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.

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 DURING A REVISION SURGERY, THE PATIENT HAD MISPLACED THORACIC SCREWS. ORIGINAL SURGERY OF PATIENT WAS ON (B)(6), CAME IN ON (B)(6) AND HAD REVISION SURGERY ON (B)(6). THERE WAS NO KNOWN IMPACT ON THE PATIENT OUTCOME. THE ORIGINAL SURGERY OCCURRED ON (B)(6) 2022, HOWEVER THE PATIENT DID NOT COME BACK TO THE HOSPITAL UNTIL (B)(6) 2022 AND HAD REVISION SURGERY ON (B)(6) 2022. T11 TO L3 BURST FRACTURE AT L1. SURGEON WAS PLANNING ON PLACING SCREWS FROM T11 TO L3, INCLUDING SCREWS AT L1 IF IT WAS POSSIBLE. THE CASE WAS DONE MIS USING SOLERA 5.5/6.0 VOYAGER. THE RESIDENTS MADE A SMALL INCISION AND PLACED THE SINGLE AMBER CLAMP ON THE SPINOUS PROCESS OF L1. ALL THE STEPS WERE TAKEN TO ACQUIRE THE IMAGING SYSTEM SCAN WITHOUT ISSUE. THE MANUFACTURER REPRESENTATIVE PLANNED THE SCREWS AS THE SURGEON WATCHED AND INFORMED THE REP WHERE HE WANTED THEM PLACED. THE PATIENT HAD VERY SMALL PEDICLES WITH SOME INTERESTING ANATOMY. THEY NOTED A POTENTIAL SKIVE AT T12 ON THE RIGHT. THEY STARTED AND THE RIGHT AND WENT TOP DOWN. THEY SENT EACH TRAJECTORY AND THE RESIDENTS MARKED THE SKIN. T

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.

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 THERE WAS A DEVIATION DURING A L3-L4 MINI-OPEN TLIF WITH RADIOLUCENT RETRACTORS. THE SURGICAL SYSTEM WAS MOUNTED TO THE PATIENT USING A SCHANZ PIN PLACED IN THE RIGHT SIDE OF THE PATIENT CONNECTED TO A BONE MOUNT BRIDGE. ALL SCREWS WERE ACCURATE EXCEPT FOR RIGHT L2. LEFT L2 WAS ACCURATELY PLACED. AT RIGHT L2, THE PATIENT JUMPED DURING DRILLING. THE RIGHT L2 TRAJECTORY WAS INITIALLY INFERIOR BY 3.5-10 MM WHEN TAKING FLUORO IMAGES. THE SURGEON WENT TO RIGHT L3 AND THE TRAJECTORY LOOKED OFF SO THEY WENT TO LEFT L3 AND L4 AND PLACED ACCURATE SCREWS. RIGHT L4 WAS THEN ACCURATELY PLACED. THE SURGEON WENT BACK TO RIGHT L2 AND REMOVED THE SCREW. REGISTRATION WAS REDONE. THE REGISTRATION SEGMENTATION LINES WERE ADJUSTED AT L2 INCASE THE LINES WERE PARTIALLY CUT OFF. THE SURGICAL ARM WAS SENT TO THE TRAJECTORY AND IMAGES WERE TAKEN WITH THE CANNULA, WHICH WAS ACCURATE. THE SCREW WAS TESTED AND CAME BACK AT 5. AN AP IMAGE WAS TAKEN AND THE SCREW WAS MEDIAL EVEN THOUGH NAVIGATION LOOKED ACCURATE. THE SCREW SKIVED BETWEEN 3.5-10 MM. THE SURGEON DECIDED TO ABORT THE USE OF THE GU

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).

