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

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, A PATIENT SIDE MANIPULATOR (PSM) WAS NOT FREE TO MOVE MESSAGE. THE TECHNICAL SUPPORT ENGINEER (TSE) REQUESTED THE CLINICAL TERRITORY ASSOCIATE (CTA) POWER DOWN THE SYSTEM THEN EXERCISE THE PSM RANGE OF MOTION. LOGS DO NOT REFLECT ANY RELATED INFORMATION. CTA DID NOT OFFER THE STEPS TO THE SURGEON AS THE SURGEON ELECTED TO CONVERT TO OPEN. CTA REPORTS THAT PRIOR TO CALLING NONE OF THE TROUBLESHOOTING STEPS SHE TOOK WITH THE CUSTOMER WORKED, TO INCLUDE: RESEATING THE INSTRUMENT, RESEATING THE STERILE ADAPTER, UNDOCKING AND REDOCKING THE ARM AND HARD POWER CYCLE. CTA DID NOT STATE THEY INSPECTED THE ARM FOR OBSTRUCTION OR THE PROPER ORIENTATION OF THE STERILE ADAPTER WHEELS. THE PROCEDURE WAS CONVERTED TO OPEN WITH NO REPORTED INJURY.

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 DURING A DA VINCI-ASSISTED THYROIDECTOMY SURGICAL PROCEDURE, THE HARMONIC INSERT WAS USED TO DISSOCIATE TISSUE. THE CUSTOMER THEN STATED THAT THE TEFLON PAD FELL OFF BUT ALLEGEDLY THERE WAS NO REPORT OF FRAGMENT(S) FALLING INSIDE THE PATIENT. THE PROCEDURE WAS CONVERTED TO OPEN/LAPAROSCOPIC SURGERY WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER CONFIRMED THAT THE TEFLON PAD FELL INSIDE THE PATIENT. THE CUSTOMER IN UNSURE IF THE INSTRUMENT WAS INSPECTED PRIOR TO USE. THE INSTRUMENT WAS USED TO RETRACT TISSUE. THERE WERE NO FUNCTIONALITY ISSUES WITH THE INSTRUMENT. THE INSTRUMENT WAS REMOVED FROM THE ARM BEFORE THE BREAKAGE AND THE SURGEON EXPERIENCE NO ISSUES WITH REMOVING THE INSTRUMENT FROM THE ARM. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL. THE FRAGMENT WAS RETRIEVED WITH A LAPAROSCOPIC INSTRUMENT DURING THE SAME PROCEDURE. THE CUSTOMER DID NOT PERFORM AN ADDITIONAL SURGICAL PROCEDURE TO REMOVE THE FRAGMENT. THERE WERE NO POST-OPERATIVE TESTS PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE PATIENT DID NOT RETURNED TO TH

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 REVIEW OF A LITERATURE ARTICLE INVOLVING DA VINCI ASSISTED ROBOTIC PROCEDURES TITLED, ¿SINGLE-PORT ROBOT ASSISTED PARTIAL NEPHRECTOMY: INITIAL EXPERIENCE AND TECHNIQUE WITH THE DA VINCI SINGLE-PORT PLATFORM (IDEAL PHASE 1)¿ THE FOLLOWING EVENTS WERE REPORTED. ONE PATIENT EXPERIENCED AN INTRA-OPERATIVE "MILD LIVER CAPSULE INJURY." DESPITE THIS EVENT, THE ARTICLE STATES THAT NO INTRA-OPERATIVE COMPLICATIONS OCCURRED, AND THERE WERE NO PROCEDURE CONVERSIONS. ADDITIONALLY, TWO PATIENTS EXPERIENCED POST-OPERATIVE RETROPERITONEAL HEMATOMAS WHICH WERE TREATED WITH SELECTIVE EMBOLIZATION.

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

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 THYROIDECTOMY SURGICAL PROCEDURE, THE HARMONIC ACE WAS NOTED TO BE BROKEN UPON FIRING. THE CUSTOMER RETRIEVED THE TIP FROM THE BODY, AND THE NURSE CHANGED THE NEW INSTRUMENT TO FINISH THE PROCEDURE. AFTER THE PROCEDURE THE NURSE DISCARDED THE BROKEN TIP. THERE WAS NO REPORTED INJURY.

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.

