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

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: INTUITIVE SURGICAL, INC. (ISI) RECEIVED MW5109522 ON (B)(6) 2022 AND THE FOLLOWING INFORMATION WAS PROVIDED: "DURING USE OF THE XI ROBOTIC SYNCHROSEAL INSTRUMENT, THE PLASTIC SHEATH COVERING TIP OF INSTRUMENT TORE OFF SHAFT OF INSTRUMENT AND WAS FOUND INSIDE PATIENT. SURGEON AND STAFF MEMBERS NOTICED PIECE OF INSTRUMENT INSIDE PATIENT. THE INSTRUMENT WAS REMOVED FROM SURGICAL USE AND DISLODGED PIECE WAS REMOVED FROM INSIDE PATIENT. BOTH INSTRUMENT AND PIECE WERE SAVED AND PLACED IN DIRTY UTILITY ROOM TO SENT BACK TO COMPANY FOR INSPECTION. FDA SAFETY REPORT ID# (8)(4). SYNCHROSEAL IS A BIPOLAR ELECTROSURGICAL INSTRUMENT FOR USE WITH A COMPATIBLE DA VINCI SURGICAL SYSTEM AND A COMPATIBLE ELECTRO SURGICAL GENERATOR. IT IS INTENDED FOR GRASPING, DISSECTION, SEALING AND TRANSECTION OF TISSUE. SYNCHROSEAL CAN BE USED TO SEAL VESSELS UP TO AND INCLUDING 5 MM IN DIAMETER AND TISSUE BUNDLES THAT FIT IN THE JAWS OF THE INSTRUMENT. SYNCHROSEAL, WHEN USED WITH A COMPATIBLE ELECTROSURGICAL GENERATOR, CREATES A SEAL AND TRANSECTS TISSUE BY APPLICATION OF RADIOFREQUENCY (RF) ENERGY TO VESSELS AND TISSUE BUNDLES THAT FIT IN THE JAWS OF THE INSTRUMENT. ELECTRODE SEALING SURFACES AND A CUT ELECTROD

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 WITH LYMPHADENECTOMY PROSTATECTOMY SURGICAL PROCEDURE, A GRAY PIECE OF THE SYNCHOSEAL INSTRUMENT COMPLETELY FELL OFF INTO THE PATIENT. THE PIECE WAS REMOVED AND ANOTHER INSTRUMENT WAS USED AS A REPLACEMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ON (B)(6) 2022, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING INFORMATION FROM THE SURGEON: FOR THE LYMPHADENECTOMY PROSTATECTOMY PROCEDURE, ALL FRAGMENTS WERE RETRIEVED AND WAS CONFIRMED VISUALLY. NO ADDITIONAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT AND NO POST-OPERATIVE TESTS WERE PERFORMED. THE SURGEON SUSPECTED THAT THE INSULATION WRAPPING SIMPLY HAD WEAR AND FELL OFF THE INSTRUMENT. THE SURGEON NOTED THAT THIS OCCURRED LESS THAN AN HOUR AFTER THE INSTRUMENT WAS FIRST USED. THE INSTRUMENT WORKED COMPLETELY FINE AND DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS DURING THE PROCEDURE. THE INSTRUMENT WAS REMOVED IMMEDIATELY AFTER THE FRAGMENT FELL. IT WAS NOTED THAT THERE WAS NO RESISTANCE IN THE CANNULA, THE INSTRUMENT WRIST WAS STRAIGHTENED, NO DAMAGE TO THE CANNULA HAD OCCURRED, AND THERE WAS NO OTHER DAMAGE TO THE INSTRUMENT. THERE WAS NO PATIENT INJURY RE

