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, THE HARMONIC ACE INSTRUMENT BROKE. THE CUSTOMER USED THE SAME INSTRUMENT TO COMPLETE THE PROCEDURE. FRAGMENTS WERE REPORTED TO FALL INSIDE THE PATIENT AND WERE RETRIEVED FROM THE BODY DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED VIA A SOCIAL MEDIA POSTING THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE INNER SILICONE PORTION OF A UNIVERSAL SEAL (5-12MM) BROKE OFF. THE INITIAL REPORTER INDICATED THAT IT SEEMS THAT WHEN CERTAIN INSTRUMENTS ARE INSERTED, A PIECE WOULD RIP OFF AND END UP INSIDE 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 SIGMOID COLECTOMY, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY THAT WAS INSTALLED ON AN MCS INSTRUMENT WAS LEFT INSIDE THE PATIENT. ACCORDING TO THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) WHO WAS PRESENT DURING THE CASE, THE CUSTOMER HABITUALLY INCLUDES THE TIP COVER ACCESSORY IN THE INTRAOPERATIVE COUNTS, BUT DID NOT REALIZE THE COUNT WAS INCORRECT UNTIL AFTER THE PATIENT WAS CLOSED. THE PATIENT REMAINED IN THE OPERATING ROOM AND UNDER ANESTHESIA THROUGHOUT THE EVENT. THE STAFF SPENT ROUGHLY 20 MINUTES SEARCHING THE OR FOR THE MISSING TIP COVER ACCESSORY BEFORE THE SURGEON REOPENED THE PATIENT. A 12MM AND TWO 5MM PORTS WERE USED DURING REENTRY, AND THE TIP COVER ACCESSORY WAS FOUND WITHIN A COUPLE OF MINUTES OF MANIPULATING THE BOWEL. ONCE RETRIEVED, THE CSR INSPECTED THE TIP COVER ACCESSORY AND THERE WAS NO DAMAGE NOTED. ADDITIONALLY, THERE WERE NO ISSUES WITH THE INSTALLATION OF THE TIP COVER ACCESSORY AND NO LUBRICATION WAS USED. DURING THE PROCEDURE, THE CUSTOMER DID NOT EXPERIENCE ANY ISSUES WITH THE INSTRUMENT. THERE WAS NO BULGING OF THE TIP COVER ACCESSORY OBSERVED ON THE MCS INSTRUMENT

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A PATIENT WHO WAS ENROLLED IN A STUDY UNDERWENT A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE. APPROXIMATELY NINE MONTHS LATER, THE PATIENT UNDERWENT A SURGERY FOR INTESTINAL ADHESIONS. ON POST-OPERATIVE DAY THREE, A SMALL AMOUNT OF RED AND WHITE PUS DISCHARGED FROM THE UMBILICAL WOUND WHEN CLEANING WITH SALINE. THE DRESSING WAS SWITCHED TO A WET SALINE DRESSING. ON POST-OPERATIVE DAY SEVEN, THE PATIENT UNDERWENT STOMA SURGERY, WITH A STOMA PLACED IN THE LOWER RIGHT ABDOMEN, A NASOGASTRIC TUBE FOR CONTINUOUS DRAINAGE, AND A RECTAL TUBE FOR CONTINUOUS DRAINAGE OF MODERATE AMOUNTS OF DARK GREENISH-BROWN LIQUID STOOL. ON POST-OPERATIVE DAY EIGHT, A SMALL AMOUNT OF BROWNISH EXUDATE WAS FOUND FROM THE UMBILICAL WOUND. ON THE FOLLOWING DAY, A SAMPLE OF THE BROWNISH EXUDATE FROM THE UMBILICAL WOUND WAS TAKEN FOR CULTURE, AND ANTIBIOTICS WERE ADMINISTERED. ON POST-OPERATIVE DAY 10, THE RECTAL AND NASOGASTRIC TUBES REMOVED. THE ABDOMINAL DISTENSION IMPROVED SIGNIFICANTLY, AND THE DISCOMFORT WAS REDUCED. THE CLEAR LIQUID DIET WAS WELL-TOLERATED. ON POST-OPERATIVE DAY 11, THE UMBILICAL WOUND HAD BROWNISH EXUDATE. THE SUTURES WERE REMOVED, AND POVIDONE-IODINE WAS USED TO PACK T

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: 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 PANCREATODUODENECTOMY SURGICAL PROCEDURE, THE TIP FELL OFF FROM THE SINGLE PORT (SP) MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A BACKUP INSTRUMENT OF SAME KIND. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SP MCS INSTRUMENT AND THE SP MCS TIP ACCESSORY WERE INSPECTED PRIOR TO USE WITH NO DAMAGE NOTED. DURING THE PROCEDURE, THE PLASTIC PART OF THE SP MCS INSTRUMENT WAS BROKEN WHILE DISSECTING THE TISSUE. THIS PLASTIC PART AND THE SP MCS TIP ACCESSORY FELL INSIDE THE PATIENT AND WERE RETRIEVED DURING SAME PROCEDURE. POST-OPERATIVE TESTS WERE NOT PERFORMED AS RETRIEVAL OF THE BROKEN PIECES WAS CONFIRMED WITH VISUAL INSPECTION. IN ADDITION, THE SP MCS INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS AND THE SP MCS TIP ACCESSORY APPEARED TO BE PROPERLY INSTALLED DURING USE. THERE WAS NO DIFFICULTY IN REMOVING THE INSTRUMENT AND SP MCS TIP ACCESSORY AND THE INSTRUMENT WRIST WAS STRAIGHTENED UPON REMOVAL. THE CUSTOMER INDICATED THAT NO DAMAGE, TEARS OR HOLE FOUND ON THE SP MCS TI

