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: 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.

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.

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.

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

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.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DR...PERFORMED AN I&D WITH TIBIAL INSERT EXCHANGE DUE TO POSSIBLE INFECTION OF A LEFT MEDIAL UNI.

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

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: SPINAL FUSION COMPLETED USING MAZOR ROBOT. SCREWS WERE PLACED PER DIRECTION OF MAZOR ROBOT. AFTER SURGERY, PT FOUND TO HAVE MALPOSITIONED SCREWS RESULTING IN PT 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NEPHRECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY CAME OFF THE MCS INSTRUMENT. IT WAS NOTED THAT THEY "FLIPPED BETWEEN ROBOT TO OPEN TO LAP SEVERAL TIMES" FOR THE PROCEDURE AND THAT DURING ONE OF THE TRANSITIONS THEY NOTICED THAT THE MCS TIP COVER ACCESSORY WAS MISSING. THE CUSTOMER WAS ASKING IF THE ITEM WAS DETECTABLE VIA X-RAY OR CT SCAN. THE CUSTOMER LATER FOLLOWED UP TO LET US KNOW THAT THE MCS TIP COVER ACCESSORY WAS RETRIEVED DURING THE SAME PROCEDURE, AND THAT THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) PERFORMED FOLLOW-UP ON 21-JUNE-2021. THE CUSTOMER WAS UNABLE TO SPECIFY AT WHAT POINT THE MCS TIP COVER ACCESSORY HAD FALLEN OFF OF THE INSTRUMENT. NO FURTHER DETAILS WERE AVAILABLE.

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 A PATIENT WITH A HISTORY OF LUPUS AND A RECENT BRONCHOSCOPY FOR A BIOPSY OF THE LEFT LUNG NODULE RETURNED TO THE HOSPITAL THE FOLLOWING MORNING FOR PAIN IN THE LEFT CHEST AND REQUESTED A CHEST X-RAY FOR FURTHER EVALUATION. THE PATIENT DENIES SHORTNESS OF BREATH BUT REPORTS INCREASED PAIN WITH DEEP BREATHING. THE PATIENT DID HAVE A POST PROCEDURE X-RAY DONE FOLLOWING THE PROCEDURE WHICH SHOWED NO PNEUMOTHORAX. THE PATIENTS PAIN STARTED ON THE WAY HOME FROM THE PROCEDURE THE PREVIOUS DAY. A THORA VENT WAS PLACED INTO THE LEFT CHEST. SUCTIONING WAS USED FOR ABOUT AN HOUR. A REPEAT X-RAY AT THAT TIME SHOWED NEAR COMPLETE RESOLUTION OF THE PNEUMOTHORAX ON THE LEFT. THE PATIENT CONTINUED TO FEEL WELL AND WAS NOT HOSPITALIZED. THE PATIENT RETURNED THE FOLLOWING DAY TO HAVE THE THORA VENT REMOVED AND REPORTED TOLERATED THE DEVICE WELL, NO SHORTNESS OF BREATH AS WELL AS NO SIGNIFICANT LEFT CHEST PAIN.

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, "MOST RECENTLY WAS AN ISSUE WITH THE NEW SYNCHROSEAL INSTRUMENT, PATIENT SAFETY CONCERN WITH BROKEN PIECE." THERE WAS NO REPORT OF PATIENT HARM, ADVERSE OUTCOME OR INJURY. CUSTOMER FEEDBACK RELATED TO AN INTUITIVE SURGICAL, INC. (ISI) PRODUCT WAS RECEIVED VIA A BLIND SURVEY. ISI IS UNABLE TO PERFORM FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION DUE TO THE NATURE OF HOW THIS INFORMATION WAS COLLECTED. NO PRODUCT, REPORTER, OR SITE INFORMATION WAS AVAILABLE.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