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 GUIDANCE SYSTEM WAS USED DURING A FRACTURE TRAUMA CASE. THREE DAYS LATER, A REVISION WAS DONE TO REVISE TWO BREACHED SCREWS AT T6. THE LEFT AND RIGHT T6 SCREWS WERE 2 MM MEDIAL TO PLAN. A C-ARM WAS USED TO REMOVE AND PLACE THE SCREWS AT T6. DURING THE INITIAL PROCEDURE, THE SURGICAL SYSTEM WAS MOUNTED TO THE PATIENT USING A SPINOUS PROCESS CLAMP PLACED AT T9 AND THE BONE MOUNT BRIDGE. T7 WAS TOO UNSTABLE FOR THE CLAMP DUE TO THE FRACTURE AND THE SURGEON DID NOT WANT TO USE T8 SINCE THEY THOUGHT THE CLAMP WOULD BE IN THE WAY OF THE TRAJECTORY. A CT TO FLUORO WORKFLOW WAS USED AND SCREWS WERE PLACED AT LEFT T6 AND LEFT T8. THE SURGEON THEN SWITCHED TO THE RIGHT SIDE. NO NEUROMONITORING WAS DONE TO TEST MOTOR FUNCTION DUE TO THE PATIENT'S AIRWAY (TRACHEOSTOMY TUBE IN PLACE). THE SURGEON QUESTIONED ACCURACY DURING THE CASE AND A 10 POINT ACCURACY TEST WAS SUCCESSFULLY COMPLETED. NAVIGATION WAS ACCURATE WHEN CHECKED WITH THE PASSIVE PLANAR BEING PLACED ON THE SPINOUS PROCESS AND THE DIVOT ON THE ARM GUIDE. THE SURGEON WAS ON TRAJECTORY WITH THE TAP, SCREW, AND DILATO

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

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 THERE WAS A DEVIATION DURING A L4/L5 CASE. THE LEFT L4 SCREW WAS MEDIAL AND BREACHED THE CANAL. NAVIGATION WAS USED WITH THE DILATOR, BUT NOT WHEN PLACING THE SCREWS. THE SURGICAL SYSTEM WAS MOUNTED TO THE PATIENT USING A SCHANZ PIN PLACED IN THE PSIS. ACCURACY WAS NOT CHECKED THROUGHOUT THE PROCEDURE. THE SURGEON DID NOT THINK THE DEVIATION WAS DUE TO THE GUIDANCE SYSTEM AND THEY THOUGHT THE RETRACTOR PUSHED THE CANNULA MEDIALLY. THE AMOUNT OF DEVIATION WAS UNKNOWN. THE USE OF THE GUIDANCE SYSTEM WAS ABORTED AND THE SCREW WAS REPOSITIONED USING NAVIGATION. THE PROCEDURE WAS DELAYED LESS THAN AN HOUR.

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 THE PATIENT UNDERWENT DA VINCI ASSISTED LOW ANTERIOR RESECTION (LAR) WITH TOTAL MESORECTAL EXCISION (TME) ON 10-MAY-2022 AS PART OF A CLINICAL STUDY. IT WAS NOTED THAT THE PATIENT WAS FOUND WITH SUPERFICIAL FLUID COLLECTION CONSISTENT WITH A SEROMA ON 29-NOV-2022 ON THE MEDIAL OF THE SCAR FROM THE COLOSTOMY TAKEDOWN. THERE WAS NO REPORT OF FEVER, CHILLS OR PURULENT DRAINAGE. DRAINAGE WAS PERFORMED BY THE DERMATOLOGIST, AND WAS DRESSED WITH A BAND-AID. NO ANTIBIOTICS WERE PRESCRIBED BUT TYLENOL WAS RECOMMENDED FOR PAIN CONTROL IF NECESSARY. THE SEROMA WAS REPORTED AS RESOLVED ON 21-DEC-2022. THE STUDY INVESTIGATOR ASSESSED THIS EVENT WAS NOT RELATED TO THE DA VINCI DEVICES BUT RELATED TO THE PROCEDURE. THE ADVERSE EVENT WAS ASSESSED AS CLAVIEN-DINDO GRADE IIIA. THE INITIAL PROCEDURE WAS COMPLETED WITHOUT INTRA-OPERATIVE COMPLICATIONS REPORTED. THERE WAS NO REPORT OF MALFUNCTION OF THE DA VINCI SYSTEM, INSTRUMENTS, OR ACCESSORIES OCCURRED 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: 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

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON 02-APR-2020, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A "JORNAL BRASILEIRO DE PNEUMOLOGIA" ARTICLE TITLED, ¿ROBOTIC THORACIC SURGERY FOR NON-SMALL CELL LUNG CANCER: INITIAL EXPERIENCE IN BRAZIL¿ (TERRA, R. M., BIBAS, B. J., ET AL., 2020). WITHIN THE JOURNAL ARTICLE, AN OPERATIVE COMPLICATION INVOLVING A DA VINCI SURGICAL PROCEDURE WAS NOTED. IT WAS NOTED THAT A ¿PROCEDURE-RELATED DEATH OCCURRED IN 1 PATIENT (0.5%), 12 DAYS AFTER A LOBECTOMY. THAT PATIENT HAD DEVELOPED PNEUMONIA, SEPSIS, AND MULTIPLE ORGAN FAILURE.¿ THE ARTICLE CORRESPONDENT WAS CONTACTED TO GATHER ADDITIONAL INFORMATION AND THE INFORMATION WAS RECEIVED: THE ARTICLE CORRESPONDENT STATED THAT THERE WERE NO ALLEGATIONS OR CLAIMS THAT A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY MALFUNCTIONED DURING THE PROCEDURE. THE ARTICLE CORRESPONDENT ALSO STATED THAT "THE PROCEDURE-RELATED DEATH WAS ONE CASE IN WHICH THE PATIENT COURSED WITH PNEUMONIA AFTER THE PROCEDURE. NOTHING RELATED TO THE ACCESS ROUTE OR DA VINCI SYSTEM."

