ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT A REVISION SURGERY WAS NEEDED TO REMOVE AND REPLACE MISPLACED SCREWS THAT WERE PLACED USING THE EXCELSIUS GPS SYSTEM.

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 SINGLE PORT (SP) SIMPLE PROSTATECTOMY SURGICAL PROCEDURE, AN ERROR 25741 WAS DISPLAYED WHEN DOCKING. THE SITE TRIED TO RECOVER THE FAULT BY PERFORMING AN EMERGENCY POWER OFF (EPO), AND CYCLING THE CANNULA MOUNT LEVER, HOWEVER, THE ERROR PERSISTED. THE PROCEDURE WAS CONVERTED TO A DA VINCI MULTIPORT SYSTEM. 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 HYSTERECTOMY PROCEDURE, THE E-100 GENERATOR TURNED OFF UNEXPECTEDLY AND WHEN THE SURGEON WAS ATTEMPTING TO USE THE SYNCHROSEAL INSTRUMENT, THE SURGEON REPORTED HAVING TROUBLE MOVING THE INSTRUMENT. THE SURGEON INDICATED THAT THE INSTRUMENT WAS NOT WORKING OR RESPONDING CORRECTLY AND WOULD NOT OPEN. BY THE TIME THE SURGICAL STAFF TURNED THE GENERATOR BACK ON, THE SURGEON HAD REPORTEDLY OBSERVED BLEEDING AND ELECTED TO CONVERT THE PROCEDURE TO OPEN SURGERY. ON (B)(6) 2022, INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SURGEON AND RECEIVED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: AFTER THE ISSUE OCCURRED WITH THE SYNCHROSEAL INSTRUMENT, THE SURGICAL STAFF OPENED A SECOND SYNCHROSEAL INSTRUMENT. THE SURGEON WAS ABLE TO USE THE BACKUP SYNCHROSEAL INSTRUMENT WITHOUT ANY ISSUES. HOWEVER, THE SURGEON ELECTED TO CONVERT THE CASE TO OPEN SURGERY DUE TO BLOOD LOSS AND TO CONTROL BLEEDING. THE CAUSE OF THE BLEEDING WAS NOT PROVIDED. HOWEVER, THE SURGEON MENTIONED THAT THE DA VINCI SYSTEM WAS A CONTRIBUTING FACTOR TO THE INTRA-OPERATIVE COMPLICATION SINCE HE COULD NOT CONTROL BLEEDING AND WAS UNABLE TO CAUTERIZE. TH

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 WHILE USING THE EXCELSUS GPS SYSTEM, THE CASE WAS ABORTED DUE TO ROBOTIC ERROR, AND SCREWS WERE THEN PLACED WITHOUT ROBOT.

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 VIDEOSURGERY AND OTHER MINIMALLY INVASIVE TECHNIQUES ARTICLE TITLED, ¿SINGLE PLUS ONE-PORT ROBOTIC SURGERY USING THE DA VINCI SINGLE-SITE PLATFORM VERSUS CONVENTIONAL MULTI-PORT LAPAROSCOPIC SURGERY FOR LEFT-SIDED COLON CANCER¿ (BAE, S. U., JEGON, W. K. AND BAEK, S. K., 2022). THE STUDY COMPARES THE CLINICAL AND COSMETIC OUTCOMES OF SINGLE PLUS ONE-PORT ROBOTIC SURGERY (SPORS) WITH THOSE OF MULTI-PORT LAPAROSCOPIC SURGERY (MPLS),WHICH IS PRESENTLY THE STANDARD SURGICAL TREATMENT FOR COLON CANCER. THE STUDY INCLUDED 36 PATIENTS WHO UNDERWENT SPORS AND 61 PATIENTS WHO UNDERWENT MPLS FOR LEFT-SIDED COLON CANCER BETWEEN AUGUST 2014 AND JANUARY 2016. WITHIN THE JOURNAL ARTICLE, OPERATIVE COMPLICATIONS INVOLVING DA VINCI-ASSISTED SURGICAL PROCEDURES WERE NOTED: TWO PATIENTS IN THE SPORS GROUP DEVELOPED A SUPERFICIAL SURGICAL SITE INFECTION AT THE SPECIMEN EXTRACTION SITE. ONE INSTANCE OF POSTOPERATIVE ANASTOMOTIC SITE BLEEDING OCCURRED IN THE SPORS GROUP, BUT REOPERATION OR ANOTHER INTERVENTION WAS NOT REQUIRED. ADDITIONALLY, IN THE SPORS GROUP, THERE WAS ONE CASE OF POST-OPERATIVE ILEUS AND TWO CASES OF POST-OPERATIVE PSEUDOMEMBRANOUS COL

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 VIDEOSURGERY AND OTHER MINIMALLY INVASIVE TECHNIQUES ARTICLE TITLED, ¿SINGLE PLUS ONE-PORT ROBOTIC SURGERY USING THE DA VINCI SINGLE-SITE PLATFORM VERSUS CONVENTIONAL MULTI-PORT LAPAROSCOPIC SURGERY FOR LEFT-SIDED COLON CANCER¿ (BAE, S. U., JEGON, W. K. AND BAEK, S. K., 2022). THE STUDY COMPARES THE CLINICAL AND COSMETIC OUTCOMES OF SINGLE PLUS ONE-PORT ROBOTIC SURGERY (SPORS) WITH THOSE OF MULTI-PORT LAPAROSCOPIC SURGERY (MPLS),WHICH IS PRESENTLY THE STANDARD SURGICAL TREATMENT FOR COLON CANCER. THE STUDY INCLUDED 36 PATIENTS WHO UNDERWENT SPORS AND 61 PATIENTS WHO UNDERWENT MPS FOR LEFT-SIDED COLON CANCER BETWEEN AUGUST 2014 AND JANUARY 2016. WITHIN THE JOURNAL ARTICLE, OPERATIVE COMPLICATION INVOLVING DA VINCI SURGICAL PROCEDURES WERE NOTED: ONE PATIENT REQUIRED CONVERSION FROM SINGLE PORT TO REDUCED PORT LAPAROSCOPIC SURGERY DUE TO AIR LEAK AND COLLISIONS OF ROBOTIC ARMS. IT WAS FURTHER NOTED, "REGARDING SINGLE PORTS, THE SINGLE-SITE PORT USED IN THE FIRST 3 CASES WAS NOT FLEXIBLE AND HAD POOR DURABILITY. IN ANOTHER CASE, A THIRD PATIENT CHANGED FROM A SINGLE PORT OF A GLOVE PORT TO SECURE DISTANCE BETWEEN INSTRUMENT TIPS AND THE

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 THE PHYSICIAN NAVIGATED TO THE LESION, AND WHEN THE RADIAL ENDOBRONCHIAL ULTRASOUND (REBUS) PROBE WAS INTRODUCED, IT PUSHED A SMALL WHITE FOREIGN BODY (FB) OUT OF THE MONARCH SCOPE INTO THE PATIENT'S LUNGS. THE PHYSICIAN WAS ABLE TO REMOVE THE FB USING FORCEPS AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: SCREW PLACED MEDIAL AT L3.