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 ESOPHAGECTOMY SURGICAL PROCEDURE, ERROR 23002 OCCURRED. THE CUSTOMER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) OF THE EVENT, AND THE TSE TRIED TO COLLECT MORE INFORMATION TO PROVIDE TROUBLESHOOTING ASSISTANCE, BUT THE NURSE STATED SHE WAS BUSY AND STATED HAD ALREADY PROVIDED THE INFORMATION TO THE FIELD SERVICE ENGINEER (FSE). THERE WAS NO REPORTED INJURY. IT WAS FURTHER REPORTED THAT ERROR 23002 OCCURRED MANY TIMES DURING THE PROCEDURE. THE ERROR WAS POINTING TO THE RIGHT MASTER TOOL MANIPULATOR (MTM). THE CUSTOMER HAD REBOOTED THE SYSTEM WITH NO RESOLVE. THE FSE SUGGESTED TO RECOVER THE FAULT AND REBOOT THE SYSTEM, BUT THE CUSTOMER STATED THAT THEY REBOOTED THE SYSTEM AND THE ISSUE PERSISTED. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY WITH NO REPORTED INJURY. THE SYSTEM WAS IN USE FOR 30 MINUTES BEFORE THE PROCEDURE WAS CONVERTED. THE FSE INDICATED THAT FULL TROUBLESHOOTING WAS NOT EXHAUSTED TO ADDRESS THE REPORTED ISSUE PRIOR TO THE CONVERSION. ON 12-APRIL-2021, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION FROM THE FSE: THE REPORTED ISSUE WAS CALLED IN BY THE NURSE. THE NURSE STATED 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 THYROIDECTOMY SURGICAL PROCEDURE, THE HARMONIC ACE WAS NOTED TO BE BROKEN UPON FIRING. THE CUSTOMER RETRIEVED THE TIP FROM THE BODY, AND THE NURSE CHANGED THE NEW INSTRUMENT TO FINISH THE PROCEDURE. AFTER THE PROCEDURE THE NURSE DISCARDED THE BROKEN TIP. THERE WAS NO REPORT OF FRAGMENT(S) FALLING INSIDE THE PATIENT. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE REPORTED PRODUCT WAS INSPECTED PRIOR TO USE. THE INSTRUMENT WAS USED FOR 30 MINUTES AND BROKE UPON FIRING THE INSTRUMENT. SITE CONFIRMED A FRAGMENT OF THE HARMONIC INSERT BROKE IN THE PATIENT AND THE ASSISTANT RETRIEVED THE FRAGMENT FROM THE PATIENT'S BODY. IT IS UNKNOWN IF THE INSTRUMENT COLLIDED WITH OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE PROCEDURE. NO POST-OPERATIVE TESTS WERE PERFORMED TO CHECK FOR ANY REMAINING FRAGMENTS. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT. NO INFORMATION WERE PROVIDED PERTAINING TO THE PATIENT'S PRE-EXISTING MEDICAL CONDITIONS AND RELEVANT TESTS/

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 BROKE APART. PIECES FELL INSIDE THE PATIENT BUT THE SURGEON WAS ABLE TO RETRIEVE ALL OF THE PIECES. THE SITE STATED THAT THEY HAD THREE DIFFERENT OPERATING ROOM STAFF CONFIRM THAT ALL OF THE PIECES WERE REMOVED FROM THE PATIENT, MATCHED UP, AND NO SMALL FRAGMENTS BROKE OFF. NO POST-OP X-RAY WAS COMPLETED. THEY REPLACED THE HARMONIC INSTRUMENT WITH A DIFFERENT HARMONIC TO COMPLETE THE PROCEDURE. 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 INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL RETROPERITONEAL NEPHRECTOMY PROCEDURE, A TIP COVER ¿SPLIT¿ ON THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WHICH RESULTED IN AN, ¿INVERTED BLEED FROM AN ARTERY¿. TO RESOLVE THE ISSUE, THE SURGEON CONVERTED THE PROCEDURE TO OPEN SURGERY TO CONTROL THE BLEEDING. THE PATIENT WAS REPORTED AS BEING IN STABLE CONDITION FOLLOWING THE PROCEDURE. ON 15-MAR-2021, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: DURING A DA VINCI-ASSISTED PARTIAL RETROPERITONEAL NEPHRECTOMY PROCEDURE, AN ¿MCS TIP COVER WAS TORN AT SOME POINT DURING THE PROCEDURE AND NOBODY NOTICED IT¿. THE SITE BELIEVED THAT THERE WAS ARCING THAT CAUSED, ¿EXCESSIVE BLEEDING TO AN UNSPECIFIED ARTERY WHICH REQUIRED A BLOOD TRANSFUSION¿, UNKNOWN AMOUNT, AND THE PROCEDURE CONVERTED TO OPEN SURGERY. THE SURGEON DID NOT KNOW WHERE THE BLEEDING WAS COMING FROM AND DID NOT KNOW WHAT CAUSED THE BLEEDING. THE DA VINCI-ASSISTED PARTIAL NEPHRECTOMY PROCEDURE CONVERTED TO OPEN RADICAL NEPHRECTOMY SURGERY. THE OPEN PROCEDURE COMPLETED. THE PATIENT WAS DESCRIBED AS DOING WELL POST-OPERATIVELY. INTUITIVE SURGICAL, INC