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 PATIENT UNDERWENT A NAVIGATIONAL BRONCHOSCOPY FOR SAMPLING OF THE RIGHT MIDDLE LOBE (RML). A RIGHT-SIDED PNEUMOTHORAX WAS NOTED, AND A PIGTAIL CHEST TUBE WAS PLACED. THE CATHETER WAS SUTURED IN PLACE AND ATTACHED TO-20CMH20 SUCTION. THE PATIENT WAS ADMITTED OVERNIGHT FOR OBSERVATION. POST CHEST TUBE PLACEMENT CHEST X-RAYS (CXR) SHOWED RESOLUTION OF THE PNEUMOTHORAX. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WAS A DEVIATION DURING A SCAN PLAN L1-L4 FUSION TRANS-FACIAL PROCEDURE. THE SURGICAL SYSTEM WAS MOUNTED TO THE PATIENT USING A SPINAL PROCESS CLAMP AT L2. RIGIDITY WAS CHECKED BY THE SURGEON AND THEY FELT THE MOUNT WAS SOLID. BILATERAL RETRACTION WAS VERY LIGHT AND USED ON THE SKIN. THE PATIENT HAD FRACTURES AT L2 AND L3. THERE WAS A 2 CM SHIFT DURING THE PROCEDURE. THE LEFT L1 SCREW WENT LATERAL AND THE RIGHT L1 SCREW WENT THROUGH THE CANAL. THE SCREWS WERE REMOVED. SEVEN SPINS WERE TAKEN TO IDENTIFY THE DEVIATION. THE SURGEON DECIDED TO ABORT THE USE OF THE GUIDANCE SYSTEM AND PLACE SCREWS AT L1 USING NAVIGATION. THE PROCEDURE WAS DELAYED AN HOUR.

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 DUE TO CONCERNS FOR POTENTIAL PNEUMOTHORAX (HIGH PEAK PRESSURE AND DECLINING 02 SATURATIONS). THE PHYSICIAN OBTAINED A PORTABLE CHEST X-RAY (CXR) AND A LEFT SIDED PNEUMOTHORAX WAS NOTED. THE PHYSICIAN PROCEEDED TO PLACE A 14G WAYNE PNEUMOTHORAX CHEST TUBE AT THE BEDSIDE. THE PATIENT WAS ADMITTED FOR OBSERVATION. THE CHEST TUBE WAS REMOVED, AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: LEGAL DEPARTMENT HAS INFORMED US THAT THE CUSTOMER IS INVOLVED IN A LEGAL DISPUTE IN WHICH IT IS ALLEGED THAT A MAKO DID NOT WORK PROPERLY. ADDITIONAL INFORMATION RECEIVED: ON (B)(6) 2022, THE PATIENT, UNDERWENT A KNEE TEP IMPLANTATION USING THE MAKO SYSTEM. THE PREOPERATIVE ANATOMICAL AXIAL DEVIATION SHOWED A VARUS DEFORMITY OF 7° WITH 10° FLEXION. BASED ON THESE FINDINGS, DOCTOR DECIDED TO PERFORM A BONE CUT ON THE TIBIA WITH 1° VARUS AND 0.7° VALGUS, WHICH RESULTED IN A PLANNED TOTAL AXIS CORRECTION OF 0.3° VARUS. AFTER MAKING THE PLANNED INCISIONS ON THE FEMUR AND TIBIA AND INSERTING THE TRIAL IMPLANTS, THE MECHANICAL LEG AXIS WAS MEASURED INTRAOPERATIVELY USING THE MAKO SYSTEM. THE RESULT SHOWED AN AXIS OF 1° VARUS WITH 1° FLEXION. THE ACCURACY OF THE MEASUREMENT WAS CONFIRMED BY THE MPS SYSTEM. THE SURGEON, DID NOT OBJECT TO THE MEASUREMENTS, SO THAT THE FINAL IMPLANTS WERE INSERTED IN ACCORDANCE WITH THE PLANNING. POSTOPERATIVELY, HOWEVER, THE X-RAY CHECK REVEALED AN AXIAL POSITION IN THE VALGUS AREA. TKA 1.0 UPDATE AS PER SALES REP 17-OCT-2025: THE PATIENT UNDERWENT KNEE REVISION SURGERY ON (B)(6) 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: PATIENT CALLED TO REPORT AN ADVERSE EVENT INVOLVING A DA VINCI ROBOTIC DEVICE THAT WAS USED DURING A HERNIA REPAIR SURGERY ON (B)(6) 2022. PATIENT STATED SHE SPENT 4+ HOURS IN POST-OP AND THEY COULDN'T KEEP HER BLOOD PRESSURE STABLE. PATIENT SAID SHE KEPT PASSING OUT DUE TO LOSS OF BLOOD AND WAS HAVING INTENSE PAIN AT THE SURGICAL SITE. PATIENT STATED SHE REQUIRED AN EMERGENCY SURGERY TO EVACUATE THE BLOOD AND REATTACH THE MUSCLE THAT WAS DAMAGED DURING THE SURGERY. PATIENT SAID SHE SPENT SEVERAL DAYS IN THE ICU AND CONTINUES TO HAVE PAIN AND SWELLING DUE TO THE UNEXPECTED BLEED THAT OCCURRED AT THE SURGICAL SITE WHERE THE ROBOTIC DEVICE WAS USED. PATIENT SAID SHE IS NOW ANEMIC AND STILL CAN'T BEND OVER OR DO NORMAL DAY-TO-DAY ACTIVITIES AS SHE'S STILL HEALING FROM THE EVENT.