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 14-MAY-2020, INTUITIVE SURGICAL, INC (ISI) BECAME AWARE OF A HEAD & NECK ARTICLE TITLED, ¿ONE-YEAR OUTCOMES FOR DA VINCI SINGLE PORT ROBOT FOR TRANSORAL ROBOTIC SURGERY¿ (VAN ABEL, K. M., YIN, L. X., ET AL., 2020). WITHIN THE JOURNAL ARTICLE, AN OPERATIVE COMPLICATION INVOLVING A DA VINCI SURGICAL PROCEDURE WAS NOTED. WITHIN THE ARTICLE, THE FOLLOWING IS NOTED: ¿THERE WERE 4 POSTOPERATIVE HEMORRHAGES FOR AN OVERALL BLEED RATE OF 5.1 %. THE DETAILS ON THESE POSTOPERATIVE HEMORRHAGE EVENTS ARE REPORTED IN TABLE 3. THERE WERE TWO MORTALITIES IN THIS COHORT OF 78, ONE SECONDARY TO A POST-TONSILLECTOMY HEMORRHAGE AND ANOTHER SECONDARY TO A POSTOPERATIVE PULMONARY EMBOLUS, FOR AN OVERALL MORTALITY RATE OF 2.6%¿ PROCEDURE INFORMATION PROCEDURE CATEGORY PROCEDURE NAME TRANSORAL ROBOTIC SURGERY. ISI FOLLOWED-UP WITH THE AUTHOR, WHO STATED THE FOLLOWING REGARDING THE REPORTED COMPLICATIONS: "NO, THERE WAS NO ALLEGATION OR CLAIM THAT A MALFUNCTION OF THE SYSTEM OR INSTRUMENT WAS INVOLVED IN THESE COMPLICATIONS. THESE ARE KNOWN RISKS WITH THIS SURGICAL PROCEDURE, DOCUMENTED WITH THE SI AND TRANSORAL LASER MICROSURGERY AS WELL. WE DID NOT IDENTIFY A RATE HIGHER THAN THE PUBLISHED AVERAGES."

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 SURGEON HAD TO CONVERT TO OPEN SURGERY. 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 REPORTED THAT THE SURGEON DECIDED TO CONVERT TO OPEN SURGERY BASED ON COMFORT LEVEL. THE SURGEON HAD PLANNED TO CONVERT TO OPEN AND THE ROOM WAS ALREADY SETUP. THERE WERE NO DA VINCI CONTRIBUTING FACTORS TO CONVERTING THE PROCEDURE; THIS WAS A DECISION MADE COMPLETELY BY THE SURGEON. THE CUSTOMER FOLLOWED UP WITH THE PATIENT THE NEXT DAY AND THE PATIENT WAS DOING WELL.

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 SURGERY ARTICLE TITLED, ¿PERIOPERATIVE OUTCOMES OF MINIMALLY INVASIVE ILEOCOLIC RESECTION FOR COMPLICATED CROHN DISEASE: RESULTS FROM A REFERRAL CENTER RETROSPECTIVE COHORT¿ (ABDALLA, S., ET AL., 2022). A STUDY WAS CONDUCTED TO COMPARE THE INTRAOPERATIVE AND POSTOPERATIVE OUTCOMES OF MINIMALLY INVASIVE ILEOCOLIC RESECTION (MISICR) FOR COMPLICATED VERSUS UNCOMPLICATED CROHN DISEASE (CD). A RETROSPECTIVE ANALYSIS OF ALL CONSECUTIVE ADULT PATIENTS WITH CD UNDERGOING MISICR FROM 01-SEP-2014 AND 31-MAR-2021 WAS CONDUCTED. PATIENTS WERE DIVIDED INTO 2 GROUPS, COMPLICATED AND UNCOMPLICATED, BASED ON THE PREOPERATIVE AND INTRAOPERATIVE FINDINGS. PERIOPERATIVE OUTCOMES WERE COMPARED BETWEEN PATIENTS WITH COMPLICATED CD (COMPLICATED GROUP) AND PATIENTS WITHOUT THESE LESIONS (UNCOMPLICATED GROUP). THE FOCUSED WAS ON ROBOTIC AND LAPAROSCOPIC ILEOCOLIC RESECTIONS (ICR) FOR CD. WITHIN THE JOURNAL ARTICLE, OPERATIVE COMPLICATIONS INVOLVING A DA VINCI SURGICAL PROCEDURE WERE NOTED: INTRAOPERATIVE COMPLICATIONS OCCURRED IN 4 PATIENTS WITHOUT DIFFERENCES BETWEEN GROUPS. IN THE UNCOMPLICATED GROUP, 2 PATIENTS HAD AN UNINTENDED FULL-THICKNESS BOWEL INJUR

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 DURING A MONARCH BRONCHOSCOPY THE PATIENT SUSTAINED A SMALL PNEUMOTHORAX. THERE WAS VERY LIMITED INITIAL INFORMATION PROVIDED, AND NO RESPONSE AFTER REACHING OUT TO THE CUSTOMER ON MULTIPLE OCCASIONS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF AN UROLOGY ARTICLE TITLED, ¿INTRAOPERATIVE DECISION-MAKING: THERMAL INJURY DURING ROBOTIC PYELOPLASTY¿ (HIGGINS, M., AND SALTZMAN, A., 2020). WITHIN THE CLINICAL JOURNAL ARTICLE, IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PYELOPLASTY PROCEDURE, AN INADVERTENT THERMAL INJURY TO A URETER OCCURRED DUE TO ARCING FROM A MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT TO A FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT. THE INJURY OCCURRED WHILE THE SURGEON WAS PERFORMING INITIAL PROXIMAL URETERAL DISSECTION AND WHILE ACTIVATING ENERGY WITH THE MCS INSTRUMENT WHICH WAS TOUCHING THE FBF INSTRUMENT. AT THE TIME THE INJURY OCCURRED, THE FBF INSTRUMENT WAS BEING USED TO PROVIDE UPWARD URETERAL RETRACTION. ON 22-JUN-2020, ISI OBTAINED THE FOLLOWING ADDITIONAL INFORMATION FROM THE AUTHOR OF THE ARTICLE REGARDING THE REPORTED EVENT: THERE IS NO ALLEGATION OR CLAIM THAT A MALFUNCTION OF A DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE INVOLVING THE OPERATIVE COMPLICATION. THERE IS ALSO NO ALLEGATION OR CLAIM THAT A MALFUNCTION OF A DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY CAUSED OR CONTRIBUTED TO THE OPER

