Ion Endoluminal 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 AN ION TRANSBRONCHIAL LUNG BIOPSY PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX REQUIRING PLACEMENT OF A CHEST TUBE AND HOSPITALIZATION. THE TARGETED LESION WAS A LEFT UPPER LOBE INFERIOR NODULE ABUTTING THE MOST INFERIOR PART OF THE LINGULA BEHIND THE HEART. PER THE PHYSICIAN, THERE WERE SUBOPTIMAL ANGLES AND THE DEPTH PERCEPTION WAS NOT GOOD. FINE NEEDLE ASPIRATIONS (FNA) PASSES AND FORCEPS WERE USED. THE PHYSICIAN REPORTED THAT THEY INSERTED THE FORCEPS FURTHER THAN INTENDED AND LIKELY CAUSED THE PNEUMOTHORAX. A LARGE PNEUMOTHORAX WAS IDENTIFIED DURING THE ION PROCEDURE; THEREFORE, A 14 FRENCH CHEST TUBE WAS PLACED AND THE PROCEDURE WAS ABORTED. THE PATIENT WAS HOSPITALIZED 4 DAYS THEN DISCHARGED HOME IN STABLE CONDITION. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. THE DIAGNOSIS WAS MAC-NTM (MYCOBACTERIUM AVIUM COMPLEX NONTUBERCULOUS MYCOBACTERIA).

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) 2023, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF AN ARCHIVES OF PLASTIC SURGERY ARTICLE TITLED, ¿SINGLE-PORT ROBOT-ASSISTED PROSTHETIC BREAST RECONSTRUCTION WITH THE DA VINCI SP SURGICAL SYSTEM: FIRST CLINICAL REPORT¿ (JOO, O.Y., ET AL., 2021). WITHIN THE JOURNAL ARTICLE, TWO PATIENTS UNDERWENT A DA-VINCI ASSISTED NIPPLE SPARING MASTECTOMY (NSM) FOLLOWED BY IMMEDIATE ROBOT-ASSISTED EXPANDER INSERTION AND PRE-PECTORAL DIRECT-TO-IMPLANT BREAST RECONSTRUCTION. FOLLOWING THE NSM, ONE OF THE PATIENTS WAS FOUND WITH AN UNINTENTIONAL BURN AND WAS CAREFULLY MANAGED BY PLASTIC SURGERY TEAM DURING BREAST RECONSTRUCTION. THERE WAS NO MENTION OF THE CAUSE OF THE BURN. THE PATIENT ALSO EXPERIENCED MILD INFECTION ON A SINGLE BREAST, WHICH RESOLVED WITH INTRAVENOUS ANTIBIOTIC TREATMENT WITHOUT THE NEED FOR IMPLANT REMOVAL. THERE WERE NO CONVERSIONS TO OPEN SURGERY, NOR ANY MAJOR POST-OPERATIVE COMPLICATIONS SUCH AS A HEMATOMA OR TOTAL NIPPLE OR SKIN NECROSIS THAT OCCURRED WITH THESE TWO PATIENTS. THERE WERE NO ALLEGATIONS OF ANY MALFUNCTIONS OF ANY DV SYSTEMS, INSTRUMENTS, OR ACCESSORIES MENTIONED IN THE ARTICLE. INTUITIVE SURGICAL, INC, (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBT

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY BENIGN SURGICAL PROCEDURE, THE SURGEON FOUND A "FOREIGN OBJECT" INSIDE THE PATIENT. THE OBJECT WAS DESCRIBED AS POSSIBLY BEING A NEEDLE AND THE SURGEON WAS UNCERTAIN HOW THE OBJECT GOT INSIDE THE PATIENT. THERE WERE SEVERAL POSSIBILITIES CONSIDERED BY THE CUSTOMER, BUT NOTHING HAS BEEN DETERMINED TO DEFINITIVELY IDENTIFY THE OBJECT. WHILE CLOSING THE LEFT SIDE OF THE CUFF THE SURGEON NOTED APPROXIMATELY ¼ INCH OF A FOREIGN OBJECT, THOUGHT TO BE A NEEDLE STICKING OUT. THE SURGEON PULLED ON THE FOREIGN OBJECT AND WAS ABLE TO MOMENTARILY RETRIEVE THE OBJECT. WHILE ATTEMPTING TO REMOVE THE FOREIGN OBJECT WITH A LAPAROSCOPIC INSTRUMENT THE STAFF LOST THE FOREIGN OBJECT. THE STAFF ATTEMPTED TO VIEW THE OBJECT THROUGH X-RAY BUT WERE UNABLE TO LOCATE THE OBJECT. THE STAFF ORIGINALLY THOUGHT THE FOREIGN OBJECT COULD HAVE BEEN FROM THE DA VINCI INSTRUMENTS. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) RECOMMENDED THE STAFF RMA THE INSTRUMENTS FOR FAILURE ANALYSIS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: TH

