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)".

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 VIA SOCIAL MEDIA THAT AFTER UNDERGOING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY PROCEDURE, THE PATIENT CLAIMED THAT HE EXPERIENCED A POST-OPERATIVE COMPLICATION AS A RESULT OF ALLEGED DAMAGE TO HIS URINARY SPHINCTER. WITHIN THE WEB ARTICLE, "FDA SOUNDS AN ALARM ON USING ROBOTIC DEVICES IN CANCER SURGERIES, CITING CONCERNS ABOUT SAFETY AND RESULTS" (DATED 02/28/2019), THE PATIENT POSTED THE FOLLOWING COMMENT: (B)(6).

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 A DA VINCI-ASSISTED NISSEN FUNDOPLICATION PROCEDURE, A PUNCTURE WOUND WAS FOUND ON THE PATIENT'S SIGMOID COLON. THE PATIENT WAS REPORTEDLY STILL IN THE HOSPITAL. ON (B)(4) 2019, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT WAS OBTAINED: THE CSR WAS PRESENT DURING THE DA VINCI-ASSISTED NISSEN FUNDOPLICATION PROCEDURE WHICH WAS NOT RECORDED ON VIDEO. NO INTRA-OPERATIVE COMPLICATIONS WERE IDENTIFIED. THERE WERE ALSO NO REPORTS OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. THE SURGICAL PROCEDURE WAS COMPLETED ROBOTICALLY. ON POST-OPERATIVE DAY #1, THE PATIENT HAD COMPLAINTS OF ABDOMINAL PAIN. THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM (OR) AND A PUNCTURE WOUND ON THE SIGMOID COLON WAS IDENTIFIED. A BOWEL RESECTION WAS PERFORMED BY A COLORECTAL SURGEON TO ADDRESS THE BOWEL INJURY. ON AN UNSPECIFIED DATE POST-OPERATIVELY, THE CSR WAS INFORMED THAT THE PATIENT ULTIMATELY EXPIRED. THE CSR SPOKE TO THE SURGEON ABOUT THE POST-OPERATIVE COMPLICATION (I.E. BOWEL INJURY). ACCORDING TO THE CSR, THE SURGEON DID NOT K

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS INITIALLY REPORTED THAT DURING AN UNSPECIFIED DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGICAL STAFF ENCOUNTERED BLEEDING. THE SURGICAL STAFF ATTEMPTED UNSUCCESSFULLY TO CONTROL THE BLEEDING USING A "TACHOSIL TISSUE SEALING SHEET." ANOTHER PHYSICIAN WAS CALLED IN TO ASSESS THE EVENT. THE PATIENT¿S BLOOD PRESSURE HAD REPORTEDLY ¿DROPPED TO LESS THAN 60¿ DURING THE EVENT. THE CAUSE OF THE BLEEDING IS UNKNOWN AND IT IS UNCLEAR WHAT ADDITIONAL MEDICAL INTERVENTION, IF ANY, WAS ADMINISTERED DUE TO THE INTRA-OPERATIVE COMPLICATION. ON (B)(6) 2019, A PHYSICIAN FROM THE SITE PROVIDED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE PATIENT EXPERIENCED HEMORRHAGING FROM THE PULMONARY VEINS AND THE CASE WAS CONVERTED TO A THORACOTOMY.

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 PULMONARY WEDGE RESECTION PROCEDURE, THE JAWS OF A CURVED-TIP STAPLER 30 INSTRUMENT ALLEGEDLY GOT STUCK ON TISSUE. THE SURGICAL STAFF ATTEMPTED UNSUCCESSFULLY TO OPEN THE JAWS OF THE CURVED-TIP STAPLER 30 INSTRUMENT USING A STAPLER RELEASE KIT (SRK). THE SURGICAL STAFF ENDED UP USING A TRADITIONAL LAPAROSCOPIC STAPLER INSTRUMENT TO REMOVE THE ROBOTIC STAPLER INSTRUMENT. THERE WAS NO REPORT OF A PATIENT INJURY BY THE INITIAL REPORTER. ON (B)(6) 2019, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE'S ROBOTICS COORDINATOR AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: A 3RD-PARTY INSTRUMENT WAS USED LAPAROSCOPICALLY TO REMOVE THE CURVED-TIP STAPLER 30 INSTRUMENT AND THE SURGERY WAS COMPLETED WITH NO REPORTED INJURY TO THE PATIENT. "EXTRA TISSUE" WAS REPORTEDLY REMOVED DURING THE PROCESS OF RETRIEVING THE ROBOTIC STAPLER INSTRUMENT. THE ROBOTICS COORDINATOR EXPLAINED THAT TISSUE WITHIN THE CLAMPED JAWS OF THE CURVED-TIP STAPLER 3 WAS REMOVED. THERE WAS NO REPORTED EXTRA BLEEDING AS A RESULT. THERE HAVE BEEN NO REPORTS OF INJURY/HARM TO PATIENT POST-OPERATIVELY. IT WAS REPORTED THAT THERE WAS AN ISSUE WIT

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED ABDOMINOPERINEAL RESECTION (APR) PROCEDURE, THE SURGICAL STAFF IDENTIFIED A BURN ON THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY THAT WAS INSTALLED ON A MCS INSTRUMENT. AFTER EXAMINING THE BOWEL, A ¿SMALL BURN¿ WAS DISCOVERED. THE MCS TIP COVER ACCESSORY WAS REMOVED AND REPLACED. THE SURGICAL PROCEDURE WAS COMPLETED ROBOTICALLY. ON (B)(6) 2019, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE CSR WAS NOT PRESENT DURING THE SURGICAL PROCEDURE. THE SITE¿S ROBOTICS COORDINATOR CONTACTED THE CSR AND INFORMED HIM THAT THE SURGEON HAD PLACED A STITCH OVER THE BURN INJURY. NO OTHER CLINICAL INFORMATION WAS PROVIDED.

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 THROUGH A SOCIAL MEDIA BLOG THAT AFTER UNDERGOING A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE IN 2013, THE PATIENT WAS FOUND TO HAVE SUSTAINED VAGINAL CUFF DEHISCENCE WITH VAGINAL CUFF CELLULITIS AND A PELVIC ABSCESS. AS A RESULT, THE PATIENT UNDERWENT SUBSEQUENT SURGERY. THE PATIENT HAS ALSO REPORTEDLY EXPERIENCED CHRONIC PAIN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY 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 AN UNSPECIFIED DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT EXPERIENCED POST-OPERATIVE ILEUS. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. ON (B)(4) 2019, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE DA VINCI-ASSISTED SURGICAL PROCEDURE WAS COMPLETED AS PLANNED. THE CYSTECTOMY WAS COMPLETED ROBOTICALLY AND THE ILEAL CONDUIT WAS PERFORMED OUTSIDE OF THE PATIENT'S BODY CAVITY. ON (B)(6) 2019, THE PATIENT WAS REPORTEDLY STILL IN THE HOSPITAL. HOWEVER, THE REASON FOR THE PROLONGED HOSPITALIZATION IS UNKNOWN. ON (B)(4) 2019, ISI CONTACTED THE SITE AND WAS INFORMED THAT THE PATIENT WAS DISCHARGED ON AN UNSPECIFIED DATE. A NURSE AT THE SITE INDICATED THAT THE "DECREASE IN INTESTINAL MOVEMENT" WAS "TEMPORARY" AND WAS POSSIBLY ATTRIBUTED TO ANESTHESIA.