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: C3-T4 OPEN POSTERIOR CERVICO-THORACIC FUSION. 1.1R4 SOFTWARE. PRE-OP CT WORKFLOW. 12" FLUOROSCOPY. CT-SCAN LOADED AND SCREWS PREPLANNED. HE ONLY PLANNED TO USE EGPS TO PUT IN SCREWS AT T2-T4. PRIOR TO THE SURGERY, THE PATIENT HAD A FRACTURE AT C7-T1 CAUSING THE PREVIOUS POSTERIOR SCREWS TO PULL OUT AT T1-T2. DR. (B)(6) PUT THE ANGLED SPINOUS PROCESS CLAMP ON T5 AND DUE TO THE AMOUNT OF SKIN THE ANGLED SPINOUS PROCESS CLAMP WAS POINTING STRAIGHT UP. THUS NOT ALLOWING THE C-ARM INTO TO POSITION FOR REGISTRATION IMAGED. FOLLOWING THAT MISTAKE HE PUT A SHORTER SPINOUS PROCESS CLAMP ON THE SP. SM WAS ON THE SAME CLAMP. THIS ALLOWED THE C-ARM TO MOVE UNDER THE BED WITHOUT HITTING THE MAYFIELD ATTACHMENT HOWEVER, THE LATERAL SHOT WAS DIFFICULT TO VISUALIZE ON THE C-ARM. DR. (B)(6) HAD A DIFFICULT TIME IDENTIFYING EACH LEVEL DUE TO THE MINIMAL CONTRAST OF THE C-ARM. THE SETTING WERE ADJUSTED TO BETTER THE IMAGE ON THE C-ARM BUT THE MERGE WAS UNSUCCESSFUL. THE MERGE LOOKED LIKE IT HAD FOUND THE AN IMAGE ON THE CT THAT WAS IN AN OBLIQUE AP VIEW. FOR THE LATERAL, IT COULD NOT IDENTIFY THE CORRECT LEVEL. WE RESET THE SOFTWARE, FOLLOWED BY COMPLETE REBOOT BUT IT CONTINUED TO FAIL THE MERGE. SCO

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 SOCIAL MEDIA POST THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGEON PRESSED THE INCORRECT PEDAL AND BURNED THE COLON. THE SURGEON RECOGNIZED THE ERROR AND WAS ABLE TO STAPLE MORE PROXIMALLY. ON 29-SEP-2020, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: DURING AN UNDISCLOSED DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGEON PRESSED THE INCORRECT ENERGY PEDAL ON THE SURGEON SIDE CONSOLE (SSC) AND THE PATIENT SUSTAINED A SMALL 2ND DEGREE BURN ON THE SMALL INTESTINE; REPAIRED BY RESECTING 2CM OF THE SMALL INTESTINE. THE PATIENT WAS REPORTED AS FINE. THE SURGEON CONFIRMED THAT THERE [WASN¿T A] DA VINCI ERROR. THE SURGEON ATTRIBUTED THE ISSUE TO HIS ¿MALFUNCTION¿; SURGEON ERROR, NOTHING ELSE. THE SURGEON WAS UNWILLING TO PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE INCIDENT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF AN ANNALS OF SURGICAL TREATMENT AND RESEARCH ARTICLE TITLED, ¿INITIAL EXPERIENCES OF ROBOTIC SP CHOLECYSTECTOMY: A COMPARATIVE ANALYSIS WITH ROBOTIC SI SINGLE-SITE CHOLECYSTECTOMY¿ (CRUZ, C. J., HUYNH, F., ET AL., 2021). WITHIN THE JOURNAL ARTICLE, AN OPERATIVE COMPLICATION INVOLVING A DA VINCI SURGICAL PROCEDURE WAS NOTED: ¿ONE PATIENT HAD A SMALL BOWEL INJURY DURING PORT PLACEMENT DUE TO UNEXPECTED INTRA-ABDOMINAL ADHESIONS, WHICH WAS REPAIRED INTRA-CORPOREALLY.¿ 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: DURING THE PROCEDURE, THE SCRUB TECH NOTICED THAT THE INSTRUMENT PULLED OUT FROM THE ABDOMEN WAS MISSING THE TIP COVER. SHE LOOKED AROUND AND MADE SURE IT WASN'T IN HER FIELD AND INFORMED THE SURGEON AND ASSISTANT SURGEON. THE TEAM IN THE ROOM LOOKED THRU AND AROUND THE STERILE FIELD, AND ALSO WENT THRU THE TRASH, BUT WERE UNABLE TO FIND THE MISSING TIP COVER. THE SURGEON AND ASSISTANT EXPLORED INSIDE THROUGH THE SCOPE BEFORE AND AFTER SPECIMEN WAS REMOVED. XRAY DID NOT REVEAL ANY FOREIGN BODY. 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: ON 26-NOV-2020, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF THE GENERAL THORACIC AND CARDIOVASCULAR SURGERY ARTICLE TITLED, ¿IS LEFT-SIDE DAVINCI PROCEDURE CHALLENGING? INITIAL EXPERIENCES OF A SINGLE INSTITUTE.¿ WITHIN THE ARTICLE, THE FOLLOWING IS NOTED: CASE #3 INVOLVED A 69 YEAR OLD MALE PATIENT WITH STAGE 1B CANCER WHO UNDERWENT A DA VINCI-ASSISTED LEFT UPPER LOBECTOMY PROCEDURE ON AN UNSPECIFIED DATE. THE CAUSE OF THE CONVERSION PER TABLE 3 IN THE ARTICLE WAS AN ¿INJURY OF PA¿ (PULMONARY ARTERY). ¿IN CASE 3, WHEN DISSECTING THE ARTERIAL BRANCH TO THE APICO-POSTERIOR SEGMENT OF THE LEFT UPPER LOBE, THE ROOT OF THE BRANCH WAS INJURED AND THE SURGERY WAS CONVERTED TO OPEN THORACOTOMY.¿ THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED IN RELATION TO THE REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) HAS 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: ON 22-APR-2020, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A JOURNAL OF ULTRASOUND ARTICLE TITLED, ¿INFERIOR EPIGASTRIC ARTERY PSEUDOANEURYSM SECONDARY TO PORT PLACEMENT DURING A ROBOT-ASSISTED LAPAROSCOPIC RADICAL CYSTECTOMY.¿ PER THE CLINICAL ARTICLE, DURING A DA VINCI-ASSISTED RADICAL CYSTECTOMY WITH BRICKER URETEROILEOCUTANEOSTOMY AND EXTENDED PELVIC LYMPH NODE DISSECTION, THE PATIENT DEVELOPED AN INFERIOR EPIGASTRIC ARTERY (IEA) PSEUDOANEURYSM SECONDARY TO AN 8-MILLIMETER (MM) PORT PLACEMENT. THE PRE-OPERATIVE COMPUTED TOMOGRAPHY (CT) SCAN SHOWED NO LYMPHOADENOMEGALY AND BILATERAL HYDRONEPHROSIS, AND NO OTHER LOCALIZATION THAN THE BLADDER. THE PSEUDOANEURYSM WAS INITIALLY DIAGNOSED POST-OPERATIVELY BY CONTRAST-ENHANCED ULTRASOUND (CEUS); SUBSEQUENTLY, A CT SCAN AND AN ANGIOGRAPHY TEST WERE PERFORMED. THE PSEUDOANEURYSM WAS THEN TREATED SUCCESSFULLY WITH COIL EMBOLIZATION OF THE INFERIOR EPIGASTRIC ARTERY. NO COMPLICATIONS OCCURRED DURING OR AFTER THE EMBOLIZATION PROCEDURE. ON 03-JUN-2020, IS OBTAINED THE FOLLOWING ADDITIONAL INFORMATION FROM THE AUTHOR OF THE CLINICAL ARTICLE REGARDING THIS EVENT: "THERE WAS NO MALFUNCTION OF THE DA VINCI SYSTEM, THIS COMPLICATION CAN OCC

