da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER A COMPLETED SINGLE PORT (SP) COLORECTAL IDE STUDY LOW ANTERIOR RESECTION (LAR) WITH TOTAL MESORECTAL EXCISION (TME) PROCEDURE ON (B)(6) 2022, THE PATIENT DEVELOPED BILATERAL EDEMA OF THE LOWER EXTREMITIES AND GIDDINESS. THE LEG SWELLING AND GIDDINESS WERE NOTED ON (B)(6) 2022, DURING A FOLLOW-UP VISIT WITH HER PRIMARY CARE PHYSICIAN (PCP) AND THE PATIENT'S ORAL LOSARTAN WAS PLACED ON HOLD BY HER PCP, AND SHE WAS ADVISED TO FOLLOW-UP IN 2-3 WEEKS¿ TIME. ON (B)(6) 2022, THE PATIENT WENT TO THE ER FOR GENERALIZED WEAKNESS AND DIZZINESS FOR A FEW WEEKS. THE DIZZINESS WAS WORSE UPON STANDING UP. SHE ALSO HAD LOSS OF APPETITE. THERE WAS NO PAIN. SHE STATED THAT THE WEAKNESS AND LOSS OF APPETITE STARTED EVER SINCE SHE HAD A BARIUM ENEMA ON (B)(6) 2022. A BLOOD TEST SHOWED ACUTE RENAL FAILURE WITH CREATININE 2.2, BUN 106, SODIUM 119, POTASSIUM 5.4. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE SITE. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

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

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

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

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

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

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

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, AN UNSPECIFIED INSTRUMENT BROKE AND FRAGMENTS FROM THE INSTRUMENT FELL INTO THE PATIENT. THE FRAGMENTS WERE RETRIEVED DURING THE SAME SURGERY. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

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

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

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.

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

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

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INCISIONAL HERNIA REPAIR PROCEDURE WITH INTRAPERITONEAL ONLAY MESH (IPOM), THE SURGEON WAS HOLDING THE SMALL BOWEL WITH A CADIERE FORCEPS INSTRUMENT WHEN HE ACTIVATED THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT ON THE RIGHT ARM. AT THAT TIME, IT WAS NOTICED THAT THE SMALL BOWEL IN THE JAWS OF THE CADIERE FORCEPS INSTRUMENT HAD CHANGED COLOR AND WAS BURNED. AS A RESULT, THE SURGEON HAD TO PLACE SUTURES ON THE SMALL BOWEL TO ADDRESS THE BURN. ALTHOUGH THERE WAS NO ARCING OBSERVED FROM THE MCS INSTRUMENT, IT IS UNKNOWN WHAT CAUSED THE BOWEL BURN. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON AND OBTAINED THE FOLLOWING INFORMATION: THE SURGEON STATED HE HAD THE CADIERE FORCEPS INSTRUMENT INSTALLED ON THE LEFT ARM AND THE MCS INSTRUMENT INSTALLED ON THE RIGHT ARM. THE SURGEON WAS HOLDING THE SMALL BOWEL WITH THE CADIERE FORCEPS INSTRUMENT. THE SURGEON ACTIVATED THE MCS INSTRUMENT ON THE RIGHT ARM. AT THAT TIME, THE SURGEON NOTICED THE SMALL BOWEL IN THE JAWS OF THE CADIERE FORCEPS INSTRUMENT HAD CHANGED COLOR AND WAS BLANCHED (AS AN IMPRINT OF THE INSTRUMENT JAWS ON THE SMALL BOWEL). AS A RESULT, THE SURGEON HAD TO PLACE SUTURES