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) WAS MADE AWARE OF A SOCIAL MEDIA POST INDICATING THAT 4-5 WEEKS AFTER A DA-VINCI ASSISTED HYSTERECTOMY, THE PATIENT EXPERIENCED VAGINAL CUFF TEAR WITH "LOTS OF BLEEDING". THE PATIENT WAS BROUGHT BACK FOR AN EMERGENT SURGERY TO RE-STITCH THE VAGINAL CUFF. IT IS UNKNOWN ON WHICH DATE WAS THE DA-VINCI ASSISTED SURGERY AND AT WHICH HOSPITAL. THE AMOUNT OF BLOOD LOSS IS UNKNOWN AT THIS TIME. INTUITIVE SURGICAL, INC, (ISI) MADE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, AT THE TIME OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A CLINICAL STUDY, IT WAS REPORTED THAT A PATIENT UNDERWENT DA-VINCI ASSISTED PULMONARY LOBECTOMY ON (B)(6) 2023 AND THE PATIENT PRESENTED WITH RAPID WORSENING SHORTNESS OF BREATH WITH ESCALATING OXYGEN REQUIREMENTS ON (B)(6) 2023 WITH PROLONGED HOSPITALIZATION REQUIRED. A CHEST X-RAY SHOWED COLLAPSE OF THE REMAINING RIGHT LUNG WITH CONCERN FOR MUCOUS PLUGGING POST RIGHT UPPER LOBECTOMY WITH PARTIAL CHEST WALL RESECTION. A BEDSIDE BRONCHOSCOPY REVEALED TENACIOUS SECRETIONS IN BRONCHI WITH MUCOUS PLUGGING WHICH WAS CLEARED WITH LAVAGE. THERE WAS NO IMMEDIATE COMPLICATIONS AND THE PATIENT WAS PLACED BACK ON NASAL CANULA OXYGEN, WHICH WAS RAPIDLY TITRATED DOWN. A COMPUTERIZED TOMOGRAPHY (CT) SCAN ON (B)(6) 2023 REVEALED A MODERATE TO LARGE RIGHT PLEURAL EFFUSION WITH COMPRESSIVE ATELECTASIS OF THE RIGHT LUNG. WHEN THE PLEURAL SPACE WAS ENTERED, A GUSH OF AIR AND SEROUS FLUID WERE OBSERVED. A 14 FRENCH PIGTAIL CHEST TUBE AS INSERTED AND CONNECTED TO A CHEST DRAINAGE SYSTEM WHICH IMMEDIATELY DRAINED APPROXIMATELY 600ML OF SEROSANGUINOUS FLUID. THE PATIENT REPORTED BREATHING WAS IMPROVING, BUT STILL WITH SHORTNESS OF BREATH WITH OXYGEN SUPPLEMENT REQUIRED. THE PATIENT WAS REPOR

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE THAT THE MONOPOLAR ENERGY WAS NOT WORKING. THE SITE KEPT GETTING MESSAGES TO CHECK THE MONOPOLAR ENERGY CORD, THE INSTRUMENT TIP, AND/OR SHEATH. THE SITE TRIED THREE DIFFERENT ENERGY CORDS, THREE INSTRUMENTS, THREE TIPS, AND TWO SHEATHS, ALL WITH DIFFERENT MESSAGES AND NO MONOPOLAR ENERGY. THE SITE DID A POWER CYCLE OF THE SYSTEM, AND VISION SIDE CART (VSC) BREAKER, WITH NO CHANGE. THE SITE HAD AN ORANGE INSTRUMENT CORD LED ON THE ENERGY SHIELD CONSTANTLY. THE SITE RESEATED THE CORD FROM THE ENERGY SHIELD TO THE ERBE GENERATOR WITH NO CHANGE. THE SITE SWAPPED OUT THE SYSTEM FOR AN XI SYSTEM AND ENDED THE CALL. THERE WERE NO REPORTS OF PATIENT INJURY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE CUSTOMER RECEIVED ERROR 86. THE CUSTOMER POWERED CYCLED THE SYSTEM AND ERROR COME BACK. ONSITE WAS NOT FUNCTIONAL DUE TO BROKEN CABLE/CONNECTOR IN THE OPERATING ROOM (OR). THE CUSTOMER WAS ABLE TO PROVIDE INFORMATION REGARDING ROOT CAUSE; THE NODE INVOLVED WAS 32 AND IT WAS POINTING TO THE ICC BOARD AND/OR POWER SUPPLY. THE PROCEDURE WAS ABORTED POST ANESTHESIA AND PORT PLACEMENT WITH NO REPORTED INJURY. 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: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AT THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, POST-ANESTHESIA AND PORT PLACEMENT, THE SURGICAL TEAM HAD A NON-RECOVERABLE ERROR 86. PRIOR TO CALLING, THE CUSTOMER PERFORMED A REBOOT OF THE VISION SIDE CART (VSC) CIRCUIT BREAKER, BUT THE PROBLEM PERSISTED. THE TECHNICAL SUPPORT ENGINEER (TSE) INFORMED THE CUSTOMER ABOUT THE ROOT CAUSE FOR THE ISSUE, WHICH WAS A FAULTY POWER BOARD IN THE CORE OF THE VSC. THE SYSTEM WAS NOT USABLE ANYMORE. THE PROCEDURE WAS ABORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: SYSTEM FUNCTIONALITY WAS CHECKED WHEN THE SYSTEM WAS POWERED ON AND THE SYSTEM STARTED WITHOUT PROBLEMS, THE STERILE COVERING OF THE ARMS WAS PERFORMED WITHOUT ISSUES, AND THERE WERE NO ERROR MESSAGES. OPEN SURGERY WAS NOT PERFORMED, THE SURGERY WAS CANCELLED. THE FIRST TROCAR WAS ALREADY PLACED, THEN SUDDENLY THE ERROR MESSAGE APPEARED. IT WAS A SUDDEN OCCURRENCE OF THE ERROR MESSAGE WITHOUT PREVIOUS USE OF THE ROBOT, AS ONLY THE OPTICS WERE USED MANUALLY. NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE PATIENT WAS SCHEDULED FOR ROBOTIC-ASSISTED RADICAL PROSTATECTOMY. THE TE

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HIATAL HERNIA REPAIR PROCEDURE, THE BLADE OF THE HARMONIC ACE INSTRUMENT FELL OFF INSIDE THE PATIENT. AT THE TAIL END OF THE DISSECTION OF THE LESSER BLOOD SUPPLY ALONG THE GREATER CURVATURE OF THE STOMACH, THE SYSTEM ASKED FOR THE SURGEON TO RELEASE TENSION/PRESSURE FROM THE INSTRUMENT AND REAPPLY THE INSTRUMENT. THE SURGEON DID AS THE SYSTEM INSTRUCTED. WHEN THE SURGEON STARTED DISSECTING AGAIN THE WARNING REAPPEARED. THE SURGEON ONCE AGAIN DID AS THE SYSTEM INSTRUCTED. AS THE SURGEON WENT IN TO GRAB THE TISSUE FOR A THIRD TIME, THE MOBILE BLADE OF THE INSTRUMENT FELL OFF. THE INSTRUMENT WAS REMOVED AND REPLACED. THE INSTRUMENT FRAGMENT/PIECE WAS FOUND AND REMOVED SAFETY FROM THE PATIENT'S ABDOMINAL CAVITY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: IT WAS CONFIRMED THAT THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGE WAS SEEN. THE SURGEON BELIEVE IT WAS CAUSED BY A FAULTY BUILD. THE INSTRUMENT BROKE ROUGHLY THREE QUARTERS OF THE WAY THROUGH THE CASE. NO ISSUES WERE SEEN WITH THE FUNCTIONALITY

