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.

A judge has denied Tesla's request to overturn a $243 million jury verdict that held the automaker partially responsible for a fatal crash involving its Autopilot driver assistance system.

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.

Monarch Platform — 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 ROBOTICALLY ASSISTED BRONCHOSCOPY PROCEDURE, AS THE PHYSICIAN WAS TAKING ANTERIOR/POSTERIOR SCOUT SHOTS USING A 3D C-ARM, THE PATIENT BEGAN TO EXHIBIT IRREGULAR HEART RHYTHMS. THE PHYSICIAN DECIDED TO ABORT THE PROCEDURE. THE PATIENT WENT INTO ATRIAL FIBRILLATION AND CODED. CHEST COMPRESSIONS WERE STARTED IMMEDIATELY. THE CODE CONTINUED FOR 30 - 35 MINUTES, AND THE PATIENT PASSED AWAY. NO BIOPSIES OR NEEDLE ASPIRATIONS WERE PERFORMED DURING THE PROCEDURE. NO ISSUES WERE REPORTED INVOLVING THE DEVICES USED DURING THE PROCEDURE.

ExcelsiusGPS — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AT THE HOSPITAL THEIR ELDERLY PATIENT WITH A THORACIC FRACTURE. THE PATIENT WAS UNWELL AND EVEN HAD AN ISSUE DURING THE SURGERY. EGPS WAS USED WITH E3D AND ALL SCREWS WERE EXECUTED. UNFORTUNATELY THE NEXT DAY THE PATIENT PASSED AWAY. POST OP IMAGING CONFIRMS SCREWS WERE ACCURATE BUT THERE WERE QUESTIONS ABOUT THE ROBOTIC CASE. NO SCREWS WERE FOUND DEVIATED TO HAVE A CLINICAL DEFICIT.

Crash With

Motorcycle

Highest Injury Severity Alleged

Fatality

SV Pre-Crash Movement

Making Right Turn

SV Contact Area

Rear

SV Precrash Speed (MPH)

8

CP Pre-Crash Movement

Proceeding Straight

CP Contact Area

Front Left, Front Right

Within ODD?

Yes

Automation System Engaged?

ADS

Roadway Type

Street

Weather

Clear

Investigating Agency

Tempe Police Department

Make

JAGUAR

Model

I-PACE

SV is the subject vehicle — the one whose operator filed the report. CP is the crash partner, the other party. Contact area is where each was struck. NHTSA requires a report for any crash involving the driving system regardless of fault.

On September [XXX], 2025 at 1:21 AM PT a Waymo Autonomous Vehicle ("Waymo AV") operating in Tempe, Arizona was in a collision involving a motorcycle on [XXX] at [XXX]. The Waymo AV was traveling north in the rightmost lane on [XXX] and began slowing with its right turn signal activated in preparation for a right turn into a parking lot at [XXX], yielding to a pedestrian crossing the driveway entrance to the parking lot on the right-hand sidewalk. While the Waymo AV was slowing with its right turn signal activated, a motorcycle in the rightmost lane approached the Waymo AV from behind and the front of the motorcycle made contact with the rear left corner of the Waymo AV. The impact with the Waymo AV resulted in the motorcyclist falling from the motorcycle and into the roadway to the left of the Waymo AV. Immediately afterwards, a passenger car in the second-from-the-rightmost lane passed the Waymo AV on the left and struck the motorcyclist in the roadway. The passenger car did not stop and left the scene. The motorcyclist was transported from the scene to a hospital, where they were declared deceased. At the time of impact, the Waymo AV's Level 4 ADS was engaged in autonomous mode, and the Waymo AV was not carrying passengers. Following contact with the motorcycle, the Waymo AV came to a complete stop and remained stopped until the vehicle was towed away several hours later. The Waymo AV and the motorcycle sustained damage. The extent of the damage to the passenger car that left the scene is unknown at this time. Waymo is reporting this crash under Request No. 1 of Standing General Order 2021-01 because of a fatality. Waymo may supplement or correct its reporting with additional information as it may become available.

Last August, a jury awarded a $243 million verdict against Tesla over its culpability in a 2019 fatal crash in Florida that killed Naibel Benavides and critically injured Dillon Angulo. The jury assigned the driver two-thirds of the blame, and attributed one-third to Tesla.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A REVIEW OF AN ARTICLE WAS CONDUCTED, WHICH AIMED TO EVALUATE THE INITIAL EXPERIENCE AND FEASIBILITY OF ROBOTIC-ASSISTED PYLORUS-PRESERVING PANCREATICODUODENECTOMY PROCEDURES (PPPD) USING THE DA VINCI SP SYSTEM VERSUS THE DA VINCI XI SYSTEM. THE STUDY WAS A RETROSPECTIVE CASE SERIES ANALYZING 14 PATIENTS UNDERGOING PPPD FROM DECEMBER 2021 AND SEPTEMBER 2023. ONE PATIENT WITH COMMON BILE DUCT CANCER DIED DURING AT AN UNSPECIFIED TIME POST-PROCEDURE DUE TO THE PROGRESSION OF CANCER. THERE WAS NO REPORT OR INDICATION IN THE ARTICLE OF ANY DA VINCI SP SYSTEM MALFUNCTIONS. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE CORRESPONDING AUTHOR WERE MADE; HOWEVER, NO RESPONSE HAS BEEN 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: A REVIEW OF AN ARTICLE WAS PERFORMED THAT EVALUATED OUTCOMES OF ROBOTIC INGUINAL HERNIA REPAIR (RIHR) IN A SINGLE INSTITUTION STUDY COMPARING SURGEONS WITH VARYING ROBOTIC EXPERIENCE. THE STUDY ANALYZED 297 PATIENTS UNDERGOING ROBOTIC INGUINAL HERNIA REPAIR BETWEEN JULY 2016 AND SEPTEMBER 2021. ONE PATIENT DIED WITHIN 30 DAYS POST SURGERY DUE TO ASPIRATION PNEUMONIA LEADING TO CARDIAC ARREST. NO DEVICE MALFUNCTIONS WERE REPORTED, AND THE AUTHORS DID NOT REPORT ANY EVENTS CAUSED BY ANY ISI DEVICE. INTUITIVE SURGICAL INC, (ISI) CONTACTED THE AUTHOR WHO REPORTED THAT THERE WERE NO ISSUES SEEN OR RECORDED WITH THE DA VINCI SYSTEM DURING THE STUDY. THE SYSTEM ITSELF DID NOT CONTRIBUTE TO THE DEATH IN THE STUDY WHICH WAS RELATED TO THE PATIENTS CO MORBIDITY AND NOT THE SURGERY ITSELF.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A REVIEW OF THE CLINICAL ARTICLE WAS CONDUCTED, WHICH SUMMARIZED THE CLINICAL EXPERIENCE AND OUTCOMES OF TRANSORAL ROBOTIC SURGERY (TORS) IN THE TREATMENT OF HYPOPHARYNGEAL CARCINOMA. THE RETROSPECTIVE MULTICENTER STUDY ANALYZED 28 PATIENTS (ALL MALE, AGED 47- 82 YEARS) UNDERGOING TRANSORAL ROBOTIC SURGERY USING THE DA VINCI SI OR XI SURGICAL SYSTEM BETWEEN SEPTEMBER 2017 AND MARCH 2024. THE ARTICLE REPORTED TWO POSTOPERATIVE DEATHS WITHIN ONE MONTH OF SURGERY WITHOUT ANY OTHER DETAILS. NO DEVICE MALFUNCTIONS WERE REPORTED, AND THE AUTHORS DID NOT REPORT ANY EVENTS CAUSED BY THE DA VINCI SURGICAL SYSTEM. REQUESTS FOR ADDITIONAL INFORMATION WERE MADE TO THE CORRESPONDING AUTHOR, BUT NO RESPONSE HAS BEEN 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 MEDIASTINAL MASS RESECTION, THE BRACHIOCEPHALIC ARTERY WAS INJURED AND THE PROCEDURE WAS CONVERTED TO OPEN. THE PATIENT EXPIRED ON POST-OPERATIVE DAY ONE. THE SURGEON REPORTED THAT THE ARTERY WAS INJURED WHEN USING THE SYNCHROSEAL INSTRUMENT TO DISSECT LYMPH NODES. THE ARTERY WAS ADHERED TO TISSUE AND TO THE LYMPH NODES, RESULTING IN THE ARTERY NOT BEING VISIBLE TO THE SURGEON. THE ARTERY BEGAN TO BLEED AFTER IT WAS GRASPED WITH THE SYNCHROSEAL INSTRUMENT. THE PROCEDURE WAS CONVERTED TO THORACOTOMY. THERE WAS NO MALFUNCTION OF THE SYNCHROSEAL INSTRUMENT OR ANY OTHER DA VINCI PRODUCTS USED DURING THIS PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

