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, PIECES FROM THE CANNULA SEAL BROKE OFF AND FELL INSIDE THE PATIENT'S ABDOMEN. THE SURGEON WAS ABLE TO RETRIEVE ALL FRAGMENTS DURING THE SAME PROCEDURE. THE CANNULA SEAL IS AVAILABLE FOR RETURN TO INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION; HOWEVER, THE FRAGMENTS ARE NOT ABLE TO BE RETURNED. THE CUSTOMER REPLACED THE CANNULA SEAL WITH A BACK-UP ACCESSORY OF THE SAME KIND AND COMPLETED THE PROCEDURE WITH NO REPORTED INJURY. ISI MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

Monarch Platform — 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 A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE LOCATION OF THE PNEUMOTHORAX WAS RIGHT LOWER LOBE. A CHEST TUBE WAS PLACED, AND PATIENT WAS HOSPITALIZED FOR OBSERVATION. THE CHEST TUBE WAS REMOVED AND THE PATIENT WAS DISCHARGED.

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 A DA VINCI ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE PATIENT EXPERIENCED POST-OPERATIVE BLEEDING AND REQUIRED HOSPITALIZATION IN THE ICU. THE SURGEON SAID HE NO LONGER WILL USE THE SYNCHROSEAL INSTRUMENT. INTUITIVE SURGICAL INC. (ISI) CONTACTED THE SURGEON WHO PERFORMED THIS PROCEDURE AND ADDITIONAL INFORMATION WAS OBTAINED ABOUT THE EVENT: THE PROCEDURE OCCURRED IN JUNE BUT THE EXACT DATE WAS NOT PROVIDED. THE PROCEDURE WAS PERFORMED ON A DA VINCI SI SYSTEM WITH AN UNKNOWN SERIAL NUMBER. THE SYNCHROSEAL INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NOTHING ABNORMAL FOUND. THE SURGEON REPORTED THAT THE SYNCHROSEAL INSTRUMENT WORKED FINE AND NO ERRORS WERE GENERATED FOR THE INSTRUMENT. THE TARGET ISSUE WAS THE PROSTATE PEDICLE. THE TARGET TISSUE WAS REPORTEDLY UNDER TENSION DURING THE SEALING AND CUTTING PROCESS. THE TARGET TISSUE WAS NOT A VESSEL GREATER THAN 5MM, HAD NO CALCIFICATION, AND NO PREVIOUS RADIATION OR CHEMOTHERAPY. THE SURGEON REPORTED THAT THEY OBSERVED TISSUE EFFECT DURING THE SEALING/SYNCH CYCLE. THE SURGEON SAID THE SYNCHROSEAL INSTRUMENT NEVER CAME INTO CONTACT WITH METAL OBJECTS SUCH AS STAPLES, SUTURES, AND CLIPS DURING 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY SLIPPED OF THE MCS INSTRUMENT AND FELL INTO THE PATIENT. THE MCS TIP COVER ACCESSORY WAS REMOVED FROM THE PATIENT AND WAS REPORTEDLY DISCARDED. THE PROCEDURE WAS COMPLETED USING A BACKUP MCS TIP COVER ACCESSORY WITH NO REPORTED INJURY. THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL TERRITORY ASSOCIATE (CTA) PROVIDED THE FOLLOWING INFORMATION: THE OPERATING ROOM NURSE WHO REPORTED THIS ISSUE TO THE CTA STATED SHE DOES NOT HAVE THE EVENT DATE INFORMATION. THE MCS INSTRUMENT AND MCS TIP COVER ACCESSORY WERE INSPECTED PRIOR TO USE. INSTALLATION OF TIP COVER ACCESSORY ON THE MCS INSTRUMENT WAS "EASIER THAN NORMAL." THE MCS TIP COVER ACCESSORY FELL INTO THE ABDOMEN AND THEY RETRIEVED IT WITH THE REMAINING INSTRUMENTS. INSTRUMENT REMOVAL TASK WAS BEING PERFORMED WHEN THE MCS TIP COVER ACCESSORY FELL INSIDE THE PATIENT. THE NURSE TOLD THE CTA THAT THE MCS TIP COVER ACCESSORY AND THE MCS WERE NOT BEEN DAMAGED. THE ORANGE SURFACE WAS NOT VISIBLE AFTER THE MCS TIP COVER ACCESSORY WAS INSTALLED. NO ELECTROLUBE OR OTHER LUBRICANT APPLIED TO THE MCS INSTRUMENT 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 REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE WAS SUDDENLY BROKEN. THERE WAS NO REPORT OF FRAGMENT(S) FALLING INSIDE THE PATIENT. A SIMILAR BACKUP DA VINCI INSTRUMENT WAS USED. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT HARM, ADVERSE OUTCOME, OR INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS USED FOR ABOUT ONE HOUR AND THE INSTRUMENT BLADE WAS BROKEN INSIDE THE PATIENT. THE SURGEON REMOVED THE FRAGMENT BY USING A GRASPER, DURING THE SAME PROCEDURE. THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO DAMAGE FOUND. DURING A DA VINCI-ASSISTED THYROIDECTOMY SURGICAL PROCEDURE, THE INSTRUMENT BROKE WHILE IT WAS BEING USED FOR DISSECTING TISSUE. ALL THE FRAGMENTS WERE RETRIEVED UPON VISUAL INSPECTION. IT WAS UNKNOWN WHAT CAUSED THE BREAKAGE AS THE INSTRUMENT DID NOT COLLIDE WITH ANY HARD MATERIALS OR OTHER INSTRUMENTS. THERE WAS NO PATIENT INJURY. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT. THE FRAGMENT(S) DID NOT FALL INSIDE THE PATIENT DURING AN INSTRUMENT TIP OR ACCESSORY COLLISION. THE INSTRUMENT WAS NO