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 AN UNSPECIFIED DA VINCI-ASSISTED SURGICAL PROCEDURE, THE TIP OF THE HARMONIC ACE INSTRUMENT WAS BROKEN WHILE GRASPING TISSUE. THE INSTRUMENT FRAGMENTS FELL INSIDE THE PATIENT¿S CAVITY AND WERE RETRIEVED DURING THE SAME PROCEDURE. THERE WAS NO BLEEDING. THE CUSTOMER CONFIRMED THAT THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO ABNORMALITY. THE PROCEDURE WAS COMPLETED WITH A BACKUP INSTRUMENT OF THE SAME KIND. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: DURING THE PROCEDURE, THE INSTRUMENT TIP WAS FOUND BROKEN ON THE CAMERA SCREEN AFTER USING THE INSTRUMENT FOR ABOUT 10 MINUTES. ALL THE FRACTURED PARTS WERE FOUND, RETRIEVED, CONFIRMED TO BE INTACT BY PUTTING THE PIECES TOGETHER, AND THERE WAS NO RESIDUE IN THE FIELD OF VIEW. THE SURGEON BELIEVED THERE WAS AN INSTRUMENT COLLISION DURING THE CASE BUT THE ISSUE WAS DUE TO INSTRUMENT QUALITY. THE INSTRUMENT WAS NOT REMOVED DURING THE PROCEDURE (PRIOR TO THE BREAKAGE). NO FUNCTIONAL ISSUES WERE FOUND. UPON FINAL REMOVAL OF THE INSTRUMENT, THE INSTRUMENT'S WRIST WAS STRAIGHTENED, AND THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON

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 PULMONARY LOBECTOMY SURGICAL PROCEDURE, SYSTEM GENERATED A NON-RECOVERABLE FAULT 297. PRIOR TO CALLING TECH SUPPORT THE CUSTOMER TRIED TO RESTART SYSTEM SEVERAL TIMES WITHOUT SUCCESS. THE ERROR KEPT ON TRIGGERING. SURGEON DECIDED TO CONVERT TO OPEN SURGERY. TECHNICAL SUPPORT ENGINEER (TSE) CHECKED THE LOGS THAT WERE SHOWING REPEATED NON-RECOVERABLE FAULT 297 POINTING TO AUXILIARY VIDEO BOARD (AVP)3. TSE CONNECTED TO SYSTEM TO DISABLE AVP3 NODE, BUT WHEN USER RESTARTED SYSTEM IN NORMAL MODE THERE WAS NON-RECOVERABLE FAULT 40019, THAT MAY INDICATE THAT THE MODIFICATION IN DOWNLOAD APP DID NOT GO WELL. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGERY WAS NOT PERFORMED WITH A ROBOTIC APPROACH BECAUSE THE FAILURE WAS NOT RECOVERED BEFORE SURGERY STARTED. THEREFORE, IT WAS DECIDED THAT THE SAFEST APPROACH FOR THE PATIENT, SINCE IT WAS A COMPLEX CASE IN WHICH THE ROBOT COULD HELP, WAS OPEN SURGERY.

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 SURGICAL PROCEDURE, THE ENDOSCOPE COULD NO LONGER BE ROTATED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM, WITH A BACKUP ENDOSCOPE, AND WITH A DELAY OF 50 MINUTES. 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 THE PATIENT UNDERWENT DA-VINCI ASSISTED LOBECTOMY ON (B)(6) 2023 AS PART OF THE CGMH SP CLINICAL STUDY. ON (B)(6) 2023, THE PATIENT DEVELOPED CHYLOTHORAX WITH HIGH TRIGLYCERIDES (TG) AND REQUIRED PROLONGED HOSPITALIZATION. DIET CONTROL WAS IMPLEMENTED INCLUDING KABIVEN (TOTAL PARENTERAL NUTRITION) ADMINISTERED ON (B)(6) 2023 FOR TWO DAYS. THE PATIENT WAS STARTED CLEAR LIQUID DIET ON (B)(6) 2023 AND STARTED NON-FAT DIET ON (B)(6) 2023. THE PATIENT`S CHEST TUBE WAS REMOVED ON (B)(6) 2023. THE STUDY INVESTIGATOR ASSESSED THE REPORTED EVENT AS TO NOT RELATED TO THE DV SYSTEM, INSTRUMENTS OR ACCESSORIES, NOT RELATED TO THE DV ASSISTED SURGERY. INTUITIVE SURGICAL, INC, (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO ADDITIONAL INFORMATION. HOWEVER, AT THE TIME OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL TONSILLECTOMY SURGICAL PROCEDURE, THE INSTRUMENTS MOVED BACKWARDS WHEN PLACED ON THE ROBOT. PRIOR TO CALLING AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOR ASSISTANCE, THE CUSTOMER HAD CONVERTED THE PROCEDURE TO TRADITIONAL LAPAROSCOPIC SURGERY. THE SITE WAS USING A 0-DEGREE ENDOSCOPE WHEN THE ISSUE OCCURRED AND THEY WERE UNSURE IF THEY HAD CAMERA UP OR DOWN SELECTED. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE REPORTER CONFIRMED THE PATIENT TOLERATED THE CONVERSION WELL AND THERE WAS NO INJURY TO THE PATIENT.