Monarch Platform — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT THE PATIENT CODED DURING PROCEDURE, THE PHYSICIAN HAD CONDUCTED 4-BIOPSIES AND ON THE 5TH BIOPSY AN ABNORMAL AMOUNT OF BLOOD WAS COMING THROUGH THE ET TUBE. THE SCOPE AND THE PATIENT INTRODUCER WERE REMOVED AND THEY WERE ABLE TO STABILIZE THE PATIENT IN THE ROOM. THE PATIENT WAS MOVED TO ICU WHERE THEY LATER CODED AND PASSED AWAY. THE PHYSICIAN STATED THAT THE MONARCH DID NOT CAUSE OR CONTRIBUTE TO THE DEATH.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DRS. (B)(6), PLEASE NOTE, MS. (B)(6), WHO DIED WITHIN ONE YEAR FOLLOWING ROBOTIC MASTECTOMY FOR STAGE 2 BREAST CANCER: PLEASE NOTE - MS. (B)(6) CASE WAS ADVERTISED AS THE FIRST ROBOTIC MASTECTOMY OPERATION PERFORMED IN THE U.S. FOR TREATMENT OF BREAST CANCER: PLEASE NOTE, 5-YR SURVIVAL RATES FOR STAGE 2 BREAST CANCER USING THE CONVENTIONAL APPROACH TO MASTECTOMY IS OVER 80%. MS. (B)(6) DIED WITHIN ONE YEAR OF HER ROBOTIC MASTECTOMY SURGERY. PLEASE ENSURE THAT INTUITIVE SURGICAL HAS FORMALLY REPORTED THIS PATIENT MORTALITY FOLLOWING HER ROBOTIC MASTECTOMY TO THE FDA. ON JAN 5, 2025, AT 11:37 PM, (B)(6) WROTE: DRS. (B)(6), I AM WRITING THIS LETTER OF SAFETY AND ETHICS CONCERN/WARNING TO YOU BASED ON THE TWO RECENT HUMAN SUBJECT RESEARCH PUBLICATIONS FROM SOUTH KOREA, WHICH WERE SUPPORTED BY INTUITIVE SURGICAL: HTTPS://JAMANETWORK.COM/JOURNALS/JAMASURGERY/FULLARTICLE/2822315, HTTPS://WWW.NATURE.COM/ARTICLES/S41598-024-84807-0. THESE STUDIES INVOLVE THE USE OF THE DA VINCI ROBOTIC SYSTEM TO PERFORM MASTECTOMIES ON PATIENTS WITH BREAST CANCER, WHICH AS YOU KNOW WELL, IS CONSIDERED A NON-STANDARD AND OFF-LABEL APPROACH IN THE US AND WESTERN EUROPE. ADDITIONALLY, THESE EXPERIMENTAL SURGER

At 10:35 a.m. on December 2, 2024, Employee #1 was performing maintenance on a sensor inside a robotic enclosure. As he entered the area, the robot was stopped by entrance sensors. While he was cleaning the sensor, a coworker reset the machine from the control panel, unaware that Employee #1 was still inside the enclosure. The robotic arm activated and struck Employee #1, reportedly lifting and placing him onto a roller platform. He sustained multiple internal and external injuries and was killed as a result of the incident.

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 PANCREATODUODENECTOMY PROCEDURE, AN UNSPECIFIED VESSEL WAS DAMAGED LEADING TO BLEEDING. THE PROCEDURE WAS CONVERTED TO OPEN; THE PATIENT ULTIMATELY EXPIRED. AN INTUITIVE CLINICAL TERRITORY ASSOCIATE (CTA) WHO WAS PRESENT IN THE OR DURING THE PROCEDURE REPORTED THAT WHEN THE INJURY TO THE VESSEL OCCURRED, THE SURGEON CLAMPED THE BLEEDING VESSEL WITH A ROBOTIC INSTRUMENT. THE SURGEON STATED THAT DURING THE OPEN PROCEDURE THEY COULD NOT OBTAIN FULL CONTROL OF THE BLEEDING. CHEST COMPRESSIONS WERE PERFORMED, BUT THE PATIENT EXPIRED ON THE OR TABLE. THE SURGEON STATED THAT, "THE COMPLICATION WAS NOT RELATED TO THE DEVICES BUT TO [THE] COMPLEXITY OF THE SURGERY AND DEGREE OF CANCER." COINCIDENTALLY, PRIOR TO THE VESSEL INJURY EVENT, THE CTA CALLED INTUITIVE TECHNICAL SUPPORT ENGINEERING (TSE) TO REPORT THAT WHEN SWAPPING INSTRUMENTS, THE UNIVERSAL SURGICAL MANIPULATOR 3 (USM ARM3) WOULD JUMP MORE THAN NORMAL AND WOULD CANCEL GUIDED TOOL CHANGE (GTC). THE (TSE) REVIEWED THE SYSTEM LOGS AND FOUND NO RELATED ERRORS AT THE TIME OF THE CALL. THE CTA ALSO REPORTED A SYNCHROSEAL INSTRUMENT IN USE ON USM ARM3 COULD ONLY ROTATE TO THE RIGHT. THE TSE