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 GASTRIC BYPASS SURGICAL PROCEDURE, A SMALL DISC FELL OFF OF THE SYNCHROSEAL INSTRUMENT AND INTO THE ABDOMEN OF THE PATIENT. THE SMALL DISC WAS REMOVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON (B)(6) 2021 AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE FRAGMENT WAS RETRIEVED VIA ROBOTIC INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE AND WAS UNSURE OF THE CAUSE OF THE ISSUE. THE FOLLOWING WAS INFORMATION WAS REQUESTED, BUT WAS UNKNOWN: WHAT SURGICAL TASK WAS BEING PERFORMED AT THE TIME OF THE ISSUE, HOW LONG THE INSTRUMENT HAD BEEN IN USE AT THE TIME OF THE ISSUE, IF THERE WERE ANY COLLISIONS, IF THE INSTRUMENT WAS REMOVED THROUGH THE CANNULA PRIOR TO THE ISSUE, AND IF THERE WAS ANY OTHER DAMAGE TO THE INSTRUMENT OR THE CANNULA ONCE THE INSTRUMENT HAD BEEN REMOVED. THE INSTRUMENT IS AVAILABLE FOR RETURN TO ISI. THERE ARE PHOTOGRAPHIC IMAGES AVAILABLE OF THE INSTRUMENT AND THE FRAGMENT. PATIENT-RE

Monarch Platform — 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 A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE A PATIENT DEVELOPED AN IATROGENIC PNEUMOTHORAX IN THE LEFT UPPER LOBE (LUL). THE PATIENT HAD POSTPROCEDURAL CHEST X-RAYS AT 3:30 P.M. THAT DEMONSTRATED A SMALL APICAL 3-4 MM PNEUMOTHORAX. REPEAT CHEST X-RAY AT 6:30 P.M. SHOWED INCREASED PNEUMOTHORAX TO 1 CM DESPITE BEING ON A FULL-FACE MASK. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION AND PLACED ON 15 L SALTER CANNULA FOR SUPPORTIVE TREATMENT OF THE PNEUMOTHORAX. OVERNIGHT, THE PATIENT HAD REPEATED X-RAYS WHICH WAS FOUND TO BE STABLE AND THERE WAS NO EVIDENCE OF DESATURATION WITHOUT SUPPLEMENTAL O2. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY.

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 MAIN MACHINE OF THE ULTRASONIC KNIFE WAS REPORTING THAT THE PRESSURE OF THE KNIFE HEAD WAS TOO LARGE. DURING THE OPERATION, THE PATIENT SUFFERED FROM "A LOT OF BLEEDING." THE NURSE PULLED OUT THE ULTRASONIC KNIFE FOR RE-TESTING, AND THE MAIN MACHINE OF THE ULTRASONIC KNIFE SUGGESTED THAT THE INSTRUMENT SHOULD BE REPLACED. THERE WAS NO REPORT OF ANY FRAGMENT(S) FALLING INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A BACKUP DA VINCI INSTRUMENT OF THE SAME KIND, AND THERE WAS NO REPORTED INJURY. 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.