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS INITIALLY REPORTED THAT AFTER UNDERGOING TWO UNSPECIFIED SURGICAL PROCEDURES INVOLVING THE PROSTATE, TWO PATIENTS SUBSEQUENTLY CONTRACTED COVID-19 AND EXPIRED. PRIOR TO UNDERGOING THE SURGICAL PROCEDURES, THE PATIENTS HAD TESTED NEGATIVE FOR COVID-19 PRIOR TO THE PROCEDURE. THE INITIAL REPORTER COULD NOT CONFIRM IF THE PROCEDURES IN QUESTION INVOLVED THE USE OF A DA VINCI SURGICAL SYSTEM. IN ADDITION, THE INITIAL REPORTER ALSO DID NOT WHAT HOSPITAL(S) OR SURGEON(S) WERE INVOLVED. ON 04-MAY-2020, THE INITIAL REPORTER WAS CONTACTED AND THE FOLLOWING INFORMATION WAS OBTAINED: THE INITIAL REPORTER DISCUSSED THE SURGERIES WITH REPORTING PROFESSOR/SURGEON ON 29-APR-2020. THE TWO SURGERIES WERE PROSTATECTOMIES; HOWEVER, IT IS UNKNOWN WHETHER A DA VINCI SYSTEM WAS EVEN USED FOR EITHER SURGERY. THE REPORTING PROFESSOR/SURGEON WAS UNABLE TO PROVIDE THE ASSOCIATED HOSPITAL(S) OR SURGEON NAME(S) AS HE DOES NOT REMEMBER BECAUSE IT WAS SECONDHAND INFORMATION. THE REPORTING PROFESSOR/SURGEON BROUGHT THESE CASES UP DURING A CONVERSATION ABOUT FAULTY COVID-19 TEST RESULTS. THE REPORTING PROFESSOR/SURGEON STATED THAT IT IS UNKNOWN WHETHER THE TWO PATIENTS HAD RECEIVED FALSE NEGATIVE TESTS PRI

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON 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: 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." NOTE

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON 14-MAY-2020, INTUITIVE 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. THE ARTICLE¿S CONCLUSION CONTAINS THE FOLLOWING: ¿THERE WERE NO COMPLICATIONS DIRECTLY RELATED TO THE ROBOTIC PLATFORM, MAKING THE SP A SAFE SURGICAL INSTRUMENT FOR UPPER AERODIGESTIVE TRACT TUMORS. ALTHOUGH THE NEW SYSTEM POSED UNIQUE TECHNICAL CHALLENGES, THE OVERALL LEARNING CURVE FOR THE SP WAS RAPID AMONG EXPERIENCED TORS SURGEONS.¿ INTUITIVE SURGICAL, INC. (ISI) FOLLOWED-UP WITH THE AUTHOR WHO STATED THE FOLLO

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS INITIALLY REPORTED THAT AFTER UNDERGOING TWO UNSPECIFIED SURGICAL PROCEDURES INVOLVING THE PROSTATE, TWO PATIENTS SUBSEQUENTLY CONTRACTED COVID-19 AND EXPIRED. PRIOR TO UNDERGOING THE SURGICAL PROCEDURE, THE PATIENTS HAD TESTED NEGATIVE FOR COVID-19 PRIOR TO THE PROCEDURE. THE INITIAL REPORTER COULD NOT CONFIRM IF THE PROCEDURES IN QUESTION INVOLVED THE USE OF A DA VINCI SURGICAL SYSTEM. IN ADDITION, THE INITIAL REPORTER ALSO DID NOT WHAT HOSPITAL(S) OR SURGEON(S) WERE INVOLVED. ON 04-MAY-2020, THE INITIAL REPORTER WAS CONTACTED AND THE FOLLOWING INFORMATION WAS OBTAINED: THE INITIAL REPORTER DISCUSSED THE SURGERIES WITH THE REPORTING PROFESSOR/SURGEON ON (B)(6) 2020. THE TWO SURGERIES WERE PROSTATECTOMIES; HOWEVER, IT IS UNKNOWN WHETHER A DA VINCI SYSTEM WAS EVEN USED FOR EITHER SURGERY. THE REPORTING PROFESSOR/SURGEON WAS UNABLE TO PROVIDE THE ASSOCIATED HOSPITAL(S) OR SURGEON NAME(S) AS HE DOES NOT REMEMBER BECAUSE IT WAS SECONDHAND INFORMATION. THE REPORTING PROFESSOR/SURGEON BROUGHT THESE CASES UP DURING A CONVERSATION ABOUT FAULTY COVID-19 TEST RESULTS. THE REPORTING PROFESSOR/SURGEON STATED THAT IT IS UNKNOWN WHETHER THE TWO PATIENTS HAD RECEIVED FALSE NEGATIVE TESTS