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 REPORTED THAT DURING INITIAL ENTRY WITH AN INTUITIVE SURGICAL, INC. (ISI) TROCAR AND OBTURATOR AT THE START OF A VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT EXPERIENCED BLEEDING. THE PROCEDURE WAS CONVERTED TO AN OPEN SURGICAL PROCEDURE TO IDENTIFY THE SOURCE OF THE BLEEDING. THREE OTHER SURGEONS WERE ASKED TO ASSIST WITH FINDING THE SOURCE OF THE BLEEDING. HOWEVER, THE SURGEONS COULD NOT IDENTIFY THE INJURED VESSEL, AND THE PATIENT REPORTEDLY EXPIRED. ISI CONTACTED THE SURGEON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: IN AN ATTEMPT TO GAIN INITIAL ACCESS TO THE ABDOMINAL CAVITY, THE SURGEON INSERTED AN ISI 8MM TROCAR IN THE LEFT UPPER QUADRANT UNDER DIRECT VISUALIZATION. THE ABDOMINAL CAVITY WAS NOT SUCCESSFULLY ENTERED DURING THE FIRST ATTEMPT AS THE SURGEON ONLY SAW FAT. DURING THE SECOND ATTEMPT, THE SURGEON AGAIN FAILED TO GAIN ACCESS. HOWEVER, AFTER THE SECOND ATTEMPT TO GAIN ACCESS, BLOOD WAS SEEN ALONG WITH FAT. THE SURGEON WAS NOT SURE IF THERE WAS ANY MISIDENTIFICATION OF ANATOMY DUE TO THE AMOUNT OF FAT. THE ANESTHESIOLOGIST STATED THAT THE BLOOD PRESSURE WAS INITIALLY STABLE. THE SURGEON THEN CONVERTED TO AN OPEN SURGICAL