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

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TOTAL GASTRECTOMY SURGICAL PROCEDURE, THE CUSTOMER DISCOVERED THAT THE HARMONIC ACE INSTRUMENT BLADE WAS DAMAGED. THE HARMONIC ACE INSTRUMENT BLADE BROKE OFF AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE CUSTOMER REPLACED THE HARMONIC ACE INSTRUMENT WITH A BACK-UP INSTRUMENT OF THE SAME KIND AND COMPLETED THE PROCEDURE WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) PERFORMED FOLLOW-UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE INSTRUMENT WAS REPORTEDLY INSPECTED PRIOR TO USE, AND NO ISSUES WERE NOTED. THE INSTRUMENT DID NOT MAKE CONTACT WITH ANY OTHER INSTRUMENT OR HARD MATERIAL DURING THE SURGICAL PROCEDURE. THE SURGEON WAS DISSECTING TISSUE AT THE TIME OF THE EVENT. THE INSTRUMENT WAS IN USE FOR THIRTY MINUTES AND PERFORMED AS INTENDED UP UNTIL IT BROKE. AFTER THE BLADE OF THE INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT, THE FRAGMENT WAS VISUALLY LOCATED AND RETRIEVED DURING THE SAME PROCEDURE. IT WAS CONFIRMED THAT ALL FRAGMENTS WERE RETRIEVED. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED, AND THERE WERE NO POST-OPERAT

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

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION PROCEDURE, THE HARMONIC ACE INSTRUMENT TIP BROKE DURING INTRAOPERATIVE USE. AS A RESULT, A FRAGMENT FELL INSIDE THE PATIENT. THE BROKEN PIECE WAS RETAINED. THE USER COMPLETED THE PROCEDURE USING THE BACKUP INSTRUMENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: ALL THE INSTRUMENTS AND ACCESSORIES WERE INSPECTED PRIOR TO USE AND NO DAMAGE OR ANY ABNORMALITY WAS FOUND. APPROXIMATELY AN HOUR WHEN TISSUE DISSECTION WAS BEING PERFORMED WHEN THE PIECE OF THE INSTRUMENT BROKE AND FELL INSIDE THE PATIENT. THE ENTIRE FALLEN PIECE WAS RETRIEVED USING ANOTHER INSTRUMENT. NO POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRASOUND REQUIRED. NO POST-SURGICAL COMPLICATIONS REPORTED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED THYROIDECTOMY SURGICAL PROCEDURE, THE CUSTOMER FOUND A CRACK ON THE HARMONIC ACE INSTRUMENT JAW. THERE WAS NO REPORT OF ANY FRAGMENTS FALLING INSIDE THE PATIENT. THE CUSTOMER REPLACED THE HARMONIC ACE INSTRUMENT WITH A BACK-UP INSTRUMENT OF THE SAME KIND AND COMPLETED THE PROCEDURE WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) PERFORMED FOLLOW-UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE INSTRUMENT WAS REPORTEDLY INSPECTED PRIOR TO USE, AND NO ISSUE WAS NOTED. NO INSTRUMENT COLLISION WAS OBSERVED DURING THE PROCEDURE. THE INSTRUMENT BLADE BROKE OFF AND FELL INSIDE THE PATIENT. THE SURGEON WAS MAKING AN INCISION AT THE TIME OF THE EVENT. THE INSTRUMENT PERFORMED AS INTENDED UP UNTIL IT BROKE. AFTER THE BLADE OF THE INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT, THE FRAGMENT WAS LOCATED AND RETRIEVED WITH LAPAROSCOPIC INSTRUMENT FORCEPS DURING THE SAME PROCEDURE. IT WAS CONFIRMED THAT ALL FRAGMENTS WERE RETRIEVED. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED, AND THERE WERE NO POST-OPERATIVE TESTS PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE INSTRUMENT WAS NOT

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

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

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.

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.

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 — 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

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

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

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.

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

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.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE USING THE EXCELSUS GPS SYSTEM, THE CASE WAS ABORTED DUE TO ROBOTIC ERROR, AND SCREWS WERE THEN PLACED WITHOUT ROBOT.

