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 SURGEON WAS NOT ABLE TO USE AUTOSCANNING FUNCTION. IT HAS BEEN REPORTED THAT THE SURGERY HAS BEEN ABORTED.

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 ROBOTIC ARM COLLIDED WITH THE PLATFORM AND PRODUCED A "COMMUNICATION FAILURE" ERROR AND THE ROBOT ARM WAS NON-FUNCTIONAL. IT HAS BEEN REPORTED THAT THE SURGERY HAS BEEN ABORTED.

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 HEAD HOLDER ADAPTOR WAS NON-FUNCTIONAL. THE PROCEDURE HAS BEEN COMPLETED WITH A TRADITIONAL SURGERY TECHNIQUE.

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 06/01/2016, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF THE UNPLUG THE ROBOT INTERNET BLOG TITLED, (B)(6) STORY. ACCORDING TO THE INTERNET BLOG, THE PATIENT ALLEGED THAT HER SMALL INTESTINE WAS PERFORATED WHILE UNDERGOING A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE PERFORMED ON (B)(6) 2015. THE INTERNET BLOG DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED OR CAUSED/CONTRIBUTED TO THE OPERATIVE COMPLICATIONS. REFER TO THE FOLLOWING INTERNET LINK FOR ACCESS TO THE INTERNET BLOG: (B)(6) BASED ON THE INTERNET BLOG, THE FOLLOWING INFORMATION WAS PROVIDED: AFTER THE DA VINCI-ASSISTED SURGICAL PROCEDURE WAS PERFORMED, THE DOCTOR REPORTEDLY INFORMED HER FAMILY THAT EVERYTHING WENT WELL. THE PATIENT WAS SENT HOME THE SAME DAY. WHILE RESTING AT HOME, THE PATIENT FELT SICK, WAS VOMITING, AND HAD LEAKING AT THE INCISION SITE. THE PATIENT COULD NOT KEEP ANYTHING DOWN AND SHE HAD NO APPETITE. AFTER THE PATIENT'S HUSBAND CALLED THE HOSPITAL, THE PATIENT WAS INSTRUCTED TO RETURN TO THE HOSPITAL. WHEN THE PATIENT RETURNED TO THE HOSPITAL, SHE CLAIMED THAT SHE HAD NO BLOOD PRESSURE AND WAS VERY CLOSE TO DYING. THE PATIENT ALSO ALLEGED T

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 CRASH HAS BEEN DETECTED. A SURGERY DELAY OF 2 HOURS HAS BEEN 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, THE ARM COLLIDES WITH FRAME AND A SOFTWARE CRASH HAS BEEN DETECTED. A SURGERY DELAY OF 2 HOURS HAS BEEN 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 AFTER THE SURGERY, A FEW ELECTRODES WERE APPROXIMATELY 6MM PARALLEL TO WHERE THEY SHOULD HAVE BEEN. THE SURGEON NOTED THAT MOST OF THE INACCURATE TRAJECTORIES WERE LATERAL, WHILE THE MEDIAL TRAJECTORIES SEEM TO SHOW BETTER ADHERENCE TO THE PLANNING. A SURGERY DELAY HAS BEEN REPORTED MORE THAN 2 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, SYSTEM IS FORCED TO RESTART AFTER DETECTING COLLISION WITH THE NURSE AND A SOFTWARE CRASH HAS BEEN DETECTED. A SURGERY DELAY OF 2 HOURS HAS BEEN REPORTED.

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 A PATIENT UNDERWENT A DA VINCI MITRAL VALVE REPAIR PROCEDURE ON (B)(6) 2015 AND PASSED AWAY ON AN UNSPECIFIED DATE/TIME. ACCORDING TO THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR), THE DA VINCI SURGICAL PROCEDURE WAS COMPLETED. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED OR CAUSED/CONTRIBUTED TO THE PATIENT'S DEMISE.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DATE OF DEATH = (B)(6) 2015. THIS MDR SUBMISSION IS ACTUALLY A FOLLOW-UP #1 MDR TO MFR. REPORT # 2955842-2015-01059 (PATIENT IDENTIFIER # (B)(6)) WHICH WAS INITIALLY SUBMITTED ON 08/03/2015. ON 11/07/2018, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE DATE OF THE PATIENT'S DEMISE (NOTE: THE COMPLAINT HANDLING SYSTEM THAT WAS USED TO SUBMIT THE INITIAL MDR IS NO LONGER AVAILABLE FOR SUBMITTING EMDRS).

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 THE SURGEON MERGED THE POST-OP CT IMAGE AND FOUND THAT ON ALL BUT ONE TRAJECTORY, THERE WAS A SIGNIFICANT DISCREPANCY IN THE PLAN AND IN THE TRUE POSITION OF ELECTRODES. THERE APPEARS TO BE, ACCORDING TO THE SURGEON, A CONSISTENT 5MM CEPHALAD ENTRY POINT CONSISTENT WITH THE PLAN. ELECTRODES, ACCORDING TO THE SURGEON, APPEAR TO BE PARALLEL TO THE PLAN AND THE TARGET POINTS DIFFER AS WELL. ONE ELECTRODE IS INFERIOR TO PLAN. THE SURGEON IS REQUESTING SUPPORT TO ANALYZE THE REASON FOR PLACEMENT RESULTS AND DOES NOT PLANNING ON REPLACING ELECTRODES AT THIS TIME. AFTER OPERATION PATIENT IS "VERY DYSARTHRIC." PATIENT HAS EXPERIENCED A STROKE PRIOR TO THIS OPERATION. NO SEIZURES HAVE YET BEEN RECORDED IN THE EMU FOLLOWING SURGERY, SO NO EPILEPTIFORM ACTIVITY HAS BEEN OBSERVED IN THE DEPTH ELECTRODES.

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 FIRST RECEIVED BY INTUITIVE SURGICAL, INC. (ISI) BETWEEN (B)(4) 2014 - (B)(4) 2015. FOR THOSE CLAIMS WHERE PROCEDURE DATES ARE PROVIDED, THE DATES RANGE FROM (B)(6) 2002 - (B)(6) 2014.