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 INGUINAL HERNIA SURGICAL PROCEDURE, AN UNKNOWN INSTRUMENT WAS OBSERVED TO HAVE A BROKEN PRONG. UPON INSERTION, A PRONG FELL OFF THE INSTRUMENT INTO THE PATIENT'S ABDOMEN. THE PIECE HAD TO BE REMOVED AND A NEW INSTRUMENT WAS THEN USED. THE PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUES. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGEON WAS NOT ABLE TO PROVIDE WHAT TYPE OF INSTRUMENT HAD THE BREAKAGE ISSUE OR IF THE INSTRUMENT WAS INSPECTED PRIOR TO USE. THE INSTRUMENT BROKE IMMEDIATELY UPON INSERTION AND THE PIECE INTO THE ABDOMEN. ALL FRAGMENTS WERE RETRIEVED BY DIRECT VISUALIZATION. THE SURGEON WAS UNAWARE IF THE INSTRUMENT WILL BE RETURNED FOR ANALYSIS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE WHEEL HOLDING THE SHEATH OF THE SYNCHROSEAL INSTRUMENT CAME OFF AND FELL INTO THE PATIENT WHEN THE INSTRUMENT TOUCHED THE ENDOSCOPE. THE FRAGMENT WAS REMOVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ON 19-MAY-2022: THE BROKEN WHEEL FELL ON THE DIGESTIVE TRACT AND WAS RETRIEVED WITH A LAPAROSCOPIC SURGICAL FORCEPS. IT WAS CONFIRMED THAT THE ENTIRE WHEEL WAS RETRIEVED AND NO ADDITIONAL POSTOPERATIVE TESTS WERE PERFORMED TO REMOVE IT. THE SURGEON BELIEVED THAT HE MIGHT HAVE HIT THE ENDOSCOPE WITH THE SYNCHROSEAL INSTRUMENT JUST BEFORE THE WHEEL WAS SEEN ON THE DIGESTIVE TRACT. THE SYNCHROSEAL INSTRUMENT WAS IN USE FOR APPROXIMATELY 3 HOURS PRIOR TO ISSUE OCCURRED AND THE SURGEON WAS PERFORMING A HEPATECTOMY: SECTION OF THE LIVER. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO ISSUES WERE NOTED. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE. THERE WAS NO PATIENT INJURY AND

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 MISPLACED SCREWS DURING THE PROCEDURE. ALL OF THE MISPLACED SCREWS WERE MEDIAL BETWEEN 3.5-10 MM. THE SURGICAL SYSTEM WAS MOUNTED TO THE PATIENT USING A SCHANZ ARM CONNECTED TO A SCHANZ PIN PLACED IN THE RIGHT PSIS. THE SURGEON WAS ON THE LEFT SIDE OF THE PATIENT AND IMPLANTED IPSILATERAL PEDICLE SCREWS FROM L4-S1. THE SURGEON THEN IMPLANTED IPSILATERAL L4-S1 FROM THE RIGHT SIDE. THEN THEY IMPLANTED A CONTRALATERAL S2AI SCREW FROM THE PATIENT'S RIGHT. THE SURGEON FINALLY IMPLANTED THE PATIENT'S RIGHT S2AI SCREW FROM THE LEFT SIDE OF THE PATIENT. ALL WERE MEDIAL EXCEPT ONE OF THE S2 SCREWS. AN ACCURACY CHECK HAD BEEN RUN AFTER PLACING THE L5 RIGHT AND THE SYSTEM APPEARED ACCURATE AT THAT TIME. NO PATIENT SHIFT OR SOFT TISSUE TENSION WAS NOTED WHEN PLACING THE SCREWS DURING THIS OPEN PROCEDURE. MINIMAL RETRACTION WAS NEEDED. THE MALIGNED SCREWS WERE NOTICED IN A POSTOP CT SCAN. THERE WAS NO SPIN PERFORMED TO CHECK THE PLACEMENT OF THE IMPLANTS INTRAOPERATIVELY. A SEPARATE REVISION WAS PLANNED TO REVISE THE SCREWS. THE PROCEDURE WAS NOT DELAYED.