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 DA VINCI-ASSISTED RIGHT PULMONARY LOBECTOMY PROCEDURE, THE PATIENT DEVELOPED A POSTOPERATIVE CHYLOTHORAX. THE SURGEON COMMENTED THAT THE SEALING OF THE SYNCHROSEAL MAY BE UNSATISFACTORY. THE PATIENT WAS HOSPITALIZED AND UNDER OBSERVATION. IT IS UNKNOWN IF ANY MEDICAL/SURGICAL INTERVENTION WAS TAKEN. THE PROCEDURE WAS COMPLETED AS PLANNED. ON (B)(6) 2021, INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE ISI CLINICAL SALES REPRESENTATIVE (CSR), WHO SPOKE TO THE CUSTOMER, AND OBTAINED THE FOLLOWING INFORMATION: THE SYSTEM, INSTRUMENT AND ACCESSORY WERE INSPECTED BEFORE USE AND THERE WAS NOTHING OUT OF THE ORDINARY. THERE WAS NO MALFUNCTION OF AN ISI SYSTEM, INSTRUMENT OR ACCESSORY THAT OCCURRED. THERE WAS NO EVIDENCE OF INSUFFICIENT SEALING/CAUTERY ISSUE/INTRA-OPERATIVE COMPLICATION OBSERVED DURING THE PROCEDURE AND THE SURGERY WAS COMPLETED AS PLANNED. THERE WAS NO UNEXPECTED BLEEDING OBSERVED DURING THE PROCEDURE. THE CUSTOMER CONFIRMED THAT THE TISSUE BUNDLE WAS LESS THAN 5 MM, THE TISSUE FIT IN THE JAWS OF THE INSTRUMENT, THERE WAS NO TISSUE TENSION, NO CONTACT WITH HARD MATERIAL, NO EVIDENCE OF VESSEL CALCIFICATION AND THE INSTRUMENT JAWS WERE 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: IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE HARMONIC ACE WAS FOUND TO HAVE A MELTED TEFLON PAD. FRAGMENTS FROM THE INSTRUMENT REPORTEDLY FELL INSIDE THE PATIENT DURING AN INSTRUMENT TIP OR ACCESSORY COLLISION AND WERE "VERY HARD TO BE RETRIEVED." THE SURGEON RETRIEVED THE FRAGMENTS WITH A BACKUP INSTRUMENT AND NOTED CONCERN ABOUT THE QUALITY OF THE TEFLON PAD. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT HARM, ADVERSE OUTCOME, OR INJURY. THE FRAGMENTS ARE NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. 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 IDENTIFIED. THE INSTRUMENT WAS IN USE FOR APPROXIMATELY 10 TO 20 MINUTES BEFORE THE ISSUE. ALL THE FRAGMENTS WERE RETRIEVED DURING THE SAME PROCEDURE AND CONFIRMED WITH VISUAL INSPECTION. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT. IT WAS UNKNOWN WHAT CAUSED THE BREAKAGE TO OCCUR. THE REPORTER NOTED THAT THE INSTRUMENT DID NOT COLLIDE WITH ANY HARD MATERIALS OR OTHER INSTRUMENTS AS WAS INITIALLY REPORTED. THERE WAS NO PATIENT 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: INTUITIVE SURGICAL INC. (ISI) BECAME AWARE OF A EUROPEAN UROLOGY OPEN SCIENCE ARTICLE TITLED, ¿SALVAGE VERSUS PRIMARY ROBOT-ASSISTED RADICAL PROSTATECTOMY: A PROPENSITY-MATCHED COMPARATIVE EFFECTIVENESS STUDY FROM A HIGH-VOLUME TERTIARY CENTRE¿ (NATHAN, A., FRICKER, M., ET AL., 2021). WITHIN THE CLINICAL JOURNAL ARTICLE, IT WAS CITED -ONE PATIENT SUFFERED FROM A HEMATOMA REQUIRING REOPERATION AND WASHOUT AFTER HIFU THERAPY. ON 15-JUN-2021, ISI OBTAINED THE FOLLOWING ADDITIONAL INFORMATION FROM THE AUTHOR REGARDING THE REPORTED EVENT: IT WAS REPORTED THAT THE DURING PORT INCISION, THERE WAS A VESSEL (VEIN) INJURY. AS A RESULT, THE PATIENT EXPERIENCED A HEMATOMA. THE ESTIMATED BLOOD LOSS INTRA-OPERATIVELY WAS 250-500MLS. THERE WAS PROCEDURE FOR A WASHOUT AND HEMOSTASIS. THERE WAS NO BLOOD TRANSFUSION ADMINISTERED TO THE PATIENT. THE SURGEON HAD CONFIRMED THERE WAS NO RELATION TO THE DA VINCI PRODUCT. HOWEVER, IT IS UNKNOWN IF THE TROCAR WAS AN ISI PRODUCT OR A THIRD-PARTY PRODUCT. AT THIS TIME, IT WAS UNCONFIRMED AS TO WHETHER A DA VINCI SURGICAL SYSTEM WAS INVOLVED IN THE REPORTED EVENT AND THERE IS NO KNOWN ALLEGATION OF A MALFUNCTION OF A DA VINCI PRODUCT.