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 MAIN MACHINE OF THE ULTRASONIC KNIFE WAS REPORTING THAT THE PRESSURE OF THE KNIFE HEAD WAS TOO LARGE. DURING THE OPERATION, THE PATIENT SUFFERED FROM "A LOT OF BLEEDING." THE NURSE PULLED OUT THE ULTRASONIC KNIFE FOR RE-TESTING, AND THE MAIN MACHINE OF THE ULTRASONIC KNIFE SUGGESTED THAT THE INSTRUMENT SHOULD BE REPLACED. THERE WAS NO REPORT OF ANY FRAGMENT(S) FALLING INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A BACKUP DA VINCI INSTRUMENT OF THE SAME KIND, AND THERE WAS NO REPORTED INJURY. 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.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: UPON FURTHER REVIEW, IT IS NOTED THE PATIENT EXPERIENCED A BLISTER. BLISTERS ARE A FLUID FILLED SAC LOCATED UNDER THE TOP LAYER OF THE SKIN. THESE RESULT DUE TO HEAT OR FRICTION AT THE SITE AND MOST OFTEN RESOLVE ON THEIR OWN. REVIEWING THE OFFICE NOTE PROVIDED, THE DOCTOR DOES NOT MENTION AN INTERVENTION AND STATES HE EXPECTS THE BLISTER TO RESOLVE ON ITS OWN. AS A BLISTER IS A MILD INJURY AND NO INTERVENTION IS NOTED, THIS WOULD NOT BE CONSIDERED A SERIOUS INJURY OR REPORTABLE.

Monarch Platform — 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 MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED BLEEDING. NO BLOOD TRANSFUSION AND NO MEDICAL INTERVENTION WAS REQUIRED. THE PNEUMOTHORAX WAS DISCOVERED DURING ENDOBRONCHIAL ULTRASOUND. THE LOCATION OF THE PNEUMOTHORAX WAS RIGHT UPPER LOBE. A CHEST TUBE WAS PLACED, AND PATIENT WAS HOSPITALIZED FOR OBSERVATION. THE CHEST TUBE WAS REMOVED 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 PROSTATECTOMY PROCEDURE, THE USER OBSERVED THAT "THE PART THAT HOLDS THE SYNCHROSEAL INSTRUMENT JAW COVER WAS DAMAGED" AND A FRAGMENT FELL INSIDE THE PATIENT. THE BROKEN FRAGMENT WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE. THE USER NOTED THAT THE INSTRUMENT WAS NOT INVOLVED IN ANY KNOWN INSTRUMENT COLLISION. THE INSTRUMENT WAS REMOVED AND REPLACED TO THE BACKUP. THE USER COMPLETED THE PROCEDURE WITH NO FURTHER ISSUE. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND FOUND NO ISSUE. INSTRUMENT OPERATED WITH NO FUNCTIONAL ISSUE. SURGEON ALLEGES NO INCIDENT OF INSTRUMENT COLLISION. THE INSTRUMENT WAS IN USE FOR APPROXIMATELY AN HOUR. THE FALLEN FRAGMENT WAS REMOVED THROUGH THE ASSIST PORT. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT. STANDARD POST-OPERATIVE TESTS WERE PERFORMED AND CONFIRMED NO RETAINED FRAGMENT.

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: DA VINCI XI ROBOT EXPERIENCED NONRECOVERABLE FAULT ERROR CODE 307 DURING MID PROCEDURE. INSTRUMENT ARMS WERE LEFT IN PATIENT. REP ADVISED TOTAL SYSTEM SHUTDOWN AND RESTART. SYSTEM SHUT DOWN AND RESTARTED 3 TIMES, NONRECOVERABLE FAULT RESULTED EACH TIME. INSTRUMENTS AND DA VINCI REMOVED MANUALLY AS RESULT OF FAILURE. PROCEDURE CONTINUED THORACOSCOPICALLY. AFTER TROUBLESHOOTING THIS ISSUE, DA VINCI REP DETERMINED THE TITLE PRO CABLE CONNECTED TO THE STORZ CAMERA SYSTEM FRIED THE TITLE PRO INPUT BOX IN THE DA VINCI ROBOT, RESULTING IN NONRECOVERABLE FAULT ERROR CODE 307. VENDOR CAME ONSITE 5/16 AND REPAIRED UNIT. UNIT RETURNED TO SERVICE. VIDEO OUTPUT ON VISION TOWER WAS REPLACED. COMPOSITE VIDEO COMPONENT PROTRUDES FROM EQUIPMENT LEADING TO HIGHER LIKELIHOOD OF DAMAGE. FDA SAFETY REPORT ID # (B)(4).

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.

