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 A TRANSLATIONAL ANDROLOGY AND UROLOGY ARTICLE TITLED, ¿ROBOT-ASSISTED LAPAROSCOPIC RETROPERITONEAL LEIOMYOSARCOMA RESECTION WITH INFERIOR VENA CAVA GRAFT REPLACEMENT: A CASE REPORT¿ (CHENG, G., RUAN, H., ET AL., 2021). WITHIN THE JOURNAL ARTICLE, OPERATIVE COMPLICATIONS INVOLVING DA VINCI SURGICAL PROCEDURES WERE NOTED: "OWING TO THE UNEXPOSED SIGHT OF RIGHT RENAL ARTERY, THE ACCIDENTAL INJURY OCCURRED INTRAOPERATIVELY AND THUS THE PATIENT SUFFERED FROM RIGHT RENAL INSUFFICIENCY WITH LOWER GFR RATE." ADDITIONAL INFORMATION OBTAINED FROM THE ARTICLE: THE ESTIMATED BLOOD LOSS DURING THE PROCEDURE WAS ABOUT 2,000 ML AND THE PATIENT WAS TRANSFUSED BLOOD PLASMA WITH 600 ML INTRAOPERATIVELY. THE PATIENT WAS GIVEN AN INFUSION OF HEPARIN (AN ANTICOAGULANT) INTRA-OPERATIVELY. MRI DONE AT 1 WEEK POST-OPERATIVELY SHOWED THAT THE CONTINUITY OF RIGHT RENAL ARTERY IMAGING WAS INTERRUPTED AND SIGNALING OF THE RIGHT KIDNEY WAS WEAKER THAN THE LEFT ONE, WHICH IMPLIED STRICTURE OF RIGHT RENAL ARTERY. DURING THE 3-MONTH FOLLOW-UP OF THE PATIENT, DYNAMIC RENOGRAPHY REVEALED THAT GFR OF THE RIGHT KIDNEY WAS SIGNIFICANTLY DECREASED TO 27.4 ML/MIN, WHICH IND

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: ON 08/29/2021, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A RETROSPECTIVE OBSERVATIONAL STUDY ARTICLE, VIA AN ISI CLINICAL JOURNAL REVIEW, FROM THE ¿JOURNAL OF ROBOTIC SURGERY¿, TITLED, ¿ROBOTIC ABDOMINAL WALL REPAIR: ADOPTION AND EARLY OUTCOMES IN A LARGE ACADEMIC MEDICAL CENTER¿ (PEREIRA, X., LIMA, D. L., ET AL., 2021). WITHIN THE JOURNAL ARTICLE, AN OPERATIVE COMPLICATION INVOLVING A ¿ROBOTIC-ASSISTED¿ PROCEDURE WAS NOTED. THE JOURNAL ARTICLE CITED, IN A ¿RETROSPECTIVE REVIEW OF ALL PATIENTS UNDERGOING ANY RAWR FROM JULY 1, 2016 TO MARCH 18, 2020¿, THAT DURING A ROBOTIC-ASSISTED ABDOMINAL WALL REPAIR (RAWR). THE JOURNAL ARTICLE CITED THAT THIS STUDY WAS CLASSIFIED BY SURGICAL MODALITY AS EITHER OPEN, LAPAROSCOPIC, OR ROBOTIC HERNIA REPAIR, OF 312 PATIENTS INCLUDED IN THE REVIEW, THERE WERE TWO REPORTED INTRAOPERATIVE EVENTS AND NINE OPERATIVE CONVERSIONS. 60 PATIENTS HAD AT LEAST ONE COMPLICATION AT 30 DAYS, AND THERE WAS ONE MAJOR INTRAOPERATIVE EVENT REQUIRING A DEVIATION OF THE PLANNED SURGERY AND PROLONGED ADMISSION. OF THE TWO ¿REPORTABLE INTRAOPERATIVE EVENTS: ONE REQUIRED A CHANGE IN THE INITIAL OPERATIVE PLAN AND HAD A HISTORY OF CIRRHOSIS AND CONTROLLED PORTAL HYPER

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: ON 08/28/2021, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A WORLD JOURNAL OF UROLOGY ARTICLE TITLED, ¿NEW TECHNIQUE OF ROBOT-ASSISTED LAPAROSCOPIC ARTIFICIAL URINARY SPHINCTER IMPLANTATION IN FEMALE BY A POSTERIOR APPROACH WITH INTRAOPERATIVE CYSTOSCOPIC MONITORING¿ (BROUDEUR, L., LOUBERSAC, T., ET AL., 2021). WITHIN THE JOURNAL ARTICLE, OPERATIVE COMPLICATIONS INVOLVING DA VINCI SURGICAL PROCEDURES WERE NOTED: "TWENTY-FOUR PATIENTS WERE INCLUDED, THE MEDIAN AGE WAS 66 YEARS, 23/24 (96%) HAD PREVIOUS STRESS URINARY INCONTINENCE (SUI) OR PROLAPSE SURGERY. TWO CONVERSIONS TO OPEN SURGERY DUE TO MAJOR PELVIC ADHESIONS AND POOR RESPIRATORY TOLERANCE TO PNEUMOPERITONEUM. 2 PATIENTS UNDERWENT MODIFICATIONS OF THE SURGICAL TECHNIQUE WITH ANTERIOR DISSECTION OF THE BLADDER NECK DUE TO MAJOR VESICOVAGINAL ADHESIONS. OVERALL, 20 PATIENTS UNDERWENT THE ROBOTIC POSTERIOR APPROACH. ELEVEN INTRAOPERATIVE COMPLICATIONS IN 10 PATIENTS (50%) OCCURRED, INCLUDING 7 BLADDER INJURIES , 4 VAGINAL INJURIES, WITHOUT THE NEED TO STOP THE PROCEDURE. THE MEDIAN HOSPITAL STAY WAS 3 DAYS (2¿7). ONE ARTIFICIAL URINARY SPHINCTER (AUS) WAS REMOVED AT 1 YEAR DUE TO VAGINAL EROSION." ISI MADE MULTIPLE FOLLOW-UP