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 THROUGH A SOCIAL MEDIA BLOG THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY, THE PATIENT CLAIMED THAT THE SURGEON AND THE ROBOT "HURT" HER URETER. AS A RESULT OF THE ALLEGED OPERATIVE COMPLICATION, THE PATIENT INDICATED THAT SHE NEEDED A NEPHROSTOMY TUBE PLACED FOR 2 YEARS FOLLOWED BY THE NEED FOR URETERAL STENT REPLACEMENT EVERY 3 MONTHS. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY 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-ASSISTED INGUINAL HERNIA REPAIR PROCEDURE, THE PATIENT WAS RELEASED AFTER RECOVERY. ON AN UNSPECIFIED DATE POST-OPERATIVELY, THE PATIENT RETURNED TO THE HOSPITAL DUE TO INTERNAL BLEEDING AND UNDERWENT A SMALL BOWEL RESECTION. IT WAS ALLEGED THAT THE OPERATIVE COMPLICATIONS WERE CAUSED BY ¿STRAY ENERGY¿ FROM A MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT. ON (B)(6) 2019, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE¿S OR MANAGER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THERE WERE NO REPORTED ISSUES WITH THE DA VINCI SURGICAL SYSTEM AND NO INTRA-OPERATIVE COMPLICATIONS DURING THE CASE. ON (B)(6) 2019, THE PATIENT RETURNED TO THE HOSPITAL AND WAS FOUND TO HAVE A HOLE IN THE SMALL BOWEL. THE PATIENT UNDERWENT A SMALL BOWEL RESECTION VIA OPEN SURGERY TO ADDRESS THE SMALL BOWEL COMPLICATION. THE'S SITES PATHOLOGY DEPARTMENT ANALYZED THE SPECIMEN AND COULD NOT DETERMINE A CAUSE FOR THE BOWEL COMPLICATION. ACCORDING TO THE ISI CLINICAL SALES REPRESENTATIVE (CSR), THE SURGEON SPECULATED THAT THE BOWEL INJURY WAS A RESULT OF "CAPACITIVE COUPLING" FROM THE MCS INSTRUMENT. THE CSR INDICATED THAT THE SITE

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 RADICAL HYSTERECTOMY PROCEDURE, ELECTRICAL ENERGY BURNED THROUGH A MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY THAT WAS INSTALLED ON A MCS INSTRUMENT. AS A RESULT, THE PATIENT SUSTAINED AN INJURY THROUGH THE ILIAC ARTERY. THE CASE WAS REPORTEDLY CONVERTED TO OPEN SURGERY. ON (B)(4) 2019, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES ASSOCIATE (CSA) AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE CSA WAS NOT PRESENT DURING THE SURGICAL PROCEDURE. THE SITE¿S ROBOTICS COORDINATOR CLAIMED THAT ELECTRICAL ENERGY ¿ESCAPED¿ THROUGH THE MCS TIP COVER ACCESSORY. THE SURGICAL STAFF INITIALLY ATTEMPTED TO REPAIR THE VESSEL INJURY USING THE DA VINCI SURGICAL SYSTEM. HOWEVER, THE CASE WAS REPORTEDLY CONVERTED TO OPEN SURGERY TO REPAIR THE VESSEL. AFTER THE VESSEL WAS REPAIRED, THE HYSTERECTOMY WAS COMPLETED VIA OPEN SURGERY. NO POST-OPERATIVE COMPLICATIONS HAVE BEEN REPORTED. THE CSA INDICATED THAT THE LAST TIME HE HAD SPOKEN TO THE CUSTOMER, THE SITE¿S RISK MANAGEMENT DEPARTMENT HAD THE MCS INSTRUMENT AND/OR MCS TIP COVER ACCESSORY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS INITIALLY REPORTED THAT AFTER UNDERGOING A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE AND THE PATIENT WAS DISCHARGED, THE PATIENT¿S BOWEL WAS FOUND TO BE STUCK TO THE ABDOMINAL WALL. THE PATIENT UNDERWENT ANOTHER UNSPECIFIED SURGICAL PROCEDURE ON AN UNSPECIFIED DATE TO TAKE DOWN THE BOWEL USING BLUNT DISSECTION. THERE WAS NO REPORT OF A BOWEL PERFORATION. THE ROOT CAUSE OF THE POST-OPERATIVE COMPLICATION IS UNKNOWN. ON 12/13/2018, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED FROM AN ISI CLINICAL TERRITORY ASSOCIATE (CTA): THE CTA WAS PRESENT DURING THE DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE WHICH WAS NOT RECORDED ON VIDEO. THERE WERE NO INTRA-OPERATIVE COMPLICATIONS OR REPORTS OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. THE CASE WAS COMPLETED ROBOTICALLY. ON AN UNSPECIFIED DATE POST-OPERATIVELY, THE PATIENT DEVELOPED UNSPECIFIED SYMPTOMS AND UNDERWENT AN UNSPECIFIED NON-ROBOTIC SURGICAL PROCEDURE TO TAKE DOWN THE BOWEL WHICH WAS FOUND TO BE STUCK TO THE PELVIC WALL BY THE CUFF CLOSURE. THE CTA SPOKE TO THE SURGEON ABOUT THE POST-OPERATIVE COMPLICATION. THE SURGEON DID NOT KNOW THE CAUSE OF THE POST-O

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS INITIALLY REPORTED THAT DURING COMPLETION OF A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE, A PULMONARY ARTERY WAS ¿HIT¿ AND AS A RESULT, THE PATIENT BLED OUT AND EXPIRED. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. ON (B)(6) 2018 AND (B)(6) 2019, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THERE WAS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. THE CSR DID NOT KNOW WHAT SURGICAL TASK THE SURGEON WAS PERFORMING WHEN THE VESSEL WAS ALLEGEDLY ¿HIT.¿ ACCORDING TO THE CSR, THE GENERAL CONSENSUS SO FAR WAS THAT THE EVENT WAS RELATED TO ¿GENERAL SURGICAL TECHNIQUE AND AN UNEXPECTED VESSEL.¿ THE CSR SPOKE TO THE HEAD OF THE DEPARTMENT. ACCORDING TO THE CSR, THE HEAD OF THE DEPARTMENT BELIEVES THE VESSEL TORE DUE TO TENSION AND TRAUMA DURING DISSECTION BUT IT IS IMPOSSIBLE TO KNOW FOR CERTAIN WITHOUT VIDEO. THE SURGEON HIMSELF REITERATED THAT HE WAS NOT WORKING ON THE VESSEL AT THE TIME AND IT WAS THE RESULT OF TENSION ON A SMALL WEAK BRANCH. HOWEVER, THE ROOT CAUSE OF THE

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE, A CABLE ON A FENESTRATED BIPOLAR FORCEPS INSTRUMENT ALLEGEDLY ¿RUPTURED.¿ THERE WAS NO REPORTED HARM TO THE PATIENT ALTHOUGH IT WAS NOTED THAT THE CASE WAS CONVERTED TO OPEN SURGERY. THE INITIAL REPORTER INDICATED, HOWEVER, THAT THE CONVERSION TO OPEN SURGERY WAS NOT DUE TO THE ALLEGED INSTRUMENT ISSUE. ON (B)(4) 2018, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE¿S ROBOTICS COORDINATOR AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: AFTER THE DA VINCI-ASSISTED HYSTERECTOMY WAS COMPLETED, IT WAS ALLEGED THAT ¿ENDOSCOPICALLY INVISIBLE, SILENT BLEEDING¿ OCCURRED. AS A RESULT, THE CASE WAS CONVERTED TO OPEN SURGERY. THE ROBOTICS COORDINATOR INDICATED THAT THE PATIENT WAS ¿FINE¿ AND THERE HAVE BEEN NO REPORTED POST-OPERATIVE COMPLICATIONS. HOWEVER, AT THIS TIME, THE ROOT CAUSE OF THE INTRA-OPERATIVE COMPLICATION IS UNKNOWN.