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 OTHER URINARY DIVERSION SURGICAL PROCEDURE, THE RIGHT EYE IN THE SURGEON SIDE CONSOLE (SSC) WAS BLACK. THE RIGHT AND LEFT IMAGES WORKED FINE IN THE VISION SIDE CART (VSC). THE BLUE FIBER CABLE WAS PROPERLY CONNECTED TO THE SSC AND THE LED WAS BLUE. THE TECHNICAL SUPPORT ENGINEER (TSE) ASKED THE CALLER TO EMERGENCY POWER OFF (EPO) THE SSC AND VISION SIDE CART (VSC), BUT THE RIGHT MONITOR REMAINED COMPLETELY BLACK. THE SURGEON WAS UNDECIDED TO AS TO WHETHER TO CONVERT OR ABORT THE PROCEDURE AT THAT TIME. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS A ONE HOUR DELAY AS THE PROCEDURE WAS CONVERTED TO OPEN SURGERY. THE ISSUE DID NOT OCCUR DURING A CRITICAL STEP. IT IS UNKNOWN IF SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM. THE SYSTEM WAS ONLY ABLE TO SEE THROUGH ONE EYE OF THE HRSV.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DAVINCI ROBOTIC SURGERY WAS PREFORMED ON THIS PATIENT, WHILE THE SURGEON WAS IN THE CONSOLE, THE INSTRUMENTS WERE USED TO TAKE DOWN ADHESIONS AND AFTER THAT OCCURRED, THE ARMS EXPERIENCED AN ISSUE. THE SURGEON DESCRIBED IT "AS THE LEFT HAND WAS MOVED WITH THE VESSEL SEAL DEVICE, THE ROBOTIC ARM MOVED ERRATICALLY AND IMMEDIATELY I NOTED A THROUGH AND THROUGH PERFORATION OF THE SIGMOID COLON." THE INSTRUMENT WAS LEFT IN PLACE AND A GENERAL SURGERY CONSULT WAS COMPLETED IMMEDIATELY FOR REPAIR. AFTER DISCUSSION WITH THE TEAM, WE BELIEVE THAT THE ROBOTIC ARM DRAPE WAS FAULTY AND WE IMMEDIATELY CALLED THE REP AND THE TECH SUPPORT PERSON. THEY RECOMMENDED THAT WE PULL ALL THOSE DRAPES WITH THAT LOT NUMBER #DM1220807. FDA SAFETY REPORT ID# (B)(4).

Senhance — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) -2022, THE COMPLAINANT, (B)(6) REPORTED THAT ON DAY 7, PATIENT COMPLAINED OF FEVER AND NOTED PURULENT DISCHARGE FROM THE ANUS; ADDITIONALLY, PATIENT PRESENTED WITH LEUKOCYTOSIS AND ELEVATED CRP. THIS ADVERSE EVENT WAS ANASTOMOTIC LEAKAGE AS REVEALED BY DIGITAL EXAMINATION FOR WHICH ANTIBIOTIC TREATMENT WAS ADMINISTERED (METRONIDAZOLE-500 MG 3X DAILY AND CEFUROXIME-1 G). PATIENT SYMPTOMS DISSAPEARED FOR A RESOLUTION DATE OF (B)(6) 2022. THIS EVENT DID NOT OCCUR WITHIN THE UNITED STATES. THE EVENT OCCURRED IN (B)(6). IT WAS REPORTED THAT THE CAUSALITY TO THE SENHANCE SURGICAL SYSTEM WAS POSSIBLE. THE EVENT OCCURRED ON (B)(6) 2022, AND ASENSUS SURGICAL WAS INTERNALLY MADE AWARE ON 09-AUGUST-2023.

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, THE JAWS OF HARMONIC ACE FELL INSIDE OF THE PATIENT. THE FALLEN PIECE WAS RETRIEVED DURING THE SAME PROCEDURE WITH A BACKUP INSTRUMENT. THE INSTRUMENT IS NOT AVAILABLE FOR RETURN. 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 WAS ABLE TO RETRIEVE THE BROKEN PIECE WITH A LAPAROSCOPIC INSTRUMENT. NO ADDITIONAL PROCEDURES WERE REQUIRED TO RETRIEVE THE BROKEN PIECE. NO POST-OPERATIVE TESTS NEEDED TO BE PERFORMED TO CHECK FOR ANY REMAINING PIECES. THE CUSTOMER WAS NOT SURE WHAT THE SURGEON THOUGHT CAUSED THE INSTRUMENT TO BREAK. THE INSTRUMENT WAS USED MAYBE 20 MINS PRIOR TO BREAKING. THE INSTRUMENT WAS INTACT WHEN IT WAS REMOVED FROM THE STERILE PACKAGE. THE CUSTOMER WAS DISSECTING TISSUE WHEN THE INSTRUMENT BROKE. RIGHT BEFORE THE CUSTOMER NOTICED THE INSTRUMENT WAS BROKEN THE HARMONIC MACHINE HAD AN ERROR BUT SHE COULD NOT REMEMBER WHAT THE ACTUAL ERROR SAID. THE CUSTOMER COULD NOT RECALL IF THE INSTRUMENT COLLIDED WITH ANY OTHER INSTRUMENT DURING THE PROCEDURE

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: EXCELCIUS GPS CASE THE FIRST TWO SCREWS WERE MISPLACED OFF PLAN. FLUOR SHOTS WERE TAKEN TO SHOW SCREWS OFF PLAN AND NAVIGATION INACCURATE. REQUESTING EVALUATION OF LOGS SUBMITTED TO IN PORTAL THIS EVENING. EXCELCIUS GPS SERIAL NUMBER (B)(6).