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 COMPLETION OF A DA VINCI-ASSISTED TOTAL BENIGN HYSTERECTOMY PROCEDURE, THERE WAS A ¿PORT SITE TROCAR BURN¿. THE ISSUE WAS FOUND WHEN UNDOCKING THE SYSTEM ARM AND THE SURGEON STARTED TO ¿SUTURE-CLOSE¿ THE PORT SITE. THE BURN WAS IN THE SHAPE OF A CIRCLE ABOUT 2MM WIDE ALL AROUND THE PORT SITE. THE SURGEON EXCISED THE BURNT SKIN AND SUTURED THE PORT SITE. THE PROCEDURE WAS REPORTEDLY COMPLETED ROBOTICALLY. ON (B)(6) 2021, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE SURGEON REPORTEDLY DID NOT KNOW WHAT CAUSED THE ISSUE TO OCCUR, BUT THE SURGEON DID STATE THAT ALL INSTRUMENTS WORKED AS EXPECTED AND AS INTENDED BUT THEN NOTICED THE PORT SITE TISSUE BURN AND COULD NOT EXPLAIN WHAT CAUSED IT. THE PORT IN WHICH THE SYNCHROSEAL (SS) INSTRUMENT WAS USED WAS UNKNOWN. IT WAS ALSO UNKNOWN WHICH PORT SITE WAS INVOLVED WITH THE EVENT. WHILE THE SEVERITY OF THE PORT SITE BURN WAS UNKNOWN, THE BURN WAS DESCRIBED AS ¿A DARK CIRCLE OF BURNT SKIN AROUND ONLY ONE OF THE PORT SITES AND IT WAS ABOUT 2MM WIDE¿ FOR WHICH THE SURGEON ¿EXCISED THE BURNT SKIN AND SUTURED THE PORT SITE AS USUAL¿. THE PROCEDURE WAS COM

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 HARMONIC ACE INSTRUMENT WAS DAMAGED AND NON-FUNCTIONAL AFTER ONE HOUR OF USE. THERE WAS ¿DEBRIS¿ LEFT IN THE PATIENT. THE ¿DEBRIS¿ WAS RETRIEVED IN THE SAME PROCEDURE AND THE HARMONIC ACE WAS REMOVED. 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 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 HARMONIC ACE INSTRUMENT TIP BROKE AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. 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 ELECTED TO CANCEL THE RMA FOR THIS INSTRUMENT. NO FURTHER DETAILS WERE AVAILABLE.