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 28-MAR-2023, INTUITIVE SURGICAL BECAME AWARE OF A JOURNAL OF BREAST CANCER ARTICLE TITLED, ¿DEVELOPMENT OF ROBOTIC MASTECTOMY USING A SINGLE-PORT SURGICAL ROBOT SYSTEM¿ (PARK, H.S., ET AL., 2020). WITHIN THE JOURNAL ARTICLE, IT WAS MENTIONED AFTER A BILATERAL DA-VINCI ASSISTED MASTECTOMY PERFORMED ON (B)(6) 2018 ON A PATIENT WITH DUCTAL CARCINOMA IN SITU (DCIS), THERE WAS A MINOR SKIN BURN FOUND ON THE RIGHT BREAST. THERE WAS NO MENTION OF MEDICAL TREATMENT TO ADDRESS THE MINOR SKIN BURN IN THE ARTICLE. THERE WERE NO OTHER IMMEDIATE POSTOPERATIVE COMPLICATIONS. THE PATIENT WAS DISCHARGED ON POSTOPERATIVE DAY 15 AND DRAIN WAS REMOVED ON DAY 24. PATIENT RE-VISITED THE CLINIC ON DAY 55 BECAUSE OF REDNESS AND HEATING SENSATION OF THE RIGHT BREAST. ANTIBIOTICS AND CONSERVATIVE TREATMENT INCLUDING DRESSING AND RE-INSERTION OF THE DRAIN WERE APPLIED. HER SYMPTOMS SUBSIDED AFTER 1 DAY OF TREATMENT AND NO MAJOR SURGICAL INTERVENTION WAS NEEDED. THERE WAS NO MENTION OF ANY MALFUNCTIONS OF ANY DV SYSTEMS, INSTRUMENTS OR ACCESSORIES. FENESTRATED BIPOLAR FOCEPS (FBF) INSTRUMENT, MARLAND FORCEPS INSTRUMENT AND MONOPOLAR CURVED SCISSORS (MCS) WERE INSTALLED ON UNIVERSAL SURGICAL MANIPULATOR(US

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 A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT WAS FOUND TO HAVE A PANCREATIC FISTULA/LEAK. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. THERE IS NO INDICATION OR ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. ON (B)(6) /2018, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION FROM A SURGEON AT A DIFFERENT HOSPITAL POSSIBLY RELATED TO THE REPORTED EVENT. THE SURGEON INDICATED THAT THE PATIENT HAD POSSIBLY EXPIRED AFTER SURGERY. THE SURGEON WAS UNABLE TO PROVIDE ANY ADDITIONAL DETAILS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS INITIALLY REPORTED THAT AFTER UNDERGOING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT WAS FOUND TO HAVE A PANCREATIC FISTULA/LEAK. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. THERE IS NO INDICATION OR ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. ON (B)(4) 2018, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION FROM A SURGEON AT A DIFFERENT HOSPITAL POSSIBLY RELATED TO THE REPORTED EVENT. THE SURGEON INDICATED THAT THE PATIENT HAD POSSIBLY EXPIRED AFTER SURGERY. THE SURGEON WAS UNABLE TO PROVIDE ANY ADDITIONAL DETAILS.

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 7 DAYS AFTER UNDERGOING A DA VINCI-ASSISTED PANCREATECTOMY (WHIPPLE) PROCEDURE, THE PATIENT ALLEGEDLY EXPIRED AS A RESULT OF A POST-OPERATIVE BLEED. POST OPERATIVELY, THE PATIENT DEVELOPED SEPSIS WITH RAISED BLOOD PRESSURE. AT THIS TIME, THE ROOT CAUSES OF THE PATIENT'S POST-OPERATIVE COMPLICATIONS ARE UNKNOWN. ON (B)(4) 2018, THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) PROVIDED ADDITIONAL INFORMATION FROM THE LEAD SURGEON REGARDING THE REPORTED ISSUE: THERE WAS NO MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, AND/OR ACCESSORY DURING THE SURGICAL PROCEDURE. DURING THE PROCEDURE, THE PATIENT DEVELOPED A SMALL BLEED FROM A VEIN NEAR THE BILE DUCT. THE CSR STATED THAT THERE WAS NO MEDIUM-LARGE CLIP APPLIER INSTRUMENT OR CLIPS AVAILABLE DURING THE PROCEDURE, THEREFORE, THE SURGEON USED A LARGE CLIP APPLIER INSTRUMENT. IT WAS SPECULATED BY THE LEAD SURGEON THAT THE LARGE SIZE OF THE CLIP APPLIER INSTRUMENT MIGHT HAVE CAUGHT THE VESSEL, ALLEGEDLY CAUSING THE BLEED. THE SURGEON APPLIED PRESSURE VIA A SWAB AND MORE CLIPS WERE APPLIED TO ACHIEVE HEMOSTASIS. THE PROCEDURE WAS COMPLETED ROBOTICALLY AND THE PATIENT RECOVERED WELL POST-OPERATIVELY

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 DURING A DA VINCI-ASSISTED INGUINAL HERNIA REPAIR PROCEDURE, THE PATIENT EXPERIENCED AORTIC BLEEDING AND THE CASE WAS CONVERTED TO OPEN SURGERY. THE PATIENT REPORTEDLY EXPIRED IN THE INTENSIVE CARE UNIT (ICU). ON 16-NOV-2018 AND 19-NOV-2018, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE ISI CLINICAL SALES REPRESENTATIVE (CSR): THE SURGICAL PROCEDURE WAS NOT RECORDED ON VIDEO. AN ASSISTANT IN THE OPERATING ROOM (OR) REPORTEDLY INSERTED A CAMERA INCORRECTLY AND THEREFORE, VISUALIZATION WAS NOT OPTIMAL. THE CAMERA WAS INSERTED INCORRECTLY FROM THE START OF THE SURGICAL PROCEDURE. THE SITE ATTRIBUTED THE INCORRECT INSERTION OF THE CAMERA TO USER-ERROR. WHILE REPORTEDLY LOOKING FOR THE INSTRUMENTS, THE SURGEON ASSUMED SHE WAS PRESSING ON THE AORTA. THE EVENT OCCURRED WHILE THE SURGEON WAS IN THE PROCESS OF PLACING MESH AND HER HEAD WAS IN THE HIGH RESOLUTION STEREO VIEW (HRSV). THE SURGICAL STAFF INDICATED THAT THERE WAS NO DIRECT INFLUENCE OF THE DA VINCI SURGICAL SYSTEM ON THE VESSEL INJURY. AFTER THE BLEEDING WAS OBSERVED, THE CASE WAS CONVERTED TO OPEN SURGERY. THE PATIENT SUSTAINED A