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-MAR-2022, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A "GASTROENTEROLOGY REPORT" JOURNAL ARTICLE TITLED, ¿ROBOTIC TOTAL GASTRECTOMY FOR CARCINOMA IN THE REMNANT STOMACH: A COMPARISON WITH LAPAROSCOPIC TOTAL GASTRECTOMY¿ (LI, Z., LIU, J., ET AL., 2021). THE PURPOSE OF THE ARTICLE WAS TO COMPARE THE EFFICACY AND SAFETY OF ROBOTIC TOTAL GASTRECTOMY (RTG) AND LAPAROSCOPIC TOTAL GASTRECTOMY (LTG) FOR THE TREATMENT OF CARCINOMA IN THE REMNANT STOMACH (CRS). A RETROSPECTIVE ANALYSIS OF DATA FROM PATIENTS WHO UNDERWENT RTG OR LTG FOR CRS AT A SPECIFIED HOSPITAL BETWEEN MAY 2006 AND OCTOBER 2019 WAS CONDUCTED. ALL SURGERIES WERE PERFORMED BY ONE SURGEON. THE SURGEON PERFORMED A TOTAL OF 27 ROBOTIC GASTRECTOMIES (RG). THE SURGICAL METHOD OF ROBOTIC VERSUS LAPAROSCOPIC WAS SELECTED BY EACH PATIENT. THE DA VINCI SURGICAL SYSTEM WAS USED FOR 29 PATIENTS. FIVE CASES IN THE RTG GROUP UNDERWENT CONVERSION TO OPEN SURGERY. THE REASONS FOR CONVERSION TO OPEN SURGERY IN THE ROBOTIC GROUP INCLUDED 3 CASES OF EXTENSIVE ADHESIONS, 1 CASE OF TUMOR INVASION TO THE TRANSVERSE COLON, AND 1 CASE OF TUMOR INVASION TO THE DIAPHRAGM. POST-OPERATIVELY, 1 PATIENT EXPERIENCED PNEUMONIA, 1 HAD AN INTRA-AB

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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 MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, THE METAL PIECE OF THE SYNCHROSEAL INSTRUMENT FELL INTO THE PATIENT AND IT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT INJURY. SYNCHROSEAL IS A BIPOLAR ELECTROSURGICAL INSTRUMENT FOR USE WITH A COMPATIBLE DA VINCI SURGICAL SYSTEM AND A COMPATIBLE ELECTRO SURGICAL GENERATOR. IT IS INTENDED FOR GRASPING, DISSECTION, SEALING AND TRANSECTION OF TISSUE. SYNCHROSEAL CAN BE USED TO SEAL VESSELS UP TO AND INCLUDING 5 MM IN DIAMETER AND TISSUE BUNDLES THAT FIT IN THE JAWS OF THE INSTRUMENT. SYNCHROSEAL, WHEN USED WITH A COMPATIBLE ELECTROSURGICAL GENERATOR, CREATES A SEAL AND TRANSECTS TISSUE BY APPLICATION OF RADIOFREQUENCY (RF) ENERGY TO VESSELS AND TISSUE BUNDLES THAT FIT IN THE JAWS OF THE INSTRUMENT. ELECTRODE SEALING SURFACES AND A CUT ELECTRODE WITHIN THE JAWS ENABLE SEALING AND CUTTING. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A TKA ROBOTIC ASSISTED SURGERY THE POSTERIOR RESECTION WAS 4.5MM MORE THAN PLANNED ON BOTH SIDES, RESULTING IN AN UNEQUAL BALANCE BETWEEN EXTENSION AND FLEXION AND THE USE OF A THICKER POLY. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT AT THIS TIME. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RETROPERITONEAL PARTIAL NEPHRECTOMY, THE RENAL ARTERY WAS IDENTIFIED AND SKELETONIZED. THE SURGEON PLACED TWO SCANLAN BULLDOG CLAMPS (A 3RD-PARTY MANUFACTURER PRODUCT) ON THE RENAL ARTERY. FIREFLY WAS USED TO CONFIRM OCCLUSION OF THE ARTERY. HOWEVER, FIREFLY SHOWED THAT THE ARTERY WAS NOT PROPERLY OCCLUDED AND THE KIDNEY WAS STILL PERFUSED. AS A RESULT, THE SURGEON REMOVED THE SCANLAN BULLDOG CLAMPS AND PLACED UNSPECIFIED LAPAROSCOPIC CLAMP(S). ON 25-APR-2022, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON AND OBTAINED ADDITIONAL INFORMATION: DURING THE SURGICAL PROCEDURE, THE SURGEON CONFIRMED THAT THERE WAS NO MALFUNCTION OF THE SP FENESTRATED BIPOLAR INSTRUMENT THAT WAS USED IN CONJUNCTION WITH THE SCANLAN BULLDOG CLAMPS. THE SURGEON EXPLAINED THAT AFTER PROPER SKELETONIZATION, THE SP BULLDOG CLAMPS WERE APPLIED AND THEN FIREFLY WAS TURNED ON. THE FIELD APPEARED GREEN. THE SURGEON STATED THAT HE FELT THE CLAMPING FORCE WAS INADEQUATE. THE SURGEON SWITCHED TO UNSPECIFIED LAPAROSCOPIC BULLDOG CLAMP(S) TO CONTINUE THE PROCEDURE WITH NO FURTHER ISSUES. THE SURGEON CONFIRMED THERE WAS NO ISSUE WITH ANY OF THE DA VINCI SP INSTRUMEN

