da Vinci Surgical 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 A DA VINCI-ASSISTED CHOLECYSTECTOMY PROCEDURE, THE PATIENT SIDE MANIPULATOR (PSM) 2 ALLEGEDLY MOVED ON ITS OWN WITH A PERMANENT CAUTERY HOOK INSTRUMENT INSTALLED. THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART (PSC) THAT PROVIDES STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENT. THE EVENT REPORTEDLY OCCURRED WHILE THE SURGEON WAS WAITING FOR INSTRUMENT REMOVAL. AS A RESULT, THE INITIAL REPORTER INDICATED THAT THE INSTRUMENT INJURED THE PATIENT'S LIVER AND BLEEDING ENSUED. AFTER THE SURGEON CONTROLLED THE BLEEDING USING CAUTERY WITH THE SAME PERMANENT CAUTERY HOOK INSTRUMENT, THE SURGICAL STAFF PROCEEDED WITH THE SURGICAL PROCEDURE. WHEN THE EVENT OCCURRED, THE INITIAL REPORTER AND SURGICAL STAFF CONTACTED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOR SUPPORT. THE TSE INFORMED THE INITIAL REPORTER OF THE POSSIBLE CAUSES OF THE PSM DRIFTING. THE INITIAL REPORTER WAS GOING TO FOLLOW UP WITH THE SURGEON TO ENSURE HE REMOVES HIS HEAD FROM THE HIGH RESOLUTION STEREO VIEWER (HRSV) BEFORE RELEASING HIS GRIPS ON THE MASTER TOOL MANIPULATORS (MTMS). ON 12/05/2016, ISI CONTACTED THE INITIAL REPORTER AND OBTAINED THE FOLLOWING I

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 COMPLETION OF A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE, THE PATIENT WAS FOUND TO HAVE SUSTAINED A BOWEL INJURY THAT WAS NOT IDENTIFIED INTRA-OPERATIVELY. THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) WAS INFORMED ABOUT THE REPORTED EVENT FROM THE SURGEON'S 1ST ASSIST. THE CSR WAS NOT PRESENT DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE. THERE WERE NO REPORTS OF ANY INTRA-OPERATIVE COMPLICATIONS. THERE WAS ALSO NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. AFTER THE SURGICAL PROCEDURE WAS COMPLETED, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON AN UNKNOWN DATE. ON (B)(6) 2016, THE PATIENT RETURNED TO THE HOSPITAL AND WAS SEPTIC. AN EXPLORATORY LAPAROTOMY WAS PERFORMED ON THE PATIENT AND A HOLE WAS FOND ON THE TRANSVERSE COLON. PER THE CSR, THE SURGEON INFORMED HIM THAT DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE, HE WAS NOWHERE NEAR WHERE THE BOWEL INJURY WAS LOCATED. ACCORDING TO THE CSR, THE SITE DOES NOT KNOW WHAT CAUSED THE BOWEL INJURY. HOWEVER, THE CSR INDICATED THAT THE SITE IS SUSPECTING THAT THE BOWEL INJURY OCCURRED DURING INSERTION OF AN

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE, THE SURGICAL STAFF ENCOUNTERED A DOUBLE-VISION ISSUE. THERE WERE NO REPORTS OF ANY PATIENT HARM ACCORDING TO THE INITIAL REPORTER, A ROBOTICS COORDINATOR. ON 12/15/2016, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE'S RISK MANAGER AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT. IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE, THE SURGEON ENCOUNTERED A DOUBLE-VISION ISSUE WITH THE DA VINCI SI SURGICAL SYSTEM AND WAS EXPERIENCING MIGRAINE-LIKE SYMPTOMS. THE ISI CLINICAL SALES REPRESENTATIVE (CSR) USED A BACKUP CAMERA TO REPLACE THE CAMERA OF THE PATIENT SIDE CART (PSC). THE RISK MANAGER STATED THAT PATIENT HARM OCCURRED DURING THE SURGICAL PROCEDURE. HOWEVER, THE RISK MANAGER DID NOT HAVE ACCESS TO THE PATIENT'S RECORDS AND COULD NOT PROVIDE ADDITIONAL DETAILS REGARDING THE PATIENT HARM. ISI ALSO CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR). THE CSR INDICATED THAT HE WAS AT ANOTHER HOSPITAL AND IN THE MIDDLE OF ANOTHER DA VINCI-ASSISTED SURGICAL PROCEDURE WHEN THE ROBOTICS COORDINATOR CALLED HIM FOR ASSISTANCE WITH THE DOUBLE-VISION ISSUE. ACCORDING TO THE CSR, AT T

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ATTORNEYS HAVE ALLEGED THAT THEIR CLIENTS SUFFERED INJURIES ASSOCIATED WITH DA VINCI SURGICAL PROCEDURES. THESE CLAIMS DO NOT INVOLVE REPORTABLE DEATHS OR MALFUNCTIONS. THESE ALLEGATIONS WERE RECEIVED BY INTUITIVE SURGICAL, INC.(ISI) BETWEEN JULY 2, 2016 - OCTOBER 1, 2016. FOR THOSE CLAIMS WHERE PROCEDURE DATES ARE PROVIDED, THE DATES RANGE FROM FEBRUARY 2013 - APRIL 2015.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS BEEN REPORTED THAT DURING A SURGERY, A SOFTWARE FAILURE HAS BEEN DETECTED. THE WRIST OF THE ROBOT ARM HIT THE MAYFIELD SCREW, CAUSING A COLLISION THAT MADE THE SYSTEM SHUT DOWN. BECAUSE THERE WAS STILL PRESSURE BEING PUT ON THE ROBOT ARM BY THE MAYFIELD SCREW, THE SURGEON COULDN'T POWER THE ARM AGAIN TO MOVE IT IN COOPERATIVE MODE AND RESUME SURGERY. A SURGERY DELAY HAS BEEN REPORTED BETWEEN 30 MINUTES AND 1 HOUR.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING ROBOTIC ASSISTED LAPAROSCOPIC RADICAL PROSTATECTOMY A 1.5 CM PIECE OF PLASTIC SHEATH FROM THE MONOPOLAR CURVED SCISSORS CAME OFF OF THE DEVICE AND COULD NOT BE LOCATED. THE SCISSORS WERE NOTED TO HAVE A CRACK IN THE PLASTIC HOUSING DURING THE CASE. THE INSTRUMENT AND PORT WERE REMOVED AND A PIECE OF THE PLASTIC HOUSING WAS NOTED TO BE MISSING. THE SURGICAL TEAM INSPECTED THE SURGICAL FIELD AND THE ABDOMEN THROUGH BOTH THE CAMERA AND AIRSEAL PORT. THEY ALSO EXTENDED THE PORT INCISION AND INSPECTED THE ABDOMINAL WALL. THEY WERE UNABLE TO LOCATE THE MISSING FRAGMENT.