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 WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED DUE TO ROBOTIC ERROR, AND SCREWS WERE THEN PLACED WITHOUT ROBOT.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PNEUMOTHORAX WAS REPORTED DURING MONARCH BRONCHOSCOPY PROCEDURE AND PATIENT WAS HOSPITALIZED OVERNIGHT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE, A BURNING ACCIDENT OCCURRED WHILE THE SURGEON WAS USING A MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT AT THE BEGINNING OF THE PROCEDURE. THE TIP OF THE MCS INSTRUMENT HEATED UP AND BURST INTO FLAMES WHEN THE SURGEON ACTIVATED THE MCS INSTRUMENT FOR THE FIRST TIME. THE MCS INSTRUMENT WAS ON ITS THIRD USAGE. THERE WAS INJURY TO THE PATIENT'S SMALL INTESTINE AND ABDOMINAL WALL NEAR THE TROCAR AS A RESULT. A BACKUP MCS INSTRUMENT WITH TIP COVER WAS USED. THE FRAGMENTS THAT FELL IN THE PATIENT FROM THE BURNT TIP COVER WERE RETRIEVED DURING THE SAME PROCEDURE. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE OPERATING ROOM NURSE AND OBTAINED THE FOLLOWING INFORMATION: THERE WAS NO ERROR GENERATED BY THE SYSTEM AFTER INSTALLING THE INSTRUMENT. THE FLAME WAS SEEN ARISING FROM THE TIP OF THE MCS. WHEN THE INSTRUMENT WAS REMOVED FROM THE CANNULA, THE MCS INSTRUMENT WAS STILL FLAMING. THE SURGEON SUTURED THE HOLE IN THE INTESTINE AND CLEANED UP THE RESIDUE. THE SURGEON USED A BACKUP FORCE TRIAD GENERATOR, NEW CAUTERY CABLE, MCS INSTRUMENT AND TIP COVER TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT HAVE ANY IMPLANTS. N

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 (LAR) PROCEDURE, THERE WAS ARCING FROM THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT FROM A LOCATION OTHER THAN THE TIP. THE PATIENT SUSTAINED A RESULTING BURN INJURY TO THE INTESTINAL TRACT. A BACKUP MCS INSTRUMENT WAS USED, AND THE PROCEDURE WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE OR NURSE AND OBTAINED THE FOLLOWING INFORMATION: THE INSTRUMENT AND CANNULA WERE INSPECTED BEFORE USE. THE SURGEON STATED THAT THERE WAS SOMETHING "WRONG" WITH THE MCS FROM THE BEGINNING OF THE PROCEDURE BUT NO INFORMATION WAS PROVIDED TO FURTHER DESCRIBE WHAT THE ISSUE WAS. THE GROUNDING PAD WAS PLACED PROPERLY ON THE PATIENT AND THERE WERE NO DEFECTS SEEN. ISI CONTACTED THE SURGEON AND ADDITIONAL INFORMATION WAS OBTAINED ABOUT THE COMPLAINT: THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NOTHING ABNORMAL NOTICED. THE SURGEON REPORTEDLY NOTICED DAMAGE TO THE INSTRUMENT AND/OR ACCESSORY PRIOR TO THE ARCING EVENT. THE CANNULA WAS INSPECTED PRIOR TO USE AND THE PIN GAUGE TEST WAS PERFORMED. IT WAS REPORTED THAT ARCING WAS OBSERVED COMING FROM THE MIDDLE PART OF THE TIP COVER AND THAT THIS GENERAT

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE, THE PATIENT EXPERIENCED A TEAR IN THE AIRWAY. THE PATIENT WAS HOSPITALIZED OVERNIGHT FOR OBSERVATION AND DISCHARGED FOLLOWING DAY. THE PHYSICIAN NAVIGATED TO THE LESION IN PAIRED MODE. AT SOME POINT THE PHYSICIAN DROPPED THE SHEATH AND ADVANCED THE SCOPE ONLY. AT THE LESION, THE PHYSICIAN ADVANCED THE SHEATH ONLY TO PROVIDE MORE STABILITY WHILE INTRODUCING BIOPSY TOOLS. WHEN THE PHYSICIAN HAD COMPLETED AND RETRACTED BOTH THE SCOPE AND SHEATH THE PHYSICIAN NOTICED A TEAR IN THE AIRWAY.

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 COMPLETED SINGLE PORT (SP) COLORECTAL IDE STUDY LOW ANTERIOR RESECTION (LAR) WITH TOTAL MESORECTAL EXCISION (TME) PROCEDURE ON (B)(6) 2022, THE PATIENT DEVELOPED BILATERAL EDEMA OF THE LOWER EXTREMITIES AND GIDDINESS. THE LEG SWELLING AND GIDDINESS WERE NOTED ON (B)(6) 2022, DURING A FOLLOW-UP VISIT WITH HER PRIMARY CARE PHYSICIAN (PCP) AND THE PATIENT'S ORAL LOSARTAN WAS PLACED ON HOLD BY HER PCP, AND SHE WAS ADVISED TO FOLLOW-UP IN 2-3 WEEKS¿ TIME. ON (B)(6) 2022, THE PATIENT WENT TO THE ER FOR GENERALIZED WEAKNESS AND DIZZINESS FOR A FEW WEEKS. THE DIZZINESS WAS WORSE UPON STANDING UP. SHE ALSO HAD LOSS OF APPETITE. THERE WAS NO PAIN. SHE STATED THAT THE WEAKNESS AND LOSS OF APPETITE STARTED EVER SINCE SHE HAD A BARIUM ENEMA ON (B)(6) 2022. A BLOOD TEST SHOWED ACUTE RENAL FAILURE WITH CREATININE 2.2, BUN 106, SODIUM 119, POTASSIUM 5.4. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE SITE. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE, THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE TARGET LOCATION WAS LEFT UPPER LOBE (LUL). AN ENDOBRONCHIAL ULTRASOUND (EBUS) AND CHEST X-RAY (CXR) WERE BOTH PERFORMED. A POST-OP CHEST X-RAY REVEAL A PNEUMOTHORAX. A CHEST TUBE WAS PLACED AND PATIENT WAS ADMITTED TO THE HOSPITAL. THE CHEST TUBE WAS REMOVED THE FOLLOWING DAY AND PATIENT WAS DISCHARGED.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE, THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE TARGET LOCATION WAS LEFT UPPER LOBE(LUL). AN ENDOBRONCHIAL ULTRASOUND (EBUS) AND CHEST X-RAY (CXR) WERE BOTH PERFORMED. A POST-OP CHEST X-RAY REVEAL A PNEUMOTHORAX. A CHEST TUBE WAS PLACED AND PATIENT WAS ADMITTED TO THE HOSPITAL. THE CHEST TUBE WAS REMOVED THE FOLLOWING DAY AND PATIENT WAS DISCHARGED