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 A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT WAS FOUND TO HAVE A PANCREATIC FISTULA/LEAK. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. THERE IS NO INDICATION OR ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. ON (B)(6) 2018, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION FROM A SURGEON AT A DIFFERENT HOSPITAL POSSIBLY RELATED TO THE REPORTED EVENT. THE SURGEON INDICATED THAT THE PATIENT HAD POSSIBLY EXPIRED AFTER SURGERY. THE SURGEON WAS UNABLE TO PROVIDE ANY ADDITIONAL DETAILS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2019, INTUITIVE SURGICAL, INC. (ISI) RECEIVED SUS VOLUNTARY EVENT REPORT #MW5084047 WITH THE FOLLOWING EVENT DESCRIPTION: ¿NEEDLE FROM DAVINCI ROBOT FELL INTO PT¿S SURGICAL WOUND DURING ROBOTIC HYSTERECTOMY. NEEDLE MAY HAVE FALLEN INTO SURGICAL WOUND AT SOME POINT DURING CASE. DID NOT DISCOVER UNTIL AFTER CLOSURE. NEEDLE TOO SMALL TO DETECT ON X-RAY. PT DOING WELL. SURGEON NOTIFIED. HOOK ON THE MONOPOLAR STOPPED WORKING.¿

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS INITIALLY REPORTED THAT AFTER UNDERGOING AN UNSPECIFIED DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT DEVELOPED A "CONTAGIOUS DISEASE WITH FEVER." THE PATIENT WAS REPORTEDLY HOSPITALIZED FOR AN EXTENDED PERIOD OF TIME. HOWEVER, AT THIS TIME, THE ROOT CAUSE OF THE PATIENT'S POST-OPERATIVE COMPLICATION IS UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. ON 12/10/2018 AND 12/11/2018, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE PATIENT UNDERWENT A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY PROCEDURE ON (B)(6) 2018. THERE WAS NO REPORT THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THERE WERE NO REPORTED INTRA-OPERATIVE COMPLICATIONS. ON (B)(6) 2018, THE PATIENT REPORTEDLY DEVELOPED AN UNSPECIFIED ¿CONTAGIOUS DISEASE WITH FEVER.¿ AS OF (B)(6) 2018, THE CAUSE OF THE DISEASE WAS UNKNOWN AND THE SITE WAS INSPECTING THE CASE. IN ADDITION, AS A RESULT OF THE ALLEGED COMPLICATIONS, THE PATIENT WAS ADMINISTERED UNSPECIFIED ¿TRANSFUSION AND ANTIBIOTICS.¿ THE PATIENT WAS STILL RECOVERING.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS INITIALLY REPORTED THAT AFTER UNDERGOING A DA VINCI-ASSISTED SLEEVE GASTRECTOMY PROCEDURE, THE PATIENT CAME BACK SEVERAL WEEKS LATER WITH A HEMATOMA AND BLEEDING. THE SURGEON PERFORMED AN OPEN SURGICAL PROCEDURE AND CLEANED THE AREA AROUND THE HEMATOMA. ACCORDING TO THE INITIAL REPORTER, THE SURGEON INDICATED THAT EVERYTHING LOOKED SEALED FROM WHAT HE COULD SEE AND THERE WAS NO EXTRA BLEEDING. IT WAS ASSUMED THAT THE STAPLES WERE INTACT. THE PATIENT WAS REPORTEDLY STABLE. ON (B)(4) 2018, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE CSR WAS PRESENT DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE WHICH WAS NOT RECORDED ON VIDEO. THERE WAS NO REPORT THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THERE WERE ALSO NO REPORTED INTRA-OPERATIVE COMPLICATIONS. THE SURGEON WAS NOT SURE WHAT CAUSED THE POST-OPERATIVE HEMATOMA AND BLEEDING. ACCORDING TO THE CSR, THE HEMATOMA APPEARED TO BE NEAR THE STAPLE LINE. HOWEVER, THERE WERE NO ISSUES IDENTIFIED WITH THE STAPLE LINE INTRA-OPERATIVELY OR POST-OPERATIVEL

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IN A LETTER SEEKING COMPENSATION DIRECTLY FROM INTUITIVE SURGICAL, INC. (ISI), THE PATIENT¿S WIFE REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE PERFORMED ON (B)(6) 2018, THE PATIENT ALLEGEDLY SUSTAINED A BURN INJURY WHICH DAMAGED THE PATIENT'S LYMPH SYSTEM. IN (B)(6) 2013, THE PATIENT HAD AN IVC FILTER IMPLANTED FOR BLOOD CLOTS AT A LOCAL HOSPITAL. IT WAS NOT A COOK FILTER, BUT A RETRIEVABLE FILTER WHICH WAS SUPPOSED TO HAVE BEEN REMOVED IN 6 MONTHS. THE PATIENT ALLEGES HE WAS NOT INFORMED OF THAT, AND THE HOSPITAL DID NOT FOLLOW-UP EITHER. IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE AT A DIFFERENT HOSPITAL IN A DIFFERENT TOWN. IMMEDIATELY AFTER SURGERY, FLUID WAS LEAKING FROM THE CENTRAL INCISION AND WAS TREATED WITH A PRESSURE WRAP. AFTER THE PATIENT WAS RELEASED, FLUID CONTINUED TO LEAK FROM THE INCISION BUT THE SURGEON DETERMINED IT WAS NOT FROM THE SURGERY. IN (B)(6) 2018, THE PATIENT HAD ABDOMINAL DISCOMFORT AND WENT TO A LOCAL UROLOGIST. AN ULTRASOUND WAS PERFORMED, AND A LOT OF FLUID WAS IDENTIFIED. THE PATIENT CONTACTED THE ROBOTIC SURGEON; HOWEVER, THE SURGEON¿S RESIDENT RECOMMENDED 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 08/27/2018, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF THE JOURNAL OF THE SOCIETY OF LAPAROENDOSCOPIC SURGEONS CLINICAL ARTICLE TITLED ¿ROBOTIC-ASSISTED TRANSTHORACIC ESOPHAGEAL DIVERTICULECTOMY¿ (BALCI ET AL., 2018). IT WAS REPORTED THAT AFTER UNDERGOING A DA VINCI-ASSISTED ¿TRANSTHORACIC ESOPHAGEAL DIVERTICULECTOMY PROCEDURE, A PATIENT EXPERIENCED POST-OPERATIVE COMPLICATIONS AND SUBSEQUENTLY EXPIRED." ON AN UNSPECIFIED DATE, THE PATIENT UNDERWENT THE DA VINCI-ASSISTED SURGICAL PROCEDURE FOR A DIVERTICULUM. THE PATIENT ALSO UNDERWENT WEDGE BIOPSIES FROM THE RIGHT LUNG. THE OPERATIVE TIME WAS 165 MINUTES AND IT WAS NOTED THAT THERE WERE NO INTRA-OPERATIVE COMPLICATIONS. ON POST-OPERATIVE DAY #2, LIQUIDS WERE STARTED AFTER NO LEAKS WERE FOUND. ON POST-OPERATIVE DAY #4, THE PATIENT HAD A FEVER OF 100.4 DEGREES FAHRENHEIT ALTHOUGH THERE WAS NO EVIDENCE OF LEAKAGE. ON POST-OPERATIVE DAY #5, THE PATIENT DEVELOPED RESPIRATORY DISTRESS IN ADDITION TO HAVING ONGOING FEVER. A CT-SCAN WAS PERFORMED FOR SUSPICION OF AN ANASTOMOTIC LEAKAGE. PLEURAL EFFUSION WAS OBSERVED IN THE RIGHT LUNG WITH FREE FLUID AND AIR IN THE OPERATIVE AREA. THE PATIENT WAS TRANSFERRED TO THE ICU AND ANTIBIOTI