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 HYSTERECTOMY PROCEDURE, THE SURGICAL STAFF NOTICED THAT THE SKIN AROUND ONE OF THE CANNULA PORT SITES WAS BURNED. ACCORDING TO THE INITIAL REPORTER, THE SITE'S ROBOTICS COORDINATOR, THE SKIN AROUND THE CANNULA ON THE PATIENT'S RIGHT SIDE WAS CHARRED. ON (B)(6) 2015, A TECHNICAL FIELD SPECIALIST (TFS) PERFORMED A FIELD EVALUATION AT THE SITE. THE TFS INSPECTED THE DA VINCI SURGICAL SYSTEM AND PERFORMED AN ELECTRICAL SAFETY TEST ON THE PATIENT SIDE CART (PSC). NO ISSUES WERE FOUND DURING THE TEST. THE TFS TESTED THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT (PART 420179; LOT N10141202-002) THAT WAS USED DURING THE SURGICAL PROCEDURE. THE TFS WAS UNABLE TO DUPLICATE ANY ISSUE OF ENERGY ARCING FROM THE INSTRUMENT AND DID NOT FIND ANY DEFECTS WITH THE DEVICE. NO PARTS WERE REPLACED. THE TFS VERIFIED THAT THE DA VINCI SURGICAL SYSTEM WAS READY FOR USE. THE TFS ALSO MONITORED THE DA VINCI SURGICAL SYSTEM DURING SEVERAL SUBSEQUENT PROCEDURES AND THERE WERE NO RECURRENCES OF THE REPORTED PORT SITE BURN ISSUE. ACCORDING TO THE TFS, THE SITE REPLACED THE FORCE FX ELECTROSURGICAL UNIT (ESU) THAT WAS USED DURING THE PROCEDURE AND THERE HAVE B

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 HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY, THE PATIENT WAS FOUND TO HAVE POST-OPERATIVE SMALL BURNS LOCATED ON BOTH 8MM TROCAR INCISION SITES. ACCORDING TO THE INITIAL REPORTER, THE BURNED TISSUE WAS CUT OUT BEFORE SUTURING WAS PERFORMED. ON (B)(4) 2015, INTUITIVE SURGICAL, INC. (ISI) RECEIVED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE INITIAL REPORTER. NO PICTURES OR PHOTOS OF THE PORT SITE BURNS WERE AVAILABLE FOR REVIEW. ACCORDING TO THE INITIAL REPORTER, THE BURNED TISSUE APPEARED BLACK IN COLOR AND COMPLETELY SURROUNDED EACH PORT SITE AS A 1 MM RING. THE INITIAL REPORTER ALSO DESCRIBED THE BURNED TISSUE AS BEING SECOND DEGREE BURNS. THE BURNED TISSUE WAS CUT OUT PRIOR TO SUTURING BUT NO TISSUE SAMPLES WERE OBTAINED FOR ANALYSIS. THE INSTRUMENTS INSTALLED AT EACH PORT INVOLVED WITH THE PORT SITE BURNS WERE AN UNSPECIFIED BIPOLAR CLAMP INSTRUMENT AND AN UNSPECIFIED SCISSOR INSTRUMENT. NO ISSUES OR EVIDENCE OF ARCING WERE OBSERVED WITH EACH INSTRUMENT DURING THE PROCEDURE. THE GROUNDING PAD WAS INSTALLED ON THE PATIENT'S LEG AND NO ISSUES WERE OBSERVED WITH THE PAD. AN ERBE ELECTROSURGICAL UNIT (ESU) WA

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 SACROCOLPOPEXY PROCEDURE PERFORMED ON (B)(6) 2015, THE SURGEON EXPERIENCED AWKWARD MOVEMENT ON ARM-3. DURING THE SAME SURGICAL PROCEDURE, THE PATIENT'S SMALL BOWEL WAS REPORTEDLY PERFORATED. A SMALL BOWEL RESECTION WAS PERFORMED AND THE DA VINCI SURGICAL PROCEDURE WAS ABORTED. ON (B)(4) 2015, AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE. THE FSE WAS UNABLE TO REPRODUCE THE REPORTED CUSTOMER FAILURE MODE OF ARM-3 MOVING AWKWARDLY. THE FSE TESTED AND INSPECTED THE SYSTEM, AND VERIFIED THAT THE SYSTEM WAS READY FOR USE. NO PART REPLACEMENTS WERE REQUIRED. ON (B)(4) 2015, ISI RECEIVED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE SURGEON. PRIOR TO PERFORMING THE REPORTED DA VINCI SURGICAL PROCEDURE, THE SURGEON HAD PERFORMED 2 OTHER DA VINCI SURGICAL PROCEDURES EARLIER THAT SAME DAY WITHOUT ANY ARM ISSUES. THE SURGEON INDICATED, THE AWKWARD MOVEMENT WAS PRIMARILY THE CAMERA ARM WHEN REACHING A NEAR MAXIMUM WORKING UP ON THE LEFT SIDE WALL ON ADHESIONS. THE THIRD ARM APPEARED TO BE FORCEFULLY JOSTLED UPON THE 'SPASM' OR JERKING MOVEMENT OF THE CAMERA. ON ARM 3, A PROGRASP FOR

In addition, as further described in Note 7 to the Consolidated Financial Statements included in Part II, Item 8, we are currently named as a defendant in approximately 102 individual product liability lawsuits and a multi-plaintiff product liability lawsuit filed on behalf of 20 patients who underwent da Vinci 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: ON (B)(6) 2014, INTUITIVE SURGICAL, INC. (ISI) RECEIVED NOTIFICATION OF A BOSTONHERALD.COM ARTICLE TITLED, ROBOTS IN THE O.R.: SUIT TARGETS ROBOTIC SURGERY RISKS AND DATED NOVEMBER 20, 2014. ACCORDING TO THE ARTICLE, A PATIENT AGREED TO UNDERGO A DA VINCI HYSTERECTOMY ON AN UNSPECIFIED DATE IN THE SPRING OF 2009. THE ARTICLE INDICATES, THE SURGERY RESULTED IN A TEAR IN HER SMALL INTESTINE..., AND THE PATIENT, HAD SEPSIS, AND HAD SUBSEQUENT SURGERIES TO REPAIR THE TISSUE. SHE SPENT MONTHS IN AND OUT OF THE HOSPITAL. THE ARTICLE ALSO STATES, BECAUSE OF THE COMPLICATIONS, SHE COULDN'T COMPLETE CHEMOTHERAPY AND NEVER STARTED RADIATION TREATMENT. SHE DIED ON (B)(6) 2010. THERE IS NO CLAIM WITHIN THE ARTICLE THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE 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 LEADING TO ACCURACY ISSUE. A SURGERY DELAY HAS BEEN REPORTED BETWEEN 1:30 HOUR AND 2 HOURS.