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 APPROXIMATELY 25-30 MINUTES INTO A DA VINCI-ASSISTED SIMPLE PROSTATECTOMY PROCEDURE, THE PATIENT EXPERIENCED HEMODYNAMIC INSTABILITY WITH A DROP IN BLOOD PRESSURE AND HYPOXIA. THE CARDIAC ANESTHESIOLOGIST PERFORMED A TRANSESOPHAGEAL ECHOCARDIOGRAM AND A CO2 GAS EMBOLUS WAS OBSERVED IN THE RIGHT VENTRICLE. THE SURGICAL FELLOW REPORTED THAT THE PATIENT WAS IN A TRENDELENBURG POSITION OF APPROXIMATELY 10 DEGREES AND THE 3RD PARTY INSUFFLATION DEVICE PRESSURE WAS SET TO 12 MMHG. THE PROCEDURE WAS ABORTED; THEY WERE AT THE PROSTATE ENUCLEATION STEP WITH APPROXIMATELY ANOTHER 15-20 MINUTES REMAINING IN THE PROCEDURE. THE PATIENT DECOMPENSATED A SECOND TIME IN THE INTENSIVE CARE UNIT AND EXPIRED ABOUT 4-5 HOURS POST-OPERATIVELY. THE PATIENT HAD A HISTORY OF CARDIAC COMORBIDITIES. THE REPORTED CAUSE OF DEATH WAS CO2 EMBOLUS AND MYOCARDIAL INFARCTION. THE FELLOW STATED THAT THE EVENT WAS NOT CAUSED BY ANY DA VINCI PRODUCT; IT WAS A COMBINATION OF THE PRE-EXISTING CARDIAC CONDITION AND ABSORPTION OF CO2 GAS.

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 RADICAL PROSTATECTOMY PROCEDURE, THE PATIENT DIED OF A PULMONARY EMBOLISM ON AN UNSPECIFIED DATE. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS AND THE PATIENT HAD A FAST INITIAL POST-OPERATIVE RECOVERY. THE SURGEON AND THE HOSPITAL TEAM DO NOT THINK THIS IS DIRECTLY RELATED TO THE DA VINCI SINGLE PORT (SP) SYSTEM USED. ADDITIONAL INFORMATION WAS REQUESTED FROM THE SURGEON AND A RESPONSE IS PENDING.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A LITERATURE ARTICLE THAT DESCRIBED A COHORT STUDY OF 2225 PATIENTS THAT UNDERWENT ROBOT-ASSISTED SURGERY (RAS) IN GYNECOLOGICAL ONCOLOGY FROM JANUARY 2015 TO DECEMBER 2022. THE AIM OF THE STUDY WAS TO PROVIDE A COMPREHENSIVE DESCRIPTION OF PERIOPERATIVE MORBIDITY ASSOCIATED WITH ROBOT-ASSISTED SURGERY (RAS) IN GYNECOLOGICAL ONCOLOGY TO ENHANCE PREOPERATIVE COUNSELING AND SUPPORT SHARED DECISION-MAKING. A GYNECOLOGICAL ONCOLOGIST PERFORMED THE SURGERY IN 98% OF THE CASES, AND 64% OF THESE SURGEONS WERE ALREADY EXPERIENCED IN RAS (>50 ROBOTIC PROCEDURES). THE DA VINCI SI SYSTEM WAS USED IN 524 CASES AND THE DA VINCI XI SYSTEM IN 1701 CASES. AMONG THE 2225 PATIENTS, THE ARTICLE NOTED THAT ONE PATIENT DIED DUE TO CARDIOGENIC SHOCK 2 WEEKS AFTER UNCOMPLICATED RAS, THE CAUSE OF DEATH WAS FOUND TO BE MAJOR THROMBOEMBOLIC EVENT (TEE). THERE WERE NO DA VINCI DEVICE MALFUNCTIONS REPORTED, NOR DID THE AUTHORS ALLEGE THAT ISI PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENTS. THE STUDY CONCLUDED THAT RAS IN A HIGH-VOLUME GYNECOLOGICAL ONCOLOGY SETTING RESULTED IN LOW RATES OF MAJOR PERIOPERATIVE MORBIDITY AND CONVERSION TO LAPAROTOMY. THE FINDINGS SUPPORT THE USE OF RAS FOR SUITABLE PATIEN

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A LITERATURE ARTICLE DESCRIBED A RETROSPECTIVE ANALYSIS BETWEEN 2011-2022 OF 184 PATIENTS THAT UNDERWENT DA VINCI ASSISTED TORS SURGERY WITH NECK DISSECTION IN ONE SINGLE INSTITUTION, PERFORMED BY TWO TRAINED SURGEONS. THE STUDY WAS CONDUCTED TO EVALUATE THE ONCOLOGICAL OUTCOMES OF POST-TRANSORAL ROBOTIC SURGERY (TORS) FOR HPV-ASSOCIATED OROPHARYNGEAL SQUAMOUS CELL CARCINOMA. THE 3-YEAR AND 5-YEAR DISEASE-SPECIFIC SURVIVAL WERE 98.6% (95% CI 96.7¿100%) AND 94.4% (95% CI 89.9¿99.0%), RESPECTIVELY. THREE PATIENTS DIED FROM CAUSES UNRELATED TO DISEASE RECURRENCE. ONE PATIENT (0.5%) HAD AN EARLY POSTOPERATIVE HEMORRHAGE, DEFINED BY BLEEDING OCCURRING LESS THAN 24 HOURS FOLLOWING SURGERY, RESULTING IN DEATH FOUR DAYS LATER. ONE PATIENT DIED FROM CARDIOPULMONARY ARREST; ANOTHER PATIENT DIED FROM A SECOND TUMOR METASTASIS. THERE WERE NO DA VINCI DEVICE ISSUES REPORTED IN THE ARTICLE. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION FROM THE DESIGNATED AUTHOR WERE MADE, BUT NO RESPONSE HAS BEEN 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: REVIEW OF AN ARTICLE WAS COMPLETED OF A RANDOMIZED CONTROLLED TRIAL BASED ON DA VINCI-ASSISTED ROBOTIC PANCREATICODUODENECTOMY (RPD) WHERE THE AUTHORS COMPARED THE SHORT-TERM POSTOPERATIVE OUTCOMES OF RPD WITH THOSE OF OPEN PANCREATICODUODENECTOMY (OPD). THE TRIAL, CONDUCTED BETWEEN MARCH 5 AND DECEMBER 20, 2022, INCLUDED 164 PATIENTS RANDOMLY ASSIGNED TO EITHER THE RPD OR OPD GROUP. IN THE RPD GROUP, THERE WAS ONE IN-HOSPITAL DEATH (1%) WITHIN 90 DAYS AFTER THE OPERATION. SPECIFICALLY, ONE (1%) OF 81 PATIENTS IN THE RPD GROUP DEVELOPED POSTOPERATIVE PANCREATIC FISTULA RELATED HEMORRHAGE ON POSTOPERATIVE DAY 9, UNDERWENT TRANS-ARTERIAL EMBOLIZATION AND A SUBSEQUENT REOPERATION, BUT DIED OF SEPTIC SHOCK ON DAY 30. THERE WERE NO DA VINCI DEVICE MALFUNCTIONS REPORTED. THE OPD SUBSET ALSO HAD ONE PATIENT DEATH DUE TO A PULMONARY EMBOLISM ON POSTOPERATIVE 5. THE ARTICLE STATES THAT WHILE RPD SHOWED BENEFITS IN REDUCING HOSPITAL STAY, THE OVERALL CLINICAL BENEFIT REMAINS UNCLEAR, ESPECIALLY CONSIDERING THE EXTRA COSTS AND PATIENT PERCEPTIONS OF QUALITY OF LIFE AND RECOVERY AFTER DISCHARGE.