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY PROCEDURE, ARCING WAS OBSERVED FROM THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT. THE EXTERNAL ILIAC ARTERY, WHICH WAS IN CONTACT WITH THE ELECTRICAL LEAKAGE SITE WAS INJURED, RESULTING IN ARTERIAL BLEEDING. THE BLEEDING POINT WAS SUTURED AFTER CLAMPING THE ARTERY. THE VIDEO OF THE PROCEDURE WAS REVIEWED BY THE SURGEON AND SHOWED THAT A FEW MINUTES BEFORE THE MCS TIP COVER ACCESSORY WAS FOUND TO BE TORN, THE WRIST OF THE MCS INSTRUMENT WAS OBSERVED TO BE SEVERELY BENT AND COLLIDED WITH A PROGRASP FORCEPS INSTRUMENT WHICH WAS OUT OF VIEW FROM THE SURGICAL FIELD. ALSO, AFTER THE ARCING INCIDENT, THE MCS TIP COVER ACCESSORY WAS REMOVED AND UPON EXAMINATION, THERE WERE MULTIPLE HOLES SEEN ON THE MCS TIP COVER ACCESSORY.INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SURGEON AND OBTAINED THE FOLLOWING INFORMATION: THE CANNULA, MCS INSTRUMENT, AND MCS TIP COVER ACCESSORY WERE INSPECTED BEFORE USE AND THERE WAS NO ABNORMALITY FOUND. THE MCS TIP COVER ACCESSORY APPEARED TO BE PROPERLY INSTALLED DURING THE CASE. THE MCS INSTRUMENT WAS IN USE FOR ABOUT 1 HOUR BEFORE THE ARCING OCCURRED. ARCING OR

CyberKnife — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A CUSTOMER CONTACTED ACCURAY INDICATING THERE WAS A POTENTIAL MISTREATMENT THAT OCCURRED AT THEIR SITE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2022, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF AN INTRA-OPERATIVE COMPLICATION, WHICH WAS RECEIVED VIA A USER MEDWATCH REPORT #MW5110571. WITHIN THE USER MEDWATCH REPORT, IT WAS REPORTED THAT DURING AN UNSPECIFIED DA VINCI-ASSISTED SURGICAL PROCEDURE, WHICH ALLEGEDLY THE SURGEON USED TO TAKE DOWN THE ADHESIONS, AND ¿AFTER THAT OCCURRED, THE ARMS EXPERIENCED AN ISSUE¿. THE SURGEON DESCRIBED IT ¿AS THE LEFT HAND WAS MOVED WITH THE VESSEL SEAL DEVICE, THE ROBOTIC ARM MOVED ERRATICALLY¿ AND IMMEDIATELY THE SURGEON NOTED ¿A THROUGH AND THROUGH PERFORATION OF THE SIGMOID COLON¿. THE INSTRUMENT WAS LEFT IN PLACE AND A GENERAL SURGERY CONSULT WAS COMPLETED IMMEDIATELY FOR REPAIR. OTHER INFORMATION RECEIVED FROM THE USER REPORT FURTHER INDICATED THAT ¿AFTER DISCUSSING WITH THE TEAM, WE BELIEVE THAT THE ROBOTIC ARM DRAPE WAS FAULTY¿. ISI IS NOT ABLE TO CONDUCT FOLLOW-UP INVESTIGATION WITH THE USER FACILITY/SURGEON REGARDING THE REPORTED ISSUE DUE TO THE LACK OF FACILITY/SURGEON¿S NAME, ADDRESS AND PHONE NUMBER, ETC. ADDITIONALLY, ISI IS UNABLE TO CONDUCT THE SYSTEM OR INSTRUMENT LOG REVIEW DUE TO LACK OF SYSTEM/INSTRUMENT DETAIL (I.E. SYSTEM SERIAL #, SURGEON NAME, TYPE OF PR

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A JOURNAL ONCOLOGY ARTICLE TITLED, ¿OPERATIVE AND SURVIVAL OUTCOMES OF ROBOTIC-ASSISTED SURGERY FOR COLORECTAL CANCER IN ELDERLY AND VERY ELDERLY PATIENTS: A STUDY IN A TERTIARY HOSPITAL IN SOUTH KOREA¿ (CUELLAR-GOMEZ, H., RUSLI, S. M., ET AL., 2022). WITHIN THE JOURNAL ARTICLE, POST-OPERATIVE COMPLICATIONS INVOLVING A DA VINCI SURGICAL PROCEDURE WERE NOTED. A RETROSPECTIVE STUDY WAS PERFORMED TO EVALUATE THE POSTOPERATIVE AND SURVIVAL OUTCOMES OF ROBOTIC-ASSISTED COLORECTAL CANCER SURGERY (RACS) IN ELDERLY PATIENTS. ALL PATIENTS =75 YEARS WHO UNDERWENT A ROBOTIC-ASSISTED CURATIVE RESECTION AT A SINGLE CENTER BETWEEN JANUARY 2007 AND JANUARY 2021 WERE EXTRACTED FROM A PROSPECTIVELY MAINTAINED COLORECTAL CANCER DATABASE. PER THE ARTICLE, POST-OPERATIVE COMPLICATIONS WERE REPORTED ACCORDING TO THE MODIFIED CLAVIEN-DINDO CLASSIFICATION, TOGETHER WITH THE TYPE OF COMPLICATION, LENGTH OF HOSPITAL STAY (LOS), AND REOPERATION RATE (PATIENTS RE-OPERATED WITHIN 30 DAYS FROM INITIAL SURGERY). MAJOR COMPLICATIONS WERE OBSERVED IN 2.1% OF PATIENTS AND THE 30-DAY MORTALITY RATE WAS 0%. REPORTED COMPLICATIONS INCLUDED: ANASTOMOTIC LEAKAGE (4); INTRA