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 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 — 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 TONGUE BASE RESECTION SURGICAL PROCEDURE, THE HARMONIC ACE CURVED SHEARS INSTRUMENT BLADE BROKE OFF. A BACKUP INSTRUMENT OF THE SAME TYPE WAS USED AND THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION. THE CUSTOMER REPORTED THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO ISSUES IDENTIFIED. THE INSTRUMENT WAS IN USE WITHOUT ISSUE FOR APPROXIMATELY 20 MINUTES FOR HEMOSTASIS WHEN THE INSTRUMENT BLADE BROKE AND 1 FRAGMENT FELL INTO THE PATIENT'S ORAL CAVITY AND WAS RETRIEVED DURING THE SAME PROCEDURE. REPORTEDLY, NO INTRAOPERATIVE COLLISIONS OCCURRED AND NO RESISTANCE WAS FELT REMOVING THE INSTRUMENT THROUGH THE CANNULA. THE CUSTOMER STATED THERE WAS NO INJURY AND THE PATIENT HAS NOT RETURNED TO THE HOSPITAL WITH ANY POST-SURGICAL COMPLICATIONS.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON 5-MAY-2021, INTUITIVE SURGICAL, INC. (ISI) RECEIVED MW5100203 STATING: ¿A (B)(6) Y/O FEMALE WITH A HISTORY OF 12DM. HTN. UTERINE ADENO CANCER S/P HYSTERECTOMY (2016), HX OF APPENDICEAL ADENOMA SEEN ON ENDOSCOPY THAT WAS SUSPICIOUS FOR MALIGNANCY UNDERWENT A ROBOTIC ASSISTED LAP RIGHT HEMICOLECTOMY ON (B)(6) 2021. ON (B)(6) 2021 THE PATIENT BECAME HYPOXIC AND CARDIAC ARRESTED. THE PATIENT UNDERWENT THREE ROUNDS OF CPR BEFORE OBTAINING ROSC. THE PATIENT WAS TRANSPORTED TO ICU, AND THREE UNITS OF EMERGENCY RELEASED PRSCS WERE TRANSFUSED, DUE TO A PROFOUND DROP IN HER HGB, THE PATIENT REMAINED HEMODYNAMICALLY UNSTABLE AND A DECISION WAS MADE TO RETURN TO THE OPERATING ROOM FOR AN EXPLORATORY LAPAROTOMY. IN THE OPERATING ROOM, THE ILEOCOLIC ARTERY WAS FOUND TO HAVE A PULSATILE BLEED AND WAS SUBSEQUENTLY LIGATED. ON RETURN TO THE ICU, PT. REMAINED HEMODYNAMICALLY UNSTABLE WITH WORSENING HYPOXIA. THE PATIENT REQUIRED INCREASED PRESSURE SUPPORT THROUGHOUT THE DAY. ON (B)(6) 2021 THE PATIENT¿S CONDITION CONTINUED TO WORSEN. ABDOMINAL COMPARTMENT SYNDROME WAS SUSPECTED AND THE DECISION WAS MADE BY THE ICU TEAM TO RE-OPEN THE ABDOMEN AT THE BEDSIDE. UPON ENTRY INTO THE ABDOMEN, 1000 CCS OF

da Vinci Surgical System — 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

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 ON 25-NOV-2020 THAT AFTER A DA VINCI-ASSISTED GYNECOLOGY PROCEDURE IN 2018, THERE WAS A ¿SURGICAL SITE INFECTION¿. THE CUSTOMER (INFECTION CONTROL) SUBSEQUENTLY REQUESTED A MEETING WITH INTUITIVE SURGICAL, INC. (ISI) TO FOLLOW UP ON THE REPORT. AT THIS TIME, THE PROCEDURE TYPE, THE DATE OF THE PROCEDURE, THE SEVERITY OF THE INFECTION, AND THE STEPS TAKEN TO ADDRESS THE INFECTION REMAIN UNKNOWN. ISI HAS REACHED OUT TO THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION BUT HAS NOT YET RECEIVED A RESPONSE. ALL FOLLOW-UP ATTEMPTS HAVE BEEN EXHAUSTED.

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 ON 25-NOV-2020 THAT AFTER A DA VINCI-ASSISTED GYNECOLOGY PROCEDURE IN 2019, THERE WAS A ¿SURGICAL SITE INFECTION¿. THE CUSTOMER (INFECTION CONTROL) SUBSEQUENTLY REQUESTED A MEETING WITH INTUITIVE SURGICAL INC. (ISI) TO FOLLOW UP ON THE REPORT. AT THIS TIME, THE PROCEDURE TYPE, THE DATE OF THE PROCEDURE, THE SEVERITY OF THE INFECTION, AND THE STEPS TAKEN TO ADDRESS THE INFECTION REMAIN UNKNOWN. INTUITIVE SURGICAL, INC. (ISI) HAD REACHED OUT TO THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION BUT HAS NOT YET RECEIVED A RESPONSE. ALL FOLLOW-UP ATTEMPTS HAVE BEEN EXHAUSTED.