At 10:00 p.m. on February 22, 2024, an employee working as a machine operator for a landscape architectural service had been monitoring a production line (Line 1). The employee started his shift at 3:00 p.m. He was operating the conveyer that carries pallets loaded with landscape materials such as bags of mulch, decorative rocks, and soil. The employee works with a robotic arm that picks up landscape materials from the conveyor and places them on a pallet. When the pallet is full, it moves down the conveyer. A coworker who operates a forklift noticed a pallet was crooked and mentioned it to the employee before leaving the area to do his assigned work. After returning to the area, the coworker saw the employee inside the cage with the door closed. The employer stated that the employee must have entered across the conveyer causing the robot to pick the employee up thinking he was a pallet. The employee was caught within the cage under a robotic arm and died from crushing injuries to his chest.

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 THE PATIENT UNDERWENT AN UNEVENTFUL DA VINCI ASSISTED LOW ANTERIOR RESECTION FOR COLORECTAL CANCER. THE SURGEON STATED THAT THE ANASTOMOSIS WAS END-TO-END, CREATED WITH AN ETHICON ILS 29 CIRCULAR STAPLER. TESTING OF THE ANASTOMOSIS WAS PERFORMED DURING THE OPERATION AND NO LEAKAGE WAS FOUND. THE PATIENT EXPERIENCED COMPLICATIONS POSTOPERATIVELY AND EXPIRED APPROXIMATELY 69 DAYS POST-PROCEDURE. THERE WAS NO REPORT OF ANY ISSUES WITH THE DAVINCI PRODUCTS. ON POST-OPERATIVE DAY 4 (POD) THE PATIENT'S BLOOD PRESSURE SIGNIFICANTLY DROPPED AND CT SCANS SHOWED PNEUMOPERITONEUM. ANASTOMOSIS LEAKAGE, PERITONITIS, AND SEPSIS WERE SUSPECTED AND AN EMERGENT RE-OPERATION WAS PERFORMED. THE PATIENT REQUIRED POST-OPERATIVE CIRCULATORY AND OXYGEN SUPPORT VIA VENO-ARTERIAL AND VENO-VENO EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) AND VASOPRESSORS DUE TO RESPIRATORY FAILURE AND SEPTIC SHOCK. ON POD 7 THE CIRCULATORY SUPPORT WAS CHANGED TO VENO-VENOUS ECMO ONLY, WHICH WAS REMOVED FIVE DAYS LATER AFTER THE PATIENT WAS HEMODYNAMICALLY STABLE. THE PATIENT WAS TREATED WITH ANTIBIOTICS FOR ILEOSTOMY AND WOUND INFECTIONS. THE PATIENT'S HAND BECAME CYANOTIC FROM THE ECMO TREATMENT REQUIRI

A power-plant worker flying a drone to survey waterway facilities died after the aircraft auto-returned on low battery and came down on a hillside beside the road. He crossed the guardrail and went down the slope on a hand-held rope to retrieve it, fell 30 to 40 metres to a riverbed and died of blunt chest and abdominal trauma. The investigators name the unsafe retrieval as the cause — crossing the barrier without equipment, and no hazard assessment for the work — not the aircraft. Taiwan Ministry of Labour occupational accident case 1131701161.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING INVESTIGATION OF AN UNRELATED EVENT, A SURGEON NOTIFIED AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE THAT THE COUNTY MEDICAL EXAMINER (ME), WHILE PROVIDING AUTOPSY RESULTS FOR THE UNRELATED EVENT, "RECALLED TWO PREVIOUS PATIENT DEATHS CAUSED BY ROBOTIC STAPLE LINES NOT HOLDING UP ON ARTERIES AND CAUSING BLEEDING." THE ME RECALLED THAT ONE PATIENT HAD RECEIVED A ROBOTIC-ASSISTED PROSTATECTOMY, AND THE OTHER PATIENT RECEIVED A ROBOTIC-ASSISTED SPLENECTOMY. THERE WAS NO ADDITIONAL INFORMATION EXCHANGED, OTHER THAN THE EVENTS OCCURRED AT DIFFERENT HOSPITALS. THE MEDICAL EXAMINERS OFFICE WAS CONTACTED TO REQUEST ADDITIONAL INFORMATION. THE ME ASSISTANT STATED THEY WOULD REVIEW PREVIOUS CASES TO DETERMINE IF THERE WERE ANY SIMILAR CASES. UPON FOLLOW UP, THE ME ASSISTANT REPORTED FINDING A PROSTATECTOMY CASE FROM 2015, AND THE ONLY INFORMATION THEY COULD SHARE WAS THE DATE OF DEATH AND HOSPITAL WHERE THE PROCEDURE WAS PERFORMED. THERE WERE NO SIMILAR SPLENECTOMY CASES FOUND IN THE MEDICAL EXAMINERS RECORDS. THE MEDICAL EXAMINER DECLINED TO PROVIDE ANY FURTHER INFORMATION AND DESCRIBED THE CONVERSATION AS A BRIEF COLLEAGUE-TO-COLLEAGUE OBSERVATION. NO ADDITIONAL 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 DURING A DA VINCI ASSISTED HIATAL HERNIA REPAIR, THE INFERIOR VENA CAVA (IVC) WAS INJURED. THE SURGEON REPORTED THAT THE INJURY OCCURRED DUE TO ATYPICAL ANATOMY. WHILE USING THE HARMONIC ACE SHEARS TO DIVIDE THE GASTROHEPATIC LIGAMENT, A MALPOSITION OF THE IVC RELATIVE TO ITS NORMAL POSITION WAS ENCOUNTERED. THE IVC WAS TENSELY PULLED ACROSS THE DIAPHRAGM AND UNRECOGNIZED AS IT WAS TUCKED RIGHT BEHIND THE GASTROHEPATIC LIGAMENT. THE SURGEON BELIEVES THE SIDEWALL OF THE IVC WAS UNKNOWINGLY GRASPED IN THE INSTRUMENT JAWS WHILE DIVIDING THE LIGAMENT. THE PROCEDURE WAS CONVERTED TO OPEN TO ADDRESS THE INJURY, BUT THE PATIENT EXPIRED. THERE WAS NO REPORTED INTUITIVE SURGICAL, INC. (ISI) PRODUCT MALFUNCTION.