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS INITIALLY REPORTED THAT DURING THE START OF A DA VINCI-ASSISTED MINIMALLY INVASIVE DIRECT CORONARY ARTERY BYPASS (MID CAB) PROCEDURE, A PATIENT EXPERIENCED DANGEROUS HEART RHYTHMS. THE OPERATIVE COMPLICATION REPORTEDLY OCCURRED UPON INITIAL ENTRY/INSERTION OF A TROCAR AND WHILE CONNECTING TO AN ERBE GENERATOR. AS A RESULT OF THE OPERATIVE COMPLICATION, THE PATIENT HAD TO BE SHOCKED TWICE IN ORDER TO GET BACK TO A REGULAR HEART RHYTHM. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: DURING THE START OF THE DA VINCI-ASSISTED MID CAB PROCEDURE, THE PATIENT EXPERIENCED DANGEROUS HEART RHYTHMS WHEN THE SURGEON APPLIED ENERGY THROUGH A BOVIE PEN (A 3RD PARTY MANUFACTURER PRODUCT) WHICH IS CONNECTED TO THE INTEGRATED ELECTROSURGICAL UNIT (IESU) OF THE DA VINCI XI SURGICAL SYSTEM. AT THE TIME THE EVENT OCCURRED, THE SURGEON WAS ATTEMPTING TO USE THE BOVIE PEN TO CREATE THE FIRST INCISION PORT. THE SURGICAL STAFF SHOCKED THE PATIENT IN ORDER TO ACHIEVE A REGULAR HEART RHYTHM. AT THE TIME THE EVENT OCCURRED, THE ROBOT WAS NOT DOCKED TO THE PATIENT YET. THE SURGICAL PROC

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS INITIALLY REPORTED THAT DURING THE START OF A DA VINCI-ASSISTED MINIMALLY INVASIVE DIRECT CORONARY ARTERY BYPASS (MID CAB) PROCEDURE, THE PATIENT EXPERIENCED DANGEROUS HEART RHYTHMS. THE OPERATIVE COMPLICATION REPORTEDLY OCCURRED UPON INITIAL ENTRY/INSERTION OF A TROCAR AND WHILE CONNECTING TO AN ERBE GENERATOR. AS A RESULT OF THE OPERATIVE COMPLICATION, THE PATIENT HAD TO BE SHOCKED TWICE IN ORDER TO GET BACK TO A REGULAR HEART RHYTHM. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: DURING THE START OF THE DA VINCI-ASSISTED MID CAB PROCEDURE, THE PATIENT EXPERIENCED DANGEROUS HEART RHYTHMS WHEN THE SURGEON APPLIED ENERGY THROUGH A BOVIE PEN (A 3RD PARTY MANUFACTURER PRODUCT) WHICH IS CONNECTED TO THE INTEGRATED ELECTROSURGICAL UNIT (IESU) OF THE DA VINCI XI SURGICAL SYSTEM. AT THE TIME THE EVENT OCCURRED, THE SURGEON WAS ATTEMPTING TO USE THE BOVIE PEN TO CREATE THE FIRST INCISION PORT. THE SURGICAL STAFF SHOCKED THE PATIENT IN ORDER TO ACHIEVE A REGULAR HEART RHYTHM. AT THE TIME THE EVENT OCCURRED, THE ROBOT WAS NOT DOCKED TO THE PATIENT YET. THE SURGICAL PR

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS INITIALLY REPORTED THAT DURING A PLANNED DA VINCI-ASSISTED MINIMALLY INVASIVE DIRECT CORONARY ARTERY BYPASS (MID CAB) PROCEDURE, A PATIENT EXPERIENCED DANGEROUS HEART RHYTHMS. THE OPERATIVE COMPLICATION REPORTEDLY OCCURRED UPON INITIAL ENTRY/INSERTION OF A TROCAR AND WHILE CONNECTING TO AN ERBE GENERATOR. AS A RESULT OF THE OPERATIVE COMPLICATION, THE PATIENT HAD TO BE SHOCKED TWICE IN ORDER TO GET BACK TO A REGULAR HEART RHYTHM. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: DURING THE START OF THE DA VINCI-ASSISTED MID CAB PROCEDURE, THE PATIENT EXPERIENCED DANGEROUS HEART RHYTHMS WHEN THE SURGEON APPLIED ENERGY THROUGH A BOVIE PEN (A 3RD-PARTY MANUFACTURER PRODUCT) WHICH IS CONNECTED TO THE INTEGRATED ELECTROSURGICAL UNIT (IESU) OF THE DA VINCI XI SURGICAL SYSTEM. AT THE TIME THE EVENT OCCURRED, THE SURGEON WAS ATTEMPTING TO USE THE BOVIE PEN TO CREATE THE FIRST INCISION PORT. THE SURGICAL STAFF SHOCKED THE PATIENT IN ORDER TO ACHIEVE A REGULAR HEART RHYTHM. AFTER THE EVENT OCCURRED, THE SURGEON MADE THE DECISION TO CONVERT THE PLANNED SURGICAL PROCEDURE 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 THE DA VINCI-ASSISTED RIGHT HEMICOLECTOMY PROCEDURE, A VESSEL SEALER INSTRUMENT WAS ALLEGEDLY NOT SEALING. AT THE TIME THE INITIAL REPORTER CONTACTED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOR ASSISTANCE, THE SURGICAL STAFF HAD ALREADY CONVERTED THE SURGICAL PROCEDURE TO OPEN SURGERY. ACCORDING TO THE INITIAL REPORTER, THE SURGICAL STAFF PULLED THE VESSEL SEALER INSTRUMENT OUT AND CLAIMED THAT THE INSTRUMENT WOULD HEAT UP ON A CLOTH. HOWEVER, WHEN THE VESSEL SEALER INSTRUMENT WAS REINSERTED BACK INTO THE PATIENT, IT WAS ALLEGED THAT THE INSTRUMENT WOULD NOT SEAL A VESSEL. THE INITIAL REPORTER INDICATED THAT THE VESSEL IN QUESTION SEEMED TO BE NORMAL IN SIZE. THE INITIAL REPORTER ALSO CLAIMED THAT WHEN THE EVENT OCCURRED, THE AUDIBLE TONES INDICATING THAT THE SEALING CYCLE WAS COMPLETE WERE HEARD. THE TSE CHECKED THE SYSTEM LOGS AND DID NOT FIND ANY RELATED SYSTEM ERRORS. ON (B)(6) 2018, ISI CONTACTED THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE SURGEON HAD REPORTEDLY TESTED THE VESSEL SEALER INSTRUMENT ON FAT TISSUE TO CONFIRM ENERGY DELIVERY PRIOR TO ATTEMPTING TO SE