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 TOTAL BENIGN HYSTERECTOMY SURGICAL PROCEDURE, A PLASTIC PART OF THE SYNCROSEAL JAW FELL OFF WHILE THE INSTRUMENT WAS IN THE SURGICAL FIELD. THE OPERATING ROOM (OR) STAFF WAS ABLE TO REMOVE THE PIECE FROM THE PATIENT WITHOUT ANY ISSUES AND THERE WAS NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) COMPLETED FOLLOW-UP AND OBTAINED THE FOLLOWING INFORMATION: PER THE REPORTER, ALL FRAGMENTS WERE RETRIEVED USING A LAPAROSCOPIC GRASPER. THERE WAS NO ADDITIONAL SURGICAL PROCEDURE REQUIRED TO REMOVE THE FRAGMENT NOR WERE THERE ANY POST-OPERATIVE TESTS PERFORMED. THE SURGEON WAS USING THE MONOPOLAR CURVED SCISSORS TO CLEAN TISSUE OFF THE SYNCHROSEAL WHEN THE REPORTED ISSUE OCCURRED. THE INSTRUMENT WAS REMOVED PROPERLY AND THERE WAS NO REPORT OF PATIENT INJURY, NOR HAS THE PATIENT RETURNED TO THE HOSPITAL DUE TO POST-OPERATIVE COMPLICATIONS.

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: DURING REVIEW OF A LITERATURE ARTICLE INVOLVING DA VINCI ASSISTED ROBOTIC PROCEDURES TITLED, ¿SINGLE PORT ROBOTIC RADICAL PROSTATECTOMY VERSUS MULTI-PORT ROBOTIC RADICAL PROSTATECTOMY: A HUMAN FACTOR ANALYSIS DURING THE INITIAL LEARNING CURVE¿ THE FOLLOWING EVENTS WERE REPORTED: FROM (B)(6) 2018 TO (B)(6) 2019, THE FIRST 20 CONSECUTIVE SINGLE PORT (SP) ROBOTIC ASSISTED LAPAROSCOPIC PROSTATECTOMIES (RALPS) PERFORMED BY A SINGLE EXPERIENCED ROBOTIC SURGEON WERE COMPARED AGAINST 20 MULTIPORT (MP) RALPS PERFORMED AT ANOTHER SITE IN ITALY. OF THE 20 CASES THAT WERE PERFORMED USING THE DA VINCI SINGLE PORT (SP), ONE INTRA-OPERATIVE COMPLICATION OF SEROSAL INJURY DUE TO EXTENSIVE LYSIS OF ADHESIONS WAS REPORTED. EIGHTEEN POST-OPERATIVE COMPLICATIONS WERE MENTIONED IN THE ARTICLE, WHICH INCLUDES CLAVIEN-DINDO GRADE I TO GRADE IVB. EIGHT PATIENTS DEVELOPED GRADE I POST-OPERATIVE COMPLICATIONS INVOLVING SHOULDER PAIN, ILEUS, ELECTROLYTE DERANGEMENT, NAUSEA, AND/OR VOMITING. SIX PATIENTS EXPERIENCED GRADE II COMPLICATIONS INVOLVING URINARY TRACT INFECTION (UTI), HEALTHCARE ACQUIRED PNEUMONIA (HCAP), EPIDIDYMOORCHITIS, AND/OR PELVIC HEMATOMA WHICH REQUIRED TRANSFUSION. TWO PATIENTS HAD GRADE I

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 LIVER RESECTION PROCEDURE, THE CUSTOMER REPORTED THAT THE HARMONIC ACE INSTRUMENT TIP FROM THE JAWS FELL OFF INSIDE THE PATIENT AND WAS RETRIEVED IN THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH REPORTER AND OBTAINED THE FOLLOWING INFORMATION: THE ISSUE OCCURRED WITH THE THIRD "PASSING" OF THE INSTRUMENT. THE INSTRUMENT WAS INSPECTED BEFORE USE AND THERE WAS NO VISIBLE DAMAGE NOTED. THE INSTRUMENT TIP BROKE OFF DURING LIVER MOBILIZATION. THE SURGEON SAW THE TIP BREAK OFF IN ONE PIECE AND USED A LAPAROSCOPIC GRASPER DURING THE SAME SURGERY TO REMOVE THE FRAGMENT. NO POST-OPERATIVE INVESTIGATION WAS DONE AFTER THE PROCEDURE AS IT WAS DEEMED NOT NECESSARY. THERE WERE NO ISSUES WITH FUNCTIONALITY OF THE INSTRUMENT AND NO COLLISION OF THE INSTRUMENT WITH ANY HARD MATERIAL BEFORE THE TIP BROKE OFF. THE SURGEON BELIEVES THE INSTRUMENT TIP BROKE OFF DUE TO A DEFECTIVE INSTRUMENT. THE PATIENT WAS A (B)(6) YEAR-OLD FEMALE, WEIGHING (B)(6) KG. DATE OF BIRTH WAS (B)(6) 1960. RACE AND ETHNICITY WERE UNKNOWN. RELEVANT MEDICAL HISTORY AND INVESTIGATIONS WERE REQUESTED BUT NOT