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

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER A COMPLETED SLEEP ENDOSCOPY + MODIFIED UVULOPHARYNGOPALATOPLASTY (UPPP) + TONSILLECTOMY, BILATERAL + (SINGLE PORT, SP) ROBOT ASSISTED EXCISION OF LESION OF TONGUE (GRADE 1) IN A PARTICIPANT OF THE SP-TRANSORAL ROBOTIC SURGERY (TORS) OBSTRUCTIVE SLEEP APNEA (OSA) STUDY, THE PATIENT DEVELOPED ORAL BLEEDING ON THE 9TH POST-OPERATIVE DAY (POD). THE BLEEDING WAS INITIALLY TREATED WITH ICE WATER GARGLING AND FASTING, BUT THE ORAL BLEEDING PERSISTED. A TONGUE BASE HEMATOMA WAS FOUND ON PHYSICAL EXAMINATION AND THE PATIENT UNDERWENT A SECOND PROCEDURE UNDER GENERAL ANESTHESIA TO LIGATE THE BLEEDING VESSEL. THE BLEEDING WAS FOUND TO BE OOZING. DUE TO THIS ADVERSE EVENT, THE HOSPITALIZATION OF THE PATIENT WAS PROLONGED. IT WAS NOTED BY THE SURGEON THAT BLEEDING AFTER PROCEDURES IS EXPECTED AND NORMAL FOR PATIENTS WITH OSA SURGERY, AND THIS EVENT WAS NOT CAUSED OR INDUCED BY A MEDICAL DEVICE MALFUNCTION OR USE. THE PATIENT RECOVERED AFTER THE SECOND PROCEDURE. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SURGEON AND OBTAINED THE FOLLOWING INFORMATION: THE UPPP AND BILATERAL TONSILLECTOMY WAS CARRIED OUT VIA TRADITIONAL METHOD BY HAND. THE TONGUE WAS RESECTED

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THIS EVENT OCCURRED WITH THE RIGHT STN LEAD BEING OFF BY MORE THAN 3 MM ON THE FIRST PASS, ESSENTIALLY FALLING INTO THE SAME TRAJECTORY ON THE SECOND PASS, NOT SHIFTING ENOUGH ON THE THIRD PASS, AND FINALLY BEING PLACED IN AN ACCEPTABLE AREA ON THE FOURTH PASS. THE SECOND PASS ONLY THE TARGET WAS ADJUSTED, THE THIRD THE ENTRY WAS ADJUSTED WITH A SLIGHT ADJUSTMENT TO THE TARGET, AND THE FINAL PASS BOTH THE ENTRY AND TARGETS WERE ADJUSTED AGAIN. THERE WAS A LOT OF SPECULATION AS TO WHY THE TRAJECTORY WAS DEVIATING TO SUCH A HIGH DEGREE, THE INITIAL SUSPECT WAS THE MERGE ACCURACY, BUT UPON THE PLACEMENT OF THE LEFT LEAD IT WAS FOUND TO BE LESS THAN 0.9MM OFF AXIS AND VERY CLOSE TO THE PLAN. DR. VARDIMAN'S HYPOTHESIS WAS SOMETHING ANATOMICAL CAUSING THE DEVIATION OR SOMETHING MECHANICAL WITH THE ROBOT. REGARDLESS I BELIEVE THAT IT WARRANTS FURTHER INVESTIGATION I HAVE ALREADY UPLOADED THE CASE.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WHEN GOING TO VERIFY THE DILATOR (THE ONLY INTERBODY INSTRUMENT THAT THE SURGEON USES FOR TLIFS) WE VERIFIED OFF THE PURPLE T HANDLE ARRAY. THIS DID NOT WORK; IT SHOWED 2 SOLID DOTS AS IT WAS SEEING THE INSTRUMENTS AND VERIFICATION WOULD NOT FAIL OR BE SUCCESSFUL IT DID NOT POPULATE A RED FAILURE OR A GREEN CHECK. I THEN PROCEEDED TO ASK THE TECH TO CHANGE THE SPHERES TO THE BLUE STRAIGHT HANDLE ARRAY TO TRY AND VERIFY DILATOR OFF THAT, THAT FAILED AS WELL. WE THEN TRIED CHANGING ASSIGNED INSTRUMENTS, THIS FAILED TOO. WE THEN WENT BACK TO SCREW INSTRUMENTS AND VERIFIED HIGH SPEED DRILL, THEN WENT BACK TO INTERBODY AND TRIED TO VERIFY DILATOR AGAIN STILL FAILED. AFTER THIS I SUGGESTED WE TRY VERIFYING DILATOR OFF END EFFECTOR. WHEN TRYING TO VERIFY OFF END EFFECTOR SAME THING, IT FAILED. WE THEN RESORTED TO A HARD SHUT DOWN, WHICH IN TURN RESULTED IN US GETTING A RED REHOMING ERROR AND MOTION SELF-CHECK INCOMPLETE. TO POTENTIALLY AVOID HAVING TO REHOME THE ARM, I DID ANOTHER HARD SHUT DOWN, BUT WE STILL GOT THOSE SAME ERROR MESSAGES UPON BOOTING BACK UP. WHEN ATTEMPTING TO REHOME, IT FAILED 4 TIMES AT THIS POINT THE PATIENT WAS IN THE ROOM, AND THEY WERE READY TO POSITION. WE HAD TO