Monarch Platform — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING BRONCHOSCOPY, THE PATIENT BECAME HYPOTENSIVE. THE CRITICAL CARE PULMONOLOGY TEAM WAS CALLED TO THE BEDSIDE. A CHEST TUBE WAS INSERTED AND AN IMMEDIATE GUSH OF AIR WAS OBSERVED. SHORTLY THEREAFTER THE PATIENT ARRESTED AND CPR WAS INITIATED. A LARGER-BORE CHEST TUBE WAS PLACED, RESULTING AGAIN IN A GUSH OF AIR. THE PATIENT WAS PRONOUNCED DEAD BY THE CRITICAL CARE TEAM. NECROTIC MATERIAL WAS EXPELLED DURING THE EVENT. A RAB (ROBOT-ASSISTED BRONCHOSCOPY) WITH 7-NEEDLE ASPIRATION WAS PERFORMED. THE DEATH WAS PRESUMED TO BE DUE TO A TENSION PNEUMOTHORAX. NO ISSUES WERE REPORTED WITH THE DEVICES USED DURING THE PROCEDURE.

At 2:15 p.m. on November 29, 2022, an employee was lubricating conveyor rollers with WD-40 in an energized robotic cell referred to as the iPal palletizer machine. There were no other similar machines in the facility. The employee was between the robot arm and south side of the conveyor when he unknowingly activated the photo eye located at the roller plane which senses when pallets are ready to be picked up. The motion of moving the can of WD-40 over the conveyor area satisfied the photo eye which then sent the robot arm into motion, striking the employee in the back of the head, neck, and shoulder area pushing him down into the conveyor and piercing his neck, skull, and right hand. The robot arm stopped moving likely because the servos that moved the robot arm limited out due to sensing friction. The employee died due to crushing and piercing injuries.

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-ASSISTED HYSTERECTOMY PROCEDURE ON AN UNSPECIFIED DATE AND DIED FROM CANCER IN 2016. ACCORDING TO THE INITIAL REPORTER, THE PATIENT'S TREATMENT WAS NEGATIVELY AFFECTED BY THE DA VINCI-ASSISTED SURGERY. THE INITIAL REPORTER INDICATED THAT THE PATIENT UNDERWENT THE HYSTERECTOMY FOR CANCER THAT REOCCURRED FOR A SECOND TIME. PER THE INITIAL REPORTER, IT IS BELIEVED THAT THE ROBOTIC PROCEDURE "STIRRED UP THE CANCER" AND EXPEDITED HER DEATH BY SPREADING. THE PATIENT REPORTEDLY DIED WITHIN SIX MONTHS OF THE SURGERY. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

At 9:15 p.m. on September 1, 2022, an employee was placing welding tips into a welding tip cartridge for a spot welding robot. The spot welding robot was not locked out and activated as the employee placed the tips into the cartridge. The employee's upper torso was crushed, killing him.

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 02-APR-2020, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A "JORNAL BRASILEIRO DE PNEUMOLOGIA" ARTICLE TITLED, ¿ROBOTIC THORACIC SURGERY FOR NON-SMALL CELL LUNG CANCER: INITIAL EXPERIENCE IN BRAZIL¿ (TERRA, R. M., BIBAS, B. J., ET AL., 2020). WITHIN THE JOURNAL ARTICLE, AN OPERATIVE COMPLICATION INVOLVING A DA VINCI SURGICAL PROCEDURE WAS NOTED. IT WAS NOTED THAT A ¿PROCEDURE-RELATED DEATH OCCURRED IN 1 PATIENT (0.5%), 12 DAYS AFTER A LOBECTOMY. THAT PATIENT HAD DEVELOPED PNEUMONIA, SEPSIS, AND MULTIPLE ORGAN FAILURE.¿ THE ARTICLE CORRESPONDENT WAS CONTACTED TO GATHER ADDITIONAL INFORMATION AND THE INFORMATION WAS RECEIVED: THE ARTICLE CORRESPONDENT STATED THAT THERE WERE NO ALLEGATIONS OR CLAIMS THAT A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY MALFUNCTIONED DURING THE PROCEDURE. THE ARTICLE CORRESPONDENT ALSO STATED THAT "THE PROCEDURE-RELATED DEATH WAS ONE CASE IN WHICH THE PATIENT COURSED WITH PNEUMONIA AFTER THE PROCEDURE. NOTHING RELATED TO THE ACCESS ROUTE OR DA VINCI SYSTEM."

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 UNDERGOING TWO UNSPECIFIED SURGICAL PROCEDURES INVOLVING THE PROSTATE, TWO PATIENTS SUBSEQUENTLY CONTRACTED COVID-19 AND EXPIRED. PRIOR TO UNDERGOING THE SURGICAL PROCEDURES, THE PATIENTS HAD TESTED NEGATIVE FOR COVID-19 PRIOR TO THE PROCEDURE. THE INITIAL REPORTER COULD NOT CONFIRM IF THE PROCEDURES IN QUESTION INVOLVED THE USE OF A DA VINCI SURGICAL SYSTEM. IN ADDITION, THE INITIAL REPORTER ALSO DID NOT WHAT HOSPITAL(S) OR SURGEON(S) WERE INVOLVED. ON 04-MAY-2020, THE INITIAL REPORTER WAS CONTACTED AND THE FOLLOWING INFORMATION WAS OBTAINED: THE INITIAL REPORTER DISCUSSED THE SURGERIES WITH REPORTING PROFESSOR/SURGEON ON 29-APR-2020. THE TWO SURGERIES WERE PROSTATECTOMIES; HOWEVER, IT IS UNKNOWN WHETHER A DA VINCI SYSTEM WAS EVEN USED FOR EITHER SURGERY. THE REPORTING PROFESSOR/SURGEON WAS UNABLE TO PROVIDE THE ASSOCIATED HOSPITAL(S) OR SURGEON NAME(S) AS HE DOES NOT REMEMBER BECAUSE IT WAS SECONDHAND INFORMATION. THE REPORTING PROFESSOR/SURGEON BROUGHT THESE CASES UP DURING A CONVERSATION ABOUT FAULTY COVID-19 TEST RESULTS. THE REPORTING PROFESSOR/SURGEON STATED THAT IT IS UNKNOWN WHETHER THE TWO PATIENTS HAD RECEIVED FALSE NEGATIVE TESTS PRI