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 FIRST RECEIVED BY INTUITIVE SURGICAL, INC. (ISI) ON (B)(6) 2014. FOR THOSE CLAIMS WHERE PROCEDURE DATES ARE PROVIDED, THE DATES RANGE FROM (B)(6) 2014.

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 HYSTERECTOMY PROCEDURE PERFORMED ON 11/21/2014, THE PATIENT LOST TOO MUCH BLOOD FROM A PUMPING BLOOD VESSEL. DUE TO THE VESSEL ISSUE, THE SURGEON MADE THE DECISION TO ABORT THE DA VINCI SURGICAL PROCEDURE AND ENTER VAGINALLY. THE CAUSE OF THE BLEEDING VESSEL WAS NOT PROVIDED. ALSO, DURING THE SURGICAL PROCEDURE, THE INITIAL REPORTER INDICATED THAT THE SURGICAL STAFF ENCOUNTERED A BLADE EXPOSED MESSAGE INVOLVING THE USE OF A VESSEL SEALER INSTRUMENT. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE CSR WAS NOT PRESENT DURING THE DA VINCI SURGICAL PROCEDURE. BASED ON HIS COMMUNICATIONS WITH THE SITE, THE CSR WAS INFORMED THAT THE SURGICAL STAFF ENCOUNTERED A BLEEDING VESSEL TOWARDS THE END OF THE DA VINCI SURGICAL PROCEDURE. SINCE THE SURGEON WAS UNABLE TO USE THE VESSEL SEALER INSTRUMENT AT THE TIME, THE SURGEON MADE THE DECISION REMOVE THE DA VINCI INSTRUMENTS AND TO STOP THE VESSEL FROM BLEEDING BY ENTERING VAGINALLY. THE CSR DID NOT KNOW THE CAUSE OF THE BLEEDING VESSEL. THERE IS NO ALLEGATION THAT THE DA VINCI SYSTEM, 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 REPORTED THAT DURING A DA VINCI NISSEN FUNDOPLICATION PROCEDURE PERFORMED ON (B)(6) 2014, THE SURGICAL STAFF INDICATED THAT A FENESTRATED BIPOLAR FORCEPS INSTRUMENT AUTO-FIRED AND BURNED THE PATIENT'S TISSUE. THE INITIAL REPORTER INDICATED THAT NO CAUTERY ICONS WERE SEEN WHEN THE EVENT OCCURRED. THE INITIAL REPORTER ALSO INDICATED THAT THE ELECTROSURGICAL UNIT (ESU) GAVE A TONE AND FIRED. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER TO GATHER ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE SURGICAL PROCEDURE WAS NOT RECORDED ON VIDEO. SHE STATED THAT THE SURGEON WAS SEATED AT THE SURGEON SIDE CONSOLE (SSC) BUT WAS NOT PRESSING ANY BUTTONS OR PEDALS WHEN THE EVENT OCCURRED. ACCORDING TO THE INITIAL REPORTER, THE HEPATIC BRANCH OF THE VAGUS NERVE WAS CUT, SEVERED, AND BURNT. THE SURGEON DID NOT ATTEMPT TO REPAIR THE INJURY. THE INITIAL REPORTER STATED THAT THE SURGICAL STAFF REPLACED THE ESU AND SUCCESSFULLY COMPLETED THE DA VINCI SURGICAL PROCEDURE USING THE SAME FENESTRATED BIPOLAR FORCEP INSTRUMENT. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO RECURRENCES OF THE REPORTED ISSUE AT THE SITE. THE INITIAL REPORTER ALSO STATED THAT

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 SUCCESSFUL COMPLETION OF A DA VINCI COLON RESECTION PROCEDURE THE PATIENT EXPERIENCED POST-OPERATIVE COMPLICATIONS. UPON FOLLOW UP WITH THE SITE, THE RISK MANAGER AT THE HOSPITAL STATED THAT THE PATIENT WAS DISCHARGED WITH NO COMPLICATIONS, HOWEVER, RETURNED TO THE HOSPITAL ON (B)(6) 2014 WITH A FEVER AND REPORTED FATIGUE. NO ISSUES WERE IDENTIFIED AND NO TREATMENT WAS PROVIDED AND THE PATIENT WAS RELEASED HOME. THE PATIENT WAS FOUND EXPIRED IN HER HOME ON (B)(6) 2014. PER THE RISK MANAGER, NOTHING REGARDING THE PATIENTS OUTCOME LED HER TO BELIEVE THAT THE DA VINCI SYSTEM CAUSED OR CONTRIBUTED TO THE PATIENT'S OUTCOME. AS OF THE DATE OF THIS REPORT THE AUTOPSY RESULTS ARE PENDING.

