Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON 2/19/2021, IT WAS REPORTED THAT DURING A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE ON (B)(6) 2021, A PNEUMOTHORAX WAS IDENTIFIED. THE PATIENT HAD A SMALL PNEUMOTHORAX IN THE RIGHT UPPER LOBE THAT DID NOT REQUIRE INTERVENTION. THE PATIENT WAS RELEASED FROM THE HOSPITAL ON THE SAME DAY. DURING A POST-PROCEDURE FOLLOW-UP ON (B)(6) 2021, IT WAS OBSERVED THAT THE PNEUMOTHORAX HAD GROWN ABOUT 40 TO 50% FROM THE ORIGINAL SIZE. A CHEST TUBE WAS PLACED AND THE PATIENT WAS RELEASED THE SAME DAY. IT WAS REPORTED THAT THE PATIENT IS DOING FINE AND DID NOT REQUIRE ANY ADDITIONAL CARE.

Senhance — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE EVENT WAS REPORTED AS A COMPLAINT ON (B)(6) 2021. THE EVENT OCCURRED AT (B)(6) HOSPITAL, WHICH IS LOCATED IN THE (B)(6). THE EVENT INVOLVED TWO SENHANCE MANIPULATOR ARMS (X9000005, UDI: (B)(4), SERIAL NUMBERS (B)(4)) AND TWO JOHAN GRASPERS 15 MM Ø 5 MM X 310 MM (X0007005, UDI: (B)(4), LOT: 1845171). THE TIME OF OCCURRENCE WAS DURING A SURGICAL CASE AND THE SURGICAL PROCEDURE WAS FOR TREATMENT OF MALROTATION VOLVULUS. THE PATIENT WAS A (B)(6) CAUCASIAN FEMALE WITH WEIGHT OF (B)(6) AND BMI OF 29.2. THE SENHANCE SYSTEM AND ASSOCIATED DEVICES ARE NOT INDICATED FOR PEDIATRIC USE IN THE US. AS INITIALLY REPORTED BY THE COMPLAINANT, DURING THE CASE THE SMALL INTESTINE WAS PERFORATED 2 TIMES WITH THE JOHAN GRASPER. WHEN HOLDING THE TISSUE WITH THE GRASPER, THE TISSUE TURNED WHITE DUE TO THE GRASPING FORCE. AFTER STITCHING BOTH PERFORATIONS, THE SURGEON COULD CONTINUE WITH THE CASE. THE USE OF TWO JOHAN GRASPING FORCEPS CAUSED HEMATOMA OF THE SEROSA AND EVENTUALLY 2 PERFORATIONS OF THE SMALL INTESTINE. THE FOOTPRINT OF EVERY BITE WAS VISIBLE ON THE TISSUE. THE PROCEDURAL DELAY WAS LESS THAN 15 MINS. ADDITIONAL QUESTIONS WERE POSED TO FURTHER INVESTIGATE THE IMPACT ON THE PATIENT. THERE

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2021, ITS WAS REPORTED THAT AFTER A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE, A PNEUMOTHORAX WAS IDENTIFIED DURING POST-PROCEDURE SCREENING. INITIALLY, THE PATIENT HAD A 5 TO 10% PNEUMOTHORAX IN THE LEFT UPPER LOBE. DURING THE CASE, MONARCH FORCEPS AND MEDTRONIC ARCPOINT NEEDLE WERE USED. THE PATIENT WAS RELEASED FROM THE HOSPITAL THE SAME DAY BUT WAS ASKED TO RETURN THE FOLLOWING DAY FOR AN X-RAY. DURING THE X-RAY, IT WAS OBSERVED THAT THE PNEUMOTHORAX WAS GROWN 40 TO 50% FROM THE ORIGINAL SIZE. A CHEST TUBE WAS PLACED AND THE PATIENT WAS RELEASED THE SAME DAY. IT WAS REPORTED THAT THE PATIENT IS DOING FINE AND DID NOT REQUIRE ANY ADDITIONAL CARE OR INTERVENTION.

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 THE COMPLETION OF A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE SURGEON NOTICED THAT THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY WAS NOT INSTALLED ON THE MCS INSTRUMENT. THE CUSTOMER STATED THAT THE SURGEON SEARCHED FOR THE MCS TIP COVER ACCESSORY BUT COULD NOT LOCATE IT. THE CUSTOMER ALSO STATED THAT THE SURGEON INSERTED A PORT INTO THE PATIENT, CHECKED INSIDE OF THE PATIENT'S ABDOMINAL CAVITY, AND FOUND THAT THE MCS TIP COVER ACCESSORY HAD FALLEN INSIDE THE PATIENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE MCS TIP COVER ACCESSORY WAS INSPECTED PRIOR TO USE AND NO ABNORMALITIES WERE NOTED WITH IT. THE MCS TIP COVER ACCESSORY WAS NOT INSTALLED BEYOND THE ORANGE SURFACE DURING THE SURGICAL PROCEDURE. ALL PORTS HAD BEEN REMOVED FROM THE PATIENT AND THE SURGEON HAD ALREADY CLOSED THE PATIENT'S ABDOMEN AT THE TIME OF IDENTIFYING THE ISSUE. A PORT WAS RE-INSERTED INTO THE PATIENT TO RETRIEVE THE MCS TIP COVER ACCESSORY AND THE ITEM WAS RETRIEVED SUCCESSFULLY WITH NO INJURY OCCURRING TO THE PATIENT.

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

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2021, IT WAS REPORTED THAT DURING A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE THE PATIENT WAS OBSERVED TO HAVE A PNEUMOTHORAX. THE TARGET LOCATION WAS RIGHT UPPER LOBE. THERE WAS NO ALLEGATION OF DEVICE FAILURE. A CHEST TUBE WAS PLACED AND THE PATIENT WAS HOSPITALIZED. CHEST TUBE WAS REMOVED ON (B)(6) 2021. THE PNEUMOTHORAX WAS RESOLVED, AND THE PATIENT WAS DISCHARGED ON (B)(6) 2021.

da Vinci Surgical System — Injury 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.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER CONTACTED THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) REGARDING A MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY. THE CUSTOMER REACHED OUT WHEN AN MCS TIP COVER ACCESSORY CAME OFF OF A ROBOTIC INSTRUMENT THAT WAS BEING USED. THE CUSTOMER WAS ASKING IF IT WOULD SHOW UP ON AN X-RAY IF THEY COULD NOT FIND IT. THE CUSTOMER ALSO INDICATED THEY DID NOT USE ANY KIND OF LUBRICANT WITH THE MCS INSTRUMENT AND COULD NOT BELIEVE IT CAME OFF. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE MCS INSTRUMENT AND MCS TIP COVER ACCESSORY WERE INSPECTED PRIOR TO USE AND NO DAMAGE WAS NOTED ON EITHER. THE MCS TIP COVER ACCESSORY FELL INSIDE THE PATIENT, AND WAS RETRIEVED USING A LAPAROSCOPIC GRASPER. THE CUSTOMER WAS REMOVING THE INSTRUMENT FROM THE PATIENT WHEN THE TIP COVER FELL. SURGEON DID NOT NOTICE ANY ISSUE WITH INSTRUMENT FUNCTIONALITY AND THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENT. UPON REMOVAL OF THE MCS, THE TIP WAS STRAIGHTENED AND THERE WAS NO RESISTANCE. THERE WAS