ROSA Robotic Surgery — 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 A SURGERY, THE HEAD HOLDER ADAPTOR WAS NON-FUNCTIONAL. A SECOND REGISTRATION WAS REQUIRED DUE TO MOVEMENT OF THE PATIENT'S HEAD. A DELAY OF 30 MINUTES WAS REPORTED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PT UNDERWENT ROBOTIC PROSTATECTOMY WITH S1. AFTER ROBOT DOCKED, SURGEON NOTED HAD CONTROLS WERE NOT COINCIDING WITH THE INSTRUMENTS INSIDE THE PT. CALLED TO INTUITIVE TECHNICAL SUPPORT LINE WITH REAL TIME TROUBLE SHOOTING FOR 45 MINUTES. TECH REP UNABLE TO RESOLVE ISSUE. THE ROBOTIC PROSTATECTOMY WAS ABORTED, THE PROCEDURE CONVERTED TO AN OPEN PROSTATECTOMY FOR PT SAFETY. F/U INVESTIGATION FOUND A WIRE FROM AN ELECTRICAL BOARD ON THE CAMERA ARM AT THE UPPER JOINT HAD ACTUALLY BEEN CAUGHT IN THE JOINT. WHEN THE ARM WAS MOVED SIDE TO SIDE IT WOULD CAUSE TENSION EFFECT ON THE WIRE. THE WIRE HAD COMPLETELY SEVERED. THIS DID NOT SHOW UP ON THE IT DATA REPORT BUT WAS DISCOVERED UPON VISUAL EXAM OF THE ROBOTIC ARM.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS BEEN REPORTED THAT DURING A SURGERY, THE PC WAS NON-FUNCTIONAL. NO PATIENT IMPACT WAS REPORTED. A SURGERY DELAY HAS BEEN REPORTED OF 40 MINUTES.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS BEEN REPORTED THAT DURING A SURGERY, A SOFTWARE FAILURE WAS DETECTED. APPROX 9 OF 12 TRAJECTORIES WERE INACCESSIBLE WITH THE DISTANCE SENSOR. THE SYSTEM WAS RESTARTED AND THE SURGERY CONTINUED WITHOUT FURTHER ISSUE. A SURGERY DELAY OF 30-40 MINUTES WAS REPORTED.

da Vinci Surgical 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 APPROXIMATELY 2 WEEKS POST A SUCCESSFUL DA VINCI ASSISTED SINGLE-VESSEL SMALL THORACOTOMY PROCEDURE; THE PATIENT HAD DIMINISHED BRAIN FUNCTION. CURRENTLY THE PATIENT IS IN A COMA. ON 11/16/2016, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON WHO ASSISTED DURING THE PROCEDURE; HE STATED THAT APPROXIMATELY TWO WEEKS POST-OPERATIVELY, THE PATIENT WAS ADMITTED INTO THE EMERGENCY ROOM WITH DIMINISHED BRAIN FUNCTION. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL AFTER THE INTERNAL MAMMARY ARTERY THAT HAD BEEN HARVESTED ROBOTICALLY DURING THE PROCEDURE TWO WEEKS PREVIOUSLY WAS FOUND TO BE BLEEDING. THE SURGEON STATED HE COULD NOT CONFIRM ANY ROOT CAUSE FOR THE BLEEDING; HOWEVER, HE STATED THAT SINCE IT HAPPENED TWO WEEKS AFTER THE PROCEDURE HE BELIEVES THE COAGULUM COULD HAVE SLOUGHED OFF. AS PER THE HOSPITAL'S FOLLOW THE HEART PROGRAM, THE PATIENT WAS MONITORED AND WAS DOING WELL UNTIL THIS ACUTE EVENT HAPPENED. THE IMA HARVESTING WAS DONE ROBOTICALLY AND THE REST OF THE PROCEDURE WAS DONE AS A TRADITIONAL OPEN PROCEDURE. ON FURTHER FOLLOW UP WITH THE ISI CLINICAL SALES MANAGER IT WAS STATED THAT WHEN THE PATIENT CAME IN WITH A DIMINISHED BRAIN FUNCTION THE B

ROSA Robotic Surgery — 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 A SURGERY, THE ROBOT ARM COLLIDED WITH THE ROBOT STAND REFERENCE.

da Vinci Surgical 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 POST A SUCCESSFUL DA VINCI ASSISTED HYSTERECTOMY PROCEDURE ON AN UNSPECIFIED DATE, DURING THE PATIENT'S POST-OPERATIVE RECOVERY, THE PATIENT'S HEMOGLOBIN LEVELS HAD DROPPED. THE HOSPITAL STATED THEY WERE NOT ABLE TO LOCATE THE SOURCE AND THE PATIENT WAS ADMINISTERED 2 UNITS OF BLOOD AND THE POST-OPERATIVE BLEEDING WAS REPORTED TO HAVE RESOLVED ON ITS OWN. THE PATIENT WAS RELEASED FROM THE HOSPITAL THE FOLLOWING DAY. ON 10/12/2016, THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) WHO INITIALLY REPORTED THIS COMPLAINT PROVIDED ADDITIONAL INFORMATION, AFTER MEETING WITH THE APPLICABLE HOSPITAL STAFF, STATING THAT THE SURGEON DID NOT EXPERIENCE ANY MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE PLANNED PROCEDURE. THE SURGEON USED THE MARYLAND BIPOLAR FORCEPS INSTRUMENT TO SEAL VESSELS AND USED THE AUTO STOP FEATURE FOR THE BIPOLAR COAGULATION MODE ON THE ERBE VIO DV ELECTROSURGICAL (ESU) GENERATOR. THE SURGEON'S INTERPRETATION OF THIS FEATURE WAS THAT COMPLETION OF THE AUTO STOP TONE WAS AN INDICATION THAT A VESSEL WAS ADEQUATELY SEALED. ACCORDING TO THE CSR, AFTER COMPLETION OF THE AUTO STOP TONE, THE SURGE