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 14-MAY-2020, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A HEAD & NECK ARTICLE TITLED, ¿ONE-YEAR OUTCOMES FOR DA VINCI SINGLE PORT ROBOT FOR TRANSORAL ROBOTIC SURGERY¿ (VAN ABEL, K. M., YIN, L. X., ET AL., 2020). WITHIN THE JOURNAL ARTICLE, AN OPERATIVE COMPLICATION INVOLVING A DA VINCI SURGICAL PROCEDURE WAS NOTED. WITHIN THE ARTICLE, THE FOLLOWING IS NOTED: ¿THERE WERE 4 POSTOPERATIVE HEMORRHAGES FOR AN OVERALL BLEED RATE OF 5.1%. THE DETAILS ON THESE POSTOPERATIVE HEMORRHAGE EVENTS ARE REPORTED IN TABLE 3. THERE WERE TWO MORTALITIES IN THIS COHORT OF 78, ONE SECONDARY TO A POST-TONSILLECTOMY HEMORRHAGE AND ANOTHER SECONDARY TO A POSTOPERATIVE PULMONARY EMBOLUS, FOR AN OVERALL MORTALITY RATE OF 2.6%¿ PROCEDURE INFORMATION PROCEDURE CATEGORY PROCEDURE NAME TRANSORAL ROBOTIC SURGERY. ISI FOLLOWED-UP WITH THE AUTHOR, WHO STATED THE FOLLOWING REGARDING THE REPORTED COMPLICATIONS: THERE WAS NO ALLEGATION OR CLAIM THAT A MALFUNCTION OF THE SYSTEM OR INSTRUMENT WAS INVOLVED IN THESE COMPLICATIONS. "THESE ARE KNOWN RISKS WITH THIS SURGICAL PROCEDURE, DOCUMENTED WITH THE SI AND TRANSORAL LASER MICROSURGERY AS WELL. WE DID NOT IDENTIFY A RATE HIGHER THAN THE PUBLISHED AVERAGES." NOTE

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 14-MAY-2020, INTUITIVE BECAME AWARE OF A HEAD & NECK ARTICLE TITLED, ¿ONE-YEAR OUTCOMES FOR DA VINCI SINGLE PORT ROBOT FOR TRANSORAL ROBOTIC SURGERY¿ (VAN ABEL, K. M., YIN, L. X., ET AL., 2020). WITHIN THE JOURNAL ARTICLE, AN OPERATIVE COMPLICATION INVOLVING A DA VINCI SURGICAL PROCEDURE WAS NOTED. WITHIN THE ARTICLE, THE FOLLOWING IS NOTED: ¿THERE WERE 4 POSTOPERATIVE HEMORRHAGES FOR AN OVERALL BLEED RATE OF 5.1 %. THE DETAILS ON THESE POSTOPERATIVE HEMORRHAGE EVENTS ARE REPORTED IN TABLE 3. THERE WERE TWO MORTALITIES IN THIS COHORT OF 78, ONE SECONDARY TO A POST-TONSILLECTOMY HEMORRHAGE AND ANOTHER SECONDARY TO A POSTOPERATIVE PULMONARY EMBOLUS, FOR AN OVERALL MORTALITY RATE OF 2.6%¿ PROCEDURE INFORMATION PROCEDURE CATEGORY PROCEDURE NAME TRANSORAL ROBOTIC SURGERY. THE ARTICLE¿S CONCLUSION CONTAINS THE FOLLOWING: ¿THERE WERE NO COMPLICATIONS DIRECTLY RELATED TO THE ROBOTIC PLATFORM, MAKING THE SP A SAFE SURGICAL INSTRUMENT FOR UPPER AERODIGESTIVE TRACT TUMORS. ALTHOUGH THE NEW SYSTEM POSED UNIQUE TECHNICAL CHALLENGES, THE OVERALL LEARNING CURVE FOR THE SP WAS RAPID AMONG EXPERIENCED TORS SURGEONS.¿ INTUITIVE SURGICAL, INC. (ISI) FOLLOWED-UP WITH THE AUTHOR WHO STATED THE FOLLO

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 UNDERGOING TWO UNSPECIFIED SURGICAL PROCEDURES INVOLVING THE PROSTATE, TWO PATIENTS SUBSEQUENTLY CONTRACTED COVID-19 AND EXPIRED. PRIOR TO UNDERGOING THE SURGICAL PROCEDURE, THE PATIENTS HAD TESTED NEGATIVE FOR COVID-19 PRIOR TO THE PROCEDURE. THE INITIAL REPORTER COULD NOT CONFIRM IF THE PROCEDURES IN QUESTION INVOLVED THE USE OF A DA VINCI SURGICAL SYSTEM. IN ADDITION, THE INITIAL REPORTER ALSO DID NOT WHAT HOSPITAL(S) OR SURGEON(S) WERE INVOLVED. ON 04-MAY-2020, THE INITIAL REPORTER WAS CONTACTED AND THE FOLLOWING INFORMATION WAS OBTAINED: THE INITIAL REPORTER DISCUSSED THE SURGERIES WITH THE REPORTING PROFESSOR/SURGEON ON (B)(6) 2020. THE TWO SURGERIES WERE PROSTATECTOMIES; HOWEVER, IT IS UNKNOWN WHETHER A DA VINCI SYSTEM WAS EVEN USED FOR EITHER SURGERY. THE REPORTING PROFESSOR/SURGEON WAS UNABLE TO PROVIDE THE ASSOCIATED HOSPITAL(S) OR SURGEON NAME(S) AS HE DOES NOT REMEMBER BECAUSE IT WAS SECONDHAND INFORMATION. THE REPORTING PROFESSOR/SURGEON BROUGHT THESE CASES UP DURING A CONVERSATION ABOUT FAULTY COVID-19 TEST RESULTS. THE REPORTING PROFESSOR/SURGEON STATED THAT IT IS UNKNOWN WHETHER THE TWO PATIENTS HAD RECEIVED FALSE NEGATIVE TESTS

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 INITIAL ENTRY WITH AN INTUITIVE SURGICAL, INC. (ISI) TROCAR AND OBTURATOR AT THE START OF A VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT EXPERIENCED BLEEDING. THE PROCEDURE WAS CONVERTED TO AN OPEN SURGICAL PROCEDURE TO IDENTIFY THE SOURCE OF THE BLEEDING. THREE OTHER SURGEONS WERE ASKED TO ASSIST WITH FINDING THE SOURCE OF THE BLEEDING. HOWEVER, THE SURGEONS COULD NOT IDENTIFY THE INJURED VESSEL, AND THE PATIENT REPORTEDLY EXPIRED. ISI CONTACTED THE SURGEON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: IN AN ATTEMPT TO GAIN INITIAL ACCESS TO THE ABDOMINAL CAVITY, THE SURGEON INSERTED AN ISI 8MM TROCAR IN THE LEFT UPPER QUADRANT UNDER DIRECT VISUALIZATION. THE ABDOMINAL CAVITY WAS NOT SUCCESSFULLY ENTERED DURING THE FIRST ATTEMPT AS THE SURGEON ONLY SAW FAT. DURING THE SECOND ATTEMPT, THE SURGEON AGAIN FAILED TO GAIN ACCESS. HOWEVER, AFTER THE SECOND ATTEMPT TO GAIN ACCESS, BLOOD WAS SEEN ALONG WITH FAT. THE SURGEON WAS NOT SURE IF THERE WAS ANY MISIDENTIFICATION OF ANATOMY DUE TO THE AMOUNT OF FAT. THE ANESTHESIOLOGIST STATED THAT THE BLOOD PRESSURE WAS INITIALLY STABLE. THE SURGEON THEN CONVERTED TO AN OPEN SURGICAL