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 MYOMECTOMY SURGICAL PROCEDURE, A PORTION OF THE HARMONIC ACE INSTRUMENT BROKE OFF DURING USE. THE BROKEN PIECE WAS RETRIEVED DURING THE SAME PROCEDURE WHICH WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND THERE WAS NO NOTED DAMAGE. THE INSTRUMENT BROKE RIGHT AT THE JAW HINGE. THE INSTRUMENT WAS IN USE FOR ROUGHLY 10 MINUTES. THE SURGEON DID NOT NOTICE AN ISSUE WITH THE FUNCTIONALITY OF THE INSTRUMENT. THE INSTRUMENT DID NOT COLLIDE WITH ANOTHER INSTRUMENT. THE FRAGMENT FELL INSIDE THE ABDOMEN DURING THE PROCEDURE. THE INSTRUMENT WAS NOT REMOVED PRIOR TO BREAKAGE. THE BREAK WAS NOTICED IMMEDIATELY AS THE SURGEON SAW THE JAW FALL DOWN. THE SURGICAL STAFF GRABBED THE JAW FRAGMENT WITH GRASPERS AND REMOVED FRAGMENT THROUGH AN ASSIST PORT. AN ADDITIONAL SURGICAL PROCEDURE WAS NOT REQUIRED TO REMOVE FRAGMENT. THERE WERE NO POST-OPERATIVE TESTS. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO 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 THE PATIENT UNDERWENT DA VINCI-ASSISTED SP EXTRAPERITONEAL PROSTATECTOMY ON (B)(6) 2023 AS PART OF THE CGMH URO SP CLINICAL STUDY. THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) ON (B)(6) 2023 WITH ABDOMINAL DISCOMFORT AND SWELLING WITH NO URINE OUTPUT INTO HIS URINARY BAG. THE PHYSICIAN AT THE EMERGENCY ROOM OBSERVED THAT THE PATIENT HAD ABDOMINAL SWELLING, DISCOMFORT IN ABDOMINAL AND GENITAL AREA WITH THE PAIN ASSESSMENT 1 OUT OF 10, AND MILD HEMATURIA. CYSTOGRAPHY AND CT OF UROGRAPHY (CTU) INITIALLY CONFIRMED ASCITES. SUPRAPUBIC CYSTOSTOMY WAS PERFORMED AS TREATMENT. THE STUDY INVESTIGATOR ASSESSED THIS EVENT AS NOT RELATED TO DA-VINCI DEVICES, AND POSSIBLY RELATED TO THE PROCEDURE. INTUITIVE SURGICAL INC (ISI) OBTAINED ADDITIONAL INFORMATION AS THE FOLLOWING: THERE WERE NO INTRA-OPERATIVE COMPLICATIONS NOR ANY OTHER POST-OPERATIVE COMPLICATIONS. THERE WERE NO ALLEGATIONS OF ANY MALFUNCTIONS OF ANY DA VINCI SYSTEMS, INSTRUMENTS OR ACCESSORIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED ADVERSE EVENT. THE PATIENT WAS LATER FOUND WITH PERIVESICAL FLUID INSTEAD OF ASCITES VIA CT SCAN. A PIGTAIL DRAIN WAS PLACED. AFTER ADMISSION, CYSTOGRAPHY SHOWED MINIMAL LEA

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER CYSTECTOMY SURGICAL PROCEDURE, ERRORS OCCURRED ON THE HARMONIC ACE INSTRUMENT, AND THE INSTRUMENT BLADE BROKE OFF AND FELL INSIDE THE PATIENT AFTER TEN MINUTES INTO THE OPERATION. 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 AND OBTAINED THE FOLLOWING ADDITIONAL/UPDATED INFORMATION REGARDING THE REPORTED EVENT: THE HARMONIC ACE INSTRUMENT WAS REPORTEDLY INSPECTED PRIOR TO USE, AND NO ISSUE WAS NOTED. THE HARMONIC ACE INSTRUMENT PERFORMED AS INTENDED UP UNTIL IT BROKE WHILE THE SURGEON WAS DISSECTING UNSPECIFIED TISSUE. THE HARMONIC ACE INSTRUMENT DID NOT MAKE CONTACT WITH ANY OTHER INSTRUMENT OR HARD MATERIAL DURING THE SURGICAL PROCEDURE. AFTER THE HARMONIC ACE BLADE BROKE OFF AND FELL INSIDE THE PATIENT, THE FRAGMENT WAS VISUALLY LOCATED AND RETRIEVED DURING THE SAME PROCEDURE. THE CUSTOMER CONFIRMED ALL FRAGMENTS WERE RETRIEVED BY MATCHING THE BROKEN FRAGMENT TO THE INSTRUMENT. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED,

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, THE SURGICAL STAFF OBSERVED INVERTED IMAGING WHILE USING A 30 DEGREE ENDOSCOPE PLUS. THE ISSUE OCCURRED ONCE DURING THE PROCEDURE. THE SURGEON INDICATED THAT THE ENDOSCOPE MOVED WITH UNINTUITIVE MOVEMENTS AND WITH REVERSED CONTROL DESPITE CORRECT ALIGNMENT AND INSTALLATION. THE ENDOSCOPE WAS PULLED OUT OF THE PATIENT SIDE CART (PSC) AND RESEATED WHICH SUCCESSFULLY CLEARED THE ISSUE. PER THE SURGEON, THERE WAS A "PROLONGATION OF THE PROCEDURE" BY 15 MINUTES AND "MINIMALLY INCREASED BLOOD LOSS, BUT NO LASTING HARM." THE ESTIMATED BLOOD LOSS ASSOCIATED WITH THE EVENT IS UNKNOWN. IN ADDITION, THE SOURCE OF THE BLEEDING AND WHAT MEDICAL INTERVENTION, IF ANY, WAS RENDERED DUE TO THE COMPLICATION ARE UNKNOWN AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE LOGS AFTER PROCEDURE COMPLETION AND FOUND AN ERROR POINTING TO A SCOPE ENGAGEMENT 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: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT SUDDENLY DID NOT WORK. A FRAGMENT FROM AN UNSPECIFIED LOCATION OF THE INSTRUMENT ALLEGEDLY FELL INSIDE THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED USING A BACKUP HARMONIC ACE INSTRUMENT WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS NO FRAGMENT LEFT.

