCE BLEEDING FROM THE LINGUAL ARTERY DURING THE PROCEDURE; HOWEVER, THE BLEEDING WAS CONTROLLED WITH CAUTERY. THE SITE HAS BEEN CONTACTED FOR ADDITIONAL INFORMATION WITHOUT SUCCESS.

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-ASSISTED ROBOTIC CORONARY ARTERY BYPASS GRAFT PROCEDURE FOR CORONARY ARTERY DISEASE ON (B)(6) 2012. ISI WAS PROVIDED WITH THE DA VINCI SURGERY OPERATIVE REPORT (S) AND SUBSEQUENT MEDICAL RECORDS INCLUDING AUTOPSY REPORTS. A CAREFUL REVIEW OF THE MEDICAL DOCUMENTATION WAS CONDUCTED. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT, AND/OR ACCESSORY DURING THE OPERATION. THERE WERE NO INTRA-OPERATIVE COMPLICATIONS. THE PATIENT'S IMMEDIATE POST-OP RECOVERY IN THE HOSPITAL WAS EXCELLENT. AFTER THE DA VINCI SURGERY WAS COMPLETED, THE PATIENT PRESENTED WITH THE FOLLOWING: ON (B)(6) 2012, THE PATIENT DEVELOPED FEVER AND SHORTNESS OF BREATH. AN EKG TEST WAS PERFORMED AND THE PATIENT WAS FOUND TO HAVE A RIGHT BUNDLE BRANCH HEART BLOCK. ON (B)(6) 2012, A CARDIAC MRI REVEALED THAT THE PATIENT HAD MYOCARDITIS. THE PATIENT CONTINUED TO BE FEBRILE AND SUBSEQUENTLY BECAME HYPOTENSIVE AND HYPOXIC. ON (B)(6) 2012, THE PATIENT WAS TRANSFERRED TO THE CCU FOR ICU TREATMENT. THAT SAME DAY WHILE IN THE CATH LAB FOR PULMONARY ARTERY (PA) CATHETE

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 WHO UNDERWENT A SLEEP NASAL ENDOSCOPY, UVULOPALATOPHARYNGOPLASTY AND TONGUE BASE REDUCTION WITH DA VINCI TRANSORAL ROBOTIC SURGERY (TORS) PROCEDURE ON (B)(6) 2012 FOR SEVERE OBSTRUCTIVE SLEEP APNEA AND CPAP INTOLERANCE. ISI WAS PROVIDED WITH THE OPERATIVE REPORT AND THE PATIENT'S MEDICAL RECORDS. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. PER THE OPERATIVE REPORT, THE PATIENT WAS FOUND TO HAVE PROFOUND LINGUAL TONSIL HYPERPLASIA WHICH LED TO IMMEDIATE UPPER AIRWAY OBSTRUCTION UPON LOW DOSE ADMINISTRATION OF PROPOFOL. TO A LESSER EXTENT, THE PATIENT HAD UVULA AND SOFT PALATAL COLLAPSE. A TOTAL OF 19 ML OF TONGUE BASE WAS REMOVED. AS HEMOSTATIC AGENT WAS BEING APPLIED, BRISK BLEEDING WAS NOTED IN THE LEFT HYPOPHARYNX AND A THROAT PACK WAS PLACED. AFTER ALLOWING ADEQUATE TIME FOR HEMOSTASIS, THE THROAT PACK WAS GRADUALLY ADVANCED OUT OF THE HYPOPHARYNX AND EXPOSURE WAS ACHIEVED WITH A MOUTH GAG AND ROBOTIC CAMERA. THE SURGEON NOTED THAT THE LIKELY SOURCE OF BLEEDING WAS A SMALL BRANCH OF THE LINGUAL AR

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 4 HOURS INTO A DA VINCI S PROSTATECTOMY PROCEDURE, IT WAS NOTED BY THE ANESTHESIOLOGIST THAT THE PATIENT'S HEALTH WAS DECLINING. SEVERAL ATTEMPTS BY THE SURGICAL TEAM WERE MADE TO REVERSE THE PATIENT'S CONDITION, HOWEVER, THE ATTEMPTS WERE UNSUCCESSFUL AND THE PATIENT EXPIRED. NO OTHER ADDITIONAL 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: IT WAS REPORTED THAT AFTER AN UNCOMPLICATED DA VINCI HYSTERECTOMY PROCEDURE WAS SUCCESSFULLY COMPLETED, THE PATIENT EXPIRED LATER THAT NIGHT.