Monarch Platform — 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 MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE TARGET AND PNEUMOTHORAX WERE LOCATED RIGHT UPPER LOBE. AN ENDOBRONCHIAL ULTRASOUND WAS PERFORMED. A CHEST TUBE WAS PLACED IN THE PATIENT AND PATIENT WAS HOSPITALIZED. THE CHEST TUBE WAS REMOVED ON (B)(6) 2021. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2021.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT A REVISION SURGERY WAS DONE TO REMOVE MISPLACED SCREWS AT L4 CAUSING ADVERSE EFFECTS TO THE PATIENT.

Monarch Platform — 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 MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE LOCATION WAS RIGHT UPPER LOBE. THE LOCATION OF THE PNEUMOTHORAX WAS RIGHT SIDE. DURING THE PROCEDURE THE PATIENT WENT INTO A COMPLETE HEART BLOCK AND BECAME HYPOTENSIVE. EPINEPHRINE WAS PUSHED INTO THE PATIENT¿S INTRAVENOUS TO TACKLE HYPOTENSION AND THE SCOPE WAS REMOVED IMMEDIATELY. THE CUSTOMER TOOK THE SCOPE OFF THE ROBOTIC ARMS AT THIS TIME AND WENT ON TO REMOVE THE SCOPE OUT OF PATIENT MANUALLY. THE PATIENT SUBSEQUENTLY BECAME STABLE, E.G., SHOWED INFERIOR WALL ACUTE MYOCARDIAL INFARCTION (AMI). THE PATIENT WENT TO THE CARDIAC CATHETERIZATION LAB IMMEDIATELY AND HAD AN EMERGENT ANGIOGRAM. THE PATIENT HAS RECOVERED AND HAS BEEN DISCHARGED.

Monarch Platform — 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 A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE, THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE PNEUMOTHORAX WAS DISCOVERED VIA A CHEST X-RAY AFTER THE PROCEDURE WHEN THE PATIENT WAS AWAKE AND COMPLAINED ABOUT CHEST PAIN. THE TARGET AND PNEUMOTHORAX LOCATION WERE IN THE LEFT LOWER LOBE (LLL). A CHEST TUBE WAS PLACED IN THE PATIENT AND THE PATIENT WAS HOSPITALIZED. THE CHEST TUBE WAS REMOVED, AND PATIENT WAS DISCHARGED THE NEXT DAY.

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 HIATAL HERNIA-PARAESOPHAGEAL SURGICAL PROCEDURE, PART OF THE SHEAR OF THE HARMONIC ACE INSTRUMENT BROKE AND FELL INTO THE PATIENT. THE PIECE WAS RETRIEVED FROM THE ABDOMEN. THE CUSTOMER OPENED ANOTHER HARMONIC ACE INSTRUMENT TO COMPLETE THE CASE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. 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.

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 PANCREATECTOMY SURGICAL PROCEDURE, A PLASTIC PART FROM THE HARMONIC ACE INSTRUMENT BROKE AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED AND A BACKUP INSTRUMENT WAS USED TO CONTINUE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER RETRIEVED FRAGMENTS AND CONFIRMED BY VISUAL INSPECTION THAT ALL BROKEN PIECES WERE RETRIEVED. THERE WAS NO ADDITIONAL PROCEDURE REQUIRED TO REMOVE THE FRAGMENTS. THERE WERE NO POST-OPERATIVE TESTS PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE INSTRUMENT WAS IN USE FOR LESS THAN 1 HOUR PRIOR TO THE ISSUE. THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE SURGEON WAS REMOVING THE INSTRUMENT WHEN THE DEVICE FRAGMENT FELL INSIDE THE PATIENT. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. THE INSTRUMENT WAS NEVER REMOVED PRIOR TO THE EVENT. THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON THE FINAL REMOVA

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 LIVER RESECTION SURGICAL PROCEDURE, THE BLADE OF THE HARMONIC ACE INSTRUMENT BROKE OFF AND FELL INTO THE PATIENT. THE PIECE WAS RETRIEVED AND NO PARTS REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF DATE OF THIS REPORT REGARDING THIS EVENT.