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 PORT PLACEMENT BUT PRIOR TO DOCKING FOR A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE SITE WAS HAVING ISSUES WITH ENDOSCOPE ENGAGEMENT. PRIOR TO CALLING IN, INTUITIVE REP HAD THE STAFF RE-DRAPE TWICE AND TRY TWO DIFFERENT ENDOSCOPES. TECHNICAL SUPPORT ENGINEER (TSE) WALKED THE REP THROUGH A HARD POWER CYCLE OF THE PATIENT SIDE CART (PSC) AND REINSTALLATION OF CAMERA ARM STERILE ADAPTER. TSE RECOMMENDED CUSTOMER ATTEMPT A THIRD ENDOSCOPE, BUT SYSTEM WOULD NOT ACCEPT THE THIRD ENDOSCOPE. THE PROCEDURE WAS ABORTED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: CONFIRMED THAT PORTS WERE PLACED. THEY WERE PREPARING TO DOCK AND ENTER DIRECTLY INTO THE BLADDER. THEY CUT FACIA AND ENTERED DIRECTLY INTO THE BLADDER. THE REST OF THE INSTRUMENTS WERE DOCKED, BUT THE NONE OF THE ENDOSCOPES WOULD ENGAGE. CONFIRMED THERE WERE NO POST-OP COMPLICATIONS.

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 DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE SYNCHROSEAL INSTRUMENT HAD A PIECE OF METAL THAT BROKE OFF AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO ADDITIONAL REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAD 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 RADICAL WITH LYMPHADENECTOMY PROSTATECTOMY SURGICAL PROCEDURE THAT THE BIPOLAR ENERGY WAS NOT WORKING. THE STAFF TRIED TWO DIFFERENT BIPOLAR INSTRUMENT CORDS BEFORE CALLING. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ASKED THE STAFF TO CYCLE THE ERBE GENERATOR POWER. THE SURGEON CONVERTED TO AN OPEN PROCEDURE. 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 RADICAL PROSTATECTOMY PROCEDURE, THE PATIENT'S VAS DEFERENS WAS INJURED. THE ISSUE OCCURRED DURING THE END OF THE PROCEDURE WHILE PERFORMING THE ANASTOMOSIS. THE SURGEON ROTATED THE 0 DEGREE ENDOSCOPE PLUS SEVERAL TIMES WHILE LOOKING FOR A SUTURE NEEDLE, AFTER WHICH THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT ALLEGEDLY WENT OUT OF CONTROL TOWARDS THE VAS DEFERENS AND UNINTENTIONALLY TRANSECTED IT. IT IS UNCLEAR IF THE VAS DEFERENS WAS REPAIRED. THE ARTERY AND VEIN NEXT TO THE VAS DEFERENS DID NOT CONTACT THE MCS AND WERE THEREFORE NOT INJURED. WHILE ROTATING THE ENDOSCOPE, AN UNSPECIFIED ¿BAD SOUND¿ WAS HEARD. NO ERROR MESSAGE DISPLAYED. ALL THE INSTRUMENTS WERE THEN REMOVED FROM THEIR RESPECTIVE UNIVERSAL SURGICAL MANIPULATORS (USM)S AND REINSTALLED. THE SURGICAL STAFF THEN CONTINUED THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING AN 8MM 30 DEGREE ENDOSCOPE. THE SURGEON BELIEVES THE CAUSE OF THE INTRA-OPERATIVE COMPLICATION WAS DUE TO A PROBLEM WITH THE 0 DEGREE ENDOSCOPE PLUS FOLLOWED BY FEELING UNEXPECTED MOVEMENTS WITH THE USMS. THE PATIENT DID NOT EXPERIENCE POST-OPERATIVE COMPLICATIONS AND WAS REPORTED TO BE ¿OKAY¿. THE INTU

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 AS PART OF A CLINICAL TRIAL THAT 2 DAYS AFTER A DA VINCI-ASSISTED LOW ANTERIOR RESECTION (LAR) WITH TOTAL MESORECTAL EXCISION (TME), THE PATIENT EXPERIENCED LIGHTHEADEDNESS WITH NAUSEA AND VOMITING. A NASOGASTRIC WAS PLACED, AND ILEUS WAS SHOWN ON X-RAY. BLOOD WORK SHOWED NO CONCERNS OF BLEEDING OR INFECTION. IV FLUIDS WERE GIVEN TO THE PATIENT. NO MALFUNCTIONS OF SP SYSTEM OR INSTRUMENTS WERE REPORTED, AND THERE WERE NO INTRA-OPERATIVE COMPLICATIONS DURING THE SURGERY. ON POST-OPERATIVE DAY (POD) #5, THE PATIENT WAS REPORTED RESOLVED FROM ILEUS. THE PATIENT WAS DISCHARGED ON POD #6 WITH NORMAL BOWEL FUNCTION AND WAS TOLERATING A GENERAL DIET.

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 TONSILLECTOMY SURGICAL PROCEDURE, WHEN ATTEMPTING TO DOCK THEY WERE GETTING A CANNULA INVALID MESSAGE. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WALKED THE CUSTOMER THROUGH EMERGENCY POWER OFF (EPO) OF THE PATIENT SIDE CART (PSC) AND ERROR 1162 PERSISTED. THE TSE REVIEWED ONSITE LOGS AND CONFIRMED ERROR CODE 1162. TSE THEN WALKED THE CALLER THROUGH ADDITIONAL EPO OF PSC AND POWERING SYSTEM BACK ON WITH CANNULA INSTALLED AND SYSTEM POWERED ON AND ERROR DID NOT PERSIST. THE CALLER REPORTED THAT THE SURGEON HAD PERFORMED THE SURGERY ¿MANUALLY¿ AND THE CASE WAS COMPLETED WITHOUT THE DAVINCI ROBOT. THERE WAS NO REPORTED PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGEON¿S NAME WAS PROVIDED. THE SURGEON WAS REQUIRED TO CHANGE THE SURGICAL APPROACH TO OPEN SURGERY. THERE WAS NO INJURY TO THE PATIENT.