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: INTUITIVE SURGICAL INC. (ISI) BECAME AWARE OF A EUROPEAN UROLOGY OPEN SCIENCE ARTICLE TITLED, ¿SALVAGE VERSUS PRIMARY ROBOT-ASSISTED RADICAL PROSTATECTOMY: A PROPENSITY-MATCHED COMPARATIVE EFFECTIVENESS STUDY FROM A HIGH-VOLUME TERTIARY CENTRE¿ (NATHAN, A., FRICKER, M., ET AL., 2021). WITHIN THE CLINICAL JOURNAL ARTICLE, IT WAS CITED -ONE PATIENT SUFFERED FROM RECTAL INJURY WITH INTRAOPERATIVE PRIMARY REPAIR FOLLOWING WHOLE GLAND RADIOTHERAPY. ISI HAS MADE MULTIPLE FOLLOW-UP ATTEMPTS TO THE REACH OUT TO THE AUTHOR TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT. AT THIS TIME, IT WAS UNCONFIRMED AS TO WHETHER A DA VINCI SURGICAL SYSTEM WAS INVOLVED IN THE REPORTED EVENT AND THERE IS NO KNOWN ALLEGATION OF A MALFUNCTION OF A DA VINCI PRODUCT. MOREOVER, THERE IS INSUFFICIENT INFORMATION PROVIDED TO DETERMINE THAT AN INTUITIVE PRODUCT CAUSED OR CONTRIBUTED TO THE OPERATIVE COMPLICATION REFERENCED IN THE ARTICLE.

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 22-NOV-2021, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A INTERNATIONAL JOURNAL OF UROLOGY CASE REPORTS ARTICLE TITLED, ¿ENDOSCOPIC LASER TREATMENT FOR URINE LEAKAGE CAUSED BY AN ISOLATED CALYX AFTER ROBOT-ASSISTED PARTIAL NEPHRECTOMY¿ (INOUE, R., ISOYAMA, N., ET AL., 2021). WITHIN THE JOURNAL ARTICLE, A POST-OPERATIVE COMPLICATION INVOLVING A DA VINCI SURGICAL PROCEDURE WAS NOTED: "AN (B)(6) MAN UNDERWENT ROBOT-ASSISTED PARTIAL NEPHRECTOMY FOR THE TREATMENT OF RENAL CELL CARCINOMA (CT1BN0M0). POSTOPERATIVELY, URINE LEAKAGE WAS OBSERVED AND DID NOT IMPROVE WITH CONSERVATIVE MEASURES. RETROGRADE PYELOGRAPHY AND COMPUTED TOMOGRAPHY REVEALED THAT URINE LEAKAGE ORIGINATED FROM THE ISOLATED CALYX CAUSED BY INFUNDIBULAR STENOSIS. ENDOSCOPIC TREATMENT VIA THE TRANSURETHRAL APPROACH WAS SELECTED TO PRESERVE RENAL FUNCTION. URETEROSCOPY SHOWED THAT THE UPPER CALYX WAS COMPLETELY OBSTRUCTED BY THE SUTURES. THEREFORE, WE CUT THE SUTURE THREAD USING LASER, AND A URETERAL STENT WAS PLACED IN THE UPPER RENAL CALYX. FLUID DRAINAGE IMMEDIATELY DISAPPEARED AFTER THE PROCEDURE, AND THE PATIENT DID NOT LOSE RENAL FUNCTION." ISI HAS REACHED OUT TO THE AUTHOR TO OBTAIN ADDITIONAL INFORMATION BUT