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 LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY (LAVH-BSO) AND SUBURETHRAL SLING PROCEDURE PERFORMED ON (B)(6) 2014, THE PATIENT SUSTAINED A BOWEL INJURY. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, THE PATIENT WAS FOUND TO HAVE MULTIPLE ADHESIONS IN THE SMALL BOWEL AND OMENTUM. THE PATIENT DID NOT TOLERATE STEEP TRENDELENBURG POSITIONING; THEREFORE, THE PROCEDURE WAS PERFORMED IN MODERATE TRENDELENBURG POSITIONING. THE SURGEON INDICATED THAT THIS POSITIONING MADE THE SURGERY MORE DIFFICULT TO PERFORM DUE TO HAVING TO PUSH BOWEL AWAY. POST-OPERATIVELY, THE PATIENT HAD MINIMAL URINE OUTPUT AND COMPLAINTS OF INCREASING PAIN. THE PATIENT BECAME HYPOTENSIVE AND TACHYCARDIC WITH ELEVATED WBC AND CREATININE LEVELS. THE PATIENT RETURNED TO THE OR AND UNDERWENT AN EXPLORATORY LAPAROTOMY. THE PATIENT WAS FOUND TO HAVE SUSTAINED AN ENTEROTOMY RESULTING IN SEPTIC SHOCK AND AN INTRA-ABDOMINAL ABSCESS. THE ABSCESS WAS DRAINED AND THE ENTEROTOMY WAS REPAIRED. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE'S RISK MANAGER, THE INITIAL REPORTER OF THIS COMPLAINT, AND OBTAINED ADDITIONAL INFORMATION RE

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 UNDERGOING A DA VINCI TOTAL PROCTOCOLECTOMY WITH J-POUCH PROCEDURE ON (B)(6) 2014, THE PATIENT BLED OUT, HAD ORGAN FAILURE DUE TO BLOOD LOSS, AND PASSED AWAY ON (B)(6) 2014. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE INITIAL REPORTER INDICATED THAT THE SURGICAL PROCEDURE WAS PLANNED TO BE A COMBINATION OF A DA VINCI TOTAL PROCTOCOLECTOMY WITH J-POUCH AND TRADITIONAL LAPAROSCOPIC SURGERY. AFTER THE DA VINCI PORTION OF THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED, THE SURGEON FINISHED THE REMAINDER OF THE SURGERY VIA TRADITIONAL LAPAROSCOPIC SURGERY. NO INTRA-OPERATIVE COMPLICATIONS OR SIGNIFICANT BLEEDING WERE REPORTED DURING THE SURGERY. IN ADDITION, NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM WAS REPORTED. POST-OPERATIVELY, THE PATIENT EXPERIENCED BLEEDING AND SUBSEQUENTLY PASSED AWAY ON POST-OP DAY 10. THE INITIAL REPORTER INDICATED THAT HE SPOKE TO VARIOUS SURGEONS AT THE SITE REGARDING 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: IT WAS REPORTED THAT DURING A DA VINCI HYSTERECTOMY PROCEDURE PERFORMED ON (B)(6) 2014, THE PATIENT SUSTAINED A BOWEL INJURY. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE'S RISK MANAGER AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE RISK MANAGER SPOKE DIRECTLY TO THE SURGEON WHO PERFORMED THE DA VINCI HYSTERECTOMY PROCEDURE. ACCORDING TO THE RISK MANAGER, THERE WAS NO ALLEGATION OR CLAIM BY THE SURGEON THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THE PATIENT WAS FOUND TO HAVE EXTENSIVE ADHESIONS AND THE SURGEON NOTED THAT SHE HAD PROBLEMS PLACING A UTERINE MANIPULATOR DEVICE. THE PATIENT REPORTEDLY TOLERATED THE SURGICAL PROCEDURE WELL. POST-OPERATIVELY WHILE ON THE FLOOR, THE PATIENT BECAME SYMPTOMATIC AND SHOWED SIGNS OF BECOMING SEPTIC. ON (B)(6) 2014, THE PATIENT WAS BROUGHT BACK TO THE OR AND REPAIR OF A SMALL BOWEL ENTEROTOMY WAS PERFORMED USING SUTURES. THE SURGEON DID NOT PROVIDE A CAUSE OF THE ENTEROTOMY. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2014. NO FURTHER POST-OPERATIVE COMPLICATIONS HAVE 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 DURING A DA VINCI NEPHRECTOMY PROCEDURE PERFORMED ON (B)(6) 2014, THE PATIENT SUSTAINED A PERFORATED SMALL BOWEL. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, THE PATIENT'S LARGE BOWEL ENDED UP GETTING PUSHED THROUGH THE PERFORATION. FIVE DAYS AFTER COMPLETION OF THE SURGICAL PROCEDURE, THE PATIENT RETURNED TO THE HOSPITAL AND UNDERWENT AN X-RAY AND CT-SCAN FOR COMPLAINTS OF ABDOMINAL PAIN. ON (B)(6) 2014, THE PATIENT UNDERWENT AN OPEN SURGICAL PROCEDURE TO REPAIR THE BOWEL PERFORATION. THE PATIENT WAS ADMITTED TO THE ICU. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER. THE INITIAL REPORTER INDICATED THAT THE PATIENT WAS STILL IN THE HOSPITAL. HE ALSO STATED THAT THERE WERE NO REPORTS FROM THE SITE THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM HAD OCCURRED DURING THE DA VINCI SURGICAL PROCEDURE. ON (B)(6) 2014, ISI ALSO CONTACTED THE SITE'S RISK MANAGEMENT DEPARTMENT. THE RISK MANAGER STATED THAT HE CONFIRMED WITH THE SURGICAL STAFF THAT NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED DURING THE SURGICAL PROCEDURE. THE RISK MANAGER WAS UNABLE TO PROVIDE A POSSIBLE CAUSE OF THE PATIENT'S INTRA-OPERATIVE COMPLIC