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 DURING A DA VINCI-ASSISTED VENTRAL HERNIA REPAIR SURGICAL PROCEDURE, THE RIGHT EYE IN THE SURGEON SIDE CONSOLE (SSC) WAS BLUE. PRIOR TO CALL CUSTOMER TRIED ANOTHER SCOPE, NO CHANGE. TECHNICAL SUPPORT ENGINEER (TSE) RECOMMENDED PERFORMING A HARD POWER CYCLE OF THE VISION SIDE CART (VSC) AND RESEATING THE FIBER CABLES, NO CHANGE. TSE RECOMMENDED TRYING A THIRD SCOPE, NO CHANGE. TSE RECOMMENDED REMOVING SCOPE AND CHECK THE SSC RIGHT EYE, RIGHT EYE WAS STILL BLUE IN SSC. TSE RECOMMENDED HARD POWER CYCLING THE SSC, NO CHANGE. TSE RECOMMENDED ANOTHER HARD POWER CYCLE OF THE SSC AND RESEATING THE FIBER CABLE, NO CHANGE. TSE RECOMMENDED BRINGING IN ANOTHER DA VINCI SSC. THE SURGEON OPTED TO CONVERT TO OPEN AND NEEDS TO END THE CALL. CTA CALLED BACK TO INFORM THAT THEY WERE ABLE TO GET ANOTHER SURGEON CONSOLE IN THE OR AND COMPLETE THE CASE. THE PROCEDURE WAS CONVERTED TO ANOTHER DA VINCI SYSTEM WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: SURGEON PLACED PORTS. DOCKED THE X SYSTEM. SURGEON SAT DOWN AND NOTICED THE RIGHT EYE WAS SHOWING BLUE SCREEN. VISION TOWER TROUBLESHO

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 VIA A REPLY TO A SOCIAL MEDIA POSTING ("WHAT'S THE NICEST THING YOU CAN SAY TO A DOCTOR?"): "DON'T WORRY, WE'RE NOT GOING TO SUE YOU." SAID BY MY HUSBAND TO THE SURGEON (WHO WAS CRYING) WHILE I WAS IN ICU ON A VENT, FOLLOWING A PROBLEM DURING SURGERY WITH THE DAVINCI ROBOT. WE LOVED THE SURGEON & MY HUSBAND WANTED TO ASSURE HIM THAT HE KNEW IT WASN'T THE SURGEON'S FAULT.¿ THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. 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: 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: 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 ABDOMINOPERINEAL EXCISION SURGICAL PROCEDURE, A SYNCHROSEAL INSTRUMENT PIVOT PIN WASHER DETACHED FROM THE INSTRUMENT AND FELL INSIDE THE PATIENT. IT WAS REPORTED THAT THE WASHER WAS RETAINED WITHIN THE PATIENT. IT WAS ALSO NOTED THAT THE SYNCHROSEAL INSTRUMENT¿S JAW COVER HAD A SPLIT/TEAR. 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 PIVOT PIN WASHER WAS PRESENT DURING INSTRUMENT INSPECTION AND AT THE BEGINNING OF THE PROCEDURE. THE REPORTED ISSUE OCCURRED DURING USE, BUT IT IS UNKNOWN WHAT EXACT SURGICAL TASK WAS BEING PERFORMED AT THE TIME OF THE REPORTED EVENT. THE SURGEON BELIEVED THAT THE CAUSE OF THE REPORTED ISSUE COULD HAVE BEEN A POTENTIAL CLASH WITH ANOTHER INSTRUMENT, HOWEVER THIS WAS NOT CONFIRMED TO BE THE CAUSE OF THE REPORTED EVENT. IT WAS ALSO INDICATED THAT IT IS UNKNOWN IF THE INSTRUMENT COLLIDED WITH ANOTHER INSTRUMENT OR OTHER HARD MATERIAL AT THE TIME OF THE REPORTED EVENT. THE SYNCHROSEAL INSTRUMENT WAS IN USE FOR OVER FOUR HOURS WHEN THE REPORTED USE OCCURRED. THE PIVOT PIN WASHER D