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ACCORDING TO A NEWSPAPER ARTICLE, A PATIENT WHO UNDERWENT A DA VINCI ASSISTED COMPONENT SEPARATION PROCEDURE DEVELOPED A SERIOUS COMPLICATION THAT NECESSITATED AN ADDITIONAL SURGERY. ACCORDING TO THE SURGEON, IT WAS HIS FIRST DA VINCI ASSISTED COMPONENT SEPARATION PROCEDURE THAT HE HAD PERFORMED. THERE WERE NO MALFUNCTIONS OF DA VINCI SYSTEMS, INSTRUMENTS OR ACCESSORIES REPORTED IN THE ARTICLE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ACCORDING TO A NEWSPAPER ARTICLE, THERE WAS A DA VINCI-ASSISTED COMPONENT SEPARATION SURGERY THAT HAD POST-OPERATIVE COMPLICATION WHICH REQUIRED AN ADDITIONAL SURGERY. IT WAS REPORTED THAT THE PATIENT DEVELOPED A "MICKEY MOUSE HERNIA", WHERE THE PATIENT'S INTESTINES WERE BULGING OUT OF HER SIDES. THE SURGEON THAT PERFORMED THE REPAIR BELIEVED THE PROCEDURE WAS DONE INCORRECTLY AND THAT THAT THE ORIGINAL SURGEON HAD CUT INTO THE WRONG MUSCLE PLANE. THERE WERE NO MALFUNCTIONS OF DA VINCI SYSTEMS, INSTRUMENTS OR ACCESSORIES REPORTED IN ANY OF THE PROCEDURES IN THE ARTICLE.

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: DURING THE REVIEW OF A LITERATURE ARTICLE WHICH DESCRIBED A RETROSPECTIVE COHORT STUDY, A SINGLE-PORT TRANSVESICAL (TV) ROBOT-ASSISTED SIMPLE PROSTATECTOMY (RASP) WAS PERFORMED. THE ARTICLE NOTED THAT DURING THESE SURGERIES, THERE WERE TWO SUSPECTED VENOUS AIR EMBOLI IN THE COHORT. THE AUTHORS ATTRIBUTED THIS EFFECT TO PNEUMOVESICUM PRESSURES (>12 MMHG). ONE OF THE PATIENTS HAD A SPONTANEOUS RESOLUTION IN THE OPERATING ROOM WITH HIGH-FLOW OXYGEN AND REPOSITIONING TO LEFT LATERAL DECUBITUS. THE SECOND PATIENT REQUIRED MANAGEMENT IN THE INTENSIVE CARE UNIT FOR 3 DAYS; HE WAS ALSO THE ONLY PATIENT THAT REQUIRED CONTINUOUS BLADDER IRRIGATION (CBI) POST OPERATIVELY. THE AUTHORS ALSO NOTED THAT PNEUMOVESICUM PRESSURE WAS SET AT 10 MMHG USING AN AIRSEAL (CONMED, UTICA, NY, USA) SYSTEM. THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS REPORTED, NOR DID THE AUTHORS ALLEGE THAT INTUITIVE PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENT. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP 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 SIGMOID COLECTOMY SURGICAL PROCEDURE, THE DISTAL SHAFT OFFSET ITSELF AND CAUSED PARTS OF AN INSTRUMENT TO FALL INTO THE PATIENT'S ABDOMEN. THE PARTS WERE RETRIEVED. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND NO FURTHER 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: 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: A REVIEW OF A LITERATURE ARTICLE TRANSORAL ROBOTIC SURGERY IN OROPHARYNGEAL SQUAMOUS CELL CARCINOMA: A COMPARATIVE STUDY BETWEEN DA VINCI SINGLE-PORT AND DA VINCI XI SYSTEMS WAS PERFORMED. THE STUDY'S AIM WAS TO COMPARE THE INTRA- AND POST-OPERATIVE OUTCOMES, TECHNICAL ADVANTAGES, AND SHORTCOMINGS OF TRANSORAL RESECTIONS PERFORMED WITH THE DA VINCI SINGLE PORT (SP) AND THE DA VINCI XI SYSTEMS USING A LARGE-VOLUME ACADEMIC CENTER USING TRANSORAL ROBOTIC SURGERY (TORS) TO TREAT OROPHARYNGEAL SQUAMOUS CELL CARCINOMA (OPSCC). PATIENTS DIAGNOSED WITH AN OPSCC WHO UNDERWENT TORS BY THE SENIOR AUTHOR¿S (SHK) TEAM BETWEEN JANUARY 2015 AND JANUARY 2023 WERE INCLUDED. THE ARTICLE NOTED THAT THAT DURING THESE DV SURGERIES, A TOTAL OF 6 PATIENTS HAD MAJOR POST-OPERATIVE BLEEDING THAT REQUIRED HEMOSTASIS AND 4 PATIENTS WERE DEPENDENT ON TRACHEOTOMY AND FEEDING TUBE 6 MONTHS AFTER SURGERY IN THE SP GROUP. THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS REPORTED, NOR DID THE AUTHOR ALLEGED THAT ISI PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE 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 SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT BLADE SUDDENLY BROKE. THE CUSTOMER USED A SPARE INSTRUMENT TO PROCEED. THE PROCEDURE WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE HARMONIC ACE INSTRUMENT WAS INSPECTED PRIOR TO USE AND THERE WAS NO ISSUE OBSERVED AT THE TIME. THE REPORTED ISSUE OCCURRED WHILE PERFORMING A TISSUE-DISSOLVING PLANE. THE SURGEON BELIEVED WHAT CAUSED THE ISSUE WAS A QUALITY PROBLEM. THE HARMONIC ACE INSTRUMENT ISSUE OCCURRED AT THE START OF THE PROCEDURE. THE SURGEON NOTICED FUNCTIONALITY ISSUES DURING THE SURGICAL PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR HARD MATERIAL. THE INSTRUMENT WAS REMOVED BEFORE THE BREAKAGE OCCURRED AND THE INSTRUMENT'S WRIST WAS EXTENDED OR STRAIGHTENED PRIOR TO REMOVAL. THE STAFF DID NOT FEEL RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. ALL FRAGMENTS WERE RETRIEVED. THE PROCEDURE WAS COMPLETED WITH A SPARE INSTRUMENT OF THE SAME KIND. NO ADDITIONAL MEDICAL PROCEDURES SUCH AS X-RAYS WERE PERFORMED POST-PROCEDURALLY. THERE WAS NO PA