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A NURSE'S HAND WAS POSSIBLY FRACTURED WHILE POSITIONING A PATIENT SIDE CART (PSC). ACCORDING TO THE INITIAL REPORTER, WHEN THE CART DRIVE SWITCH AND THROTTLE WERE RELEASED, THE PSC ALLEGEDLY KEPT MOVING AND THE NURSE'S HAND WAS CAUGHT BETWEEN THE CART DRIVE HANDLE AND THE WALL. ON (B)(6) 2018, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE AND THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT WAS OBTAINED: THE REPORTER, A NURSE, INDICATED THAT THE EVENT OCCURRED ON (B)(6) 2018. ACCORDING TO THE REPORTER, ANOTHER NURSE WAS ATTEMPTING TO MOVE THE PSC OUT OF THE WAY SINCE IT WAS INTERFERING WITH A BACK TABLE. THE DAY THE EVENT OCCURRED, THE NURSE'S HAND REPORTEDLY WAS SWOLLEN. THE FOLLOWING DAY, HER HAND KEPT "BOTHERING HER" SO SHE HAD AN X-RAY PERFORMED. A BROKEN BONE WAS IDENTIFIED AROUND THE KNUCKLE AREA OF ONE OF HER FINGERS ON THE RIGHT HAND. IN ADDITION, THE REPORTER INDICATED THAT A TORN LIGAMENT WAS IDENTIFIED. AS A RESULT, A HARD CAST WAS INITIALLY PLACED ON THE NURSE'S HAND. HOWEVER, THE NURSE WAS APPARENTLY ALLERGIC TO SUBSTANCES ON THE CAST. THEREFORE, THE HARD CAST WAS REPLACE

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF AN INNOVATIONS JOURNAL ARTICLE TITLED, "EARLY CLINICAL EXPERIENCES OF ROBOTIC ASSISTED AORTIC VALVE REPLACEMENT FOR AORTIC VALVE STENOSIS WITH SUTURELESS AORTIC VALVE¿ (NAGAOKA, E. ET. AL. 2020). IN THIS ARTICLE, STUDY DATA WAS RETROSPECTIVELY COLLECTED FROM 2 PATIENTS WHO UNDERWENT DA VINCI-ASSISTED AORTIC VALVE REPLACEMENT (AVR) IN A SINGLE INSTITUTION BETWEEN MAY AND JUNE 2018. THERE WERE NO MAJOR COMPLICATIONS REPORTED AND NO CONVERSIONS TO STERNOTOMY. WITHIN THE ARTICLE, THE FOLLOWING IS NOTED: "ONE PATIENT HAD FLUID OVERLOAD POSTOPERATIVELY DUE TO VASODILATATION AND REQUIRED AGGRESSIVE DIURESIS. OTHERWISE, POSTOPERATIVE CONVALESCENCE WAS UNCOMPLICATED. THEY WERE DISCHARGED HOME AT DAYS 4 AND 10 AFTER OPERATION, DUE TO POSTOPERATIVE ATRIAL FIBRILLATION RESPECTIVELY (TABLE 3)." ISI FOLLOWED UP WITH THE AUTHOR AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE ARTICLE: "THE POST-OPERATIVE OUTCOME WAS UNRELATED TO THE FUNCTION OF THE DA VINCI SYSTEM." HE FURTHER INDICATED THAT "THERE ARE NO SUCH ALLEGATIONS" THAT A MALFUNCTION OF A DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE INVOLVING THE

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING AN UNSPECIFIED DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT CLAIMED THAT HE WAS INJURED. THE PATIENT CONTACTED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOR ASSISTANCE AND WANTED TO KNOW IF THE ROBOT IS DESIGNED TO PROTECT AGAINST A SURGEON PUNCTURING THE VENA CAVA. DURING THE CALL WITH THE TSE, THE LINE UNEXPECTEDLY DISCONNECTED. NO FURTHER CLINICAL INFORMATION WAS PROVIDED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ROBOTIC MEGA NEEDLE DRIVER WIRE BREAKS WHILE INSIDE THE PATIENT. NO INJURY NOTED TO THE PATIENT. NEW NEEDLE DRIVER OPENED.

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 CYSTECTOMY PROCEDURE, THE PATIENT SUSTAINED AN UNSPECIFIED BOWEL INJURY. DUE TO THE INTRA-OPERATIVE COMPLICATION, THE SURGICAL PROCEDURE WAS REPORTEDLY CONVERTED TO OPEN SURGERY. ON AN UNSPECIFIED DATE, THE PATIENT REPORTEDLY EXPIRED. THE CAUSE OF THE DEATH WAS NOT PROVIDED. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY 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: ROBOTIC PROGRASP INSTRUMENT WAS HOLDING TISSUE AND WOULD NOT RELEASE FROM THE TISSUE. THE INSTRUMENT HAD TO BE UNLOCKED TO RELEASE THE TISSUE.

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 TWO DAYS POST A DA VINCI ASSISTED RIGHT HEMICOLECTOMY PROCEDURE THE PATIENT EXPERIENCE COMPLICATIONS AND VITAL SIGNS WERE FOUND TO BE POOR. THE PATIENT UNDERWENT A SECONDARY OPEN SURGICAL PROCEDURE AT WHICH TIME THE SURGEON DISCOVERED THAT THE PATIENT HAD SUSTAINED AN UNSPECIFIED BOWEL INJURY. THE SURGEON REPAIRED THE DAMAGE TO THE PATIENT¿S BOWEL. ON (B)(6) 2018 THE ISI CLINICAL SALES REPRESENTATIVE (CSR) STATED THAT THE PATIENT UNDERWENT THE PRIMARY SURGICAL PROCEDURE ON (B)(6) 2018 AND DURING THE SURGICAL PROCEDURE, THERE WERE NO INTRA-OPERATIVE COMPLICATIONS. ON POST-OPERATIVE DAY #2, THE PATIENT EXPERIENCED A HIGH FEVER, HAD LOW BLOOD PRESSURE, AND THE VITAL SIGNS WERE FOUND TO BE POOR. THE PATIENT WAS IMMEDIATELY FLOWN TO ANOTHER HOSPITAL WHERE THE PATIENT UNDERWENT AN OPEN SURGICAL PROCEDURE TO IDENTIFY THE CAUSE OF THE POST-OPERATIVE COMPLICATIONS. DURING THE SECONDARY PROCEDURE, THE SURGEON FOUND THAT THE PATIENT'S BOWEL HAD A PERFORATION LOCATED ON THE BACK OF THE DESCENDING COLON, WHERE AN ASSIST PORT WAS LOCATED. THE SURGEON REPAIRED THE DEFECT TO THE PATIENT'S BOWEL. THE CSR INDICATED THAT HE CONFIRMED WITH THE HOSPITAL THAT NO MALFUNCTION OF THE D