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 ABDOMINOPERINEAL RESECTION PROCEDURE, THE SURGEON NICKED AN UNSPECIFIED ARTERY. THE SURGEON WAS ABLE TO USE AN UNIDENTIFIED INSTRUMENT TO CLAMP THE ARTERY. THE SURGEON THEN MADE THE DECISION TO CONVERT THE DA VINCI SURGICAL PROCEDURE TO OPEN SURGICAL TECHNIQUES IN ORDER TO REPAIR THE INJURED VESSEL. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. ON 11/12/2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO INITIALLY REPORTED THIS COMPLAINT. THE CSR WAS PRESENT DURING THE SURGICAL PROCEDURE. HE REITERATED THAT NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED DURING THE SURGICAL PROCEDURE. THE CSR STATED THAT BLEEDING WAS OBSERVED FROM A SUPERIOR VESSEL BUT THE CAUSE OF THE VESSEL INJURY WAS NOT DETERMINED OR IDENTIFIED. THE CSR COULD NOT VERIFY THAT THE ARTERY WAS ACTUALLY NICKED. THE CASE WAS CONVERTED TO OPEN SURGERY IN ORDER TO REPAIR THE VESSEL INJURY. THE ABDOMINOPERINEAL RESECTION PROCEDURE WAS COMPLETED SUCCESSFULLY VIA OPEN SURGERY AND NO POST-OPERATIVE COMPLICATIONS WERE 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 AFTER COMPLETION OF A DA VINCI CHOLECYSTECTOMY PROCEDURE PERFORMED ON (B)(6) 2014, THE PATIENT RETURNED TO THE HOSPITAL 2 DAYS POST-OPERATIVELY WITH SYMPTOMS OF A BILE LEAK. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. ON (B)(6) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON INVOLVED WITH THIS COMPLAINT. THE SURGEON CONFIRMED THAT NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED DURING THE SURGICAL PROCEDURE. HE INDICATED THAT THE PATIENT UNDERWENT AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) AND STENT PLACEMENT. THE SURGEON ALSO STATED THAT THE PATIENT WAS CURRENTLY DOING WELL. HE WAS UNABLE TO PROVIDE A CAUSE OF THE PATIENT'S POST-OPERATIVE COMPLICATION. ON (B)(6) 2014, ISI CONTACTED THE SITE'S RISK MANAGEMENT DEPARTMENT. THE RISK MANAGER REVIEWED THE OPERATIVE REPORT AND CONFIRMED THAT NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED.

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 UNDERGOING A DA VINCI SINGLE-SITE CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2014, THE PATIENT WAS READMITTED DUE TO EXPERIENCING A BILE LEAK. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, HE WAS NOT PRESENT DURING THE SURGICAL PROCEDURE. THE SURGEON REPORTEDLY INFORMED THE INITIAL REPORTER THAT NO MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. IN ADDITION, THERE WERE NO REPORTS OF ANY INTRA-OPERATIVE COMPLICATIONS. ON AN UNSPECIFIED DATE, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. APPROXIMATELY TWO DAYS LATER, THE PATIENT PRESENTED TO THE HOSPITAL WITH UPPER QUADRANT PAIN. THE PATIENT WAS FOUND TO HAVE A BILE LEAK. THE SURGEON INDICATED THAT SHE DID NOT EXPERIENCE ANY ISSUES WITH THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT USED DURING THE CASE.

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 UNDERGOING A DA VINCI SINGLE-SITE CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2014, THE PATIENT WAS READMITTED DUE TO EXPERIENCING A BILE LEAK. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, HE WAS NOT PRESENT DURING THE SURGICAL PROCEDURE. THE SURGEON REPORTEDLY INFORMED THE INITIAL REPORTER THAT NO MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. IN ADDITION, THERE WERE NO REPORTS OF ANY INTRA-OPERATIVE COMPLICATIONS. ON AN UNSPECIFIED DATE, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. APPROXIMATELY TWO DAYS LATER, THE PATIENT PRESENTED TO THE HOSPITAL WITH UPPER QUADRANT PAIN. THE PATIENT WAS FOUND TO HAVE A BILE LEAK. THE SURGEON INDICATED THAT SHE DID NOT EXPERIENCE ANY ISSUES WITH THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT USED DURING THE CASE.

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 CYSTECTOMY PROCEDURE, THE PATIENT DEVELOPED AN INFECTION DUE TO A BOWEL LEAK. ON SEPTEMBER 25, 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON WHO PERFORMED THE PLANNED SURGICAL PROCEDURE, THE SURGEON STATED THAT THE PATIENT UNDERWENT THE DA VINCI CYSTECTOMY PROCEDURE DUE TO BLADDER CANCER AND THAT THREE DAYS POST THE SURGICAL PROCEDURE THE PATIENT COMPLAINED OF ABDOMINAL PAIN. POST-OPERATIVE DAY FIVE THE PATIENT'S PAIN BEGAN TO WORSEN AND A CT SCAN WAS PERFORMED AND SHOWED THAT THE PATIENT HAD FLUID COLLECTION WITH NO EVIDENCE OF AIR. THE SURGEON INDICATED THAT THE HOSPITAL CONTINUED TO MONITOR THE PATIENT AND ON POST-OPERATIVE DAY EIGHT THE PATIENT UNDERWENT A COLONOSCOPY PROCEDURE WHERE IT WAS DISCOVERED THAT THE PATIENT HAD A BOWEL RUPTURE 1.5CM AT THE ILIOCOLIC ANASTOMOSIS AND NECROSIS. ON (B)(6) 2014, THE PATIENT UNDERWENT AN OPEN RESECTION PROCEDURE TO REPAIR THE DEFECT. THE SURGEON INDICATED THAT HE DOES NOT KNOW WHAT CAUSED OR CONTRIBUTED TO THE BOWEL RUPTURE. THE SURGEON INDICATED THAT AS OF (B)(6) 2014 THE PATIENT WAS HOSPITALIZED AND CONTINUED TO EXPERIENCE ILEUS; HOWEVER, THE SURGEON EXPECTED THAT THE PATIENT WOULD BE DIS

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 DA VINCI-ASSISTED SURGICAL PROCEDURE ON (B)(6) 2014. THE PLAINTIFF'S ATTORNEY ALLEGES THAT AS A RESULT OF UNDERGOING THE DA VINCI SURGICAL PROCEDURE, THE PATIENT SUSTAINED SERIOUS AND PERMANENT BODILY INJURY AND ULTIMATELY PASSED AWAY ON (B)(6) 2014. ISI WAS NOT PROVIDED WITH THE DA VINCI OPERATIVE REPORT OR ANY OF THE PATIENT'S MEDICAL RECORDS.