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 BROKE AND THE INSTRUMENT TIP WAS MISSING. THE SITE WAS CONTINUING THE PROCEDURE AS PLANNED AT THAT TIME. INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE DA VINCI COORDINATOR AT THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ON (B)(6) 2021. THE FRAGMENT FROM THE HARMONIC ACE INSTRUMENT WAS RETRIEVED MANUALLY BY THE SURGEON AFTER THE PROCEDURE WAS COMPLETED. AN X-RAY WAS PERFORMED, BUT THERE WAS NO ADDITIONAL PROCEDURE REQUIRED TO RETRIEVE THE FRAGMENT. THE INSTRUMENT WAS IN USE FOR AN UNKNOWN AMOUNT OF TIME BEFORE THE ISSUE OCCURRED AND IT WAS UNKNOWN IF THE HARMONIC ACE WAS INSPECTED PRIOR TO USE. THERE WAS NO INSTRUMENT COLLISION AND THE INSTRUMENT WAS REMOVED THROUGH THE CANNULA WITH THE WRIST STRAIGHTENED. THE CAUSE OF THE INSTRUMENT BREAKAGE WAS NOT KNOWN. THERE WAS NO REPORT OF PATIENT INJURY AS A RESULT OF THE ISSUE. ALTHOUGH THE INSTRUMENT WAS REQUESTED TO BE RETURNED FOR ANALYSIS, THE CUSTOMER WAS UNSURE IF IT WOULD BE RETURNED. NO IMAGES OR PROCEDURE VIDEOS WERE AVAILABLE FOR REVIEW.

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 ORIGINALLY REPORTED THAT DURING A DA VINCI-ASSISTED OVARIAN CYSTECTOMY SURGICAL PROCEDURE, A MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS BENT TO THE LEFT AND COULD NOT BE REMOVED THROUGH THE CANNULA. THE MCS INSTRUMENT AND THE CANULA WERE REMOVED TOGETHER FROM THE PATIENT. UPON REMOVAL, IT WAS NOTED THAT FRAGMENTS FROM THE MCS TIP COVER ACCESSORY WERE MISSING AND HAD FALLEN INSIDE THE PATIENT. THE SURGEON LOCATED AND RETRIEVED TWO FRAGMENTS, BUT THEY DID NOT EQUAL THE SIZE OF THE PIECE THAT WAS MISSING FROM THE MCS TIP COVER ACCESSORY. THE LOCATION OF THE MISSING FRAGMENT(S) WAS UNKNOWN. ON 30-SEPTEMBER-2021, ISI CONTACTED THE ROBOTICS COORDINATOR (THE ORIGINAL REPORTER) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ABOUT THE EVENT. THE MCS INSTRUMENT AND THE MCS TIP COVER ACCESSORY WERE INSPECTED BEFORE THE PROCEDURE AND THERE WAS NOTHING NOTED OUT OF THE ORDINARY. SHE DID NOT KNOW WHAT CAUSED THE MCS TO BE DAMAGED AND DID NOT KNOW IF THERE WAS AN INSTRUMENT COLLISION. A ROBOTIC INSTRUMENT OF AN UNKNOWN TYPE WAS USED TO RETRIEVE THE FRAGMENTS. THEY DID AN X-RAY, BUT NO FRAGMENTS WERE VISIBLE. NO ADDITIONAL PROCEDURES WERE REQUIRED TO REMOVE FRAGMENTS. SHE IS NOT AWAR

ROSA Robotic Surgery — 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 ROBOTIC ASSISTED TOTAL KNEE ARTHROPLASTY THE PATIENT EXPERIENCED APPROXIMATELY 1-2MM OF FEMORAL NOTCHING. THERE WAS NO ADDITIONAL PATIENT IMPACT REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN 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 THAT AFTER COMPLETION OF A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY PROCEDURE, A PATIENT HAD REACHED OUT TO THE SURGEON; STATING A POST-OPERATIVE ¿BURN ON HIS UMBILICUS¿ WAS IDENTIFIED. PHOTOGRAPHS OF THE AFFECTED AREA WERE SUPPLIED TO THE SURGEON BY THE PATIENT. THE IMAGES DEPICTED A ¿PRESSURE ULCER,¿ WHICH THE SURGEON INDICATED WERE FROM A 3RD PARTY 12MM DISPOSABLE CANNULA DURING THE COURSE OF THE PROCEDURE, THE CANNULA MAY HAVE BEEN RUBBING UP AGAINST THE PATIENT POSSIBLY CAUSING THE ULCER. THE SURGEON BELIEVES THAT THE PRESSURE OF THE INDIVIDUAL AND THE CANNULA MAY HAVE CAUSED THIS. THE INITIAL DA VINCI PROCEDURE WAS COMPLETED WITH NO KNOWN OR REPORTED INJURY. ON (B)(6) 2021, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE CONSOLE SURGEON: THE SURGEON STATED THAT, ¿BELOW THE UMBILICUS IS JUST THE CLOSED PORT SITE WITH STERI-STRIPS AND DRIED BLOOD,¿ AND THAT ¿THE CRESCENT SHAPED RED AREAS¿ ABOVE THE UMBILICUS IS WHERE THE ARM PROBABLY PUSHED DOWN AND CAUSED THE PRESSURE ON A ¿DISPOSABLE 10/12 THIRD PARTY TROCAR BY ETHICON.¿ THE SURGEON SAID THAT IT APPEARS TO BE AN ABDOMINAL ¿P