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT A BRAIN SURGERY WAS PERFORMED WITH ROSA ONE BRAIN ON (B)(6) 2022. IN SEEG ELECTRODE PLACEMENT, SUBDURAL HEMATOMA WAS FOUND BY POSTOPERATIVE CT. POSTOPERATIVE ANESTHESIA AFTER AWAKENING, PARALYSIS WAS CONFIRMED IN THE GRIP STRENGTH AND BEHAVIOR OF THE LEFT FINGERTIP. ABOUT FOUR HOURS AFTER THE SURGERY, THE CONDITION WAS IMPROVED BUT IT WAS RECOGNIZED AS NEUROPATHY. THE CAUSAL RELATIONSHIP WITH THE SITE OF SUBDURAL HEMATOMA IS UNKNOWN. IF PARALYSIS REMAINS, THE ELECTRODE MAY BE REMOVED. THERE WAS NO PROBLEM WITH THE OPERATION OF ROSA DURING THE OPERATION, AND THE CAUSAL RELATIONSHIP WITH THIS COMPLICATION IS UNKNOWN.

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 11-MAR-2022, INTUITIVE BECAME AWARE OF A "TRANSLATIONAL LUNG CANCER RESEARCH" JOURNAL ARTICLE TITLED, ¿ROBOTIC-ASSISTED THORACIC SURGERY REDUCES PERIOPERATIVE COMPLICATIONS AND ACHIEVES A SIMILAR LONG-TERM SURVIVAL PROFILE AS POSTEROLATERAL THORACOTOMY IN CLINICAL N2 STAGE NON-SMALL CELL LUNG CANCER PATIENTS: A MULTICENTER, RANDOMIZED, CONTROLLED TRIAL¿ (HUANG, J., TIAN, Y., ET AL., 2021). THIS STUDY WAS DONE TO EXPLORE THE LONG-TERM EFFICACY AND POTENTIAL BENEFIT IN SURVIVAL OF ROBOTIC-ASSISTED THORACIC SURGERY (RATS) COMPARED WITH LOBECTOMY IN CLINICAL N2 (C-N2) STAGE NON-SMALL CELL LUNG CANCER (NSCLC) PATIENTS. WITHIN THE JOURNAL ARTICLE, POST-OPERATIVE COMPLICATIONS INVOLVING DA VINCI SURGICAL PROCEDURES WERE NOTED: POSTOPERATIVE COMPLICATIONS THAT OCCURRED IN THE RATS GROUP WERE PROLONGED AIR LEAK (7.9%) AND BRONCHOPLEURAL FISTULA. ADDITIONALLY, THE FOLLOWING COMPLICATIONS WERE OBSERVED AMONG THE PATIENTS IN THE RATS GROUP: 3 PATIENTS EXPERIENCED PNEUMONIA, 3 PATIENTS HAD ATRIAL FIBRILLATION, 3 PATIENTS HAD ATRIAL ARRHYTHMIA, 3 PATIENTS UNDERWENT CHEST TUBE INSERTION, 3 PATIENTS EXPERIENCED SUBCUTANEOUS EMPHYSEMA, 3 PATIENTS HAD CHYLOTHORAX, 2 PATIENTS EXPERIENCED HYPERPYRE