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING THE DBS PROCEDURE MULTIPLE O-ARM SPINS WERE MERGED TO THE FIRST BONE FIDUCIAL O-ARM SPIN. ONLY THE LAST O-ARM SPIN PRESENTED A MERGE ISSUE. THE LATEST CT SCAN WAS ROTATED 90 DEGREES OVERLAYING THE FIDUCIAL O-ARM SPIN. ADJUSTMENTS WERE MADE USING THE ROTATION AND TRANSLATION TOOLS, HOWEVER AFTER RECALCULATING, THE SYSTEM IMMEDIATELY REVERTED TO THE ORIGINAL 90 DEGREE MIS-ORIENTATION. SINCE THE SCANS WERE NOT MERGING CORRECTLY AFTER RECALCULATING, IT WAS ATTEMPTED MERGING THE LAST O-ARM CST TO THE ORIGINAL PLANNING MRI. THIS MERGE PRESENTED NO ISSUES AND AFTER CAREFUL OBSERVATION THE SURGEON ACCEPTED THE MERGE ON THE SOFTWARE. THESE LAST O-ARM SPINS DURING THE OPERATION CONFIRMED ACCURATE ELECTRODE PLACEMENT. HOWEVER, 2 WEEKS POST-OPERATION SURGEON CONTACTED ZIMMER BIOMET CLAIMING THE CT SCANS OBTAINED AFTER PROCEDURE AND O-ARMS DURING PROCEDURES DO NOT MATCH RESULTING IN INACCURATE ELECTRODE PLACEMENT. CUSTOMER IS REQUESTING AN INVESTIGATION TO DETERMINE IF THE MERGING SOFTWARE CONTRIBUTED TO INACCURATE ELECTRODE PLACEMENT. PATIENT IMPACT IS UNKNOWN HOWEVER SURGEON INDICATED A REVISION SURGERY MAY BE NECESSARY.

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.

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 THERE WERE MULTIPLE BREACHES DURING THE T9-L4 FUSION WITH ADDITIONAL RESECTIONS AND MODIFICATIONS. THE SURGICAL SYSTEM WAS MOUNTED USING A CLAMP AND SCHANZ PIN. THE PATIENT WAS NOTED TO HAVE A BMI OVER 40. THE CASE WAS SEPARATED INTO TWO SEGMENTS, T9-T11 AND T12-L4. WHEN SETTING UP THE CASE, THE 3 DEFINE SCAN FAILED SO A GENERIC WORK VOLUME WAS USED FOR THE FIRST SEGMENT. THE SURGEON HAD SOME DIFFICULTY WITH REGISTRATION, BUT THEY WERE EVENTUALLY ABLE TO GET THE SEGMENT REGISTERED. THE SURGICAL ARM WAS SENT TO THE RIGHT T9 TRAJECTORY, BUT THE TRAJECTORY LOOKED MEDIAL. THE PLAN WAS ADJUSTED AND THE SURGICAL ARM WAS RESENT TO THE TRAJECTORY. AFTER DRILLING, THE SURGEON NOTICED A CSF LEAK AND THEY FOUND A MEDIAL BREACH USING A PROBE. THE PLACEMENT OF THE SCREW WAS ADJUSTED AND THE SURGEON CONTINUED TO PLACE SCREWS THROUGH T11 LEFT AND RIGHT WITHOUT ISSUE AND JUST MINOR ADJUSTMENTS TO PLAN. EACH SECTION WAS PROBED BY THE SURGEON AND NO BREACHES WERE FOUND. THE SURGEON THEN MOVED TO THE SECOND SEGMENT. DUE TO RESECTION, NAVIGATION WITH A PERCUTANEOUS PIN REFERENCE FRAME