da Vinci Surgical 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 POST A SUCCESSFUL DA VINCI ASSISTED HYSTERECTOMY PROCEDURE ON AN UNSPECIFIED DATE, THE PATIENT'S HEMOGLOBIN LEVELS HAD DROPPED. THE PATIENT UNDERWENT AN ADDITIONAL SURGICAL PROCEDURE; HOWEVER THE HOSPITAL STATED THEY WERE NOT ABLE TO LOCATE THE SOURCE. THE PATIENT WAS ADMINISTERED 2 UNITS OF BLOOD AND THE POST-OPERATIVE BLEEDING WAS REPORTED TO HAVE RESOLVED ON ITS OWN. THE PATIENT WAS RELEASED FROM THE HOSPITAL THE FOLLOWING DAY. ON 10/12/2016, THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) WHO INITIALLY REPORTED THIS COMPLAINT PROVIDED ADDITIONAL INFORMATION, AFTER MEETING WITH THE APPLICABLE HOSPITAL STAFF, STATING THAT THE SURGEON DID NOT EXPERIENCE ANY MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE PLANNED PROCEDURE. THE SURGEON USED THE MARYLAND BIPOLAR FORCEPS INSTRUMENT TO SEAL VESSELS AND USED THE AUTO STOP FEATURE FOR THE BIPOLAR COAGULATION MODE ON THE ERBE VIO DV ELECTROSURGICAL (ESU) GENERATOR. THE DATE OF THE REPORTED EVENT WAS NOT PROVIDED BY THE HOSPITAL AND THERE IS NO VIDEO RECORDING OF THE PLANNED SURGICAL PROCEDURE.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS BEEN REPORTED THAT DURING A SURGERY, A SOFTWARE FAILURE HAS BEEN DETECTED. INCORRECT AUTOMATIC IMAGE FUSION WITH STEREOTACTIC FRAME WAS REPORTED. A SURGERY DELAY OF 2 HOURS HAS BEEN REPORTED.

da Vinci Surgical 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 POST A SUCCESSFUL DA VINCI ASSISTED CHOLECYSTECTOMY PROCEDURE ON AN UNSPECIFIED DATE, DURING THE PATIENT'S POST-OPERATIVE RECOVERY, THE PATIENT'S HEMOGLOBIN LEVELS HAD DROPPED. THE PATIENT UNDERWENT AN ADDITIONAL SURGICAL PROCEDURE TO DETERMINE THE SOURCE OF THE BLEEDING; HOWEVER, THE HOSPITAL STATED THEY WERE NOT ABLE TO LOCATE THE SOURCE. THE PATIENT WAS ADMINISTERED 2 UNITS OF BLOOD AND THE POST-OPERATIVE BLEEDING WAS REPORTED TO HAVE RESOLVED ON ITS OWN. THE PATIENT WAS RELEASED FROM THE HOSPITAL THE FOLLOWING DAY. ON 10/12/2016, THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) WHO INITIALLY REPORTED THIS COMPLAINT PROVIDED ADDITIONAL INFORMATION, AFTER MEETING WITH THE APPLICABLE HOSPITAL STAFF, STATING THAT THE SURGEON DID NOT EXPERIENCE ANY MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE PLANNED PROCEDURE. THE SURGEON USED THE MARYLAND BIPOLAR FORCEPS INSTRUMENT TO SEAL VESSELS AND USED THE AUTO STOP FEATURE FOR THE BIPOLAR COAGULATION MODE ON THE ERBE VIO DV ELECTROSURGICAL (ESU) GENERATOR. THE SURGEON'S INTERPRETATION OF THIS FEATURE WAS THAT COMPLETION OF THE AUTO STOP TONE WAS AN INDICATION THA

da Vinci Surgical 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 A DA VINCI-ASSISTED CHOLECYSTECTOMY PROCEDURE, THE SURGEON GOT INTO BLEEDING AND THE CASE WAS CONVERTED TO OPEN SURGERY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT LOST 2700 CC OF BLOOD AND WAS ALSO GIVEN 4 UNITS OF BLOOD. IT WAS ALSO REPORTED THAT THE SURGEON TRANSECTED AND CLIPPED THE COMMON DUCT DURING THE SURGICAL PROCEDURE. ON (B)(6) 2016, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE CSR WAS IN THE OR ON THE DAY OF THE SURGERY BUT HAD ALREADY LEFT WHEN THE REPORTED EVENT OCCURRED. AT THE BEGINNING OF THE SURGERY, THE CSR NOTED THE PATIENT'S GALLBLADDER AS BEING THICK AND ABNORMAL. HE ALSO STATED THAT THE PATIENT'S CYSTIC DUCT WAS VERY SHORT. FIREFLY WAS USED DURING THE SURGICAL PROCEDURE. AFTER THE REPORTED EVENT OCCURRED, THE CSR SPOKE TO THE SURGEON AND THE SITE'S ROBOTICS COORDINATOR. ACCORDING TO THE CSR, THE SURGEON THOUGHT HE HAD CLIPPED AND TRANSECTED THE CYSTIC DUCT. HOWEVER, THE SURGEON HAD INADVERTENTLY CLIPPED AND TRANSECTED THE COMMON BILE DUCT INSTEAD. AFTER REPAIRING THE COMMON BILE DUCT, THE SURGEON PROCEEDED WITH THE S

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS BEEN REPORTED THAT DURING A SURGERY, A SOFTWARE FAILURE WAS DETECTED. SEVERAL SOFTWARE COMMUNICATION ERRORS OCCURRED. THE PROCEDURE WAS COMPLETED WITH A TRADITIONAL SURGERY TECHNIQUE.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS BEEN REPORTED THAT DURING A SURGERY, A SOFTWARE FAILURE HAS BEEN DETECTED. IT WAS REPORTED THAT WHEN THE STAFF WAS PERFORMING A REGISTRATION, THE ROBOTIC ARM COULD NOT MOVE IN COOPERATIVE MODE A COMMUNICATION FAILURE OCCURRED AND THE CONTROLLER BEGAN TO BEEP. THE SURGEON REPORTED THAT HE WAS ABLE TO PLAN THE POINTS ON THE FACE FOR CONTACTLESS REGISTRATION, BUT WHEN IT CAME TIME FOR HIM TO MOVE THE ARM IN COOPERATIVE MODE, REGARDLESS OF WHETHER OR NOT THE ARM WAS PUT IN FAST OR SLOW, THE ARM REFUSED TO MOVE. HE SAID THAT HIS STAFF HAD TRIED THIS ABOUT 10 TIMES AND THE ARM CONTINUED TO HAVE A COMMUNICATION FAILURE AND SHUT DOWN. IT HAS BEEN REPORTED THAT THE SURGERY HAS BEEN CANCELLED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS BEEN REPORTED THAT DURING A SURGERY, A SOFTWARE FAILURE HAS BEEN DETECTED. IT WAS IMPOSSIBLE TO PERFORM THE REGISTRATION STEP. REGISTRATION AND VERIFICATION ERRORS OCCURRED THREE TIMES WHEN ATTEMPTING TO REGISTER THE PATIENT USING THE LASER REGISTRATION IN THE HYBEX HEAD FRAME. THE FIRST TWO TIMES WERE ON THE SAME MRI, AND THE THIRD TIME WAS ON A DIFFERENT MRI. AFTER LOOKING AT THE VERIFICATION ON THE 4TH ATTEMPT, THE SURGEON DECIDED TO MOVE FORWARD WITH THE CASE. A SURGERY DELAY HAS BEEN REPORTED OF 3 HOURS.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS BEEN REPORTED THAT DURING A SURGERY, A SOFTWARE FAILURE HAS BEEN DETECTED. IT WAS REPORTED THAT WHEN TRYING TO OPEN UP AN EXISTING PATIENT FOLDER, IT WAS SEEN THAT THE PATIENT FOLDER WAS NOT THERE. A SURGERY DELAY HAS BEEN REPORTED OF 1 HOUR.