VELYS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: SURGEON STARTED VELYS RAS ATTUNE PS PRIMARY KNEE AFTER COMPLETION OF ALL INITIALIZATION, CALIBRATION AND DRAPING AS PER THE IFU. NATURAL JOINT ASSESSMENT AND PLANNING WAS THEN COMPLETED AND THE SURGEON CHOSE TO PERFORM A 2 DEGREE VARUS CUT ON THE TIBIA. THE KNEE WAS POSITIONED WITH 'Z' RETRACTORS PLACED MEDIAL AND LATERAL TO PROTECT THE COLLATERAL LIGAMENTS. AFTER FINISHING THE CUT WITH AN OSTEOTOME THE SENSOR TENSOR WAS THEN USED TO CHECK BALANCE WITH THE ACCUBALANCE GRAPH. IT WAS THEN NOTED AN UNEXPECTED INCREASE IN MEDIAL LAXITY RELATIVE TO THE LATERAL COMPARTMENT. AFTER FURTHER ASSESSMENT IT WAS IDENTIFIED THAT THE MCL WAS DAMAGED AND NEED REPAIR WITH FIBREWIRE. THIS WAS COMPLETED AND THE FEMORAL CUTS WERE COMPLETED WITH NAVIGATION. THE REST OF THE CASE PROCEEDED WITHOUT FURTHER DELAY OR INCIDENT. DOE: (B)(6) 2022.

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 REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY WITH LYMPHADENECTOMY PROCEDURE THAT THE PATIENT'S LUNG CAPACITY STARTED TO DETERIORATE. THE PATIENT THEN EXPERIENCED AN UNSPECIFIED CARDIAC EVENT AND CODED. THE DA VINCI SYSTEM WAS UNDOCKED FROM THE PATIENT TO ATTEMPT TO REVIVE THE PATIENT, BUT THE ATTEMPTS WERE UNSUCCESSFUL. THE PATIENT REPORTEDLY EXPIRED IN THE OPERATING ROOM. ON 31-MAR-2022, AN INTUITIVE SURGICAL INC. (ISI) ENTERPRISE SOLUTIONS MANAGER (ESM) WAS CONTACTED AND ADDITIONAL INFORMATION WAS OBTAINED ON THIS EVENT: THE ESM WAS PRESENT FOR THE FIRST 45 MINUTES OF THIS PROCEDURE. THE PROCEDURE WAS GOING WELL WITH NO ISSUES. THE ESM LEFT THE OPERATING ROOM FOR 65 MINUTES AS THEY WENT TO CALL INTO A CONFERENCE CALL FOR ANOTHER EVENT. WHEN THE ESM RETURNED TO THE OPERATING ROOM HE NOTICED A CROWD OF PEOPLE AROUND THE OPERATING ROOM. THE ESM OBSERVED THE PATIENT UNDOCKED WITH THEIR PORT SITES BEING SUTURED AS IF THE PROCEDURE WAS COMPLETED. THE ESM ENCOUNTERED THE SURGEON LEAVING THE OPERATING ROOM AND ASKED WHAT HAPPENED. THE SURGEON SAID THE PATIENT CODED AND THAT THEY DID EVERYTHING THEY COULD BEFORE WALKING AWAY. THE ESM ASKED THE OPERATING ROOM STAFF STILL I