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL CYSTECTOMY WITH ILEAL DIVERSION SURGICAL PROCEDURE, DURING THE DISSECTION OF LYMPH NODES, THE MONOPOLAR CURVED SCISSORS (MCS) ACCESSORY CAME OFF FROM THE MCS INSTRUMENT, FALLING INTO THE PELVIC AREA. THE MCS TIP COVER ACCESSORY WAS RETRIEVED WITHOUT ISSUES. THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY WAS INSPECTED, AND IT WAS NOTED TO BE VISUALLY ABNORMAL. IT WAS CLEANED WITH A WET CLOTH AND DRY SPONGE. A NEW TIP COVER WAS APPLIED, AND THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE MCS INSTRUMENT AND ACCESSORY WERE INSPECTED PRIOR TO USE AND NO DAMAGE WAS IDENTIFIED. THE ASSISTANT RESIDENT USED A LAPAROSCOPIC FENESTRATED GRASPER TO RETRIEVE IT. THE MCS INSTRUMENT WAS IN USE FOR MORE THAN 1 HOUR. THE MCS INSTRUMENT WORKED FINE FOR THE MAIN DISSECTION OF URETERS PRIOR TO THE INCIDENT. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS DURING THE SURGICAL PROCEDURE. THE MCS TIP COVER ACCESSORY APPEARED TO BE PROPERLY INSTALLED DURING THE SURGICAL PROCEDURE USING THE INSTAL

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, A PIECE OF BLACK RUBBER BROKE OFF OF THE SEAL AND FELL INTO THE SURGICAL SITE. THE PROCEDURE AND THE PATIENT OUTCOMES ARE UNKNOWN. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT. THE PROCEDURE WAS ROBOTICALLY COMPLETED. PER THE SURGEON'S OPERATION NOTE AND DISCHARGE SUMMARY, THE FRAGMENT OF THE PORT WAS NOT EVEN MENTIONED. THE PATIENT WAS DISCHARGED ON TIME, AND IN STABLE CONDITION. NO PATIENT INJURY OR HARM WAS REPORTED. NO MEDIA IS AVAILABLE FOR REVIEW.

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 PULMONARY LOBECTOMY PROCEDURE, THE SYSTEM WAS LOCKED UP AND ARM 4 WAS VERY STIFF. THE CUSTOMER STATED THEY HAD TO PUSH THE EMERGENCY STOP BUTTON ON THE SYSTEM DUE TO CONVERTING TO PROCEDURE TO OPEN SURGERY. THE CUSTOMER EXPLAINED THE CASE WAS CONVERTED TO OPEN SURGERY DUE TO PATIENT ANATOMY. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE LOGS AND CONFIRMED THE EMERGENCY STOP FAULT WAS STILL ACTIVE ON THE SYSTEM. THE TSE HAD CALLER NAVIGATE TO THE SURGEON CONSOLE AND PUSH THE RESUME BUTTON TO RETURN THE SYSTEM BACK TO A NORMAL STATE. THE STAFF CONFIRMED THE SYSTEM FUNCTIONALITY RETURNED TO NORMAL AND ARM 4 WAS NOT STIFF ANYMORE. ISI FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS NO ISSUE WITH THE ROBOT OTHER THAN STAFF NOT BEING AWARE OF THE EMERGENCY RESET BUTTON ON THE SURGEON CONSOLE. THE ROBOT WORKED AS EXPECTED DURING THE EMERGENCY WITH THE PATIENT. NO FURTHER DETAILS REGARDING THE CONVERSION WERE 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 A PATIENT UNDERWENT A DA VINCI-ASSISTED SINGLE PORT (SP) BILATERAL NIPPLE SPARING MASTECTOMY AS PART OF A CLINICAL STUDY ON 31-OCT-2023. A BILATERAL NON-ROBOTIC RECONSTRUCTION PROCEDURE WAS PERFORMED IMMEDIATELY AFTER. AFTER THE PROCEDURE, WHILE THE PATIENT WAS STILL IN THE RECOVERY, AN INCREASE OF THE BLOOD FROM HER LEFT BREAST DRAIN AS WELL AS AN ENLARGED LEFT BREAST WERE IDENTIFIED. COMPRESSION WAS PERFORMED AT THE SITE AND INTRAVENOUS TRANEXAMIC ACID (TXA) WAS GIVEN TO HELP STOP THE BLEEDING. IN ADDITION, THE PATIENT WAS KEPT OVERNIGHT FOR MONITORING. NO SIGNS OF INFECTION WAS OBSERVED. THE HEMATOMA IMPROVED AND RESOLVED DURING HER HOSPITALIZATION. THE DRAINAGE VOLUME WAS STABILIZED WITH ONLY SEROSANGUINEOUS SEEN. THE PATIENT WAS DISCHARGED HOME IN STABLE CONDITION ON 02-NOV-2023, AND THE ADVERSE EVENT WAS REPORTEDLY RESOLVED ON 02-NOV-2023. THE INVESTIGATOR ASSESSED THE EVENT AS RELATED TO THE PROCEDURE, BUT NOT RELATED TO DA VINCI DEVICES.