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REPORTED FROM OPERATING ROOM THAT THE PATIENT WAS HAVING A ROBOTIC-ASSISTED LAPAROSCOPIC LOW ANTERIOR RESECTION OF THE RECTUM AND THE DAVINCI ROBOT 45 STAPLER JAMMED WHILE ATTACHED TO TISSUE AND WOULD NOT RELEASE. EVEN WITH THE USE OF THE EMERGENCY UNLOCKING KEY. INSTRUMENT WOULD NOT RELEASE TISSUE INTRACAVITY. DAVINCI TROUBLESHOOTING WAS CALLED AND THE STAFF HAD TO PRY THE STAPLER HEAD OPEN VERY CAREFULLY TO RELEASE THE TISSUE. NO HARM OCCURRED AS A RESULT. IN THE REPORT ANOTHER TYPE OF STAPLER WAS USED TO COMPLETE THE PROCEDURE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: 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: PATIENT WAS ADMITTED FOR A ROBOT ASSISTED LAPAROSCOPIC TRANSABDOMINAL RETROPERITONEAL LYMPH NODE DISSECTION AND LEFT SPERMATIC CORD RESECTION. A BLUNT TROCHAR WAS PLACED, AND 6 PORTS WERE PLACED UNDER DIRECT VISION. THE ROBOT ARMS WERE PLACED IN STANDARD FASHION TO TRIANGULATE THE RETROPERITONEUM. THE DA VINCI XI ROBOTIC SYSTEM WAS THEN DOCKED OVER THE PATIENT'S FLANK. INITIAL INSPECTION OF THE BOWEL AND ABDOMINAL CONTENTS WERE UNCOMPLICATED, WITH NO EVIDENCE OF INJURY. THE PROCEDURE WAS INITIATED WITH MOBILIZATION OF THE COLON TO REVEAL THE RETROPERITONEUM. THE SPERMATIC CORD WAS THEN IDENTIFIED AT ITS ORIGIN ON THE LEFT RENAL VEIN. AT THIS POINT THE ROBOTIC SYSTEM ALERTED AND AN UNRECOVERABLE FAULT IN THE 3RD ROBOTIC ARM WAS DISCOVERED. THE ARM WAS LOCKED IN PLACE AND THE PROCEDURE COULD NOT CONTINUE. THE ERROR CODE 319 WAS NOTED AND THE ARM COULD NOT BE MOVED. THE SURGEON AND TEAM FOLLOWED THE INSTRUCTIONS ON THE SCREEN AND REBOOTED THE SYSTEM THREE TIMES WITHOUT RESOLUTION. THEY CALLED THE INTUITIVE INC. SUPPORT AND THE DA VINCI REP TRIED TO TROUBLE SHOOT THE PROBLEM WITHOUT SUCCESS. THE FINAL ADVICE WAS A ROBOTIC ARM REPLACEMENT THE FOLLOWING DAY. THE SURGEON WAS TOLD THAT IT

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING THE ROBOTIC PORTION OF THE SURGERY, THE TIP-UP FENESTRATED GRASPER STOPPED WORKING AND WAS REMOVED FROM THE ABDOMEN BY DR. (B)(6). UPON VISUAL INSPECTION OF THE INSTRUMENT, ONE OF THE WIRES WAS NO LONGER INTACT. THE INSTRUMENT WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. WIRE THOUGHT TO HAVE SNAPPED IN HALF DURING CASE. PT RETURNED TO ED FOR BACK PAIN AND AN X-RAY WAS TAKEN FOR THAT CC. AT THAT TIME A SMALL (LESS THAN 9MM) PIECE OF FRAYED WIRE WAS SEEN IN PT - RFO.

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 TWO DAYS AFTER UNDERGOING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION, THE PATIENT WAS FOUND TO HAVE THREE UNSPECIFIED BOWEL INJURIES THAT WERE INITIALLY SUSPECTED TO BE DUE SOLELY DUE TO THE LARGE AMOUNT OF ADHESIONS INVOLVING THE BOWEL. DUE TO THE BOWEL INJURIES, THE PATIENT UNDERWENT AN OPEN SURGICAL PROCEDURE. ON 12/07/2017, AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) CONTACTED THE SURGEON AND OBTAINED ADDITIONAL INFORMATION REGARDING THE OPERATIVE COMPLICATIONS: THE SURGEON INDICATED THAT IS IT IMPOSSIBLE TO KNOW WITH CERTAINTY WHAT CAUSED THE BOWEL INJURIES. THE SURGEON EXPLAINED THAT THE PATIENT HAD SEVERAL PREVIOUS ABDOMINAL SURGERIES AND THERE WERE SO MANY ADHESIONS. THE SURGEON REPORTEDLY ADMITTED THAT HE ACCIDENTALLY PERFORATED THE PATIENT'S BOWEL IN THIS CASE WHICH REQUIRED REPAIR. THE SURGEON ALSO INDICATED THAT ANOTHER GYN SURGEON WAS CALLED INTO THE CASE TO FREE UP A RETAINED OVARY. ACCORDING TO THE CSR, THERE IS REALLY NO TELLING WHERE THE INJURIES CAME FROM. ON 12/13/2017, ISI CONTACTED THE CSR. THE CSR STATED THAT HE WAS PRESENT DURING THE SURGICAL PROCEDURE AND THE PATIENT HAD TREMENDOUS ADHESIONS. DURING THE FEW MINU