Senhance — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE EVENT OCCURED IN (B)(6) HOSPITAL IN AUSTRIA. THE EVENT OCCURED ON 2/24/2022, AND INTERNALLY MADE AWARE ON 9/6/2022. THE PATIENT EXPERIENCED RECTAL PERFORATION WHICH WAS TREATED (RESOLVED ON (B)(6) 2022). IT WAS REPORTED THAT THE CAUSALITY TO THE SENHANCE SURGICAL SYSTEM WAS PROBABLE.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A ROBOTIC ASSISTED TKA THE TIBIA WAS OVER RESECTED BY 3 MM. DUE TO THIS DISCREPANCY, A 16MM POLY INSERT WAS USED INSTEAD OF THE PLANNED 13MM INSERT. NO ADDITIONAL PATIENT IMPACT HAS BEEN REPORTED OTHER THAN THE DEVIATION FROM PLANNED IMPLANT SIZE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

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 THE CUSTOMER HAD ISSUES WITH THE FRAGMENT COMING OFF THE SYNCHROSEAL INSTRUMENT. CUSTOMER RETRIEVED FRAGMENT. INTUITIVE SURGICAL INC. (ISI) CONFIRMED THAT THE FRAGMENT CAME OFF THE DEVICE INTO THE PATIENT DURING PROCEDURE. THERE WERE NO POST-OPERATIVE COMPLICATIONS. THE SURGEON USED ANOTHER INSTRUMENT TO MANUALLY RETRIEVE THE FRAGMENT AND INSPECTED VISUALLY TO ENSURE FOREIGN MATERIAL WAS REMOVED. NO PATIENT HARM WAS NOTED. THERE WAS NO ALLEGATION OF AN ENERGY ISSUE.

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 DONE TO REMOVE AND REPLACE MISPLACED SCREWS.

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 PULMONARY HEMORRHAGE. WHEN THE RADIAL WAS REMOVED AND NEXT FLUORO SHOT MADE A HEMORRHAGE WAS SEEN BEFORE THE BIOPSY AND SCOPE FLOAT WAS NOTED. A CHEST TUBE WAS PLACED AT AND REMOVED THE SAME DAY. THE PATIENT WAS ADMITTED AND PLACED ON A BIPAP.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AFTER BOOTING UP THE ROBOT AND LOGGING IN, THE ERROR POPPED UP "MOTION CONTROL SELF-TEST INCOMPLETE". WE DID A HARD SHUT DOWN 8 TIMES ALLOWING AMPLE AMOUNT OF TIME TO SHUT OFF AND LOGGING IN AS WELL. UPON CONTACTING BRITTANY, WE WERE ABLE TO GET ON FACETIME WITH SHANE AND MIKE GILORMA TO GO THROUGH TROUBLESHOOTING STEPS. IT WAS FIXED AFTER GOING THROUGH PROPER STEPS WITH THEM.

CyberKnife — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A FEMALE PATIENT (CURRENTLY (B)(6)) RECEIVED CYBERKNIFE STEREOTACTIC RADIOSURGERY (SRS) IN 2018. ON (B)(6) 2022 DURING BRAIN SURGERY THE PATIENT WAS FOUND TO HAVE "RADIATION-RELATED NECROSIS WITH CAVERNOMA-LIKE VASCULAR PROLIFERATION AND VASCULAR INFLAMMATION".