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 PROSTATECTOMY WITH LYMPHADENECTOMY PROCEDURE THAT THE PATIENT'S LUNG CAPACITY STARTED TO DETERIORATE. THE PATIENT THEN EXPERIENCED AN UNSPECIFIED CARDIAC EVENT AND CODED. THE DA VINCI SYSTEM WAS UNDOCKED FROM THE PATIENT TO ATTEMPT TO REVIVE THE PATIENT, BUT THE ATTEMPTS WERE UNSUCCESSFUL. THE PATIENT REPORTEDLY EXPIRED IN THE OPERATING ROOM. ON 31-MAR-2022, AN INTUITIVE SURGICAL INC. (ISI) ENTERPRISE SOLUTIONS MANAGER (ESM) WAS CONTACTED AND ADDITIONAL INFORMATION WAS OBTAINED ON THIS EVENT: THE ESM WAS PRESENT FOR THE FIRST 45 MINUTES OF THIS PROCEDURE. THE PROCEDURE WAS GOING WELL WITH NO ISSUES. THE ESM LEFT THE OPERATING ROOM FOR 65 MINUTES AS THEY WENT TO CALL INTO A CONFERENCE CALL FOR ANOTHER EVENT. WHEN THE ESM RETURNED TO THE OPERATING ROOM HE NOTICED A CROWD OF PEOPLE AROUND THE OPERATING ROOM. THE ESM OBSERVED THE PATIENT UNDOCKED WITH THEIR PORT SITES BEING SUTURED AS IF THE PROCEDURE WAS COMPLETED. THE ESM ENCOUNTERED THE SURGEON LEAVING THE OPERATING ROOM AND ASKED WHAT HAPPENED. THE SURGEON SAID THE PATIENT CODED AND THAT THEY DID EVERYTHING THEY COULD BEFORE WALKING AWAY. THE ESM ASKED THE OPERATING ROOM STAFF STILL 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 DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY PROCEDURE, A THIRD PARTY STAPLER INSTRUMENT WAS USED ON UNSPECIFIED TISSUE. THE STAPLE LINE REPORTEDLY DID NOT HOLD AND CAUSED THE PATIENT TO BLEED TO DEATH. AT THIS TIME, THERE ARE NO KNOWN ALLEGATIONS AGAINST A DA VINCI PRODUCT. ON 28-JAN-2022, AN INTUITIVE SURGICAL INC. (ISI) ENTERPRISE SOLUTION MANAGER (ESM) WAS CONTACTED AND ADDITIONAL INFORMATION WAS OBTAINED ABOUT THE COMPLAINT: THE ESM WAS MADE AWARE OF THIS EVENT FROM THE SITE ROBOTICS COORDINATOR. THE CUSTOMER SITE HAS NOT PROVIDED ANY ADDITIONAL INFORMATION AT THIS TIME AS THE EVENT IS BEING REVIEWED BY THEIR RISK MANAGEMENT DEPARTMENT. IT IS UNKNOWN WHAT BRAND THIRD PARTY STAPLER WAS USED AND ON WHAT BLOOD VESSEL. THE THIRD PARTY STAPLE LINE REPORTEDLY BLED DURING THE PROCEDURE. THE SURGEON ATTEMPTED TO CONTROL THE BLEEDING AND THEN TO RESUSCITATE THE PATIENT; BUT THE PATIENT EXPIRED. IT WAS REPORTED THAT THE VESSEL THAT WAS STAPLED AND BLED WAS VERY CALCIFIED. THE SURGEON REPORTEDLY CUT MULTIPLE CABLES AT THE PATIENT BEDSIDE TO REMOVE THEM FROM THE FIELD. IT WAS REPORTED THAT THE DA VINCI SP CAMERA CABLE WAS CUT DURING THIS EVENT. ON 15-FEB-2022, ISI C

At 6:35 p.m. on November 3, 2021, an employee was performing maintenance work on a machine in the automotive engine parts manufacturing facility. As the employee performed maintenance on the tool brush inside the deenergized machine, his upper body was protruding through the part entry door on top of the machine. While working in this position, the energized gantry robot which moves parts to and from the individual machines across the crank shaft line, entered the employee's work zone and struck him. The employee was entangled and caught between the gantry's "grabber hand" and the side of the machine. The employee suffered fatal injuries due to entanglement at the waist level by the gantry and the inside of the machine causing bleeding, contusions, lacerations, and bruises in the upper arms, chest, head and rib cage areas.

ExcelsiusGPS — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AN EXCELSIUS ROBOT WAS IN USE WHEN A PATIENT EXPERIENCED ADVERSE HEALTH EFFECTS AND PASSED AWAY.

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 30-AUG-2021, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF AN UPDATES IN SURGERY ARTICLE TITLED, ¿IMPACT OF BODY MASS INDEX ON THE EARLY EXPERIENCE OF ROBOTIC PANCREATICODUODENECTOMY¿ (CHAO, Y. J., LIAO, T. K., ET AL., 2021). WITHIN THE JOURNAL ARTICLE, OPERATIVE COMPLICATIONS INVOLVING DA VINCI SURGICAL PROCEDURES WERE NOTED: "ALL OPERATIONS WERE PERFORMED USING THE DA VINCI SI SURGICAL SYSTEM. TWO PATIENTS (2.9%) WERE CONVERTED TO OPEN SURGERY IN THE OBESE GROUP DUE TO SEVERE INFLAMMATION AT THE PANCREATIC HEAD AND TUMOR ADHESIVE TO THE SUPERIOR MESENTERIC VEIN AND NONE IN THE NORMAL-WEIGHT AND OVERWEIGHT GROUPS. THIRTY THREE PATIENTS EXPERIENCED COMPLICATIONS WITH AN OVERALL COMPLICATION RATE OF 51.5%, AND THE MAJOR COMPLICATION RATE (CLAVIEN GRADE = III) WAS 19.1%. THERE WERE 17.6% CLINICALLY RELEVANT POST-OPERATIVE PANCREATIC FISTULA (CR-POPF) (16.1% GRADE B POPF, 1.5% GRADE C POPF), 8.9% GRADE B/C POST PANCREATECTOMY HEMORRHAGE (PPH), 11.8% GRADE B/C DELAYED GASTRIC EMPTYING (DGE), AND 5.9% BILE LEAKAGE. TWELVE PATIENTS (17.6%) HAD PERIPANCREATIC FLUID COLLECTIONS, AND EIGHT OF THEM REQUIRED DRAINAGE. ONE PATIENT REQUIRED REOPERATION DUE TO FAILED EMBOLIZATION OF THE PSEU