ROSA Robotic Surgery — 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 A BRAIN STEM BIOPSY, THE HEAD HOLDER ADAPTOR WAS NON-FUNCTIONAL. THE SURGEON PREPARED THE MAYFIELD ADAPTER AND LOOSENED THE SCREW TO BRING THE ADAPTER IN THE RIGHT POSITION. WHEN HE TRIED TO FIX IT AGAIN, HE WAS NOT ABLE TO FIX THE ADAPTER, BECAUSE THE SCREW WAS STUCK. IT WAS REPORTED THAT THE SURGERY WAS CANCELLED.

CyberKnife — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A SYSTEM TECHNICIAN RECEIVED AN ELECTRIC SHOCK WHILE MAKING ADJUSTMENTS IN THE EQUIPMENT ROOM.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS BEEN REPORTED THAT DURING A SURGERY, A SOFTWARE FAILURE HAS BEEN DETECTED. THE SURGEON REPORTED 2 SOFTWARE CRASHES WHILE CHECKING THE ACCESSIBILITY TO THE TRAJECTORY. THE SURGEON REBOOTED THE SYSTEM AND CONTINUED WITH THE SURGERY. A DELAY OF 30 MINUTES TO SURGERY WAS REPORTED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS BEEN REPORTED THAT DURING A SURGERY, A SOFTWARE FAILURE HAS BEEN DETECTED. THIS ISSUE HAS BEEN IDENTIFIED DURING THE PATIENT DATA FILE CREATION. THERE WAS ONE HOUR DELAY ON THE SURGERY.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS WAS REPORTED THAT DURING A SURGERY THERE WAS A LASER INACCURACY OBSERVED DURING THE REGISTRATION PROCESS. THE REGISTRATION WAS REPEATED TWICE AND THE SURGEON DECIDED TO PROCEED WITH SURGERY. A DELAY OF 30 MINUTES WAS REPORTED.

da Vinci Surgical 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 APPROXIMATELY A FEW DAYS AFTER COMPLETION OF A DA VINCI-ASSISTED CHOLECYSTECTOMY PROCEDURE, A SMALL HOLE THAT WAS DESCRIBED AS BEING PIN POINT IN SIZE WAS FOUND IN THE BOWEL. AS A RESULT THE PATIENT CAME BACK WITH UNSPECIFIED SIGNS OF INFECTION AND UNDERWENT AN EXPLORATORY LAPAROTOMY PROCEDURE ON AN UNSPECIFIED DATE TO REPAIR THE HOLE IN THE BOWEL. ON 09/30/2016, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE CSR STATED THAT HE WAS NOT PRESENT DURING THE SURGICAL PROCEDURE AND THAT THE PROCEDURE WAS NOT RECORDED. APPROXIMATELY A FEW DAYS AFTER THE PROCEDURE THE CSR BELIEVES THE PATIENT CAME BACK TO THE HOSPITAL WITH SIGNS OF INFECTION. TO HIS KNOWLEDGE, THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY PROCEDURE ON AN UNSPECIFIED DATE TO REPAIR THE HOLE. THE CSR MENTIONED THAT OTHER LAPAROSCOPIC INSTRUMENTS WERE USED DURING THE INITIAL CHOLECYSTECTOMY SURGICAL PROCEDURE. WHEN THE CSR FOLLOWED UP WITH THE SURGEON, THE SURGEON STATED ROBOTICALLY THE SURGERY WENT VERY WELL. THERE WERE NO REPORTS OF ANY INTRA-OPERATIVE COMPLICATIONS. ACCORDING TO THE CSR, TH

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2017, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA VOLUNTARY REPORT MW5066629 WITH THE FOLLOWING EVENT DESCRIPTION: ON (B)(6) 2016 MY SON, (B)(6) HAD HIS GALL BLADDER REMOVED AT (B)(6) HOSPITAL BY ROBOTIC SURGERY. TWO DAYS LATER I TOOK HIM TO THE ER WHERE IT WAS DISCOVERED THAT HIS SMALL INTESTINES HAD BEEN PUNCTURED DURING SURGERY. ULTIMATELY, HE HAD TO HAVE SMALL BOWEL RESECTION, HE HAD PERITONITIS, ETC. LIST ALL CURRENT PRESCRIPTION MEDICATIONS AND MEDICAL DEVICES BEING USE: NONE, JUST FINISHED A 2-PACK, AS HE WAS JUST DIAGNOSED WITH PNEUMONIA. LIST ALL OVER-THE-COUNTER MEDICATIONS: NONE (ADVIL FOR PAIN) OCCASIONALLY, WHEN HE CANNOT STAND IT. ON (B)(6) 2017, ISI CONTACTED THE INITIAL REPORTER. HOWEVER, THE INITIAL REPORTER WAS UNWILLING TO PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE FOLLOWING INFORMATION IS UNKNOWN AT THIS TIME: HOSPITAL NAME WHERE THE DA VINCI-ASSISTED SURGICAL PROCEDURE WAS PERFORMED AND THE NAME OF THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ADDITIONAL INFORMATION RECEIVED FROM REPORTER ON 03/01/2017 FOR MW5066629: I SUBMITTED A MEDICAL DEVICE REPORT AFTER MY SON WAS INJURED FOLLOWING SURGERY WITH A DA VINCI ROBOTIC SYSTEM. (MW5066629) AFTER I SUBMITTED MY REPORT TO YOUR AGENCY, I RECEIVED A CALL FROM SOMEONE IN THE REGULATORY COMPLAINTS DEPARTMENT AT INTUITIVE SURGICAL (MAKERS OF THE DA VINCI ROBOTIC SYSTEM). HE SAID HE HAD RECEIVED A COPY OF MY SON'S INJURY REPORT FROM THE FDA AND HE WANTED TO KNOW THE NAME OF THE SURGEON AND THE HOSPITAL WHERE THE INJURY HAPPENED. HE HAD THE DATE OF THE SURGERY, KNEW FROM MY AREA CODE THAT I WAS FROM THE (B)(6) AREA AND SAID HE DID HAVE ONE REPORT OF AN INJURY BEING REPORTED IN (B)(6) ON OR AROUND THAT DATE. ((B)(6) 2016 WAS THE DATE OF THE INITIAL SURGERY, (B)(6) 2016 WAS THE DATE OF THE EMERGENCY SURGERY AFTER THE INJURY WAS DISCOVERED). I RESPONDED, "OH GOOD, SO THE SURGEON OR THE HOSPITAL DID REPORT THE INJURY PROCEEDING THE DA VINCI SURGERY TO YOUR COMPANY." THE MAN IN THE REGULATORY DEPARTMENT THEN SAID, "WELL NOT EXACTLY, THE SURGEON REPORTED THE INJURY TO OUR DA VINCI SALES PERSON, AND I FILED MY REPORT TO THE FDA BASED UPON WHAT OUR SALES PERSON REPORTED TO ME." (I FOUND IT