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 AN OBSERVED DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGEON INFORMED THE INTUITIVE SURGICAL, INC. (ISI) REPRESENTATIVES ABOUT RECURRENT INCIDENCES OF PATIENT INJURY INVOLVING THE 12MM CANNULA THAT IS PLACED LATERALLY IN THE 8TH INTERCOSTAL SPACE (ICS) DURING PULMONARY LOBECTOMY CASES. INJURIES INCLUDE PORT SITE BRUISING, ABRASIONS AND HAIRLINE FRACTURES IN 25% OF PATIENTS. PER THE SURGEON, THIS IS DUE TO THE CANNULA RUBBING AGAINST THE RIB (INTERNALLY) ABOVE THE ICS WHEN ANGLING UPWARDS. THIS RECURRENT ISSUE WAS THE FOCUS OF AN INTERNAL STUDY CONDUCTED BY SITE RADIOLOGISTS. ADDITIONALLY, PATIENTS EXPERIENCED POST-OPERATIVE PAIN. DURING FOLLOW UP WITH THE ISI CLINICAL SALES REPRESENTATIVE (CSR), IT WAS STATED THAT THE BRUISING AND HAIRLINE FRACTURE IS OCCURRING DESPITE CORRECT USE OF THE REMOTE CENTER CANNULA INDICATORS AND WAS SAID THAT IT WAS TYPICALLY CAUSED BY THE ANGLE NEEDED ON THE UNIVERSAL SURGICAL MANIPULATOR (USM) DURING STAPLING.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING INVESTIGATION OF AN UNRELATED EVENT, A SURGEON NOTIFIED AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE THAT THE COUNTY MEDICAL EXAMINER (ME), WHILE PROVIDING AUTOPSY RESULTS FOR THE UNRELATED EVENT, "RECALLED TWO PREVIOUS PATIENT DEATHS CAUSED BY ROBOTIC STAPLE LINES NOT HOLDING UP ON ARTERIES AND CAUSING BLEEDING." THE ME RECALLED THAT ONE PATIENT HAD RECEIVED A ROBOTIC-ASSISTED PROSTATECTOMY, AND THE OTHER PATIENT RECEIVED A ROBOTIC-ASSISTED SPLENECTOMY. THERE WAS NO ADDITIONAL INFORMATION EXCHANGED, OTHER THAN THE EVENTS OCCURRED AT DIFFERENT HOSPITALS. THE MEDICAL EXAMINERS OFFICE WAS CONTACTED TO REQUEST ADDITIONAL INFORMATION. THE ME ASSISTANT STATED THEY WOULD REVIEW PREVIOUS CASES TO DETERMINE IF THERE WERE ANY SIMILAR CASES. UPON FOLLOW UP, THE ME ASSISTANT REPORTED FINDING A PROSTATECTOMY CASE FROM 2015, AND THE ONLY INFORMATION THEY COULD SHARE WAS THE DATE OF DEATH AND HOSPITAL WHERE THE PROCEDURE WAS PERFORMED. THERE WERE NO SIMILAR SPLENECTOMY CASES FOUND IN THE MEDICAL EXAMINERS RECORDS. THE MEDICAL EXAMINER DECLINED TO PROVIDE ANY FURTHER INFORMATION AND DESCRIBED THE CONVERSATION AS A BRIEF COLLEAGUE-TO-COLLEAGUE OBSERVATION. NO ADDITIONAL I

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 - PARAOESOPHAGEAL SURGICAL PROCEDURE, THE JAW OF A HARMONIC ACE INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE. THE PROCEDURE WAS COMPLETED ROBOTICALLY.

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 PRIOR TO THE START OF A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE ENDOSCOPE WOULD NOT ROTATE. A BACKUP ENDOSCOPE WAS USED, AND THE PROCEDURE WAS CONVERTED TO OPEN. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP 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 SURGICAL PROCEDURE, THE SITE REPORTED THAT HEAD SENSOR SOMETIMES NOT WORKING AND SYSTEM ASKS TO OPEN AND CLOSE GRIP MASTER TOOL MANIPULATOR (MTMS). INTUITIVE TECHNICAL SUPPORT ENGINEER (TSE) CHECKED THE LOGS, THERE ARE ONLY THE COMMUNICATIONS ERRORS. SITE PERFORMED DIFFERENT ACTIONS TO TROUBLESHOOT THE ISSUE PER TSE RECOMMENDATION. BUT, PROBLEM DID NOT RESOLVE AND THE SURGEON CONVERTED THE SURGERY IN OPEN. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL (IS) CONTACTED THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS EVENT: THE PROCEDURE WAS CONVERTED TO OPEN AS THE SURGEON COULD NOT MOVE THE MTMS ON THE CONSOLE FLUENTLY. EVEN IF HE WAS NOT MOVING HIS HEAD FROM THE 3D VIEWER, EVERY 2-3 MINUTES, THE SYSTEM RESPONDED AS IF THE DOCTOR JUST SAT AT THE CONSOLE, BLOCKING THE INSTRUMENTS AND THE MASTERS AND ASKING THE SURGEON TO MOVE THE GRIP. THE PROCEDURE WAS NOT CONVERTED FOR INTRA OPERATIVE COMPLICATIONS. THE PATIENT TOTALLY TOLERATED THE CHANGE. THERE WAS NO ANY INJURY TO THE PATIENT. SYSTEM MALFUNCTION OCCURRED PRIOR TO CONVERSION BUT, IT DID NOT LEAD TO ANY PATIENT HARM. ACCORDING TO THE SURGEON, THERE WAS A 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: 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 PATIENT'S BLOOD PRESSURE AND HEART RATE BECAME ELEVATED AFTER BEING SEDATED. THE SURGEON CHOSE TO ABORT THE PROCEDURE, AS THEY DID NOT FEEL IT WAS CORRECT TO PROCEED.