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) 2021, INTUITIVE SURGICAL, INC (ISI) RECEIVED FDA VOLUNTARY REPORT #MW5105057 WITH THE FOLLOWING EVENT DESCRIPTION: "HAD A ROBOTIC RECTOPEXY AT (B)(6) HOSPITAL. UPON DISCHARGE ON (B)(6) 2021 I CHANGED THE DRESSING AT THE OPERATIVE SITE AND NOTICED A ¿HOLE¿ OR POSSIBLE BURNED TISSUE WHICH I REPORTED TO MY PHYSICIAN ON (B)(6) 2021, AND (B)(6) 2021. SINCE HE DID SEE THE WOUNDS POST OP. HE WAS PUZZLED AND HAS REFERRED ME TO THE WOULD CARE CLINIC. I BELIEVE THE HOSPITAL USED THE DA VINCI ROBOTIC SYSTEM AS OF 2013 OR 2014. ALTHOUGH THIS IS A RARE OCCURRENCE (MY PHYSICIAN HAS DONE OVER 400 PROCEDURES), I UNDERSTAND THAT HEAT RELATED INJURIES CAN HAPPEN WHEN SPARKS COME FROM MICROSCOPIC ¿CRACKS¿ THAT MAY / MAY NOT BE SEEN FROM THE CAMERA¿S FIELD OF VISION." THE MEDWATCH REPORT WAS LABELED WITH THE "TYPE OF EVENT" AS "SERIOUS INJURY¿ AND "OUTCOMES ATTRIBUTED TO ADVERSE EVENT" AS "REQUIRED INTERVENTION." IN ADDITION, THE INITIAL REPORTER (A PATIENT) ELECTED TO NOT BE IDENTIFIED. THEREFORE, NO CONTACT 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 THAT DURING A DA VINCI-ASSISTED DISTAL PANCREATECTOMY SURGICAL PROCEDURE, THE CUSTOMER NOTED THAT THE CURVED BLADE OF THE HARMONIC ACE INSTRUMENT WAS BROKEN. THE ETHICON GENERATOR SCREEN DISPLAYED A MESSAGE INDICATING A HIGH PRESSURE BETWEEN THE ULTRASOUND KNIFE BLADES. THE SURGICAL STAFF REMOVED THE HARMONIC ACE INSTRUMENT TO CLEAN THE BLADES AND PUT IT BACK INTO THE SURGICAL FIELD TO USE; HOWEVER, THE HARMONIC ACE INSTRUMENT BLADE WAS FOUND TO BE BROKEN AFTER ONE MINUTE OF USE. THE CUSTOMER REPLACED THE HARMONIC ACE INSTRUMENT WITH A BACK-UP INSTRUMENT OF THE SAME KIND AND COMPLETED THE PROCEDURE WITH NO REPORTED INJURY. ON 29-SEP-2021, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION FROM THE CLINICAL SALES REPRESENTATIVE (CSR) REGARDING THE REPORTED EVENT: THE HARMONIC ACE INSTRUMENT WAS REPORTEDLY INSPECTED PRIOR TO USE, AND NO ISSUES WERE NOTED. THE SURGEON WAS PERFORMING TISSUE DISSOCIATION AT THE TIME OF THE EVENT. THE HARMONIC ACE INSTRUMENT DID NOT MAKE CONTACT WITH ANY OTHER INSTRUMENT OR HARD MATERIAL DURING THE PROCEDURE. A FRAGMENT FROM THE HARMONIC ACE INSTRUMENT FELL INSIDE THE PATIENT AND WAS RETRIEVED DURING THE SAME PRO

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: (B)(6) (HEREAFTER REFERRED TO AS THE SUBJECT) IS A 76-YEAR-OLD WHITE MALE WITH BMI 27.35 AND ASA CLASSIFICATION III, NON-SMOKER WITH A MEDICAL HISTORY OF CHRONIC KIDNEY DISEASE (STAGE 3), ESSENTIAL HYPERTENSION (ON TREATMENT WITH AMLODIPINE AND CARVEDILOL), RHEUMATOID ARTHRITIS, ATRIAL FIBRILLATION, ARRYTHMIA (ON ELIQUIS, STOPPED THREE DAYS PRIOR TO THE LAR PROCEDURE), DIABETES MELLITUS, MYOCARDIAL INFARCTION (1968), SLEEP APNEA AND COMPLETE HEARING LOSS IN THE LEFT EAR. HE ALSO HAS A SURGICAL HISTORY OF RIGHT KNEE JOINT REPLACEMENT IN 2013 AND ROTATOR CUFF REPAIR IN 2018. HE HAS BEEN VACCINATED FOR COVID-19 IN (B)(6) 2021. THE SUBJECT HAD A HISTORY OF DIARRHEA OVER SEVERAL MONTHS LEADING TO HOSPITALIZATION WITH HYPOTENSION AND DEHYDRATION. HE WAS SUBSEQUENTLY DIAGNOSED WITH A RECTAL MASS ON FLEXIBLE SIGMOIDOSCOPY PERFORMED ON (B)(6) 2021. ON (B)(6) 2021, THE SUBJECT MET ALL STUDY ELIGIBILITY CRITERIA AND SIGNED THE INFORMED CONSENT. ON (B)(6) 2021, THE SUBJECT UNDERWENT ROBOT-ASSISTED LOW ANTERIOR COLON RESECTION AND PRIMARY COLORECTAL ANASTOMOSIS PROCEDURE USING THE DA VINCI SP SURGICAL SYSTEM. AFTER GAINING ACCESS AND INTRODUCING THE SINGLE PORT DEVICE, A 12 MM ACCESSORY PORT WA