da Vinci Surgical 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 POST A DA VINCI ASSISTED HYSTERECTOMY PROCEDURE, IT WAS DISCOVERED THAT THE PATIENT'S URETER WAS CUT. THE PATIENT UNDERWENT 2 SUBSEQUENT SURGICAL PROCEDURES AND IS GOING TO UNDERGO A 3RD PROCEDURE TO REPAIR THE DAMAGE TO HER URETER. IT WAS ALSO REPORTED THAT THE PATIENT HAS A BAG. ON (B)(6) 2016 INTUITIVE SURGICAL, INC. (ISI) OBTAINED ADDITIONAL INFORMATION FROM THE PATIENT REGARDING THE REPORTED EVENT. ACCORDING TO THE PATIENT, SHE UNDERWENT THE PLANNED SURGICAL PROCEDURE ON (B)(6) 2016 AND WAS RELEASED FROM THE HOSPITAL THE FOLLOWING DAY. ON POST-OP DAY 3 SHE PRESENTED TO THE HOSPITAL'S EMERGENCY ROOM DEPARTMENT AND IT WAS DISCOVERED THAT HER URETER WAS CUT. ACCORDING TO THE PATIENT, THE DAMAGE TO HER URETER PREVENTED HER KIDNEY FROM DRAINING. IN ADDITION TO UNDERGOING TWO SUBSEQUENT LAPAROSCOPIC PROCEDURES TO RESOLVE THE DRAINAGE ISSUE SHE CURRENTLY HAS A TEMPORARY UROSTOMY BAG. SHE IS EXPECTED TO UNDERGO THE 3RD SURGICAL PROCEDURE TO REPAIR HER URETER IN APPROXIMATELY 1 MONTH. ACCORDING TO THE PATIENT, THERE WAS NO REPORT TO HER BY THE HOSPITAL THAT ANY MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM AND/OR INSTRUMENTS OCCURRED DURING THE SURGICAL PROCEDURE. TH

ROSA Robotic Surgery — 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 A SURGERY, A SOFTWARE FAILURE WAS DETECTED. A COMMUNICATION ERROR WAS IDENTIFIED. A SURGICAL DELAY BETWEEN 30 MINUTES AND 1 HOUR WAS REPORTED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS BEEN REPORTED THAT THERE WAS AN INACCURACY IN THE TRAJECTORY OF THE INSTRUMENT ADAPTOR DURING SURGERY. THE PROCEDURE WAS COMPLETED WITH A TRADITIONAL METHOD OF SURGERY.

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 COMPLETION OF A DA VINCI-ASSISTED INGUINAL HERNIA REPAIR PROCEDURE, THE PATIENT WAS READMITTED TO THE HOSPITAL TWO TIMES. THE DATES OF THE READMISSIONS ARE UNKNOWN. IN ADDITION, THE REASONS FOR THE READMISSIONS ARE UNKNOWN. ON AN UNSPECIFIED DATE POST-OPERATIVELY, THE PATIENT PASSED AWAY. ON (B)(6) 2016, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE CSR WAS NOT PRESENT DURING THE UNRECORDED DA VINCI-ASSISTED SURGICAL PROCEDURE. THERE WERE NO REPORTS OF ANY INTRA-OPERATIVE COMPLICATIONS. AFTER THE PATIENT PASSED AWAY ON AN UNSPECIFIED DATE, AN AUTOPSY WAS PERFORMED AND 3 SEPARATE PUNCTURE HOLES WERE FOUND ON THE PATIENT'S BOWEL. THE CSR DID NOT KNOW THE CAUSE OF THE BOWEL DEFECTS OR THE PATIENT'S DEATH.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ATTORNEYS HAVE ALLEGED THAT THEIR CLIENTS SUFFERED INJURIES ASSOCIATED WITH DA VINCI SURGICAL PROCEDURES. THESE CLAIMS DO NOT INVOLVE REPORTABLE DEATHS OR MALFUNCTIONS. THESE ALLEGATIONS WERE RECEIVED BY INTUITIVE SURGICAL, INC.(ISI) BETWEEN APRIL 1, 2016 - JULY 1, 2016. FOR THOSE CLAIMS WHERE PROCEDURE DATES ARE PROVIDED, THE DATES RANGE FROM (B)(6) 2012 - (B)(6) 2014.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS BEEN REPORTED THAT DURING A SURGERY, THE PATIENT WOKE UP, WHICH REQUIRED THE SURGEON TO PERFORM A NEW REGISTRATION. PRIOR TO THE PATIENT WAKING UP, 2 REGISTRATIONS WERE PERFORMED. AFTER THE PATIENT WOKE UP, A FURTHER 3 REGISTRATIONS WERE PERFORMED.