Monarch Platform — 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 MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE LOCATION WAS RIGHT UPPER LOBE. THE LOCATION OF THE PNEUMOTHORAX WAS RIGHT SIDE. DURING THE PROCEDURE THE PATIENT WENT IN CARDIAC ARREST FROM A TENSION PNEUMOTHORAX. A NEEDLE DECOMPRESSION WAS USED, AND PATIENT REGAINED THEIR PULSE. A CHEST TUBE WAS PLACED IN THE PATIENT AND THE PATIENT WAS HOSPITALIZED. THE CHEST TUBE WAS REMOVED ON (B)(6) 2021. 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 PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS TIP COVER ACCESSORY FELL INTO THE SITUS. THE TIP COVER ACCESSORY WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED TO FOLLOW-UP WITH THE CUSTOMER TO OBTAIN ADDITIONAL DETAILS RELATED TO THE EVENT. HOWEVER, AS OF THE DATE OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN RECEIVED.

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 PROSTATECTOMY SURGICAL PROCEDURE THE SYNCHROSEAL INSTRUMENT JAW HINGE PIN, END PIECE, FELL OFF THE INSTRUMENT INTO THE PATIENT. THE SURGEON RETRIEVED THE PIECE WITH A BACKUP INSTRUMENT AND CONTINUED THE PROCEDURE. NO OTHER PIECES WERE OBSERVED TO BE MISSING FROM THE INSTRUMENT. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ADVISED THE CALLER TO PROMPT THE CUSTOMER TO RETURN THE INSTRUMENT FOR FAILURE ANALYSIS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING A MAKO PKA CASE AN INCORRECT SIZE 3 POLY INSERT WAS IMPLANTED ONTO A SIZE 4 TIBIAL BASEPLATE. THE ERROR WAS DISCOVERED BY THE SURGEONS REG AFTER THE PATIENT HAD JUST BEEN CLOSED. THE PATIENT WAS REOPENED AND THE CORRECT SIZE 4 POLY INSERTED. PROBLEM RESOLVED. NO NEW SPINAL OR GA WAS NEEDED.

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 BENIGN HYSTERECTOMY SURGICAL PROCEDURE, IT WAS NOTED THAT ONE OF THE PADS ON THE HARMONIC SCALPEL FELL OFF INTO THE PATIENT. THE CUSTOMER INFORMED THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) THE ISSUE HAD OCCURRED AND THE CUSTOMER RETRIEVED THE GREY INSTRUMENT TIP PAD WITH NO ISSUES TO THE PATIENT. IT WAS NOTED THE CUSTOMER DISCARDED THE INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CLINICIAN INFORMED THE INSTRUMENT WAS INSPECTED PRIOR TO USE. PRIOR TO THE FRAGMENT FALLING, THE INSTRUMENT HAD BEEN IN USE FOR ABOUT 45  60 MINUTES. AT THE TIME OF THE REPORTED ISSUE, THE CLINICIAN NOTED THAT THE SURGEON WAS PERFORMING AN EXCISION OF FIBROIDS AND STATED THE HARMONIC INSTRUMENT AND TENACULUM INSTRUMENT COLLIDED. THE SURGEON DID NOT NOTICE AN ISSUE WITH THE INSTRUMENT FUNCTIONALITY DURING THE CASE. IT WAS NOTED THE FRAGMENT FELL OFF INTO THE PATIENT IN THE MIDDLE OF THE CASE AND DID NOT OCCUR DURING AN INSTRUMENT COLLISION. THE WHITE TIP OF THE HARMONIC INSTRUMENT WAS RETRIEVED IN ONE PIECE WITH A G

