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 TIP OF THE HARMONIC ACE INSTRUMENT BROKE WHILE THE SURGEON WAS DISSECTING AND A FRAGMENT FELL INSIDE THE PATIENT. THE FRAGMENT WAS SUCCESSFULLY RETRIEVED DURING THE SAME PROCEDURE. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT, NOR WERE ANY POST-OPERATIVE TESTS, SUCH AS X-RAY OR ULTRASOUND, PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE PROCEDURE WAS COMPLETED ROBOTICALLY USING A BACK-UP HARMONIC ACE INSTRUMENT. THERE WERE 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 SURGICAL PROCEDURE, THE NEUTRAL GROUNDING PAD WAS NOT RECOGNIZED BY THE ENERGY SHIELD MONITOR (ESM). BEFORE CONTACTING AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOR ASSISTANCE, THE CUSTOMER ATTEMPTED TO RESOLVE THE ISSUE BY REPLACING THE NEUTRAL PAD, BUT THE PROBLEM PERSISTED. THE CUSTOMER ALSO CONNECTED THE NEUTRAL PAD DIRECTLY TO THE ERBE GENERATOR, WHERE THE ICON APPEARED GREEN. THE TSE THEN INSTRUCTED THE CUSTOMER TO RESEAT BOTH THE INSTRUMENT AND THE NEUTRAL CABLE ON THE ESM; HOWEVER, THE ISSUE CONTINUED. THE TSE FURTHER ADVISED ATTACHING THE NEUTRAL PAD TO THE CUSTOMER¿S ARM TO CHECK ITS STATUS, BUT THE FAULT REMAINED. FINALLY, THE TSE GUIDED THE CUSTOMER THROUGH A COMPLETE POWER CYCLE OF THE ESM, YET THE ERROR PERSISTED. AS A RESULT, THE PROCEDURE WAS ABORTED AFTER ANESTHESIA WAS ADMINISTERED AND PORTS HAD BEEN PLACED.

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 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 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 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 MONOPOLAR CURVED SCISSORS (MCS) TIP INSTALLED ON AN MCS INSTRUMENT, CAME OFF AND FELL INSIDE THE PATIENT'S BODY. THE CUSTOMER RETRIEVED THE MCS TIP AND TRIED TO PUT IT BACK ON THE MCS INSTRUMENT; HOWEVER, IT DID NOT WORK FOR AN UNSPECIFIED REASON. THEREFORE, THE CUSTOMER REPLACED THE MCS TIP. THE PROCEDURE WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE MCS INSTRUMENT WAS INSPECTED PRIOR TO USE AND NOTHING ABNORMAL WAS NOTED. IT IS UNKNOWN WHAT TASK WAS BE BEING PERFORMED AT THE TIME OF THE EVENT. THE SURGEON STATED THAT THE TIP OF THE MCS INSTRUMENT HAD BECOME STUCK IN THE FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT AND THEN IT WAS FORCIBLY REMOVED, WHICH WAS THE CAUSE OF THE MCS TIP INSIDE THE PATIENT. IT IS UNKNOWN FOR HOW LONG THE INSTRUMENT WAS IN USE. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT PRIOR TO THE VENT. THE SURGEON DID NOT FEEL ANY RESISTANCE UPON FINAL REMOVAL OF THE MCS INSTRUMENT THROUGH THE CANNULA. ADDITIONALLY, THE SURGICAL STAFF DID NOT SEE ANY DAMAGE

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 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, AN INTERNAL COLLISION CAUSED THE O-RING/WASHER TO DISLODGE WHILE THE INSTRUMENT WAS IN THE PATIENT. THE O-RING WAS LOCATED AND REMOVED ALONG WITH THE DEFECTIVE INSTRUMENT AND THE PROCEDURE CONTINUED WITHOUT FURTHER INCIDENT.

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 RIGHT UPPER PULMONARY LOBECTOMY PROCEDURE, BLEEDING OCCURRED UPON REMOVAL OF THE SYNCHROSEAL INSTRUMENT FROM THE PATIENT. AT THE POINT OF VASCULAR DETACHMENT, DURING THE SEALING AND CUTTING PROCESS, THE SURGEON WAS UNABLE TO PROPERLY GRASP THE PENROSE DRAIN AT THE BACK OF THE BLOOD VESSEL. THE SURGEON STATED THAT THE SYNCHROSEAL INSTRUMENT SUCCESSFULLY SEALED AND CUT. THE SURGEON ALSO CONFIRMED THAT THE APPROPRIATE SEALING TONES WERE HEARD. HOWEVER, UPON WITHDRAWING THE SYNCHROSEAL INSTRUMENT FOR REINSERTION, BLEEDING OCCURRED FROM THE PULMONARY ARTERY (PA), LOCATED BENEATH THE INTENDED VESSEL THAT WAS SEALED AND CUT. ALTHOUGH THE EXACT VOLUME OF BLEEDING IS UNKNOWN, THE PATIENT DID NOT REQUIRE A BLOOD TRANSFUSION. THE BLEEDING WAS CONTROLLED THROUGH THE ASSISTANT'S PORT BY APPLYING COMPRESSION TO THE SITE, AND THE SURGICAL APPROACH WAS CONVERTED TO AN OPEN THORACOTOMY. WHILE THE SURGEON WAS CHECKING THE FIELD OF VIEW, THE SURGEON BELIEVES THAT THE WRIST OF THE SYNCHROSEAL INSTRUMENT INADVERTENTLY MADE CONTACT WITH THE PA, CAUSING THE VESSEL TO RUPTURE. THE PROCEDURE WAS COMPLETED AND THE PATIENT REQUIRED AN ADDITIONAL 2-3 DAYS OF HOS