da Vinci Surgical 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 AFTER COMPLETION OF A DA VINCI-ASSISTED PHARYNGECTOMY PROCEDURE, THE PATIENT ALLEGEDLY SUFFOCATED BY ASPIRATION FROM LIGHT BLEEDING. ON 09/21/2017 AND 10/02/2017, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION FROM THE SITE REGARDING THE REPORTED EVENT: THERE WAS NO REPORT OR ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THE PATIENT ALSO DID NOT EXPERIENCE ANY INTRA-OPERATIVE COMPLICATIONS. POST-OPERATIVELY, ON AN UNSPECIFIED DATE, THE PATIENT DEVELOPED EDEMA IN THE THROAT AND EXPERIENCED DYSPHAGIA. IN ADDITION, THE PATIENT ALLEGEDLY EXPERIENCED SUFFOCATION AFTER ASPIRATING BLOOD. AS A RESULT, THE PATIENT WAS ADMINISTERED ARTIFICIAL RESPIRATION AND WAS TAKEN TO THE ICU. NO ADDITIONAL MEDICAL INTERVENTION WAS ADMINISTERED IN THE ICU. THE SITE ALSO INDICATED THAT NO MEDICAL INTERVENTION WAS ADMINISTERED SPECIFICALLY FOR THE POST-OPERATIVE LIGHT BLEEDING. ON 10/02/2017, ISI RECEIVED INFORMATION INDICATING THAT THE PATIENT WAS CURRENTLY IN GOOD CONDITION AND HAS SINCE BEEN DISCHARGED FROM THE HOSPITAL.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PT WAS MY SISTER (B)(6), DOB (B)(6) 1957, WHO HAD ELECTIVE SURGERY ON (B)(6) 2016 FOR A PARTIAL HYSTERECTOMY. THE SURGERY WAS PERFORMED AT (B)(6) HOSPITAL IN (B)(6), WITH A DA VINCI ROBOT. DURING THE PROCEDURE, HER BOWEL WAS PERFORATED THREE TIMES. THIS WAS UNDETECTED BY THE SURGEON OR THE MEDICAL STAFF. SHE WAS KEPT OVERNIGHT FOR OBSERVATION DUE TO PAIN ON (B)(6) 2016 AND DISCHARGED ON (B)(6) 2016. SHE LIVED ALONE AND WAS IN TOUCH FOR A WHILE WITH DISTANT RELATIVES. WHEN NOT HEARD FROM ON (B)(6) 2014 A FRIEND WAS CALLED TO DO A WELFARE CHECK ON HER. SHE WAS FOUND UNCONSCIOUS, BLUE IN COLOR, DELIRIOUS AND IN SEVERE RESPIRATORY DISTRESS FROM SEPTIC SHOCK. SHE WAS TRANSPORTED VIA AMBULANCE TO (B)(6) HOSPITAL IN (B)(6) WHERE SHE WAS DIAGNOSED WITH SEPTIC SHOCK AND PLACED INTO EMERGENCY SURGERY. SHE DIED AT APPROX 9:45PM ON SUNDAY (B)(6) 2016. THE (B)(6) MEDICAL EXAMINER REPORT STATES THE CAUSE OF DEATH WAS SEPTIC SHOCK FROM THREE PERFORATIONS OF THE BOWEL. THIS PROBLEM FROM MY RESEARCH HAPPENS IN LESS THAN 1/2 OF ONE PERCENT OF CASES THAT ARE DONE WITH NORMAL LAPAROSCOPIC SURGERY WITH NO ROBOT. IT IS MY UNDERSTANDING THAT IT HAPPENS A LOT MORE OFTEN WITH THE DA VINCI ROBOT AND IS UNDE

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 (B)(6) 2016, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA VOLUNTARY REPORT MW5064171 WITH THE FOLLOWING EVENT DESCRIPTION: PT WAS MY SISTER (B)(6), DOB (B)(6) 1957, WHO HAD ELECTIVE SURGERY ON (B)(6) 2016 FOR A PARTIAL HYSTERECTOMY. THE SURGERY PERFORMED AT (B)(6) HOSPITAL IN (B)(6), WITH A DA VINCI ROBOT. DURING THE PROCEDURE, HER BOWEL WAS PERFORATED THREE TIMES. THIS WAS UNDETECTED BY THE SURGEON OR THE MEDICAL STAFF. SHE WAS KEPT OVERNIGHT FOR OBSERVATION DUE TO PAIN ON (B)(6) 2016 AND DISCHARGED ON (B)(6) AND DISCHARGED ON (B)(6) 2016. SHE LIVED ALONE AND WAS IN TOUCH FOR A WHILE WITH DISTANT RELATIVES. WHEN NOT HEARD FROM ON (B)(6) 2014 A FRIEND WAS CALLED TO DO A WELFARE CHECK ON HER. SHE WAS FOUND UNCONSCIOUS, BLUE IN COLOR, DELIRIOUS AND IN SEVERE RESPIRATORY DISTRESS FROM SEPTIC SHOCK. SHE WAS TRANSPORTED VIA AMBULANCE TO (B)(6) HOSPITAL IN (B)(6) WHERE SHE WAS DIAGNOSED WITH SEPTIC SHOCK AND PLACED INTO EMERGENCY SURGERY. SHE DIED AT APPROX. 9:45 PM ON SUNDAY (B)(6) 2016. THE (B)(6) MEDICAL EXAMINER REPORT STATES THE CAUSE OF DEATH WAS SEPTIC SHOCK FROM THREE PERFORATIONS OF THE BOWEL. THIS PROBLEM FROM MY RESEARCH HAPPENS IN LESS THAN 1/2 OF ONE PERCENT OF CASES THAT

da Vinci Surgical 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 UNSPECIFIED DA VINCI-ASSISTED SURGICAL PROCEDURE, A PATIENT SUSTAINED AN INJURY TO THE LUNG AND AN INJURY TO THE LIVER. DETAILS REGARDING WHAT SPECIFIC TYPES OF INJURIES WERE SUSTAINED BY THE PATIENT WERE NOT PROVIDED. IN ADDITION, THE DATE AS TO WHEN THE DA VINCI SURGICAL PROCEDURE WAS PERFORMED IS UNKNOWN. ACCORDING TO THE SURGEON, THE INJURIES ALLEGEDLY OCCURRED DURING THE INSERTION OF A DYNAMIC ATRIAL RETRACTOR INSTRUMENT. THE SURGEON EXPLAINED THAT THERE IS ROUTINELY MORE RESISTANCE TO PASS INSTRUMENTS ON THE XI THAN ON THE SI SURGICAL SYSTEMS. THE SURGEON WAS REFERRING TO THE DIFFERENCE IN RESISTANCE WHEN INSERTING AN INSTRUMENT THROUGH A CANNULA SEAL ON THE DA VINCI XI SURGICAL SYSTEM COMPARED TO THE DA VINCI SI SURGICAL SYSTEM. THE SURGEON FURTHER STATED THAT THERE HAS BEEN NO RECURRENCE OF THE ISSUE AT THE SITE AND THE SURGICAL TEAM LEARNED FROM THE EXPERIENCE WITH A BETTER UNDERSTANDING OF THE RESISTANCE DIFFERENCES BETWEEN THE CANNULA SEALS OF THE TWO DA VINCI SURGICAL SYSTEMS. THE PATIENT REPORTEDLY REQUIRED SURGERY TO REPAIR THE LIVER INJURY THE DAY AFTER THE DA VINCI-ASSISTED SURGICAL PROCEDURE WAS PERFORMED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS BEEN REPORTED THAT DURING A SURGERY, A SOFTWARE FAILURE WAS DETECTED. A COMMUNICATION ERROR HAS BEEN IDENTIFIED. A SURGERY DELAY HAS BEEN REPORTED BETWEEN 30 MINUTES AND 1 HOUR.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING THE REGISTRATION STEP, IT HAS BEEN REPORTED THAT A SOFTWARE FAILURE WAS DETECTED. A COMMUNICATION ERROR HAS BEEN IDENTIFIED. A SURGERY DELAY HAS BEEN REPORTED BETWEEN 30 MINUTES AND 1 HOUR.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS BEEN REPORTED THAT DURING A SURGERY, A SOFTWARE FAILURE WAS DETECTED. A COMMUNICATION ERROR HAS BEEN IDENTIFIED. A SURGERY DELAY HAS BEEN REPORTED ABOUT 1 HOUR.