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 NISSEN FUNDOPLICATION-ISOLATED SURGICAL PROCEDURE, A SMALL ROUND FRAGMENT ATTACHED TO THE WRIST OF THE SYNCHROSEAL INSTRUMENT FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED ROBOTICALLY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYNCHROSEAL INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO DAMAGE FOUND. THE SURGEON DID NOT KNOW WHEN THE FRAGMENT FELL EXACTLY. THE SURGEON FOUND THE SMALL ROUND FRAGMENT ON THE TISSUE, AND THEN REALIZED IT WAS FROM THE SYNCHROSEAL INSTRUMENT. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE AND THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE PROCEDURE. THE SURGEON TRIED TO RETRIEVE THE FRAGMENT THROUGH THE CANNULA BUT WAS UNABLE TO DO SO. THE CUSTOMER TRIED TO FIND THE FRAGMENT INSIDE THE PATIENT AGAIN BUT COULD NOT FIND IT. NO FRAGMENTS WERE RETRIEVED. NO POST-OPERATIVE TESTS WERE PERFORMED AS THE FRAGMENT WAS TOO SMALL TO BE REVEALED BY X-RAY. THE PATIENT HAS NOT EXPERIENCED ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT.

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 HIATAL HERNIA SURGICAL PROCEDURE, THE PROGRASP FORCEPS INSTRUMENT SCREW AT THE DISTAL MECHANISM CAME LOOSE AND FELL INSIDE THE PATIENT. THE SCREW WAS RETRIEVED DURING THE SAME PROCEDURE FROM THE PATIENT WITHOUT INJURY. THE PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUES. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROGRASP FORCEPS INSTRUMENT WAS INSPECTED PRIOR TO USE AND THERE WAS NO DAMAGE FOUND. THE INSTRUMENT WAS BEING INSERTED WHEN THE SCREW FELL OUT. THE PROCEDURE HAD JUST STARTED WHEN THE REPORTED ISSUE OCCURRED. THE SURGEON DID NOT NOTICE ANY FUNCTIONALITY ISSUES BEFORE THE INSTRUMENT BROKE. THE INSTRUMENT DID NOT COLLIDE WITH OTHER INSTRUMENTS. A NEW INSTRUMENT WAS OPENED AFTER THE SCREW WAS REMOVED AND THE PROCEDURE WAS COMPLETED ROBOTICALLY. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING POST-SURGICAL COMPLICATIONS RELATED TO FOREIGN OBJECTS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER FELL OFF IN THE PATIENT. THE TIP COVER WAS RETRIEVED DURING THE SAME PROCEDURE. THE NURSE COMMENTED THAT THE TIP COVER WAS EASIER TO PUT ON THAT DAY. THE PROCEDURE WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF 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 ENDOMETRIOSIS RESECTION PROCEDURE, THERE WAS A DELAY IN INSTRUMENT MOVEMENT AND THE ENDOSCOPE WAS NOT FLIPPING NORMAL ANGLE UP AND DOWN. THE ENDOSCOPE WAS OBSERVED TO BE ROTATING ON ITS OWN. THIS OCCURRED AT THE START OF THE PROCEDURE AND ONLY OCCURRED ONCE. TECHNICAL SUPPORT (TS) WAS CONTACTED AND RECOMMENDED TO TRY A DIFFERENT ENDOSCOPE. THE ISSUE WAS RESOLVED WITH A PHONE FIX. DUE TO THE ISSUE, THE PATIENT SUSTAINED AN UNSPECIFIED LARGE BOWEL INJURY. THE TYPE AND SEVERITY OF THE BOWEL INJURY ARE UNKNOWN. IT IS ALSO UNCLEAR HOW THE COMPLICATION OCCURRED AND WHAT TASK WAS BEING PERFORMED AT TIME OF THE INJURY. A GENERAL SURGEON WAS CALLED IN AND REPAIRED THE LARGE BOWEL INJURY WITH SUTURES AND STITCHES. THE ESTIMATED BLOOD LOSS WAS CONSIDERED NEGLIGIBLE AND WAS LESS THAN 15 MILLILITERS. THERE WAS A DELAY OF 15-20 MINUTES. THE SURGEON INDICATED THAT AFTER THE ENDOSCOPE WAS CHANGED, THE SURGICAL STAFF WAS ABLE TO COMPLETE THE CASE ROBOTICALLY WITH NO FURTHER ISSUES. THE PATIENT HAD NO POST-OPERATIVE COMPLICATIONS AND IS DISCHARGED FROM THE HOSPITAL.