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 SINGLE-SITE CHOLECYSTECTOMY PROCEDURE, THE PATIENT PASSED AWAY ON POST-OPERATIVE DAY 1. DURING THE SURGICAL PROCEDURE, THE INITIAL REPORTER OF THIS COMPLAINT INDICATED THAT THE SURGEON WAS HAVING ISSUES WITH CLIPS DISLODGING FROM A SINGLE-SITE MEDIUM-LARGE CLIP APPLIER INSTRUMENT DURING INSERTION THROUGH A CANNULA. TOWARDS THE END OF THE SURGICAL PROCEDURE, A CLIP INSTALLED ON THE SINGLE-SITE MEDIUM-LARGE CLIP APPLIER INSTRUMENT FELL INSIDE THE PATIENT. THE SURGEON SPENT ABOUT 10 MINUTES SEARCHING FOR THE CLIP USING A SINGLE-SITE MONOPOLAR CAUTERY INSTRUMENT AND A SINGLE-SITE CROCODILE GRASPER INSTRUMENT. DURING THE PROCESS OF SEARCHING FOR THE CLIP, THE SURGEON LACERATED THE LOWER LOBE OF THE PATIENT'S LIVER AS HE WAS MANIPULATING OR LIFTING THE ORGAN WITH THE SINGLE-SITE MONOPOLAR CAUTERY INSTRUMENT. THE SURGEON WAS ABLE TO CONTROL BLEEDING THAT ENSUED BY CAUTERIZING THE LACERATION. THE SURGEON THEN PROCEEDED TO COMPLETE THE DA VINCI SURGICAL PROCEDURE. PRIOR TO COMPLETION OF THE SURGICAL PROCEDURE, THE PATIENT ALSO UNDERWENT AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE AND UNSPECIFIED HERNIA REPAIR PROCEDURE. ACCORDING TO THE

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2014, ROSA DEVICE HAS BEEN USED TO GUIDE THE IMPLANTATION OF 13 DEPTH ELECTRODES FOR A CRANIAL SEEG. ON (B)(6) 2014, USER IN NEUROLOGY DEPARTMENT SENT US A LETTER ABOUT AN INCIDENT OCCURRED ON (B)(6) 2014 FOLLOWING THE SURGERY. THE INCIDENT WAS A SUBDURAL BLEEDING ON A (B)(6) MALE PT.

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 SINGLE-SITE CHOLECYSTECTOMY PROCEDURE, THE PATIENT EXPERIENCED POST-OPERATIVE COMPLICATIONS. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, DURING THE DA VINCI SURGICAL PROCEDURE, THE SURGEON EXPERIENCED CLIPS BECOMING UNSEATED AND DISLODGED FROM THE SINGLE-SITE CLIP APPLIER INSTRUMENT. HOWEVER, THE INITIAL REPORTER INDICATED THAT THE SURGEON WAS ABLE TO REINSTALL CLIPS ONTO THE SINGLE-SITE CLIP APPLIER AND CONTINUE USING THE INSTRUMENT FOR THE ENTIRE SURGICAL PROCEDURE. ON (B)(6) 2014, THE PATIENT RETURNED TO THE HOSPITAL ON POST-OPERATIVE DAY 3 WITH COMPLAINTS OF ABDOMINAL PAIN AND DISCOMFORT. A CT-SCAN WAS PERFORMED ON THE PATIENT. THE PATIENT WAS FOUND TO HAVE A DISTENDED ABDOMEN WITH FREE AIR AND ILEUS. AN NG TUBE WAS INSERTED INTO THE PATIENT TO SUCTION OUT ABDOMINAL DRAINAGE. THE PATIENT WAS HOSPITALIZED FOR 2-3 DAYS. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE'S ROBOTICS COORDINATOR. THE ROBOTICS COORDINATOR CONFIRMED THAT THE PATIENT WAS HOSPITALIZED FOR 3 DAYS AND NO OTHER INVASIVE MEDICAL INTERVENTION WAS ADMINISTERED. THE ROBOTICS COORDINATOR ALSO INDICATED THAT THERE HAVE BEEN NO RECURRENCE

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 2 DAYS POST A SUCCESSFUL COMPLETION OF A DA VINCI NISSEN FUNDOPLICATION PROCEDURE, THE PATIENT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ABDOMINAL PAIN, REQUIRING THE PATIENT TO UNDERGO AN OPEN SURGICAL PROCEDURE. DURING THE OPEN PROCEDURE, IT WAS DISCOVERED THAT THE PATIENT WAS LEAKING FROM THE STOMACH, CAUSING THE PATIENT TO BECOME SEPTIC. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE HOSPITAL'S ROBOTICS COORDINATOR (RC). ACCORDING TO THE RC, SHE WAS NOT PRESENT DURING THE SURGICAL PROCEDURE. THE RC INDICATED THAT THE PATIENT UNDERWENT THE PLANNED DA VINCI SURGICAL PROCEDURE ON SEPTEMBER 17, 2014 AND WAS DISCHARGED FROM THE HOSPITAL ON SEPTEMBER 18, 2014. ON SEPTEMBER 19, 2014, THE PATIENT RETURNED TO THE HOSPITAL'S EMERGENCY ROOM. AN ENDOSCOPIC PROCEDURE PERFORMED ON THE PATIENT REVEALED THAT THERE WAS A HOLE IN THE PATIENT'S STOMACH AND THAT STOMACH CONTENTS HAD SPILLED OUT ONTO THE PATIENT'S PERITONEUM. AS A RESULT THE PATIENT DEVELOPED SEPSIS. ACCORDING TO THE RC, THE PATIENT CODED DURING THE PATIENT'S EMERGENCY HOSPITALIZATION; HOWEVER, THE PATIENT WAS SUCCESSFULLY RESUSCITATED. THE PATIENT UNDERWENT AN OPEN SURGICAL PROCEDURE TO REPAIR