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, AN UNSPECIFIED INSTRUMENT BROKE AND FRAGMENTS FROM THE INSTRUMENT FELL INTO THE PATIENT. THE FRAGMENTS WERE RETRIEVED DURING THE SAME SURGERY. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MEDIASTINAL MASS REMOVAL PROCEDURE, THE CASE WAS CONVERTED TO OPEN SURGERY. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON AND OBTAINED THE FOLLOWING INFORMATION: THE SURGEON STATED HE PEELED THE TUMOR FROM THE HEART USING THE CADIERE FORCEPS AND THE SYNCHROSEAL INSTRUMENTS. AT THAT TIME, THE SURGEON INDICATED THAT HE "PUT A HOLE IN THE INNOMINATE VEIN" WITH THE SYNCHROSEAL INSTRUMENT. AS A RESULT, THE PATIENT EXPERIENCED BLEEDING. THE SURGEON IMMEDIATELY APPLIED PRESSURE WITH GAUZE USING THE SYNCHROSEAL INSTRUMENT (CLOSED JAWS) ON ARM 1. THE SURGEON CONFIRMED THE SYNCHROSEAL WAS NOT USED FOR SEALING AT THAT TIME. WHILE THE OR STAFF AND A RESIDENT WERE PLANNING THE CONVERSION, THE SYSTEM GENERATED A RECOVERABLE FAULT. AS A RESULT, THE SURGEON WAS UNABLE TO APPLY PRESSURE MOMENTARILY ON THE INJURED VESSEL UNTIL THE FAULT WAS RECOVERED. THE ASSISTANT RECOVERED THE FAULT WITHIN APPROXIMATELY 14-15 SECONDS, AND THE SURGEON WAS THEN ABLE TO CONTINUALLY APPLY PRESSURE ON THE INNOMINATE VEIN. HOWEVER, THE PATIENT BLED A LITTLE MORE DUE TO THE ADDITIONAL TIME IT TOOK TO RECOVER THE FAULT AND THEN THE PROCESS OF CONVERSION CONTINUED. ONC

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE, THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE TARGET LOCATION WAS NEXT TO A FISSURE. A CHEST TUBE WAS PLACED. THE PROCEDURE HAS NOT BEEN RESCHEDULED TO DATE.

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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.

Senhance — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE COMPLAINANT, (B)(6), REPORTED THAT A PATIENT EXPERIENCED NARROW STENOSIS IN THE GASTRO-ESOPHAGEAL AREA AND VOMITING FOR WHICH TREATMENT WITH ANTIEMETICS WAS ADMINISTRATED (DOMPERIDONE-50,00 MG TOTAL DOSAGE); ADDITIONALLY, AN OGD + DILATATION WAS PERFORMED FOR A (B)(6) 2022 DATE OF RESOLUTION. IT WAS REPORTED THAT CAUSALITY TO THE SENHANCE SURGICAL SYSTEM WAS POSSIBLE. THIS EVENT DID NOT OCCUR WITHIN THE UNITED STATES. THE EVENT OCCURRED IN EVANGELISCHES KRANKENHAUS WESEL GMBH IN GERMANY. ADDITIONALLY, THIS EVENT OCCURRED ON 28-MAY-2022, AND ASENSUS SURGICAL WAS INTERNALLY MADE AWARE ON 04-JULY-2022.

Senhance — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE COMPLAINANT, (B)(6), REPORTED THAT A PATIENT EXPERIENCED NARROW STENOSIS IN THE GASTRO-ESOPHAGEAL AREA AND VOMITING FOR WHICH TREATMENT WITH ANTIEMETICS WAS ADMINISTRATED (DOMPERIDONE-50,00 MG TOTAL DOSAGE); ADDITIONALLY, AN OGD + DILATATION WAS PERFORMED FOR A (B)(6) 2022 DATE OF RESOLUTION. IT WAS REPORTED THAT CAUSALITY TO THE SENHANCE SURGICAL SYSTEM WAS POSSIBLE. THIS EVENT DID NOT OCCUR WITHIN THE UNITED STATES. THE EVENT OCCURRED IN (B)(6). ADDITIONALLY, THIS EVENT OCCURRED ON (B)(6) 2022, AND ASENSUS SURGICAL WAS INTERNALLY MADE AWARE ON 29-JUNE-2022.

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 INCISIONAL HERNIA REPAIR PROCEDURE WITH INTRAPERITONEAL ONLAY MESH (IPOM), THE SURGEON WAS HOLDING THE SMALL BOWEL WITH A CADIERE FORCEPS INSTRUMENT WHEN HE ACTIVATED THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT ON THE RIGHT ARM. AT THAT TIME, IT WAS NOTICED THAT THE SMALL BOWEL IN THE JAWS OF THE CADIERE FORCEPS INSTRUMENT HAD CHANGED COLOR AND WAS BURNED. AS A RESULT, THE SURGEON HAD TO PLACE SUTURES ON THE SMALL BOWEL TO ADDRESS THE BURN. ALTHOUGH THERE WAS NO ARCING OBSERVED FROM THE MCS INSTRUMENT, IT IS UNKNOWN WHAT CAUSED THE BOWEL BURN. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON AND OBTAINED THE FOLLOWING INFORMATION: THE SURGEON STATED HE HAD THE CADIERE FORCEPS INSTRUMENT INSTALLED ON THE LEFT ARM AND THE MCS INSTRUMENT INSTALLED ON THE RIGHT ARM. THE SURGEON WAS HOLDING THE SMALL BOWEL WITH THE CADIERE FORCEPS INSTRUMENT. THE SURGEON ACTIVATED THE MCS INSTRUMENT ON THE RIGHT ARM. AT THAT TIME, THE SURGEON NOTICED THE SMALL BOWEL IN THE JAWS OF THE CADIERE FORCEPS INSTRUMENT HAD CHANGED COLOR AND WAS BLANCHED (AS AN IMPRINT OF THE INSTRUMENT JAWS ON THE SMALL BOWEL). AS A RESULT, THE SURGEON HAD TO PLACE SUTURES

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CASE WAS T10-PELVIS. INTRA-OP WORKFLOW. FIRST TWO REGISTRATIONS (L2-S2 AND S2) WENT VERY SMOOTH WITH NO ISSUES. THIRD SPIN WAS T10-L1. SURGEON PLACED SCREWS T10-T12L. WHEN TRYING TO MOVE THE EE CLOSER TO THE ANATOMY THE ARM WOULD NOT ADVANCE WHEN SURGEON BRACELET WAS ENGAGED. THEN WHEN THE SURGEON TRIED TO RESETTLE THE ARM ONTO TRAJECTORY BY USING THE FOOT PEDAL THE ARM DRIFTED INFERIOR AND DID NOT COME BACK ON TRAJECTORY. I CHECKED THE LOADCELL AND ALL VALUES WERE STEADY AT 0. WE REMOVED THE EE AND ADJUSTED THE DRAPE THEN REPLACED THE EE. TRIED TO NAVIGATE TO A TRAJECTORY AND THE ARM DRIFTED THE SAME WAY. I THEN TRIED A MOTION RESET THAT DID NOT WORK. I THEN TRIED A HARD SHUTDOWN AND THAT DID NOT WORK EITHER. THE SURGEON THEN FREEHANDED THE LAST THREE SCREWS. I REMOVED THE ROBOT FROM THE OR AND REHOMED THE ARM AND THAT SEEMED TO FIX IT BUT COULD NOT CONFIRM DUE TO NOT BEING ABLE TO NAVIGATE TO A TRAJECTORY WITH THE EE. PLEASE SEND AN FSE OUT TO CONFIRM THERE ARE NO HARDWARE ISSUES CAUSING THIS ISSUE.