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 PROCEDURE, THE TIP OF AN UNSPECIFIED SINGLE PORT (SP) INSTRUMENT APPEARED TO BE BROKEN AT THE SHAFT. THE FRAGMENT IS IN A BAG THAT THE ROBOTICS COORDINATOR IS IN POSSESSION OF AND WILL BE RETURNED WITH THE INSTRUMENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE. THE PROCEDURE WAS COMPLETED WITH 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 LIVER RESECTION SURGICAL PROCEDURE, THE SURGEON EXPERIENCED A TUMOR RUPTURE DUE TO THE PATIENT¿S TISSUE BEING TOO DELICATE AND THAT THEY COULDN¿T MANIPULATE IT WITH THE INSTRUMENTS PROPERLY. THE SURGEON THEN DECIDED TO CONVERT TO AN OPEN PROCEDURE. AS REPORTED, THE PATIENT¿S VITAL PARAMETERS WERE FINE, THERE WERE NO INSTRUMENT FAILURE OR LIFE-THREATENING SITUATION. NO REPORT OF PATIENT HARM, ADVERSE OUTCOME OR INJURY AND NO DELAYS. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED-UP WITH THE REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS EVENT: THE TUMOR RUPTURED DUE TO TISSUE BEING TOO DELICATE AND FRAGILE. THERE WAS NO MALFUNCTION OF THE DA VINCI SYSTEM OR ANY INSTRUMENTS. THE REPORTER CONFIRMED THE PATIENT WAS STABLE AND HAD SINCE LEFT THE HOSPITAL WITH NO OTHER ISSUES 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 AS PART OF A CLINICAL STUDY THAT A PATIENT UNDERWENT A DA VINCI-ASSISTED LEFT UPPER LOBECTOMY PROCEDURE FOR A 4CM LESION WITH THE DIAGNOSIS OF A PRIMARY LUNG CANCER. THERE WERE DENSE ADHESIONS BETWEEN A CALCIFIED LYMPH NODE AND THE INTERLOBAR PULMONARY ARTERY (PA). TEARING OVER THE LINGUAL-INTERLOBAR PA JUNCTION WAS ENCOUNTERED DURING THE SURGERY. IT IS UNKNOWN WHAT SPECIFIC INSTRUMENTS WERE BEING USED WHEN THE INJURY OCCURRED. THE PROCEDURE WAS CONVERTED TO A THORACOTOMY FOR HILAR BLEEDING CONTROL AND THE PA WAS REPAIRED BY A CARDIAC SURGEON. THE BLOOD LOSS VOLUME ASSOCIATED WITH THE INTRA-OPERATIVE COMPLICATION IS UNKNOWN. THE LOBECTOMY WAS PERFORMED AFTER PA REPAIR. THE PATIENT WAS HEMODYNAMICALLY STABLE AFTER THE PROCEDURE WAS COMPLETED WITH NO OBVIOUS SEQUELAE. THE SURGEON ASSESSED THE CAUSALITY OF THE EVENT WITH DA VINCI SP AS UNLIKELY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE SURGEON. 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 CHOLECYSTECTOMY PROCEDURE, THE ENDOSCOPE IMAGE BECAME INVERTED AND RESULTED IN UNEXPECTED MOTION OF AN INSTRUMENT. THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES ASSOCIATE (CSA), WHO WAS PRESENT DURING THE CASE, REPORTED THAT THE INSTRUMENTS WERE MOVING IN THE OPPOSITE DIRECTION THAN THE SURGEON INTENDED. WHEN THE SURGEON TRIED TO PULL AN INSTRUMENT AWAY, THE INSTRUMENT ALLEGEDLY MOVED FORWARD AND DAMAGED THE LIVER. THE CSA SAID THE CUSTOMER WAS ABLE TO RESOLVE THE ISSUE BE REMOVING AND RESEATING THE ENDOSCOPE TWO TIMES. THE PROCEDURE WAS REPORTEDLY COMPLETED AS PLANNED. ISI CONTACTED THE SURGEON OF THIS PROCEDURE AND ADDITIONAL INFORMATION WAS OBTAINED ABOUT THE COMPLAINT: THE INDICATION FOR THIS PROCEDURE WAS ACUTE CHOLECYSTITIS/CHOLEDOCHOLITHIASIS. THE SURGEON SAID THIS EVENT OCCURRED IMMEDIATELY AFTER THEY TOOK CONTROL AT THE SURGEON SIDE CONSOLE (SSC) WHILE THEY WERE TRYING TO SET-UP THE RETRACTION. THE PROGRASP FORCEPS INSTRUMENT REPORTEDLY WAS THE INSTRUMENT THAT MOVED DURING THIS EVENT. THE SURGEON REPORTED THAT THE PATIENT LOST 50CC OF BLOOD DUE TO THIS EVENT AND NO BLOOD TRANSFUSION WAS ADMINISTERED. THIS EVENT DELAYED TH

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 AN UNSPECIFIED DA VINCI-ASSISTED UROLOGIC PROCEDURE, THE SURGEON EXPERIENCED NON-INTUITIVE MOTION OF INSTRUMENTS INVOLVING THE USE OF A 30-DEGREE ENDOSCOPE. THE ISSUE OCCURRED WHEN THE SURGEON GAVE THE COMMAND TO TURN THE ENDOSCOPE 180 DEGREES, WHICH CAUSED THE INSTRUMENTS TO START WORKING IN THE OPPOSITE, OR MIRRORED, DIRECTION. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) VIEWED THE LIVE LOGS AND DID NOT NOTE ANY ASSOCIATED ERRORS. THE SYSTEM WAS RESTARTED, AND THE ENDOSCOPE WAS RESEATED. THERE WAS A PROCEDURAL DELAY DUE TO TROUBLESHOOTING. AFTER THE REVERSED MOTION OF THE INSTRUMENTS, A HEMATOMA FORMED ON THE KIDNEY. THE SURGEON MADE THE CLINICAL DECISION TO ABORT THE PROCEDURE AFTER DETERMINING THAT PROCEEDING WAS TOO RISKY DUE TO THE HEMATOMA. PER THE SITE, THE PROCEDURE WILL BE RESCHEDULED TO ANOTHER DAY AFTER THE HEMATOMA HAS DISSIPATED.