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 PROSTATECTOMY PROCEDURE, THE PATIENT SUSTAINED AN UNSPECIFIED THERMAL INJURY. A WEEK LATER, THE PATIENT WAS TAKEN BACK TO THE O.R AND A BOWEL RESECTION PROCEDURE WAS PERFORMED VIA OPEN SURGERY. ON 10/21/2014, INTUITIVE SURGICAL, INC. (ISI) RECEIVED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE INITIAL REPORTER OF THIS COMPLAINT. ACCORDING TO THE INITIAL REPORTER, THE THERMAL INJURY WAS LOCATED ON THE PATIENT'S BOWEL AND WAS IDENTIFIED POST-OPERATIVELY. THE INITIAL REPORTER INDICATED THAT THE PATIENT'S THERMAL INJURY WAS UNRELATED TO A MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT THAT WAS USED DURING THE SURGICAL PROCEDURE. NO ADDITIONAL POST-OPERATIVE COMPLICATIONS HAVE BEEN REPORTED.

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 UNDERGOING A DA VINCI RIGHT TRANSVERSE COLECTOMY PROCEDURE, THE PATIENT RETURNED TO THE EMERGENCY DEPARTMENT (ED) 2 WEEKS POST-OPERATIVELY WITH SYMPTOMS OF A FEVER. THE PATIENT SUBSEQUENTLY PASSED AWAY WITH UNKNOWN ETIOLOGY. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, THERE WERE NO SIGNS OF AN ADVERSE EVENT AT THE TIME OF SURGERY AND SHORTLY THEREAFTER. ON (B)(6) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO WAS PRESENT DURING PART OF THE DA VINCI SURGICAL PROCEDURE. ACCORDING TO THE CSR, HE WAS PRESENT DURING SETUP OF THE PROCEDURE AND UP UNTIL ABOUT HALF WAY THROUGH COMPLETION OF THE SURGERY. THE CSR INDICATED THAT DURING THE PROCEDURE, THE SURGICAL STAFF ENCOUNTERED AN ISSUE AT ONE POINT WHERE PATIENT SIDE MANIPULATOR (PSM) 1 DID NOT RECOGNIZE AN INSTRUMENT. THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART (PSC) THAT PROVIDES STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENT. THE CSR STATED THAT THE SURGICAL STAFF SWAPPED INSTRUMENTS BETWEEN THE PSMS AND EVERYTHING WORKED PROPERLY FROM THAT POINT ON. DURING THE TIME THE CSR WAS PRESENT DURING THE PROCEDURE, THERE WERE NO INTRA-OPERATIV

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 RIGHT HEMICOLECTOMY PROCEDURE, THE PATIENT PASSED AWAY ON POST-OPERATIVE DAY 7. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, THE PATIENT BEGAN TO REFUSE HIS MEDICATIONS AND HAD PULLED OUT HIS NG TUBE PRIOR TO PASSING AWAY. SHE ALSO INDICATED THAT POSSIBLY THE PATIENT ASPIRATED. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. ACCORDING TO THE CSR, HE WAS PRESENT DURING PARTS OF THE DA VINCI SURGICAL PROCEDURE. DURING THE TIMES THAT HE WAS PRESENT, THE CSR INDICATED THAT THERE WERE NO REPORTS THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED. THE CSR STATED THAT AN INITIAL AUTOPSY WAS PERFORMED AND THE PATIENT WAS FOUND TO HAVE DEVELOPED ILEUS. IN ADDITION, THE PATIENT'S STAPLE LINE HAD RUPTURED. ON (B)(4) 2014, ISI CONTACTED THE SITE'S RISK MANAGEMENT DEPARTMENT. THE RISK MANAGER REVIEWED THE OPERATIVE REPORT AND DID NOT FIND ANY REPORTS THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED. THE RISK MANAGER STATED THAT BASED ON THE OPERATIVE REPORT AND THE SITE'S PREL

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. A DISPLAY ERROR WAS NOTICED, THE IMAGERY AND THE POINTER WERE NOT VISIBLE. A SURGERY DELAY HAS BEEN REPORTED BETWEEN 1:30 HOUR AND 2 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 WAS DETECTED LEADING TO TRAJECTORY PLANIFICATION ISSUE. A SURGERY DELAY HAS BEEN REPORTED BETWEEN 1:30 HOUR AND 2 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 IMPOSSIBLE TO PERFORM THE REGISTRATION STEP. A SURGERY DELAY HAS BEEN REPORTED BETWEEN 1:30 HOUR AND 2 HOURS.

Robot Lawn Mower — Robotic lawnmower Hazard (Cuts): The blades of the robotic lawnmower are easily accessible and a person in the line of movement of the lawnmower could receive cuts. In addition, the blades have insufficient strength and could detach at high speed causing cuts to a person nearby. The product does not comply with the requirements of the Machinery Directive and the relevant European standard EN 60335. Action: Withdrawal of the product from the market.

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 SINGLE-SITE CHOLECYSTECTOMY, THE SURGEON INADVERTENTLY CUT THE PATIENT'S COMMON BILE DUCT WHILE LIGATING AND CUTTING THE PATIENT'S CYSTIC DUCT WITH THE MONOPOLAR HOOK INSTRUMENT. THERE WAS NO ALLEGATION THAT THE MONOPOLAR HOOK INSTRUMENT MALFUNCTIONED DURING THE EVENT. THE SURGEON THEN MADE THE DECISION TO CONVERT THE SURGICAL PROCEDURE TO OPEN SURGERY. THE SURGEON WAS ABLE TO REPAIR THE COMMON BILE DUCT AND THE CHOLECYSTECTOMY PROCEDURE WAS COMPLETED VIA OPEN SURGERY. THE PATIENT REMAINED HOSPITALIZED FOR 3-4 DAYS AND WAS IN STABLE CONDITION UPON DISCHARGE. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, HE WAS INFORMED THAT THE PATIENT WAS FOUND DECEASED IN HER HOME. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE'S RISK MANAGEMENT DEPARTMENT. THE RISK MANAGER INDICATED THAT THE CASE IS UNDER INVESTIGATION. THE RISK MANAGER WAS UNABLE AND UNWILLING TO PROVIDE ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT.