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 SLEEVE GASTRECTOMY SURGICAL PROCEDURE, A METAL PIECE CAME OUT OF THE SYNCHROSEAL INSTRUMENT AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE. THE CUSTOMER REPLACED THE SYNCHROSEAL INSTRUMENT WITH A BACK-UP INSTRUMENT OF THE SAME KIND AND COMPLETED THE PROCEDURE 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.

ROSA Robotic Surgery — 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 ROBOTIC ASSISTED TOTAL KNEE ARTHROPLASTY THERE WAS A DISCREPANCY BETWEEN THE PLANNED AND VALIDATED RIGHT FEMORAL CUTS. THE PROCEDURE WAS DELAYED APPROXIMATELY 25 MINUTES. NO ADDITIONAL PATIENT IMPACT 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 DURING A DA VINCI-ASSISTED RADICAL CYSTECTOMY WITH NEOBLADDER SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY FELL OFF INSIDE THE PATIENT AND WAS LATER RETRIEVED FROM AN ASSISTANT PORT. THE CUSTOMER DID NOT KNOW WHAT CAUSED THE ITEM TO FALL OFF. THERE WAS NO INSTRUMENT COLLISION OR BENT TIPS. THE CUSTOMER INSPECTED THE MCS TIP COVER ACCESSORY AND NOTED IT WAS DAMAGED. 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 MCS INSTRUMENT AND THE MCS TIP COVER ACCESSORY WERE INSPECTED PRIOR TO USE. THERE WAS NO DAMAGE OR ANYTHING OUT OF THE ORDINARY NOTED. THE MCS TIP COVER ACCESSORY WAS RETRIEVED. THE CUSTOMER REPLACED THE INSTRUMENT TO CONTINUE. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE MCS INSTRUMENT DURING THE SURGICAL PROCEDURE. NO INSTRUMENT COLLISION WAS NOTED. THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON THE REMOVAL OF THE MCS INSTRUMENT THROUGH THE CANNULA. THE INSTRUMENT WRIST WAS STRAIGHTENED UPON REMOVAL. THE SURGICAL STAFF NOTICED THE MCS TIP COVER ACCESSORY WAS TORN AFT

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 SCREW WAS MISPLACED AT LS1 AND RIGHT S1, RESULTING IN A DURAL TEAR, WHICH WAS REPAIRED INTRA-OPERATIVELY.

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, PATIENT EXPERIENCED A PNEUMOTHORAX. THE PNEUMOTHORAX WAS DISCOVERED DURING POST-OP CHECK VIA A CHEST X-RAY. THE LOCATION OF THE TARGET AND PNEUMOTHORAX WAS RIGHT MIDDLE LOBE. A CHEST TUBE WAS PLACED, AND PATIENT WAS HOSPITALIZED FOR OBSERVATION. THE CHEST TUBE WAS REMOVED ON 8/11/21 AND THE PATIENT WAS DISCHARGED.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE LEFT T3 TRAJECTORY WAS MEDIAL BY LESS THAN 3.5 MM DURING AN OPEN T3 - L2 PROCEDURE. THE SURGEON PLANNED THE CASE WITH THE MANUFACTURER REPRESENTATIVE PRIOR TO THE CASE. A DUAL CLAMP WAS USED TO MOUNT THE SURGICAL SYSTEM TO THE PATIENT. REGISTRATION WAS COMPLETED SUCCESSFULLY AND NO SHIFTS WERE NOTICED. THE SURGEON STARTED THE CASE AT L2 AND ALL SCREWS WERE PLACED ACCURATELY PRIOR TO REACHING RIGHT T3. MULTIPLE ADJUSTMENTS WERE MADE ON THE RIGHT SIDE DUE TO DUAL-CLAMP INTERFERENCE WITH THE PLANNED TRAJECTORIES. NAVIGATION WAS USED AND CHECKED REGULARLY DURING THE CASE. THE SURGEON CHECKED INSTRUMENTS ON THE ARM GUIDE AND PATIENT ANATOMY. WHEN THE SURGEON WAS DRILLING THE RIGHT T3 SCREW, THEY NOTICED CSF FLUID AND THE DRILL HAD BREACHED IN THE MEDIAL DIRECTION. NO SCREW WAS PLACED. NAVIGATION WAS CHECKED PRIOR TO DRILLING T3 DUE TO POSSIBLE SOFT TISSUE PRESSURE AT THE TOP OF THE INCISION. THE PATIENT EXPERIENCED TEMPORARY LOSS OF MOTOR FUNCTION ON THE RIGHT SIDE. THE SURGEON ABORTED THE USE OF THE GUIDANCE SYSTEM, REMEDIED THE CSF LEAK, REPAIRED THE DURA, AND THEN