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.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TOTAL BENIGN HYSTERECTOMY THE CUSTOMER OBSERVED A SMALL METAL RING ON TOP OF THE PATIENT'S UTERUS. THE RING WAS THOUGHT TO BE FROM THE SYNCHROSEAL INSTRUMENT THAT WAS IN USE AT THE TIME. THE RING WAS RETRIEVED, THE INSTRUMENT WAS REMOVED, AND A NEW SYNCHROSEAL INSTRUMENT WAS OPENED TO COMPLETE THE PROCEDURE. INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE CUSTOMER. IT WAS CONFIRMED THAT THE METAL RING WAS RETRIEVED FROM THE PATIENT DURING THE SAME CASE. THE SURGEON VISUALLY CONFIRMED THAT THE METAL RING FROM THE INSTRUMENT WAS RETRIEVED. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS ISSUE. NO OTHER INFORMATION WAS AVAILABLE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY PROCEDURE, THE SCANLAN BULLDOG CLAMPS DID NOT SUFFICIENTLY OCCLUDE THE RENAL ARTERY. ON (B)(6) 2022, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON AND OBTAINED ADDITIONAL INFORMATION: THE SURGEON CLAIMED THAT THE SCANLAN BULLDOG CLAMPS DID NOT SUFFICIENTLY OCCLUDE THE RENAL ARTERY WHILE EXCISING TWO TUMORS ON THE INFERIOR AND SUPERIOR POLE OF THE KIDNEY. HE INITIALLY WORKED ON THE TUMOR ON THE INFERIOR POLE OF THE KIDNEY. THE SURGEON STATED THAT HE HAD SKELETONIZED THE RENAL ARTERY AND CLAMPED IT DOWN WITH THE SCANLAN BULLDOG CLAMP. HE MADE SURE HE CLAMPED IT WELL, AND THE TIP OF THE CLAMP WAS PAST THE ARTERY. HOWEVER, THE KIDNEY STILL WAS PERFUSED. AS A RESULT, THERE WAS AN ADDITIONAL 300CC OF BLOOD LOSS AND A POTENTIALLY HAZARDOUS DELAY IN THE PROCEDURE DURING WARM ISCHEMIA. THE TOTAL ISCHEMIA TIME AND THE ACTUAL EXTRA DELAY IN TIME WERE NOT PROVIDED. THE SURGEON THEN EXCISED THE TUMOR AND ADDRESSED THE BLEEDING WITH A FEW ADDITIONAL SUTURES. FOR THE SECOND TUMOR ON THE SUPERIOR POLE OF THE KIDNEY, THE SURGEON RECLAMPED THE RENAL ARTERY AGAIN WITH THE SCALAN BULLDOG CLAMP. HE CLAMPED APPROXIMATELY 4-5MM AW

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 REGISTRATION ISSUES DURING A L3-S1 OLIF OPEN PROCEDURE. A 3 LEVEL OLIF WAS PERFORMED WITH LATERAL PLATE AT L5/S1 PRIOR TO REGISTRATION. THE SYSTEM WOULD NOT REGISTER L4-S1, BUT L3 HAD YELLOW VALUES. THE CT SCAN USED DID NOT HAVE CAGES OR PLATES IN IT. THE MANUFACTURER REPRESENTATIVE TRIED MANUAL REGISTRATION AND USING MULTIPLE IMAGES WITHOUT SUCCESS. A NEW OBLIQUE IMAGE WAS ACQUIRED, BUT REGISTRATION WAS STILL UNSUCCESSFUL. SCREWS WERE PLACED AT L3, BUT THE SURGEON DECIDED TO BRING IN AN O-ARM AND PLACE SCREWS AT L4-S1 USING A SCAN <(>&<)> PLAN WORKFLOW. THE S1 SCREW WAS FOUND TO BE MEDIAL DURING THE PROCEDURE. THE TRAJECTORY WAS RE-PLANNED AND WAS PLACED ACCURATELY. THE PROCEDURE WAS DELAYED LESS THAN AN HOUR. A POST-OP CT SCAN SHOWED THAT THE RIGHT L3-L5 SCREWS WERE ALL MEDIAL. THE SCREWS WERE DEVIATED 5.5 TO 6.5 MM ON AVERAGE. THE PATIENT WAS EXPERIENCING WEAKNESS IN THEIR RIGHT LEG. A REVISION PROCEDURE WAS DONE USING THE GUIDANCE SYSTEM.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT THE PATIENT PRESENTED A TEMPORAL HEMORRHAGE WITH READING AND NAMING DIFFICULTIES. DURING THE SURGERY, THE FUSION WAS GOOD, AS WELL AS THE PATIENT'S POSITION. THE HEAD HOLDER WAS STABLE. THE REGISTRATION COULD HAVE BEEN BETTER DONE (LASER POINTS INSTEAD OF LINES) BUT THE REGISTRATION VALUES WERE ALL GOOD (GREEN).

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