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 HIATAL HERNIA REPAIR, THE INFERIOR VENA CAVA (IVC) WAS INJURED. THE SURGEON REPORTED THAT THE INJURY OCCURRED DUE TO ATYPICAL ANATOMY. WHILE USING THE HARMONIC ACE SHEARS TO DIVIDE THE GASTROHEPATIC LIGAMENT, A MALPOSITION OF THE IVC RELATIVE TO ITS NORMAL POSITION WAS ENCOUNTERED. THE IVC WAS TENSELY PULLED ACROSS THE DIAPHRAGM AND UNRECOGNIZED AS IT WAS TUCKED RIGHT BEHIND THE GASTROHEPATIC LIGAMENT. THE SURGEON BELIEVES THE SIDEWALL OF THE IVC WAS UNKNOWINGLY GRASPED IN THE INSTRUMENT JAWS WHILE DIVIDING THE LIGAMENT. THE PROCEDURE WAS CONVERTED TO OPEN TO ADDRESS THE INJURY, BUT THE PATIENT EXPIRED. THERE WAS NO REPORTED INTUITIVE SURGICAL, INC. (ISI) PRODUCT MALFUNCTION.

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 HARMONIC ACE INSTRUMENT WAS FOUND TO HAVE A BROKEN TIP. THE PROCEDURE WAS COMPLETED USING A BACKUP HARMONIC ACE INSTRUMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE HARMONIC ACE INSTRUMENT FRAGMENT WAS RETRIEVED BY THE ASSISTANT USING AN ENDOSCOPE. ALL FRAGMENTS WERE CONFIRMED TO HAVE BEEN RETRIEVED BY THE ASSISTANT AND NURSE. THERE WAS NO ADDITIONAL SURGICAL PROCEDURE REQUIRED AND NO POST-OPERATIVE TESTS WERE PERFORMED. THE SURGEON BELIEVES THE CAUSE OF THE BREAK WAS AN INSTRUMENT QUALITY PROBLEM. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGE WAS OBSERVED. THE INSTRUMENT WAS USED FOR AN HOUR AND A HALF PRIOR TO THE BREAK. THE INSTRUMENT WAS BEING USED FOR GRASPING WHEN IT BROKE. THERE WAS NO FUNCTIONALITY ISSUE AND NO INSTRUMENT COLLISION PRIOR TO THE BREAKAGE. THE INSTRUMENT WAS ALSO NOT REMOVED DURING THE PROCEDURE PRIOR TO THE BREAKAGE. UPON FINAL REMOVAL OF THE INSTRUMENT, THERE WAS SOME RESISTANCE WHEN REMOVING THE INSTRUMENT THROUGH THE CANNULA, BUT NO DAMAGE TO THE CANNULA, AND NO FURTHER

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, A PORTION OF THE BLUE PART OF THE CANNULA SEAL BROKE OFF INSIDE THE PATIENT WHEN A REDUCER WAS INSERTED. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CANNULA SEAL WAS INSPECTED PRIOR TO USE AND NO DAMAGE WAS OBSERVED. THE TROCAR APPEARED NORMAL. A PIECE OF THE CANNULA SEAL WAS IDENTIFIED PRIOR TO THE CONCLUSION OF THE CASE, INCIDENTALLY. THE SURGEON BELIEVES THE REDUCER PLACED THROUGH THE 12MM BROKE OFF A PIECE OF THE CANNULA SEAL WHICH FELL INSIDE THE PATIENT'S ABDOMEN. THE TROCAR WAS USED THE ENTIRE CASE, BUT AIRSEAL (A 3RD PARTY MANUFACTURER PRODUCT) WOULD NOT WORK CORRECTLY ON THE AFFECTED 12MM TROCAR. THERE WERE NO DEVICE COLLISIONS AND NO INSTRUMENTS WERE REMOVED PRIOR TO BREAKAGE. THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. THE SURGICAL STAFF DID NOT NOTICE ANY DAMAGE TO THE CANNULA AFTER THE EVENT OCCURRED. THE FRAGMENT WAS REMOVED WITH A LAPAROSCOPIC GRASPER INSTRUMENT THROUGH THE CANNULA. THE FRAGMENT WAS INSPECTED AND IDENTIFIED AS THE ONLY BRO