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, WHILE CUTTING TISSUE, THE CUSTOMER FOUND THE TIP OF THE WHITE PAD OF THE HARMONIC ACE INSTRUMENT HAD FALLEN OFF OF THE INSTRUMENT AND INTO THE PATIENT. THE INSTRUMENT WAS REMOVED RIGHT AWAY. A DIFFERENT BACKUP DA VINCI INSTRUMENT WAS USED TO CONTINUE, AND THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO DAMAGE OBSERVED. THE INSTRUMENT WAS IN USE FOR ABOUT 30 MINUTES AND BROKE WHILE IT WAS BEING USED FOR DISSECTING TISSUE. ALL THE FRAGMENTS WERE RETRIEVED DURING THE SAME PROCEDURE AND CONFIRMED WITH VISUAL INSPECTION. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED. IT WAS UNKNOWN WHAT CAUSED THE BREAKAGE TO OCCUR 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 FRAGMENTS DID NOT FALL INSIDE THE PATIENT DURING AN INSTRUMENT TIP OR ACCESSORY COLLISION. THE INSTRUMENT WAS NOT REMOVED 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE CUSTOMER OBSERVED THE SCISSORS TIP/SLEEVE COVER FELL OFF INTRAOPERATIVELY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ON (B)(6) 2021. THE CHARGE NURSE REPORTED THEY SHE WAS NOT PRESENT DURING THE REPORTED ISSUE; HOWEVER, WAS CALLED INTO THE ROOM AFTER THE ISSUE OCCURRED AND ASSISTED THE STAFF. THE CHARGE NURSE INFORMED THAT THE MONOPOLAR CURVED SCISSOR (MCS) INSTRUMENT AND MCS TIP COVER ACCESSORY WERE INSPECTED PRIOR TO USE. THE INSTALLATION TOOL WAS USED AND NO ORANGE SURFACE WAS VISIBLE AFTER THE MCS TIP COVER ACCESSORY WAS INSTALLED. THE STAFF INFORMED THE CHARGE NURSE THAT DURING THE CASE, THEY HAD OBSERVED THE MCS TIP COVER ACCESSORY STARTING TO SLIDE OFF AND DECIDED TO REMOVE THE INSTRUMENT. HOWEVER, AT THE MOMENT THEY REMOVED THE INSTRUMENT THROUGH THE TROCAR, THE MCS TIP COVER ACCESSORY FELL OFF AND INTO THE PATIENT. IT WAS NOTED THE PROCEDURE HAD BEEN IN PROGRESS FOR ABOUT FIVE HOURS. IT WAS UNKNOWN IF ANY LUBRICANT WAS USED PRIOR TO THE MCS TIP COVER ACCE

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 REPRESENTATIVE FROM (B)(6) THAT DRILLING AT L4 TRAJECTORY CAUSED EXCESSIVE BLEEDING TO PATIENT THAT WAS FIXED INTRAOPERATIVELY.

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 PIECE OF PLASTIC FROM A SYNCHROSEAL INSTRUMENT FELL INSIDE THE PATIENT AND WAS RETRIEVED IN THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ROBOTICS COORDINATOR AT THE SITE ON 09-AUG-2021 AND OBTAINED THE FOLLOWING INFORMATION: BOTH THE FRAGMENT AND THE INSTRUMENT WILL BE RETURNED TO ISI. THEY RETRIEVED THE FRAGMENT WITH A LAPAROSCOPIC INSTRUMENT. SHE ESTIMATED THE INSTRUMENT WAS IN USE FOR 2 MINUTES BEFORE IT BROKE. NO POST-OPERATIVE TESTS WERE PERFORMED AND THERE HAVE BEEN NO REPORTS OF ANY COMPLICATIONS TO THE PATIENT POST-PROCEDURE. THE SURGEON DOES NOT KNOW WHAT CAUSED THE INSTRUMENT TO BREAK. THE INSTRUMENT JUST FINISHED SEALING AND CUTTING TISSUE WHEN A PIECE OF PLASTIC FELL OFF THE SYNCROSEAL INSTRUMENT. THE INSTRUMENT DID NOT COLLIDE WITH ANOTHER INSTRUMENT OR WITH ANY HARD OBJECT. THE ROBOTICS COORDINATOR DID NOT WANT TO SHARE ANY PATIENT 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 SLEEVE GASTRECTOMY SURGICAL PROCEDURE, A ¿SMALL RIVET¿ FROM THE SYNCHROSEAL INSTRUMENT FELL INTO THE PATIENT. THE BROKEN PIECE WAS RETRIEVED DURING THE SAME PROCEDURE AND THE SURGEON DISCONTINUED USING THE INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO INJURY TO THE PATIENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION ON 28-JULY-2021. THE INSTRUMENT WAS NOT INSPECTED PRIOR TO USE. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT. THE INSTRUMENT WAS USED FOR APPROXIMATELY 10 MINUTES. THE SURGEON WAS DISSECTING BY THE HIATUS WHEN THE INSTRUMENT BROKE. THE BROKEN FRAGMENT WAS RETRIEVED BY USING A LAPAROSCOPIC GRASPER. ALL FRAGMENTS WERE RETRIEVED AND IT WAS CONFIRMED VISUALLY. NO POST-OPERATIVE TESTS WERE PERFORMED.

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 DURING THE POST-OP CHEST X-RAY. THE LOCATION OF THE TARGET WAS RIGHT UPPER LOBE. A CHEST TUBE WAS PLACED, AND PATIENT WAS HOSPITALIZED. THE CHEST TUBE WAS REMOVED, AND THE PATIENT WAS DISCHARGED ON (B)(60 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.

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 SCREW WAS MISPLACED AT THE LEFT L5 DUE TO PATIENT MOVEMENT RESULTING IN A DURAL TEAR, WHICH WAS REPAIRED INTRA-OPERATIVELY.