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 MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, THE SYNCHROSEAL INSTRUMENT WAS FOUND TO HAVE THE BUTTON FELL OFF. THE BUTTON WAS IN A CUP. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: IT WAS CONFIRMED THAT THE BUTTON SIMPLY FELL OFF AND WAS DISCOVERED WITHIN THE PATIENT. THE INSTRUMENT WAS INSPECTED PRIOR TO USE. THE FRAGMENT WAS LIKELY RETRIEVED WITH A ROBOTIC/LAP INSTRUMENT DURING THE CASE. NO POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRASOUND WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT NOR ANY OTHER DAMAGE TO THE INSTRUMENT AFTER THE EVENT OCCURRED. THE WRIST WAS NOT STRAIGHTENED PRIOR TO REMOVAL BUT WAS STRAIGHTENED UPON FINAL REMOVAL OF THE INSTRUMENT. NO PATIENT INJURY WAS IDENTIFIED. THE PART L90200818-0262 WAS USED 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SPLENECTOMY PROCEDURE, BLEEDING OCCURRED. THE SURGEON REPORTED THAT HE THINKS HE GRABBED A VEIN WHICH CAUSED THE BLEEDING. THE SITE GAVE THE PATIENT A BLOOD TRANSFUSION AND CONVERTED TO OPEN SURGERY. THE SURGEON REPORTED TWO DAYS AFTER THE PROCEDURE THAT THE PATIENT WAS DOING FINE. THE SURGEON REPORTED THAT HE DOES NOT BELIEVE AN INTUITIVE SURGICAL INC. (ISI) PRODUCT CAUSED OR CONTRIBUTED TO THE REPORTED INJURY. FOLLOW-UP: ON 04/22/2021, INTUITIVE SURGICAL INC. (ISI) CONTACTED THE CONSOLE SURGEON OF THE PROCEDURE AND ADDITIONAL INFORMATION WAS OBTAINED ABOUT THE EVENT: THE BLEEDING EVENT OCCURRED WHILE TAKING THE SPLENIC MINOR ATTACHMENT WITH THE SYNCHROSEAL INSTRUMENT. THE SURGEON SAID WHILE HE WAS SEALING TISSUE BLOOD STARTED FLOWING FROM IT. THE SURGEON CLARIFIED THAT THE BLOOD APPEARED WHILE THE SYNCHROSEAL INSTRUMENT WAS SEALING WITH ENERGY. THE SURGEON GRASPED THE BLEEDING VESSEL AT THE INFLOW SIDE, BUT THE BLOOD VOLUME INCREASED; THE PROCEDURE WAS THEN CONVERTED TO OPEN TO CONTROL THE BLEEDING VESSEL WITH SUTURES. THE SURGEON SAID THE VESSEL WAS NOT LARGER THAN 5MM AND THAT THE SYNCHROSEAL WAS WORKING FINE DURING THE WHOLE 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 REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MASTER KNIFE WAS CUTTING THE LIVER, AND THE ULTRASONIC KNIFE HEAD SUDDENLY BROKE OFF WITHOUT ANY HINT. FORTUNATELY, THE BROKEN KNIFE HEAD WAS PICKED OUT. THE FRAGMENT WAS RETRIEVED DURING THE OPERATION. THE PROCEDURE WAS COMPLETED WITH A BACKUP DA VINCI INSTRUMENT OF THE SAME KIND, AND THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE. THE INSTRUMENT WAS USED FOR APPROXIMATELY ONE HOUR PRIOR TO THE BREAKAGE. THE SURGEON HAD NO ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE PROCEDURE. THE SURGEON HAD NO ISSUES WITH REMOVING THE INSTRUMENT FROM THE ARM PRIOR TO THE BREAKAGE. THERE WAS NO REPORT OF COLLISION WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL. ALL FRAGMENT(S) WERE RETRIEVED WITH THE ENDOSCOPIC INSTRUMENT DURING THE SAME PROCEDURE. NO SURGICAL PROCEDURES WERE REQUIRED TO REMOVE THE FRAGMENT. NO POST-OPERATIVE TESTS WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. NO INFORMATION WAS PROVIDED PERTAINING TO IF THE PATIENT HAS RETURNED TO THE HOSPITAL DUE TO PO

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: 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 PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, AFTER INSERTING THE SYNCHROSEAL INSTRUMENT INTO THE BODY CAVITY IMMEDIATELY AFTER THE START OF SURGERY, THE PART WHICH HOLDS THE JAW COVER FELL INTO THE BODY WHEN THE WRIST WAS MOVED. THE PART WAS REPORTEDLY IMMEDIATELY RETRIEVED. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE REPORTER ON 15-APRIL-2021 AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION RELATED TO THE EVENT. THE FRAGMENT WAS RETRIEVED BY USING THE SYNCHROSEAL INSTRUMENT. NO POST-OPERATIVE TESTS WERE REQUIRED AS IT WAS VISUALLY CONFIRMED THAT NO OTHER FRAGMENTS REMAINED INSIDE THE PATIENT. IT WAS UNKNOWN WHETHER THE INSTRUMENT WAS INSPECTED PRIOR TO USE, BUT REPORTEDLY THE INSTRUMENT DID COLLIDE WITH OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE PROCEDURE. THE INSTRUMENT WAS NOT REMOVED INTRAOPERATIVELY. UPON FINAL REMOVAL OF THE INSTRUMENT, THE WRIST WAS STRAIGHTENED THERE WAS NO RESISTANCE FELT UPON REMOVAL THROUGH THE CANNULA, AND THERE WAS NO DAMAGE NOTED TO EITHER THE INSTRUMENT OR THE CANNULA. IT WAS ALSO CONFIRMED THAT THERE WAS NO PATIENT INJURY THAT