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 ASSISTANT OBSERVED ON THE MONITOR THAT PART OF THE JAW OF THE HARMONIC ACE INSTRUMENT HAD BECOME DETACHED AND FALLEN INTO THE PATIENT'S ABDOMINAL CAVITY. THE FRAGMENT WAS PROMPTLY FOUND AND REMOVED. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND THERE WAS NO APPARENT DAMAGE. THE TASK PERFORMED WHEN THE FRAGMENT FELL WAS DISSECTING. THE SURGEON DID NOT KNOW WHAT CAUSED THE INSTRUMENT TO BREAK OR WHAT CAUSED THE FRAGMENT TO FALL. THE INSTRUMENT WAS IN USE FOR 3 HOURS PRIOR TO THE ISSUE. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR HARD MATERIAL DURING THE PROCEDURE. THE FRAGMENT FELL DURING A TIP COLLISION. THE FRAGMENT WAS RETRIEVED WITH ANOTHER ROBOTIC GRIPPER RIGHT AFTER THE EVENT. IT WAS CONFIRMED THAT ALL FRAGMENTS WERE RETRIEVED BY VIEWING AND CONFIRMING WITH THE TEAM. THERE WAS NO ADDITIONAL SURGICAL PROCEDURE REQUIRED TO REMOVE THE FRAGME

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 DAVINCI ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE END OF THE SYNCHRO SEAL CAME DETACHED. THE PIECE OF SHEATH WAS RETRIEVED, THEREFORE NO HARM TO THE PATIENTS. THE SURGEON FELT THIS OCCURRED DUE TO CLASHING OF INSTRUMENTS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL INC.(ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO REPORTED DAMAGE. THE EVENT OCCURRED WHILE GRASPING AND CAUTERIZING WHEN THE ALLEGED INSTRUMENT WAS TOO CLOSE TO ANOTHER INSTRUMENT LEADING TO CLASHING. THE CLASH WAS DUE TO NARROW PELVIS. PER SURGEON, THE PORTS SHOULD HAVE BEEN PLACED HIGHER UP. THERE WAS NO ISSUE WITH INSTRUMENT FUNCTIONING BEFORE THE OCCURRENCE OF EVENT. THERE WAS NO RESISTANCE WHILE REMOVING THE INSTRUMENT FROM SURGICAL FIELD. THE FALLEN FRAGMENT WAS REMOVED THROUGH THE PORT WITH GRASPER. IT WAS SINGLE FRAGMENT. NO POST-OPERATIVE TESTS WERE PERFORMED. THE PROCEDURE WAS COMPLETED WITH BACK-UP INSTRUMENT WITH NO PATIENT HARM. THERE IS NO REPORT OF POST SURGICAL 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: 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 LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE SURGERY WAS CONVERTED TO A LAPAROTOMY PROCEDURE AFTER THE SURGEON FOUND IT DIFFICULT TO IDENTIFY THE INCISION LINE OF THE TISSUE CONTAINING CANCER. THE PATIENT WAS UNDERGOING CHEMOTHERAPY AND HAD SEVERE LYMPH NODE EDEMA. THE SURGICAL FIELD WAS EXTREMELY WET DUE TO CHEMOTHERAPY, AND THE IDENTIFICATION OF THE CUTTING LINE WAS DIFFICULT. THE DOCTOR COMMENTED THAT LAPAROTOMY WAS A BETTER OPTION TO IDENTIFY THE INCISION LINE THAN CONTINUING TO USE DA VINCI SYSTEM. THERE WAS NO ISSUE WITH THE DA VINCI SYSTEM, AND THE CONVERSION WAS DONE AT THE DOCTOR'S DISCRETION. THE HOSPITAL CONFIRMED THAT THE SURGERY WAS COMPLETED SUCCESSFULLY.

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 ON AN ONLINE NEWS ARTICLE THAT AFTER A PATIENT UNDERWENT A ROBOTIC ASSISTED OVARIAN CYSTECTOMY FOR HER OVARIAN TERATOMA, THE PATIENT EXPERIENCED HIGH FEVER AND ABDOMINAL PAIN. THE PATIENT WAS FOUND WITH SMALL INTESTINE PERFORATION. FOLLOW-UP HAS BEEN ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION, BUT THERE'S CURRENTLY NO INFORMATION ABOUT THE PROCEDURE DATE, NOR THE MEDICAL INTERVENTION THAT WAS PERFORMED TO ADDRESS THE COMPLICATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING REVIEW OF A LITERATURE ARTICLE WHICH COMPARED INTRA-ABDOMINAL INFECTIOUS COMPLICATIONS OF ROBOTIC ASSISTED GASTRECTOMY SURGICAL PROCEDURES WITH LAPAROSCOPIC GASTRECTOMY SURGICAL PROCEDURES, THE FOLLOWING WAS IDENTIFIED: THIS RETROSPECTIVE, SINGLE-INSTITUTION STUDY AIMED TO ASSESS WHETHER ROBOTIC SURGERY (RG) OFFERS CLINICAL BENEFITS OVER LAPAROSCOPIC SURGERY (LG) FOR OBESE PATIENTS, LEVERAGING THE ROBOT¿S MECHANICAL ADVANTAGES. THE AUTHORS COMPARED SHORT-TERM OUTCOMES BETWEEN RG AND LG FOR PATIENTS WITH AND WITHOUT VISCERAL OBESITY. IN THE WHOLE COHORT, THE OVERALL COMPLICATION RATE WAS 13.0% FOR THE ROBOTIC GROUP, WHILE IN THE MATCHED COHORT, THE COMPLICATION RATE WAS HIGHER FOR RG. HOWEVER, THE INCIDENCE OF SEVERE COMPLICATIONS (CLAVIEN-DINDO GRADE III OR HIGHER) WAS NOT SIGNIFICANTLY DIFFERENT BETWEEN RG AND LG IN EITHER COHORT. INTRA-ABDOMINAL INFECTIOUS COMPLICATIONS (IAICS) SUCH AS PANCREATIC FISTULA, ANASTOMOTIC LEAKAGE, AND INTRA-ABDOMINAL ABSCESSES WERE IDENTIFIED, WITH VISCERAL OBESITY BEING A SIGNIFICANT RISK FACTOR. ALTHOUGH THE ROBOTIC SYSTEM DID NOT DEMONSTRATE A CLEAR ASSOCIATION WITH INCREASED SPECIFIC COMPLICATIONS COMPARED TO LG, THE OVERALL COMPLICATION RA