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, PATIENT EXPERIENCED A PNEUMOTHORAX. THE BIOPSY OF A LESION IN THE RIGHT MIDDLE LOBE. THE LOCATION OF THE PNEUMOTHORAX WAS RIGHT SIDE. A CHEST TUBE WAS PLACED TO TREAT THE PNEUMOTHORAX. THE PATIENT WAS RELEASED THE SAME DAY.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT TWO WEEKS AFTER AN L3-L5 PROCEDURE, THE PATIENT EXPERIENCED FOOT DROP SYMPTOMS. AFTER IMAGING, THE RIGHT L4 SCREW WAS FOUND TO BE MEDIAL BY 4-5 MM. THE MANUFACTURER REPRESENTATIVE STATED THAT THE PATIENT HAD HIGH BMI AND THERE WAS SOFT TISSUE PRESSURE ON THE TOOLS DURING THE PROCEDURE. THERE WAS NO SKIVE POTENTIAL IN THE PLANNING FOR THE TRAJECTORIES. A REVISION PROCEDURE TO REPOSITION THE SCREW USING NAVIGATION WAS PLANNED. THERE WAS NO DELAY TO 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: INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A CUREUS JOURNAL ARTICLE TITLED, ¿USE OF BARIATRIC PORTS IN 4-ARM ROBOTIC PARTIAL NEPHRECTOMY: A COMPARATIVE STUDY WITH THE STANDARD 3-ARM TECHNIQUE¿ (EL-ASMAR, J. M., SEBAALY, R., ET AL., 2021). WITHIN THE JOURNAL ARTICLE, POST-OPERATIVE COMPLICATIONS INVOLVING A DA VINCI SURGICAL PROCEDURE WERE NOTED: "TWO PATIENTS REQUIRED POSTOPERATIVE SELECTIVE ARTERIAL EMBOLIZATION FOR POSTOPERATIVE BLEEDING/ HEMATOMA." ISI CONTACTED THE AUTHOR CORRESPONDENCE WHO CONFIRMED THAT THESE CASES WERE PERFORMED IN THEIR CENTER. THE AUTHOR CORRESPONDENCE INDICATED THAT NONE OF THE COMPLICATIONS IN QUESTION WERE DUE TO A SYSTEM MALFUNCTION AND "THESE OCCURRENCES ARE EXPECTED COMPLICATIONS AFTER PARTIAL NEPHRECTOMY AND ARE INHERENT TO THIS TYPE OF SURGERY WHATEVER THE APPROACH OPEN, LAPAROSCOPIC OR ROBOTIC."

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 IN USE FOR 30 MINUTES AND A FRAGMENT FROM THE TEFLON PAD WAS FOUND TO BE MISSING. THE CUSTOMER STATED THAT THE WHITE FRAGMENTS FELL INSIDE THE PATIENT WHEN ACTIVATING THE ENERGY. A SIMILAR BACKUP DA VINCI INSTRUMENT WAS USED TO CONTINUE. 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 INSPECTED PRIOR TO USE WITH NO DAMAGE OBSERVED. THE INSTRUMENT WAS IN USE FOR ABOUT 30 MINUTES AND BROKE WHILE IT WAS BEING USED FOR DISSECTING TISSUE. ALL THE FRAGMENTS WERE RETRIEVED DURING THE SAME PROCEDURE AND CONFIRMED WITH VISUAL INSPECTION. THE SURGEON BELIEVED THE WHITE PART OF THE TIP MELTED WHEN ENERGY WAS ACTIVATED. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT. THE INSTRUMENT DID NOT COLLIDE WITH ANY HARD MATERIALS OR OTHER INSTRUMENTS. THE INSTRUMENT WAS NOT REMOVED DURING THE PROCEDURE (PRIOR TO THE BREAKAGE)

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 SURGICAL PROCEDURE, A PIECE OF THE WHITE MATERIAL, REPORTED TO BE ABOUT 0.5 MM WAS MISSING FROM INSIDE THE JAW OF THE SYNCHROSEAL. THE SURGEON REPORTEDLY DECIDED TO CONTINUE USING THE PRODUCT, AND FELT THAT SINCE THE MISSING PART WAS VERY SMALL THAT THEY WOULD NOT BE ABLE TO FIND THE MISSING PART. IT WAS UNKNOWN WHETHER THE MISSING FRAGMENT HAD FALLEN INSIDE THE PATIENT OR ELSEWHERE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ON 27-JULY-2021: IT WAS UNKNOWN IF ANY FRAGMENT FELL INSIDE THE PATIENT AND UNKNOWN IF ANY FRAGMENT WAS RETRIEVED. NO POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRASOUND WAS PERFORMED TO CHECK FOR RETAINED FRAGMENTS. THE PROCEDURE HAD BEEN IN PROCESS FOR 4 HOURS AND THE SYNCHROSEAL INSTRUMENT WAS IN USE FOR ABOUT 20 MINUTES. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGE WAS FOUND. THE SURGEON DID NOT NOTICE ANY ISSUE WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE. THE SURGEON DOES NOT KNOW WHAT CAUSED THE ISSUE TO OCCUR. IT WAS UNKNO

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PROGRASP INSTRUMENT HAD A FRACTURED WIRE IN ITS CABLE SYSTEM. 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.