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 INITIALLY REPORTED THAT AFTER COMPLETION OF A DA VINCI-ASSISTED TRANSORAL ROBOTIC (TORS) PROCEDURE, THE PATIENT ALLEGEDLY EXPERIENCED A CAROTID BLEED AND BLED TO DEATH. ON JULY 26, 2016, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: ISI WAS INFORMED OF THE PATIENT DEATH BY THE SURGEON. THE DA VINCI-ASSISTED SURGICAL PROCEDURE WAS PERFORMED ON (B)(6) 2016 AND WAS UNRECORDED ON VIDEO. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THERE WERE ALSO NO REPORTS OF ANY INTRA-OPERATIVE COMPLICATIONS. THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED. ON (B)(6) 2016, THE CAROTID BLEED WAS IDENTIFIED AND THE PATIENT PASSED AWAY THE SAME DAY. PRIOR TO PASSING AWAY, IT IS UNKNOWN IF THE PATIENT RECEIVED ANY MEDICAL INTERVENTION DUE TO THE CAROTID BLEED. IT IS UNCLEAR AT THIS TIME IF AN AUTOPSY HAS BEEN OR WILL BE PERFORMED. NO FURTHER CLINICAL INFORMATION WAS PROVIDED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS BEEN REPORTED THAT DURING A SURGERY, THE ROBOT ARM WAS NON-FUNCTIONAL. A COLLISION OCCURED LEADING TO SOFTWARE CRASH. A SURGERY DELAY OF 1 HOUR HAS BEEN REPORTED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS BEEN REPORTED THAT AFTER COMPLETION OF THREE SEPARATE DA VINCI-ASSISTED SURGICAL PROCEDURES, EACH PATIENT DEVELOPED A SERIOUS POST-OPERATIVE INFECTION/ABSCESS. AS A RESULT OF THE POST-OPERATIVE COMPLICATIONS, TWO OF THE PATIENTS UNDERWENT A FOLLOW-UP, UNSPECIFIED SURGICAL PROCEDURE AND WERE THEN ADMITTED TO THE INTENSIVE CARE UNIT (ICU). THE TWO PATIENTS WERE REPORTEDLY RECEIVING ARTIFICIAL RESPIRATION. THE THIRD PATIENT WAS SCHEDULED TO UNDERGO AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2016, BUT IT IS UNKNOWN WHETHER THIS OCCURRED. ALL THREE PATIENTS HAD BLOOD RESULTS THAT WERE POSITIVE FOR DIFFERENT STRAINS OF ESCHERICHIA COLI (E.COLI) BACTERIA. ON JULY 22, 26, AND 29, 2016, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED POST-OPERATIVE INFECTIONS: REPORTEDLY, TWO OF THE AFFECTED PATIENTS UNDERWENT DA VINCI-ASSISTED RADICAL PROSTATECTOMY PROCEDURES ON (B)(6) 2016. BOTH SURGICAL PROCEDURES WERE PERFORMED BY THE SAME SURGEON. THE THIRD PATIENT REPORTEDLY HAD A DA VINCI-ASSISTED RADICAL PROSTATECTOMY PROCEDURE ON (B)(6) 2016, BY A DIFFERENT SURGEON. ALL THREE PATIENTS RECEIVED CEFUROXIME, AN ANTIBIOTIC, INTRAVENOUSLY. 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: ON DECEMBER 12, 2017, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA VOLUNTARY REPORT MW5073827, WITH THE FOLLOWING EVENT DESCRIPTION: ON (B)(6), MY MOTHER (B)(6), (DOB (B)(6)) WAS OPERATED ON VIA DA VINCI ROBOTIC PROCEDURE BY TWO PHYSICIAN AT ROPER HOSPITAL IN (B)(6) FOR RIGHT UPPER LOBECTOMY. SHE IMMEDIATELY COMPLAINED OF ABDOMINAL PAIN (NEAR 8TH INTERCOSTAL SPACE WHERE CAMERA FROM ROBOT WAS INSERTED). THAT AFTERNOON FOLLOWING PROCEDURE, AND EVERY DAY THEREAFTER (DOCUMENT IN NURSE'S NOTES) UNTIL IT WAS DISCOVERED A FEW WEEK [SIC] LATER, HER RIGHT COLON HAD BEEN PERFORATED FOR SOME TIME AND EMERGENCY SURGERY WAS PERFORMED, AND THEN ALMOST BLED OUT FROM ANASTOMOSIS. THE DELAYED DIAGNOSIS OF PERFORATED COLON RESULTED IN A HEALTH DECLINE THAT RESULTED IN HER DEATH ON (B)(6) 2016. SHE TESTED POSITIVE FOR C. FREUNDII, CITROBACTER FREUNDII IS A SPECIES FACULTATIVE ANEROBIC GRAM-NEGATIVE BACTERIA OF THE (ENTERFOBACTERIACEAE FAMILY) IN HER RIGHT LUNG, AND WHITE BLOOD CELL COUNT WAS 59,000 FROM BACTERIA'S AND STOOL LEAKING OUT INTO ABDOMINAL CAVITY. SHE ALSO TESTED POSITIVE FOR SEVERAL OTHER BACTERIA'S INCLUDING CANDIDA TROPICALIS (FUNGUS). THANK YOU FOR LOOKING INTO THIS MATTER TO HELP WITH