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 BY AN UNSPECIFIED SURGEON, NOT THE CONSOLE SURGEON OF RECORD, THAT THERE WAS A REPORT OF A PATIENT DEATH OCCURRING ON AN SP DA VINCI SYSTEM. ADDITIONAL EVENT DETAILS (INCLUDING THE DATE OF THE EVENT), PATIENT DEMOGRAPHICS, PATIENT DATE OF DEATH, AND SYSTEM AND/OR PROCEDURE DETAILS WERE UNKNOWN AND UNATTAINABLE EVEN AFTER ATTEMPTS WERE MADE TO GATHER ADDITIONAL INFORMATION. INTUITIVE SURGICAL, INC. (ISI) HAS REACHED OUT TO THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION BUT HAS NOT YET RECEIVED A RESPONSE.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE PATIENT HAD A MILD HERNIA THAT NEEDED REPAIR. IT WAS DONE ROBOTICALLY USING THE DAVINCI SYSTEM. THE PATIENT HAD A PUNCTURED ARTERY AND A LACERATED BOWEL FROM SURGICAL ERRORS DURING THE PROCEDURE. THERE WAS EXTENSIVE INTERNAL BLEEDING. THE PATIENT BECAME SEPTIC AND WITHIN THREE DAYS WAS DEAD. THE PATIENT WAS HEALTHY WHEN HE WALKED IN EVEN THOUGH HE WAS AN OLDER PATIENT. THE PATIENT WENT TO THE HOSPITAL WITH UPPER ABDOMINAL PAIN. IT WAS DETERMINED HE HAD A HERNIA AND HE WAS SENT TO A DOCTOR TO HAVE IT REPAIRED. FDA SAFETY REPORT ID # (B)(4).

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 5-MAY-2021, INTUITIVE SURGICAL, INC. (ISI) RECEIVED MW5100203 STATING: ¿A (B)(6) Y/O FEMALE WITH A HISTORY OF 12DM. HTN. UTERINE ADENO CANCER S/P HYSTERECTOMY (2016), HX OF APPENDICEAL ADENOMA SEEN ON ENDOSCOPY THAT WAS SUSPICIOUS FOR MALIGNANCY UNDERWENT A ROBOTIC ASSISTED LAP RIGHT HEMICOLECTOMY ON (B)(6) 2021. ON (B)(6) 2021 THE PATIENT BECAME HYPOXIC AND CARDIAC ARRESTED. THE PATIENT UNDERWENT THREE ROUNDS OF CPR BEFORE OBTAINING ROSC. THE PATIENT WAS TRANSPORTED TO ICU, AND THREE UNITS OF EMERGENCY RELEASED PRSCS WERE TRANSFUSED, DUE TO A PROFOUND DROP IN HER HGB, THE PATIENT REMAINED HEMODYNAMICALLY UNSTABLE AND A DECISION WAS MADE TO RETURN TO THE OPERATING ROOM FOR AN EXPLORATORY LAPAROTOMY. IN THE OPERATING ROOM, THE ILEOCOLIC ARTERY WAS FOUND TO HAVE A PULSATILE BLEED AND WAS SUBSEQUENTLY LIGATED. ON RETURN TO THE ICU, PT. REMAINED HEMODYNAMICALLY UNSTABLE WITH WORSENING HYPOXIA. THE PATIENT REQUIRED INCREASED PRESSURE SUPPORT THROUGHOUT THE DAY. ON (B)(6) 2021 THE PATIENT¿S CONDITION CONTINUED TO WORSEN. ABDOMINAL COMPARTMENT SYNDROME WAS SUSPECTED AND THE DECISION WAS MADE BY THE ICU TEAM TO RE-OPEN THE ABDOMEN AT THE BEDSIDE. UPON ENTRY INTO THE ABDOMEN, 1000 CCS OF

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 BY A PROFESSOR OF RESPIRATORY SURGERY THAT A PATIENT UNDERWENT AN UNSPECIFIED UROLOGICAL DA VINCI-ASSISTED SURGICAL PROCEDURE ON AN UNSPECIFIED DATE. THE PROFESSOR INDICATED THAT THE PATIENT DIED FROM AN AIR EMBOLISM AS A RESULT OF USING AN AIR SEAL (A 3RD PARTY MANUFACTURER DEVICE) BY INCREASING THE PRESSURE TO INCREASE THE HEMOSTATIC EFFECT. ON 12-MAR-2020, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE ISI CLINICAL SALES REPRESENTATIVE (CSR) REPORTEDLY HEARD THAT THE RESPIRATORY SURGEON HAD CONDUCTED THE DA VINCI-ASSISTED UROLOGICAL PROCEDURE. THE SURGICAL PROCEDURE WAS RECORDED ON VIDEO. HOWEVER, IT IS UNKNOWN IF THE VIDEO IS AVAILABLE FOR ISI TO REVIEW. THERE WERE NO REPORTED INTRA-OPERATIVE COMPLICATIONS. NO FURTHER CLINICAL OR PATIENT INFORMATION WAS PROVIDED. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

At 8:00 a.m. on October 16, 2019, an employee was working on the paint line in Section 1200 and entered into an area that was chained off with LOTO signs to free a jammed pallet. The employee was struck by a fiber concrete board that was rejected by a Guidel Gantry Systems Robot and crushed between it and a stack of other rejected boards, killing him.

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 VIA SOCIAL MEDIA (I.E. (B)(6) POST) THAT A PATIENT UNDERWENT AN UNSPECIFIED DA VINCI-ASSISTED ¿BIOPSY¿ PROCEDURE AND ALLEGEDLY EXPERIENCED OPERATIVE COMPLICATIONS. PER THE INITIAL (B)(6) POSTING, THE FOLLOWING WAS NOTED: ¿MY FATHER DIED TWO YEARS AGO WHEN A DAVINCI-AIDED BIOPSY CAUSED MASSIVE BLEEDING. HE MADE ME PROMISE I WOULD NOT SUE. HE DID NOT MAKE ME PROMISE I WOULD NOT TALK ABOUT IT.¿ ON (B)(6) 2019, THE INITIAL REPORTER POSTED THE FOLLOWING SUBSEQUENT (B)(6) POSTING: ¿(B)(6). YOU CAN TAKE IT FROM THERE.¿ REFER TO THE FOLLOWING LINK FOR THE (B)(6) POSTINGS: "(B)(6)".