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 GASTRECTOMY SURGICAL PROCEDURE, THE CUSTOMER DISCOVERED THAT THE HARMONIC ACE INSTRUMENT BLADE WAS DAMAGED. THE HARMONIC ACE INSTRUMENT BLADE BROKE OFF AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE CUSTOMER REPLACED THE HARMONIC ACE INSTRUMENT WITH A BACK-UP INSTRUMENT OF THE SAME KIND AND COMPLETED THE PROCEDURE WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) PERFORMED FOLLOW-UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE INSTRUMENT WAS REPORTEDLY INSPECTED PRIOR TO USE, AND NO ISSUES WERE NOTED. THE INSTRUMENT DID NOT MAKE CONTACT WITH ANY OTHER INSTRUMENT OR HARD MATERIAL DURING THE SURGICAL PROCEDURE. THE SURGEON WAS DISSECTING TISSUE AT THE TIME OF THE EVENT. THE INSTRUMENT WAS IN USE FOR THIRTY MINUTES AND PERFORMED AS INTENDED UP UNTIL IT BROKE. AFTER THE BLADE OF THE INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT, THE FRAGMENT WAS VISUALLY LOCATED AND RETRIEVED DURING THE SAME PROCEDURE. IT WAS CONFIRMED THAT ALL FRAGMENTS WERE RETRIEVED. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED, AND THERE WERE NO POST-OPERAT

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2022, IT WAS REPORTED THAT A PATIENT UNDERWENT A NAVIGATION BRONCHOSCOPY. DURING THE PROCEDURE, THE PATIENT WAS NOTED TO BE HYPOXIC, WITH ELEVATED PEAK PRESSURE. AN ULTRASOUND SHOWED NO LUNG SLIDING ON RIGHT, CHEST X-RAY (CXR) CONFIRMED A MODERATE-SIZED, RIGHT PNEUMOTHORAX WITH ASSOCIATED LEFTWARD DEVIATION OF THE MEDIASTINUM, RAISING THE POSSIBILITY OF TENSION PNEUMOTHORAX, AND LEFT BASILAR ATELECTASIS. A PIGTAIL CHEST TUBE WAS PLACED IN THE RIGHT UPPER CHEST. PATIENT TOLERATED THE PROCEDURE WELL. POST PROCEDURE CXR SHOWS RESOLUTION OF PNEUMOTHORAX. CHEST TUBE WAS REMOVED. THE PATIENT REMAINED IN THE HOSPITAL FOR 7-DAYS DUE TO SYMPTOMS OF ACUTE HYPOXIC RESPIRATORY FAILURE SECONDARY TO PNEUMOTHORAX. PEDIATRIC GI FORCEPS WERE USED DURING THE PROCEDURE AS WELL AS AN UNKNOWN NEEDLE.

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, THE HARMONIC ACE INSTRUMENT TIP BROKE DURING INTRAOPERATIVE USE. AS A RESULT, A FRAGMENT FELL INSIDE THE PATIENT. THE BROKEN PIECE WAS RETAINED. THE USER COMPLETED THE PROCEDURE USING THE BACKUP INSTRUMENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: ALL THE INSTRUMENTS AND ACCESSORIES WERE INSPECTED PRIOR TO USE AND NO DAMAGE OR ANY ABNORMALITY WAS FOUND. APPROXIMATELY AN HOUR WHEN TISSUE DISSECTION WAS BEING PERFORMED WHEN THE PIECE OF THE INSTRUMENT BROKE AND FELL INSIDE THE PATIENT. THE ENTIRE FALLEN PIECE WAS RETRIEVED USING ANOTHER INSTRUMENT. NO POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRASOUND REQUIRED. NO POST-SURGICAL COMPLICATIONS 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 THYROIDECTOMY SURGICAL PROCEDURE, THE CUSTOMER FOUND A CRACK ON THE HARMONIC ACE INSTRUMENT JAW. THERE WAS NO REPORT OF ANY FRAGMENTS FALLING INSIDE THE PATIENT. THE CUSTOMER REPLACED THE HARMONIC ACE INSTRUMENT WITH A BACK-UP INSTRUMENT OF THE SAME KIND AND COMPLETED THE PROCEDURE WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) PERFORMED FOLLOW-UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE INSTRUMENT WAS REPORTEDLY INSPECTED PRIOR TO USE, AND NO ISSUE WAS NOTED. NO INSTRUMENT COLLISION WAS OBSERVED DURING THE PROCEDURE. THE INSTRUMENT BLADE BROKE OFF AND FELL INSIDE THE PATIENT. THE SURGEON WAS MAKING AN INCISION AT THE TIME OF THE EVENT. THE INSTRUMENT PERFORMED AS INTENDED UP UNTIL IT BROKE. AFTER THE BLADE OF THE INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT, THE FRAGMENT WAS LOCATED AND RETRIEVED WITH LAPAROSCOPIC INSTRUMENT FORCEPS DURING THE SAME PROCEDURE. IT WAS CONFIRMED THAT ALL FRAGMENTS WERE RETRIEVED. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED, AND THERE WERE NO POST-OPERATIVE TESTS PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE INSTRUMENT WAS NOT

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING THE SECOND CASE OF THE DAY THE PATIENT EXPERIENCED A PNEUMOTHORAX IN THE LEFT UPPER LOBE (LUL). NO CHEST TUBE WAS PLACED; HOWEVER, THE PATIENT WAS ADMITTED FOR OBSERVATION AND PLACED ON OXYGEN DUE TO THE PATIENT HAVING HAD INCIDENTAL ABNORMAL LIVER FUNCTION AND NEEDED ADDITIONAL WORK UP NOT RELATED TO PNEUMOTHORAX. THE PATIENT HAS BEEN DISCHARGED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT A REVISION SURGERY WAS NEEDED TO REMOVE AND REPLACE MISPLACED SCREWS THAT WERE PLACED USING THE EXCELSIUS GPS SYSTEM.