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 FAILED TO BE RECOGNIZED. THE USER COMPLETED THE PROCEDURE USING A BACKUP HARMONIC ACE WITH NO FURTHER ISSUES REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: A FRAGMENT OF THE HARMONIC ACE FELL INSIDE OF THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. THERE WAS NO ADDITIONAL SURGICAL PROCEDURE REQUIRED. IT WAS CONFIRMED THAT ALL FRAGMENTS WERE RETRIEVED. THERE WERE NO POST-OPERATIVE TESTS PERFORMED. UPON FINAL REMOVAL OF THE INSTRUMENT, THERE WAS NO RESISTANCE OF THE INSTRUMENT THROUGH THE CANNULA, NO DAMAGE TO THE CANNULA, AND NO ADDITIONAL DAMAGE TO THE INSTRUMENT. 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: ON 24-JAN-2024, INTUITIVE SURGICAL, INC. (ISI) RECEIVED MW5150169 STATING: THE REPORTED EVENT WAS A POSTOPERATIVE DUODENAL SEGMENT STAPLE LINE LEAK, WHICH REQUIRED A SECOND OPERATION 20 DAYS AFTER THE INITIAL ROBOTIC-ASSISTED PROCEDURE. THE AREA OF THE LEAK WAS STAPLED VIA THE USE OF A COVIDIEN STAPLER.

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 CUSTOMER NOTICED THAT THE SP MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT TIP WAS SEPARATED AND FELL OFF. UPON REMOVING THE INSTRUMENT TO CHECK, THE CUSTOMER FOUND SOME OF THE ACCESSORIES WERE NOT INTACT. THEY WERE ABLE TO RETRIEVE THE TIP, BUT SOME OF THE BROKEN PARTS COULD NOT BE CONFIRMED. THE CUSTOMER THEN CONDUCTED A LARGE AMOUNT OF IRRIGATION/SUCTION JUST IN CASE. 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: THE MCS INSTRUMENT AND MCS TIP ACCESSORY WERE INSPECTED PRIOR TO USE, AND NO DAMAGE WAS FOUND. DURING THE PROCEDURE, THE MCS TIP ACCESSORY AND FRAGMENTS FROM THE MCS INSTRUMENT FELL INTO THE PATIENT'S BODY AFTER BEING USED FOR LONGER THAN ONE HOUR TO DISSECT TISSUE. THE CUSTOMER RETRIEVED THE FRAGMENTS BUT COULD NOT CONFIRM IF THEY RETRIEVED ALL FRAGMENTS. THE CUSTOMER PERFORMED A LARGE AMOUNT OF IRRIGATION/SUCTION AS A PRECAUTIONARY MEASURE. POST-OPERATIVE TESTS AND ADDITIONAL SURGICAL PROCEDURES WERE NOT PERFORMED. THE SURGEON DID NOT NOTICE ANY I

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 PANCREATICODUODENECTOMY SURGICAL PROCEDURE, THE HARMONIC ACE TIP WAS BROKEN, AND A FRAGMENT FELL INSIDE THE PATIENT. THE FRAGMENT WAS REMOVED FROM THE PATIENT DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED USING A BACKUP HARMONIC ACE WITH NO FURTHER CONSEQUENCES KNOWN. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE FRAGMENTS OF THE HARMONIC ACE WERE RETRIEVED USING A LAPAROSCOPIC INSTRUMENT. ALL THE FRAGMENTS WERE CONFIRMED TO BE RETRIEVED. THERE WAS NO ADDITIONAL SURGICAL PROCEDURE NEEDED AS THE FRAGMENTS WERE RETRIEVED USING LAPAROSCOPIC INSTRUMENTS DURING THE SAME PROCEDURE. THERE WERE NO POST-OPERATIVE TESTS PERFORMED. THE SURGEON BELIEVES THAT THE INSTRUMENT QUALITY WAS THE CAUSE OF THE BREAK. THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO ABNORMALITIES, IT WAS USED FOR AN HOUR PRIOR TO BREAK WHEN BEING USED FOR SEPARATING A BLOOD VESSEL. THERE WAS NO FUNCTIONALITY PROBLEM PRIOR TO THE BREAK. THERE WAS NO INSTRUMENT COLLISION, AND THE INSTRUMENT WAS NOT REMOVED DURING THE PROCEDURE PRIOR TO THE BREAK. UPON FINAL REMOVAL, THERE WAS NO R

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, ANASTOMOTIC INSUFFICIENCY AT THE EDGE OF THE ANASTOMOSIS / STAPLE LINE OCCURRED. THE ISSUE WAS OBSERVED AFTER USING A SUREFORM STAPLER AND CHECKING PERFUSION OF THE ANASTOMOSIS WITH INDOCYANINE GREEN (ICG). THE STAPLE SUTURE HAD BEEN PROPERLY PLACED AND WAS CHECKED IN SITUS. THE THIRD-PARTY CIRCULAR STAPLER WAS NOTED TO BE WORKING PROPERLY.