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 ¿ADHESIOLYSIS AND REDUCTION OF A SLIPPED NISSEN WITH COMPLETION LAPAROTOMY, REPAIR OF HIATAL HERNIA AND REDO OF NISSEN FUNDOPLICATION¿ PROCEDURE ON (B)(6) 2017. THE PLAINTIFFS¿ ATTORNEY ALLEGES THAT THE PATIENT ¿EXPERIENCED COMPLICATIONS DURING THE SURGERY, NAMELY ISSUES WITH THE PATIENT¿S BLOOD PRESSURE AND OXYGENATION WHEN HE INCREASED THE PRESSURE OF THE GAS INSUFFLATING THE PATIENT¿S ABDOMINAL WALL.¿ THE PLAINTIFFS¿ ATTORNEY NOTED THAT WHEN THE PRESSURE WAS DECREASED, THE SURGEON¿S ¿VISIBILITY ALSO DECREASED, LEADING HIM TO UNDOCK THE ROBOT AND CONVERT THE OPERATION TO AN OPEN SURGERY.¿ AT AN UNSPECIFIED TIME DURING THE SURGICAL PROCEDURE, THE PATIENT ALLEGEDLY SUSTAINED AN ¿ESOPHAGEAL PERFORATION RESULTING IN THE LEAKAGE OF STOMACH CONTENTS INTO HER MEDIASTINUM.¿ AS A RESULT, THE PATIENT EXPERIENCED ¿IMMEDIATE RESPIRATORY COMPLICATIONS INCLUDING ATELECTASIS, PLEURAL FLUID AND PNEUMONIA, AND EVENTUALLY TO SEPSIS.¿ THE PATIENT ALLEGEDLY EXPERIENCED ¿PAIN AND SUFFERING¿ FROM (B)(6) 2017. DURING THIS TIME, THE PATIENT REPORTEDLY HAD ¿THE INABILITY 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: THE CLIP FOR THE INTUITIVE DA VINCI CLIP APPLICATOR COULD NOT LOAD, SEVERAL CLIPS FAILED TO ADHERE. NO HARM TO THE 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 TOWARDS THE END OF A DA VINCI-ASSISTED RADICAL TONSILLECTOMY SURGICAL PROCEDURE, THE SURGEON NICKED THE BRANCHES OF THE CAROTID ARTERY. AS A RESULT, THE PATIENT EXPERIENCED A SIGNIFICANT AMOUNT OF BLEEDING AND THE SURGEON HAD TO CONVERT THE PROCEDURE TO A TRADITIONAL SURGICAL PROCEDURE TO CONTROL THE BLEEDING. THE PATIENT WAS IN THE INTENSIVE CARE UNIT WHEN THE EVENT WAS REPORTED TO INTUITIVE SURGICAL, INC. (ISI). HOWEVER, THERE IS NO ALLEGATION BY THE SITE OR THE SURGEON THAT AN ISI DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT OR THAT AN ISI DEVICE MALFUNCTIONED. ON OCTOBER 24 AND 26, 2017, ISI CONTACTED THE CLINICAL SALES REPRESENTATIVE (CSR) WHO WAS PRESENT DURING THE PROCEDURE AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE CSR STATED THAT THE SURGEON WAS USING THE MONOPOLAR CAUTERY AND THE SCHERTEL GRASPER INSTRUMENTS WHEN THE BLEEDING OCCURRED. THE CSR STATED THAT THE EXTERNAL CAROTID ARTERY BRANCH WAS NICKED AND SHE COULD NOT CONFIRM THE CAUSE. AS A RESULT, THERE WAS A SIGNIFICANT AMOUNT OF BLEEDING AND THE PROCEDURE WAS CONVERTED TO A TRADITIONAL SURGICAL PROCEDURE TO CONTROL THE BLEEDING. SINCE THE CSR LEFT THE ROOM AFTER

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 BY THE SURGEON THAT DURING A SURGICAL PROCEDURE OF "ROBOTIC-ASSISTED LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND RIGHT OVARIAN BIOPSY": A WIRE BROKE IN "DA VINCI FENESTRATED BIPOLAR FORCEPS 8 MM." THE DEVICE WAS REPORTED TO HAVE SEVEN LIVES LEFT. THE DEVICE WAS SWITCHED OUT AND NO HARM WAS REPORTED TO THE PATIENT. THE SURGEON REPORTED NO OTHER COMPLICATIONS. NO OTHER DETAILS FOR THE DEVICE PROBLEM 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 PRIOR TO THE START OF A DA VINCI-ASSISTED LOWER ANTERIOR RESECTION PROCEDURE, THE CUSTOMER EXPERIENCED A REPEATED 32053 ERROR. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) CONFIRMED THE ERROR AT SYSTEM START-UP. THE TSE ADVISED THE CUSTOMER TO CHECK IF THE POWER CORD WAS PROPERLY SEATED AND IT WAS. IT WAS ALSO CONFIRMED THAT THE POWER CORD WAS PROPERLY CONNECTED TO THE POWER STRIP AND THAT THE POWER SWITCH WAS ON. THE CUSTOMER POWER CYCLED THE SYSTEM; HOWEVER, THE ISSUE PERSISTED. THE INSTRUMENT CONTROL BOX (ICB) WOULD NOT POWER ON AND THE POWER LED WAS NOTED TO BE OFF. THE TSE ADVISED THE CUSTOMER TO HAVE THEIR BIOMED CHECK THE FUSES AND VOLTAGE PRESSURE AT THE POWER CORD. IT WAS REPORTED THAT THE CUSTOMER WOULD PROCEED WITH THE CASE WITHOUT USE OF THE VESSEL SEALER INSTRUMENT. ISI MADE MULTIPLE FOLLOW UP ATTEMPTS AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PATIENT WAS ADMINISTERED AN HOUR AND A HALF OF ADDITIONAL ANESTHESIA DUE TO THE TROUBLESHOOTING PERFORMED. THE SURGEON THEN DECIDED TO CONVERT THE PROCEDURE TO A TRADITIONAL LAPAROSCOPIC PROCEDURE DUE TO THE REPORTED ISSUE. HOWEVER, THE SURGEON WAS UNABLE TO SEE WITH THE LA

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED INGUINAL HERNIA REPAIR PROCEDURE, THE ROBOTIC ARMS ON THE PATIENT SIDE CART (PSC) COLLIDED AND AN UNSPECIFIED SYSTEM ERROR WAS GENERATED. WHEN THE EVENT OCCURRED, THE INITIAL REPORTER ALLEGED THAT AN UNSPECIFIED INSTRUMENT ADVANCED ABRUPTLY AND HIT THE MUCOSA OF THE BOWEL. THE SURGEON APPLIED A COUPLE OF STITCHES TO ADDRESS THE BOWEL MUCOSA. IT WAS ALSO REPORTED THAT AN INSTRUMENT GOT STUCK ON ONE OF THE ROBOTIC ARMS. ON 10/04/2017, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE'S ROBOTICS COORDINATOR (THE INITIAL REPORTER), AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE ROBOTICS COORDINATOR INDICATED THAT THE ROBOTIC ARM COLLIDED BEFORE A CADIERE FORCEPS INSTRUMENT GOT STUCK ON ONE OF THE ROBOTIC ARMS. THE ROBOTICS COORDINATOR CLARIFIED THAT THE CADIERE FORCEPS INSTRUMENT ADVANCED ABRUPTLY DURING ATTEMPTS BY THE SURGICAL STAFF TO REMOVE THE STUCK INSTRUMENT. AS A RESULT, THE PATIENT REPORTEDLY SUSTAINED A SLIGHT NICK ON THE BOWEL MUCOSA. THE PATIENT DID NOT EXPERIENCE ANY POST-OPERATIVE COMPLICATIONS AND WAS DISCHARGED HOME AT THE EXPECTED TIME. THE CADIERE FORCEPS INSTRUMENT WAS DISC

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 THROUGH A SOCIAL MEDIA BLOG THAT AFTER UNDERGOING A DA VINCI-ASSISTED HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND PELVIC FLOOR REPAIR PROCEDURE ON (B)(6) 2017, THE PATIENT WAS FOUND TO HAVE SUSTAINED A SMALL BOWEL PERFORATION. THE PATIENT REPORTEDLY DEVELOPED SEPSIS AND REQUIRED EMERGENCY SURGERY TO REPAIR THE BOWEL PERFORATION. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY 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: ATTORNEYS HAVE ALLEGED THAT THEIR CLIENTS SUFFERED INJURIES ASSOCIATED WITH DA VINCI SURGICAL PROCEDURES. THESE CLAIMS DO NOT INVOLVED REPORTABLE DEATHS OR MALFUNCTIONS. THESE ALLEGATIONS WERE RECEIVED BY INTUITIVE SURGICAL, INC.(ISI) BETWEEN (B)(6) 2017. FOR THOSE CLAIMS WHERE PROCEDURE DATES ARE PROVIDED, THE DATES RANGE FROM (B)(6) 2014 - (B)(6) 2016.

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.