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 HAD A ROBOTIC HYSTERECTOMY ON (B)(6) 2022 AT THE SURGICAL HOSPITAL SINCE HER SURGERY PATIENT HAD CONTINUED ABDOMINAL PELVIC PAIN. ON (B)(6) 2023, A CT WAS OBTAINED WHEN PATIENT PRESENTED TO THE ED AND THERE WAS CONCERN FOR A FOREIGN BODY. PATIENT WAS TAKEN TO THE OPERATING ROOM FOR A LAPAROSCOPIC REMOVAL OF FOREIGN BODY ON (B)(6) 2023. THE FOREIGN BODY WAS RETRIEVED AND IDENTIFIED AS A TIP COVER ACCESSORY PLACED OVER THE MONOPOLAR CURVED SCISSOR INSTRUMENT USED IN ROBOTIC PROCEDURES. THE INSTRUMENT USED ON (B)(6) 2022 WAS MONOPOLAR CURVED SCISSOR 8MM DA VINCI XI SERIAL NUMBER (B)(4). THE INSTRUMENT IS NO LONGER IN OUR INVENTORY. THE MONOPOLAR IS CONSIDERED A SEMI-DISPOSABLE WHICH CAN BE USED UP TO 10 TIMES. IT WAS UTILIZED AGAIN ON (B)(6) 2022, (B)(6) 2022, (B)(6) 2022, AND (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: IT WAS REPORTED THAT A PATIENT UNDERWENT A DA VINCI-ASSISTED PULMONARY WEDGE RESECTION PROCEDURE AND WAS THEN CLOSED UP. THE SURGEON REPORTEDLY LEFT THE OPERATING ROOM (OR); HOWEVER, AN UNSPECIFIED TIME LATER, THE PATIENT TURNED GRAY IN COLOR. THE SURGEON WAS CALLED IN AND AN EXPLORATORY LAPAROTOMY WAS PERFORMED. IT WAS FOUND THAT A SEAL WHERE A SYNCHROSEAL INSTRUMENT WAS USED FAILED, RESULTING WITH EXCESSIVE BLEEDING. THE SURGEON WAS ABLE TO STOP THE BLEEDING. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. 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 AS PART OF A CLINICAL STUDY THAT AFTER UNDERGOING A DA VINCI-ASSISTED RIGHT LOWER LOBECTOMY PROCEDURE, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT ON POST-OPERATIVE DAY (POD) #4 WITH ABNORMAL SECRETION AND FLUID COMING OUT FROM THE CLOSURE WOUND. THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS AND HOSPITALIZATION. THE FOLLOWING DAY THE PATIENT WAS DIRECTED TO OUTPATIENT CARE. THE INTENSITY OF SECRETION WAS REDUCED ON POD #5 AND WAS ABSORBED WITHOUT A CHEST DRAIN. PER EVALUATION BY TWO PHYSICIANS, THE POSSIBLE CAUSE OF THE COMPLICATION WAS DUE TO THE PATIENT NOT FOLLOWING AGREED THORACIC EXPANSION EXERCISES. THE PLAN WAS TO ENCOURAGE THE PATIENT TO STICK TO REHABILITATION MEASURES, RE-EVALUATE THE DRAINAGE POSITION AND CONDUCT AN-PATIENT ULTRASOUND CHECK-UP BEFORE REMOVING THE CHEST DRAIN. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, FURTHER DETAILS HAVE YET TO BE 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 INITIALLY REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED BILATERAL INGUINAL HERNIA SURGICAL PROCEDURE THAT A U-02 ERROR OCCURRED AGAINST THE ERBE INTEGRATED ELECTROSURGICAL UNIT (IESU) GENERATOR, SHORTLY AFTER POWERING ON THE GENERATOR. THE SITE TRIED TO POWER CYCLE THE IESU SEVERAL TIMES PRIOR TO CALLING, BUT THE ERROR KEPT RETURNING. THE TECH SUPPORT ENGINEER (TSE) WALKED THE CUSTOMER THROUGH POWERING DOWN THE SYSTEM AND THE IESU. THE CUSTOMER DISCONNECTED ALL OF THE CABLES AT THE BACK OF THE IESU, THEN POWERED IT ON WITHOUT THE FOOT SWITCHES CONNECTED. THE ERROR SEEMED TO GO AWAY, BUT SOON RETURNED. THERE WERE NO REPORTS OF PATIENT INJURY. AT THIS TIME THE PROCEDURE OUTCOME IS UNKNOWN. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION. THE SURGICAL PORTS HAD BEEN PLACED ON THE PATIENT WHEN THE IESU ERRORS OCCURRED. THE PROCEDURE WAS ULTIMATELY CONVERTED TO AN OPEN PROCEDURE DUE TO THE GENERATOR ISSUE. THERE WAS NO REPORTED HARM TO THE PATIENT AS A RESULT OF THE CONVERSION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER A DA VINCI ASSISTED RIGHT MIDDLE LOBE PULMONARY LOBECTOMY PROCEDURE, THE PATIENT, WHO WAS PART OF A COMPLETED PILOT STUDY OF SINGLE PORT ROBOTIC SURGERY FOR ANATOMICAL LUNG RESECTION, EXPERIENCED HEMOPTYSIS. AN X-RAY DONE ON THE PATIENT SHOWED PLEURAL EFFUSION. THE PATIENT UNDERWENT A RE-OPERATION. INTRA-OPERATIVELY, SEVERE PULMONARY CONGESTION WAS FOUND DUE TO A "MAL-RESECTION" OF PREVIOUS S2 SEGMENTAL VEIN DRAINAGE. THE PLEURAL EFFUSION AND BLOOD CLOT WERE RETRIEVED BY SINGLE PORT VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS) TECHNIQUE. THE SURGEON THEN DISSECTED THE POSTERIOR PART OF THE LUNG FISSURE AND EXPLORED THE A2 ( POSTERIOR ASCENDING BRANCH OF PULMONARY ARTERY). ECCHYMOSIS OF A2 WAS FOUND. THE SURGEON COMPLETED THE ANTERIOR HORIZONTAL FISSURE USING THE HARMONIC SCALPEL TO LOOSEN THE HILAR AREA AND USED TWO HEM-O-LOCKS CLIPS AS WELL AS THE HARMONIC SCALPEL TO RESECT THE A2 BRANCH. THEN THE RIGHT UPPER LOBE CONGESTION CONDITION IMPROVED. THE SURGEON BELIEVES THAT THE CAUSE OF THE POST-OPERATIVE COMPLICATION WAS DUE TO THE UNCOMMON ANATOMY CAUSING BLOOD FROM UPPER LOBE TO FLOW BACK TO MID-LOBE, RESULTING IN THE BLOOD CLOT. THE SUSPECTED DEVICE INVOL