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS BEEN REPORTED THAT AFTER COMPLETION OF THREE SEPARATE DA VINCI-ASSISTED SURGICAL PROCEDURES, EACH PATIENT DEVELOPED A SERIOUS POST-OPERATIVE INFECTION/ABSCESS. AS A RESULT OF THE POST-OPERATIVE COMPLICATIONS, TWO OF THE PATIENTS UNDERWENT A FOLLOW-UP, UNSPECIFIED SURGICAL PROCEDURE AND WERE THEN ADMITTED TO THE INTENSIVE CARE UNIT (ICU). THE TWO PATIENTS WERE REPORTEDLY RECEIVING ARTIFICIAL RESPIRATION. THE THIRD PATIENT WAS SCHEDULED TO UNDERGO AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2016, BUT IT IS UNKNOWN WHETHER THIS OCCURRED. ALL THREE PATIENTS HAD BLOOD RESULTS THAT WERE POSITIVE FOR DIFFERENT STRAINS OF ESCHERICHIA COLI (E.COLI) BACTERIA. ON (B)(6) 2016, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED POST-OPERATIVE INFECTIONS: REPORTEDLY, TWO OF THE AFFECTED PATIENTS UNDERWENT DA VINCI-ASSISTED RADICAL PROSTATECTOMY PROCEDURES ON (B)(6) 2016. BOTH SURGICAL PROCEDURES WERE PERFORMED BY THE SAME SURGEON. THE THIRD PATIENT REPORTEDLY HAD A DA VINCI-ASSISTED RADICAL PROSTATECTOMY PROCEDURE ON (B)(6) 2016, BY A DIFFERENT SURGEON. ALL THREE PATIENTS RECEIVED CEFUROXIME, AN ANTIBIOTIC, INTRAVENOUSLY. THE E. COLI FROM 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: ON (B)(6) 2016, MY MOTHER (B)(6), (DOB (B)(6)) WAS OPERATED ON VIA DA VINCI ROBOTIC PROCEDURE BY TWO PHYSICIANS AT ROPER HOSPITAL IN (B)(6) FOR RIGHT UPPER LOBECTOMY. SHE IMMEDIATELY COMPLAINED OF ABDOMINAL PAIN (NEAR 8TH INTERCOSTAL SPACE WHERE CAMERA FROM ROBOT WAS INSERTED). THAT AFTERNOON FOLLOWING PROCEDURE, AND EVERY DAY THEREAFTER (DOCUMENTED IN NURSE'S NOTES) UNTIL IT WAS DISCOVERED A FEW WEEK LATER, HER RIGHT COLON HAD BEEN PERFORATED FOR SOME TIME AND EMERGENCY SURGERY WAS PERFORMED, AND THEN ALMOST BLED OUT FROM ANASTOMOSIS. THE DELAYED DIAGNOSIS OF PERFORATED COLON RESULTED IN A HEALTH DECLINE THAT RESULTED IN HER DEATH ON (B)(6) 2016. SHE TESTED POSITIVE FOR C. FREUNDII, CITROBACTER FREUNDII IS A SPECIES OF FACULTATIVE ANEROBIC GRAM-NEGATIVE BACTERIA OF THE (ENTEROBACTERIACEAE FAMILY) IN HER RIGHT LUNG, AND WHITE BLOOD CELL COUNT WAS 59,000 FROM BACTERIA'S AND STOOL LEAKING OUT INTO ABDOMINAL CAVITY. SHE ALSO TESTED POSITIVE FOR SEVERAL OTHER BACTERIA'S INCLUDING CANDIDA TROPICALIS (FUNGUS). THANK YOU FOR LOOKING INTO THIS MATTER TO HELP WITH COMPLIANCE AND MAY BE PREVENTING THIS FROM HAPPENING TO OTHER PTS AND FAMILIES.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED GASTRECTOMY PROCEDURE, THE PATIENT EXPERIENCED BLEEDING FROM A BRANCH OF THE SUPERIOR PANCREATICODUODENAL ARTERY. THE SURGEON REPORTEDLY USED A FENESTRATED BIPOLAR FORCEPS INSTRUMENT AND COMPRESSION TO STOP THE BLEEDING. ACCORDING TO THE INITIAL REPORTER, IT TOOK THE SURGICAL STAFF APPROXIMATELY 6 HOURS TO CONTROL THE BLEEDING. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SYSTEM, INSTRUMENTS, OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE. APPROXIMATELY 23 MINUTES AFTER THE DA VINCI-ASSISTED GASTRECTOMY PROCEDURE WAS COMPLETED AND THE PATIENT'S ABDOMEN WAS CLOSED, THE PATIENT'S BLOOD PRESSURE BEGAN TO DROP. A BLOODY DRAIN WAS ALSO IDENTIFIED. A TRANSFUSION WAS ADMINISTERED AND THE PATIENT'S BLOOD PRESSURE RECOVERED TO 70 MM HGS. THE PATIENT WAS REPORTEDLY DIAGNOSED WITH HEMOPERITONEUM AND INTRAPERITONEAL OBSERVATION WAS PERFORMED WITH A LAPAROSCOPE. FRESH BLOOD AND BLOOD CLOTS WERE FOUND. AFTER SUCTIONING WAS PERFORMED, THE SOURCE OF THE BLEEDING WAS FOUND TO BE THE PANCREATIC HEAD. THE SURGEON MADE THE DECISION TO PERFORM OPEN SURGERY IN ORDER TO CONTROL THE BLEEDING. THE SURGEON APPLIED SUTURES TO THE

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS BEEN REPORTED THAT AFTER COMPLETION OF THREE SEPARATE DA VINCI-ASSISTED SURGICAL PROCEDURES, EACH PATIENT DEVELOPED A SERIOUS POST-OPERATIVE INFECTION/ABSCESS. AS A RESULT OF THE POST-OPERATIVE COMPLICATIONS, TWO OF THE PATIENTS UNDERWENT A FOLLOW-UP, UNSPECIFIED SURGICAL PROCEDURE AND WERE THEN ADMITTED TO THE INTENSIVE CARE UNIT (ICU). THE TWO PATIENTS WERE REPORTEDLY RECEIVING ARTIFICIAL RESPIRATION. THE THIRD PATIENT WAS SCHEDULED TO UNDERGO AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2016, BUT IT IS UNKNOWN WHETHER THIS OCCURRED. ALL THREE PATIENTS HAD BLOOD RESULTS THAT WERE POSITIVE FOR DIFFERENT STRAINS OF ESCHERICHIA COLI (E.COLI) BACTERIA. ON JULY 22, 26, AND 29, 2016, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED POST-OPERATIVE INFECTIONS: REPORTEDLY, TWO OF THE AFFECTED PATIENTS UNDERWENT DA VINCI-ASSISTED RADICAL PROSTATECTOMY PROCEDURES ON (B)(6) 2016. BOTH SURGICAL PROCEDURES WERE PERFORMED BY THE SAME SURGEON. THE THIRD PATIENT REPORTEDLY HAD A DA VINCI-ASSISTED RADICAL PROSTATECTOMY PROCEDURE ON (B)(6) 2016, BY A DIFFERENT SURGEON. ALL THREE PATIENTS RECEIVED CEFUROXIM, AN ANTIBIOTIC, INTRAVENOUSLY. THE E