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) 2021, THE SUBJECT (B)(6) UNDERWENT ROBOTIC-ASSISTED LOWER ANTERIOR RESECTION WITH HANDSEWN COLO-ANAL ANASTOMOSIS USING THE DA VINCI SP SURGICAL SYSTEM WITH DIVERTING LOOP ILEOSTOMY. AFTER DOCKING THE SP ROBOT, A SECONDARY PORT FOR THE STAPLING DEVICE WAS UTILIZED IN THE RIGHT LOWER QUADRANT. IT WAS NOTED THAT THE PROCEDURE WAS SUBSTANTIALLY MORE DIFFICULT BECAUSE OF SIGNIFICANT DIFFICULTY WITH MOBILIZING AND IDENTIFYING ANATOMICAL STRUCTURES DUE TO THE ALTERED SURGICAL FIELD SECONDARY TO INFLAMMATION AND TISSUE FRIABILITY LIKELY DUE TO HIS PREVIOUS HEMATOLOGICAL MALIGNANCY AND CURRENT THERAPY. THE TUMOR WAS LOCATED WITHIN A FINGER BREADTH OF THE ANAL CANAL AND DISSECTION AROUND THIS TUMOR NECESSITATED HANDSEWN COLO-ANAL ANASTOMOSIS WHICH WAS DONE WITH A STANDARD MUCOSECTOMY. THE SPECIMEN WAS DELIVERED THROUGH THE ANAL CANAL AND THEN SEWN TO THE DESCENDING COLON WITH VICRYL SUTURES. THE ANASTOMOSIS WAS EVALUATED AND FOUND TO BE VIABLE. A SINGLE DRAIN WAS LEFT IN THE DEEP PELVIS. THE TERMINAL ILEUM WAS IDENTIFIED AND BROUGHT OUT OF THE ILEOSTOMY SITE. CLOSURE OF THE SITE WAS COMPLETED. THE SUBJECT DID NOT EXPERIENCE ANY INTRAOPERATIVE COMPLICATIONS, AND THERE WAS NO CONVERS

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT FLUORO IMAGES WERE TAKEN DURING THE PROCEDURE AND THE SURGEON CONFIRMED ACCURACY. NO PROBLEMS WERE EXPERIENCED DURING THE INITIAL PROCEDURE. THE CAUSE OF THE DEVIATION WAS DETERMINED TO BE A MEDIAL SKIVE POTENTIAL AND A DRILL BIT TAKING THE PATH OF LEAST RESISTANCE DOWN THE JOINT. THE PATIENT EXPERIENCED FOOT DROP AFTER 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE TIP OF THE SYNCHROSEAL INSTRUMENT FELL INSIDE THE PATIENT. THROUGH FOLLOW UP, IT WAS CONFIRMED THAT THE SURGEON WAS ABLE TO RETRIEVE ALL OF THE BROKEN FRAGMENTS DURING THE SAME PROCEDURE, THERE WERE NO INSTRUMENT COLLISIONS, AND THE PATIENT HAS NOT RETURNED WITH ANY POST-OPERATIVE COMPLICATIONS.

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, PATIENT EXPERIENCED A PNEUMOTHORAX. THE PNEUMOTHORAX WAS DISCOVERED DURING POST-OP CHECK VIA A CHEST X-RAY. THE LOCATION OF THE TARGET AND PNEUMOTHORAX WAS LEFT LOWER LOBE. THE PNEUMOTHORAX WAS A 30-40%. A CHEST TUBE WAS PLACED AND THE PATIENT WAS RELEASED THE SAME 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: SUBJECT 600-02 (HEREAFTER REFERRED TO AS THE SUBJECT) UNDERWENT ROBOTIC-ASSISTED LOWER ANTERIOR RESECTION WITH THE DA VINCI SP SURGICAL SYSTEM ON (B)(6) 2021. ON (B)(6) 2021, THE SUBJECT MET ALL STUDY ELIGIBILITY CRITERIA AND SIGNED THE INFORMED CONSENT. THE SP SYSTEM WAS DOCKED AFTER CREATION OF THE SP PORT AND THE ILEOSTOMY PORT. ONCE THE RECTUM WAS TRANSECTED WITH THE LAPAROSCOPIC STAPLER, THE SPECIMEN WAS DELIVERED THROUGH THE WOUND PROTECTING DEVICE IN THE SP PORT. THIS WAS THEN RESECTED AND A PROLENE PURSE STRING WAS UTILIZED TO ENTER THE ANVIL INTO THE DESCENDING COLON. AFTER THIS WAS SECURED AND REPLACED BACK INTO THE ABDOMEN, THE ABDOMEN WAS REINSUFFLATED WITH THE SP ROBOTIC DEVICE AND THE ANASTOMOSIS WAS CREATED. PROCTOSCOPIC AND FINGER EXAMINATION OF THE ANASTOMOSIS REVEALED THIS TO BE INTACT. A SECTION OF THE TERMINAL ILEUM WAS IDENTIFIED NEAR THE CECUM FOR THE DIVERTING LOOP ILEOSTOMY WHICH WAS PULLED THROUGH THE ILEOSTOMY SITE. THE SP PORT WAS REMOVED, THE SITE WAS THEN CLOSED, NO DRAINS WERE PLACED. THE ILEOSTOMY WAS THEN CREATED. THE SUBJECT DID NOT EXPERIENCE ANY INTRAOPERATIVE COMPLICATIONS, AND THERE WAS NO CONVERSION TO OPEN SURGERY, ROBOTIC MULTIPORT OR LAPAROS