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE BLADE OF THE HARMONIC ACE INSTRUMENT BROKE AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED AND A BACKUP INSTRUMENT OF THE SAME KIND WAS USED TO CONTINUE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER RETRIEVED THE WHITE POWDER FRAGMENTS BY SUCTION. THERE WAS NO ADDITIONAL PROCEDURE REQUIRED TO REMOVE THE FRAGMENT. NO POST-OPERATIVE TESTS WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE INSTRUMENT WAS IN USE FOR LESS THAN 5 MINUTES PRIOR TO THE ISSUE. THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE SURGEON WAS DISSECTING TISSUES WHEN THE DEVICE FRAGMENTS FELL INSIDE THE PATIENT. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. THE INSTRUMENT WAS NEVER REMOVED PRIOR TO THE EVENT. THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON FINAL REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA OR TO THE INSTRUMENT A

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 CHOLECYSTECTOMY PROCEDURE, THE ¿ENERGY BOX WAS NOT WORKING¿. THE CUSTOMER CONTACTED AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) WHO THEN REACHED OUT TO AN ISI TECHNICAL SUPPORT ENGINEER (TSE). THE CUSTOMER HAD TRIED TO RESEAT THE BIPOLAR ENERGY CABLE MULTIPLE TIMES, TRIED DIFFERENT ENERGY CABLES, AND TRIED TO RESEAT THE INSTRUMENTS MULTIPLE TIMES; ALL WITH NO CHANGE. A MESSAGE HAD PRESENTED ON THE VISION SIDE CART (VSC) TOUCHSCREEN (TS) MONITOR STATING, "VIO DV IS NOT CONNECTED" AND A RED QUESTION MARK DISPLAYED WITH AN INCOMPATIBLE INSTRUMENT MESSAGE ON THE ERBE GENERATOR. THE TSE CHECKED THE LIVE SYSTEM LOGS AND DID NOT SEE ANY RELEVANT ERRORS PRESENT IN THE LOGS. THE TSE HAD CUSTOMER RESEAT THE POWER CABLE ON THE BACK OF THE ERBE AND CHECK ERBE CONNECTIONS, BUT ALL FELT SECURE. THE TSE WALKED THE CUSTOMER THROUGH A SYSTEM POWER CYCLE AND THE CUSTOMER MOVED THE ERBE POWER CABLE TO A DIFFERENT OUTLET. THE CUSTOMER THEN POWER CYCLED THE ERBE GENERATOR. THE SYSTEM THEN POWERED ON WITH MONOPOLAR AND BIPOLAR ENERGY WORKING NORMALLY. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ¿A LITTLE BLEEDING DURING

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE FOLLOWING MEDICAL LITERATURE WAS REVIEWED: ROBOTIC BRONCHOSCOPY: AN INITIAL EXPERIENCE AT A TERTIARY CENTER. AUTHORS: GUSTAVO CUMBO-NACHELI, RONAK CHHAYA, AND JOHN EGAN. CITATION: CHEST ANNUAL MEETING 2019/ WEDNESDAY ELECTRONIC POSTERS 3/ VOLUME 156, ISSUE 4, SUPPLEMENT , A1767, OCTOBER 01, 2019/ DOI.ORG/10.1016/J.CHEST.2019.08.1538. TWO PATIENTS WERE REPORTED AS HAVING PNEUMOTHORAX AND REQUIRING CHEST TUBE PLACEMENT AS TREATMENT. NO DEVICE ISSUES WERE REPORTED.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE FOLLOWING MEDICAL LITERATURE WAS REVIEWED: ROBOT-ASSISTED BRONCHOSCOPY FOR PULMONARY LESION DIAGNOSIS: RESULTS FROM THE INITIAL MULTICENTER EXPERIENCE AUTHORS: UDIT CHADDHA, STEPHEN P. KOVACS, CHRISTOPHER MANLEY, D. KYLE HOGARTH, GUSTAVO CUMBO-NACHELI, SIVASUBRAMANIUM V. BHAVANI, ROHIT KUMAR, MANISHA SHENDE, JOHN P. EGAN III AND SEPTIMIU MURGU CITATION: BMC PULMONARY MEDICINE (2019) 19:243. DOI: HTTPS://DOI.ORG/10.1186/S12890-019-1010-8. FOUR PATIENTS WERE REPORTED AS HAVING PNEUMOTHORAX AND REQUIRING CHEST TUBE PLACEMENT AS TREATMENT. NO RELATED DEVICE ISSUES WERE REPORTED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: 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: 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: 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: 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 AFTER A PROSPECTIVE IRIS STUDY ROBOTIC PARTIAL NEPHRECTOMY ON (B)(6) 2021, THE PATIENT PRESENTED WITH PRE-SYNCOPAL SYMPTOMS ON (B)(6) 2021. THE PATIENT¿S ¿HEMATOCRIT (HCT) DROPPED FROM 41 TO 25, COMPUTED TOMOGRAPHY (CT) A/P¿ INDICATING A CONCERN FOR BLEEDING AT THE SURGICAL SITE. THE PATIENT UNDERWENT ¿IR COIL EMBOLIZATION OF THE RIGHT RENAL ARTERY PSEUDOANEURYSM¿ (B)(6) 2021 AND TOLERATED THE PROCEDURE WITH NO IMMEDIATE COMPLICATIONS. THE PATIENT WAS ADMITTED TO THE HOSPITAL THEN DISCHARGED ON (B)(6) 2021. ON (B)(6) 2021, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: IT WAS CONFIRMED THAT THERE WERE NO REPORTED INTRA-OPERATIVE COMPLICATIONS AND NO ISSUES WITH IRIS MEDICAL IMAGING. DUE TO THE POST-PROCEDURE COMPLICATIONS, THE PATIENT WAS ADMINISTERED AN UNSPECIFIED AMOUNT OF BLOOD BY TRANSFUSION. IT WAS CONFIRMED THAT THE SURGEON VERBALLY STATED, AND DOCUMENTED IN THE ELECTRONIC DOCUMENTATION (EDC), THAT THERE IS NO ALLEGATION OF A MALFUNCTION OF A DA VINCI PRODUCT AND NO ALLEGED CAUSAL RELATIONSHIP BETWEEN THE IRIS STUDY AND THE PATIENT¿S POST-OPERATIVE BLEEDING COMPLICATION AND SUBSEQUENT BLOOD TRAN