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 UNSPECIFIED SURGICAL PROCEDURE, ANASTOMOTIC INSUFFICIENCY WITH AN INTRACORPORAL ANASTOMOSIS OCCURRED. THE ANASTOMOSIS WAS THEN SUTURED. THE SURGEON BELIEVES THIS ISSUE WAS DUE TO THE UNSPECIFIED SUREFORM STAPLER.

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 APPENDECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY FELL OFF WHEN REMOVED FROM THE PATIENT. THE MCS TIP COVER ACCESSORY WAS RETRIEVED BUT ALMOST FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE MCS TIP COVER ACCESSORY FELL INSIDE THE PATIENT, AND WAS NOTED BY THE SCRUB UPON INSTRUMENT REMOVAL THAT THE TIP WAS GONE. THE MCS TIP COVER ACCESSORY WAS INSPECTED PRIOR TO USE AND NO DAMAGE WAS NOTED. THE MCS TIP COVER ACCESSORY WAS RETRIEVED. THE SURGEON WAS UNSURE WHAT SURGICAL TASK WAS BEING PERFORMED WHEN THE MCS TIP COVER ACCESSORY FELL INSIDE THE PATIENT. THE MCS INSTRUMENT WAS IN USE FOR 10 MINUTES. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE MCS INSTRUMENT DURING THE SURGICAL PROCEDURE. THE MCS INSTRUMENT COLLISION WITH ANY OTHER INSTRUMENTS DURING THE SURGICAL PROCEDURE WAS MINIMAL. THE MCS TIP COVER ACCESSORY WAS PROPERLY INSTALLED DURING THE SURGICAL PROCEDURE AND NO PART OF THE ORANGE SURFACE WAS VISIBLE AFTER THE MCS TIP COVER ACCESSORY WAS IN

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 PRIOR TO STARTING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THERE WAS A PATIENT SIDE CART (PSC) RUNNING ON BATTERY MESSAGE. INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) INFORMED THE ISI TECHNICAL SUPPORT ENGINEER (TSE) THAT THEY HAVE ALREADY TRIED MULTIPLE OUTLETS AND HARD POWER CYCLED THE SYSTEM WITH AN EMERGENCY POWER OFF (EPO) OF THE PSC WITH NO CHANGE. THE ISI TSE RECOMMENDED ANOTHER REBOOT WITH EPO IF POSSIBLE. THE ISI TSE ALSO RECOMMENDED INFORMING THE SURGEON IF THEY ONLY HAVE BATTERY POWER ON THE PSC, THEY WILL NOT HAVE POWER FOR VERY LONG DEPENDING ON THE CURRENT STATUS OF THE BATTERY AND MAY NOT WANT TO START A PROCEDURE WITH ONLY BATTERY POWER. ERROR LOGS SHOW 417 ERRORS FOR BOTH POWER SUPPLY 1 AND 2. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SP SYSTEM WAS REMOVED FROM THE ROOM AND DA VINCI XI WAS BROUGHT IN TO CONTINUE 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 MYOMECTOMY PROCEDURE, A "SHEATH" FELL INSIDE THE PATIENT AND WAS RECOVERED. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORT OF ANY PATIENT HARM OR INJURY. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO CONTACT THE SURGEON TO GATHER ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. HOWEVER, AS OF THE DATE OF THIS REPORT, NO NEW 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LEFT HEMICOLECTOMY PROCEDURE, THE HARMONIC ACE INSTRUMENT BROKE WHILE THE SURGEON WAS DISSECTING. A FRAGMENT FELL INSIDE THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIALS DURING THE SURGICAL PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A BACK-UP HARMONIC ACE INSTRUMENT. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL 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 THAT DURING A DA VINCI-ASSISTED THYROIDECTOMY SURGICAL PROCEDURE, THE TIP OF THE HARMONIC ACE INSTRUMENT WAS BROKEN. 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: THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO DAMAGE OBSERVED. DURING THE PROCEDURE, THE INSTRUMENT TIP BROKE OFF AND FELL INSIDE THE PATIENT'S CAVITY AFTER USING IT FOR 15 MINUTES. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE AND CONFIRMED WITH A VISUAL INSPECTION. ADDITIONAL SURGICAL PROCEDURES AND POST-OPERATIVE TESTS WERE NOT PERFORMED. ADDITIONALLY, THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIALS DURING THE SURGICAL PROCEDURE. THE INSTRUMENT WAS NOT REMOVED DURING THE PROCEDURE (PRIOR TO THE BREAKAGE). UPON FINAL REMOVAL OF THE INSTRUMENT, THE WRIST WAS STRAIGHTENED, AND THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. BOTH THE INSTRUMENT AND CANNULA HAD NO OTHER DAMAGE AFTER 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 SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT WAS NOT RECOGNIZED, NOT WORKING AT THE MIDDLE OF THE SURGERY, AND THE TIP WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE CUSTOMER TO CONFIRM THAT THE INSTRUMENT WAS INSPECTED BEFORE THE PROCEDURE. THE SURGEON WAS DISSECTING WHEN THE REPORTED ISSUE OCCURRED. THE SURGERY HAD STARTED ABOUT 2 HOURS BEFORE THE ISSUE OCCURRED. THERE WERE NO COLLISIONS WITH OTHER INSTRUMENTS. THE INSTRUMENT WRIST WAS STRAIGHTENED TO REMOVE WITH NO RESISTANCE. THE FRAGMENT WAS RETRIEVED WITH A LAPAROSCOPIC GRASPER AND WAS VISUALLY CONFIRMED. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO INJURY TO THE PATIENT.