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 CRASH HAS BEEN DETECTED. IT HAS BEEN REPORTED THAT THE SURGERY HAS BEEN CANCELLED

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 DEATHS OR DEVICE MALFUNCTIONS. THESE ALLEGATIONS WERE FIRST RECEIVED BY INTUITIVE SURGICAL, INC. DURING THE TIME PERIOD OF (B)(4) 2014. FOR THOSE CLAIMS WHERE PROCEDURE DATES ARE PROVIDED, THE DATES RANGE FROM (B)(6) 2014.

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 NEPHRECTOMY PROCEDURE, THE SURGEON MADE THE DECISION TO CONVERT TO OPEN SURGICAL TECHNIQUES. HOWEVER, THE INITIAL REPORTER OF THIS COMPLAINT INDICATED THAT THE CONVERSION TO OPEN SURGERY WAS UNRELATED TO ANY ISSUES WITH THE DA VINCI SURGICAL SYSTEM. SHE WAS NOT PRESENT DURING THE SURGICAL PROCEDURE. HOWEVER, THE INITIAL REPORTER WAS INFORMED THAT THE ROBOTIC PART OF THE PROCEDURE HAD ALREADY BEEN COMPLETED BY THE TIME THE SURGEON DECIDED TO CONVERT TO OPEN SURGERY. SHE INDICATED THAT THE SURGICAL PROCEDURE WAS COMPLETED ALTHOUGH THE PATIENT WAS NOT DOING WELL POST-OPERATIVELY. ON (B)(6) 2014, THE INITIAL REPORTER WAS NOTIFIED BY THE SITE THAT THE PATIENT HAD PASSED AWAY. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT. THE SURGEON WAS AWARE THAT THE DA VINCI NEPHRECTOMY WAS GOING TO BE DIFFICULT EVEN BEFORE THE PROCEDURE BEGAN. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED DURING THE SURGICAL PROCEDURE. THE SURGEON MADE THE DECISION TO CONVERT TO OPEN SURGERY DUE TO THE SIZE AND LOCATION OF THE PATIENT'S TUMOR

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CASE SCHEDULED FOR ROBOTIC ASSISTED HYSTERECTOMY. THE SURGEON STARTED THE PROCEDURE; THE UTERUS WAS LIFTED UP AND TO THE PATIENT'S RIGHT SIDE TO EXPOSE THE LEFT UTEROOVARIAN PEDICLE. THIS WAS ATTEMPTED TO BE CAUTERIZED WITH THE PK IN 3 CONTIGUOUS AREAS AND CUT WITH SCISSORS. HOWEVER, THE MONOPOLAR AND BIPOLAR SCISSORS WERE FOUND TO BE NON-FUNCTIONING. AT THIS TIME, DECISION WAS MADE TO CONVERT TO ABDOMINAL HYSTERECTOMY. THE SURGEON DECIDED TO ABORT THE ROBOTIC PORTION OF CASE.

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 SIGMOID COLECTOMY PROCEDURE, A SMALL VEIN WAS PUNCTURED AND THE CASE WAS CONVERTED TO OPEN SURGICAL TECHNIQUES. THE CAUSE OF THE VESSEL PUNCTURE WAS UNKNOWN. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. ACCORDING TO THE INITIAL REPORTER, SHE WAS PRESENT DURING THE SURGICAL PROCEDURE AND THERE WAS NO INDICATION THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, AND/OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THE VESSEL INJURY OCCURRED APPROXIMATELY 1.5 HOURS INTO THE SURGICAL PROCEDURE. A VASCULAR SURGEON WAS CONTACTED AFTER THE INJURY OCCURRED AND THE CASE WAS CONVERTED TO OPEN SURGERY. THE VASCULAR SURGEON WAS ABLE TO REPAIR THE PUNCTURED VEIN AND THE SIGMOID COLECTOMY PROCEDURE WAS COMPLETED VIA OPEN SURGERY. THE INITIAL REPORTER SPOKE TO THE SURGEON AFTER COMPLETION OF THE SURGERY. ACCORDING TO THE INITIAL REPORTER, THE SURGEON DID NOT KNOW WHAT CAUSED THE VESSEL INJURY. A WEEK AFTER THE EVENT OCCURRED, THE SURGEON REPORTEDLY INFORMED THE INITIAL REPORTER THAT THE PATIENT WAS DOING FINE.

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 SACROCOLPOPEXY PROCEDURE, THE SURGEON FELT AS THOUGH SHE DID NOT HAVE FULL RANGE OF MOTION WHEN THE INSTRUMENTS WERE FIRST INSTALLED. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, THE SURGEON INDICATED THAT THE RANGE OF MOTION RETURNED. HOWEVER, WHILE MOVING THE INSTRUMENTS, THE SURGEON FOUND AN ARTERY THAT WAS ALLEGEDLY NICKED BY A MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT. THE DA VINCI SURGICAL PROCEDURE WAS CONVERTED TO OPEN SURGERY. ON (B)(6) 2014, THE INITIAL REPORTER CONTACTED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOR ASSISTANCE REGARDING THE REPORTED EVENT. THE INITIAL REPORTER INDICATED THAT THE SURGEON MADE THE DECISION TO CONVERT TO OPEN SURGERY DUE TO ENCOUNTERING SYSTEM ERRORS. THE TSE REVIEWED THE SITE'S SYSTEM LOGS AND NOTED THAT A SINGLE ERROR CODE 100 HAD OCCURRED DURING THE SURGICAL PROCEDURE. AN ERROR CODE 100 IS AN INFORMATIONAL FAULT THAT SIGNIFIES THAT AN UNEXPECTED SETUP JOINT (SUJ) MOVEMENT WAS DETECTED. ON (B)(4) 2014, AN ISI FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE. THE FSE EVALUATED THE DA VINCI SURGICAL SYSTEM AND WAS UNABLE TO REPLICATE THE REPORTED I