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON 03/26/2021, IT WAS REPORTED THAT MAJOR BLEEDING WAS DISCOVERED IN A PATIENT SIX HOURS AFTER A MONARCH-ASSISTED BRONCHOSCOPIC PROCEDURE. THE LOCATION OF THE TARGET WAS THE RIGHT UPPER LOBE. THE POST PROCEDURE COMPUTED TOMOGRAPHY SCAN SHOWED A LARGE RIGHT SIDED PLEURAL EFFUSION AND A DROP IN HEMOGLOBIN THAT PROMPTED A RIGHT THORACOTOMY WITH EVACUATION OF THE HEMOTHORAX AND A RIGHT UPPER LOBE WEDGE RESECTION. NO OBVIOUS SITE OF THE BLEEDING WAS FOUND INTRAOPERATIVELY. THE PHYSICIAN BELIEVED THAT THE CAUSE OF THE BLEEDING WAS THE MASS ITSELF. THE PATIENT WAS NOT ON ANTICOAGULANTS AND THE BIOPSY POSSIBLY PRECIPITATED THE BLEEDING. THIS ADVERSE EFFECT IS RELATED TO THE PROCEDURE AND IS A RECOGNIZED OUTCOME OF A BRONCHOSCOPIC GUIDED LUNG BIOPSY. CONTRIBUTING FACTORS ARE THAT THE LESION WAS FOUND TO BE ADENOCARCINOMA AND MORE PRONE TO BLEEDING THAT NORMAL LUNG TISSUE. THE PATIENT DID REQUIRE A FOUR-UNIT BLOOD TRANSFUSION AND 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION PROCEDURE ON AN UNKNOWN EVENT DATE, THE MONOPOLAR CURVED SCISSOR (MCS) INSTRUMENT TIP COVER ACCESSORY FELL INSIDE THE PATIENT WHILE THE CUSTOMER WAS REMOVING THE INSTRUMENT THROUGH THE TROCAR. THE ITEM WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. 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.

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 EXPERIENCED A PNEUMOTHORAX. THE LOCATION OF THE TARGET AND PNEUMOTHORAX WERE IN THE ANTERIOR SEGMENT OF THE RIGHT UPPER LOBE. A CHEST TUBE WAS PLACED IN THE PATIENT AND THE PATIENT WAS HOSPITALIZED. AFTER BEING ADMITTED, THE PATIENT SUBSEQUENTLY BECAME SEPTIC, WAS DIAGNOSED WITH TUBERCULOSIS, AND REQUIRED CARE IN THE MEDICAL INTENSIVE CARE UNIT. THE PATIENT IS REPORTED AS DOING WELL BUT HAS NOT BEEN DISCHARGED DUE TO THEIR (B)(6) DIAGNOSIS.