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 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. THE PROCEDURE WAS COMPLETED WITH A BACKUP DA VINCI INSTRUMENT OF THE SAME KIND, AND THERE WAS NO REPORTED INJURY. ON 15-JULY-2021, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISI CLINICAL SALES REPRESENTATIVE (CSR) CLARIFIED THAT THE PROMPT INDICATING EXCESS PRESSURE ON THE HARMONIC ACE INSTRUMENT DISPLAYED AFTER ONE HOUR, DURING THE PROCEDURE. THERE WAS NO ALLEGATION THAT THE INSTRUMENT CAUSED OR CONTRIBUTED TO THE BLEEDING. THE BLEEDING WAS COMING FROM THE LIVER TISSUE. THERE WAS APPROXIMATELY LESS THAN 800ML OF BLOOD LOSS. NO INFORMATION WAS PROVIDED REGARDING THE CAUSE OF THE BLEEDING. THE CUSTOMER HAD TO ADMINISTER OR TRANSFUSE 400ML OF BLOOD. NO INFORMATION WAS PROVIDED REGARDING IF THE PATIENT HAD RETURNED TO THE HOSPITAL DUE TO POST

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 SURGEON FOUND THE MONOPOLAR SCISSOR TIP WAS MISSING. THE CALLER FORWARDED A PICTURE SHOWING THAT THE TIP AND THE COUPLER WERE MISSING FROM THE MONOPOLAR SCISSOR. AT THE TIME OF THE CALL THE STAFF WAS UNABLE TO LOCATE THE COUPLER. THE STAFF REPLACED THE MONOPOLAR SCISSOR TIP AND WERE PROCEEDING WITH THE PROCEDURE. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICES ENGINEER (TSE) EXPLAINED THE COUPLER IS RADIOLUCENT. THE REPORTER EXPLAINED SHE WOULD FOLLOW UP WITH ANY FURTHER DETAILS AS SHE RECEIVED THEM. THE TSE RECOMMENDED THE STAFF RMA THE MISSING MONOPOLAR SCISSOR TIP FOR FAILURE ANALYSIS. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. ISI CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING INFORMATION ON 01-JULY-2021: THIS WAS A MONOPOLAR SCISSOR TIP SINGLE PORT (SP) INSTRUMENT SO IT WAS THE PLASTIC PORTION THAT GOES OVER THE SCREWS AND THE ACTUAL TIP THAT FELL IN THE PATIENT. THE PIECES WAS RETRIEVED AT THE END OF THE PROCEDURE. WE HAVE REQUESTED TO SEND BACK THE INSTRUMENT AND THE BROKEN PIECES BACK TO ISI. SHE WAS NOT IN THE PROCEDURE, BUT SAID THE ROBOTICS

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: I HAD WHAT WAS SUPPOSED TO BE A ROUTINE GALLBLADDER REMOVAL. I SPENT THREE DAYS IN AN (B)(6) HOSPITAL, WENT HOME FOR TWO DAYS, AND SPENT AN ADDITIONAL TWO DAYS IN ANOTHER (B)(6) HOSPITAL. I EXPERIENCED BLEEDING AT A WOUND SITE (POST-SURGERY) THAT REQUIRED THREE BLOODIED DRESSING CHANGES AND SUTURING AT THE BLEEDING WOUND SITE. I WAS RELEASED FOR THE FIRST HOSPITAL, WITH A FOLEY BAG THAT WAS INSERTED ON FOUR DIFFERENT OCCASIONS, BUT NEVER SAW A UROLOGIST IN THE HOSPITAL. THE DAY AFTER DISCHARGE, I BEGAN TO BLEED, ONCE AGAIN, AT THE SUTURED WOUND SITE. I WENT TO THE LOCAL (B)(6) EMERGENCY TO HAVE THE WOUND CLEANED AND REDRESSED. TWO DAYS LATER, I CALLED A UROLOGY OFFICE NOTED IN MY DISCHARGE INSTRUCTIONS AND WAS TOLD THEY COULD NOT SEE ME FOR TWO WEEKS. I WENT BACK TO THE LOCAL (B)(6) EMERGENCY ROOM TO HAVE THE CATHETER REMOVED. THEY PERFORMED ADDITIONAL TESTS AND SAID I WAS BLEEDING INTERNALLY AND HAD POCKETS OF BLOOD IN THREE LOCATIONS IN MY ABDOMEN AND RUSHED ME TO A DIFFERENT (B)(6). A PHYSICIAN, WHO IDENTIFIED HIMSELF AS PART OF THE SURGICAL TEAM, SAID HE WANTED ME TO STAY IN THE HOSPITAL, OVERNIGHT, TO MONITOR MY HEMOGLOBIN LEVEL. I ASKED THE "SURGICAL TEAM" PHYSICIAN TO ARRANG

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED BY SALE REP THAT THERE WAS AN ACCIDENT IN MAKO TKA CASE AT SIPH ((B)(6) 2021 ) WHICH SURGEONS OF THIS CASE FOUND SOME FRACTURE OF POSTERIOR CONDYLE OF FEMUR AFTER DONE IN EVERY STEP OF BONE CUT AFFECTED TO FEMUR PROSTHESIS WHICH CAN NOT PLACE IN THERE. IT MAY BE OCCURRED FROM SOFT BONE OR TOO BIG HOUSING CUTTING BLOCK FOR SIZE 2 OF FEMUR PROSTHESIS. SO THEY ASK FOR CONSTRAIN PROSTHESIS WITH STEM TO USE REPLACED BUT WE HAVEN¿T PREPARE WITH THIS CASE BECAUSE THIS IS PRIMARY CASE. HOWEVER SURGEONS ASK FOR SUPPORT FROM ZIMMER COMPANY AND THE OPERATION WAS COMPLETELY DONE. SURGICAL DELAY 2 HOURS