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 PROCEDURE, THE PLASTIC TIP OF THE HARMONIC ACE INSTRUMENT TIP FELL OFF. A NURSE STATED THAT THE SURGEON WAS DISSECTING WHEN THE FRAGMENT FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE AND IT WAS CONFIRMED WITH VISUAL CONFIRMATION. NO ADDITIONAL SURGICAL PROCEDURE WERE REQUIRED TO REMOVE THE FRAGMENT. NO POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRASOUND WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. A BACK-UP HARMONIC ACE INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE ROBOTICALLY. 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 SURGICAL PROCEDURE, AN HOUR AND A HALF AFTER THE START OF THE PROCEDURE, WHILE THE INSTRUMENT WAS INSIDE THE PATIENT¿S ANATOMY, IT WAS DISCOVERED THAT THE WHITE PART OF THE TIP SEAL OF THE SYNCHROSEAL INSTRUMENT WAS DAMAGED. USE OF THE INSTRUMENT WAS DISCONTINUED, AND IT WAS REPLACED TO THE BACKUP. THE TIP WAS SPREAD WITH THE DA VINCI INSTRUMENT, AND THE DAMAGED LOCATION WAS MATCHED WITH THE FRAGMENT TO CONFIRM THAT THERE WAS NO MISSING MATERIAL RETAINED. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO THE RETENTION OF FOREIGN MATERIAL. THE USER COMPLETED 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: REFER TO 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 PANCREATICODUODENECTOMY SURGICAL PROCEDURE, THE TIP OF THE HARMONIC ACE WAS DAMAGED DURING THE OPERATION. THE FRAGMENT FELL INTO THE PATIENT AND WAS RETRIEVED 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 THAT DURING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY PROCEDURE, A PORTION OF THE BLACK RUBBER OF A UNIVERSAL SEAL BROKE OFF AND FELL INSIDE THE PATIENT. A BLACK FOREIGN BODY PARTICLE WAS FOUND IN PATIENT'S PELVIS. THE BLACK PARTICLE WAS REMOVED AND THE PATIENT'S PELVIS WAS RE-EXAMINED TO ENSURE ALL FOREIGN BODIES WERE REMOVED FROM PATIENT. NO OTHER FRAGMENTS WERE FOUND INSIDE THE PATIENT. ONCE PARTICLE WAS OUTSIDE OF PATIENT. THE FRAGMENT WAS EXAMINED BY A TEAM MEMBER AND IT WAS CONFIRMED THAT THE PARTICLE CAME OFF OF A UNIVERSAL SEAL.

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 SURGICAL PROCEDURE, THE PATIENT HAD A COMPUTED TOMOGRAPHY (CT) SCAN ONE YEAR AFTER THE SURGERY AND AN OBJECT WAS IDENTIFIED, THEY HAD THE SIZE AND SHAPE OF THE OBJECT AND CONFIDENT IT IS THE REPLACEMENT TOOL FOR THE MONOPOLAR CURVED SHEARS INSULATION, THE SILICONE APPLICATOR, AND THEY BELIEVE SOMEBODY LEFT IT ON WHEN THEY PLACED IT THROUGH A 12 MM PORT AND THEIR ASSUMPTION IS IT FELL OFF WITHIN THE PATIENT. THE PROCEDURE WAS COMPLETED. NO INTERVENTION WAS NOTED, AND THE PATIENT WAS REPORTEDLY DOING FINE AND ASYMPTOMATIC. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE RETAINED ITEM WAS NOT THE TIP COVER. RATHER, IT WAS THE CLEAR APPLICATOR TOOL TO APPLY AND REMOVE THE TIP COVER. THE CUSTOMER WAS NOT PLANNING TO RETURN THE APPLIER; IT IS REMAINING INSIDE OF 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 SURGICAL PROCEDURE, THE TIP ON THE HARMONIC ACE INSTRUMENT WAS BROKEN. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE. THE SURGEON WAS DISSECTING WHEN THE ISSUE OCCURRED. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR TOOL DURING PROCEDURE. THE INSTRUMENT IS AVAILABLE FOR REVIEW. NO PHOTOS OR VIDEOS ARE AVAILABLE FOR REVIEW. THE PIECE WAS COMPLETELY BROKEN OFF/MISSING. A FRAGMENT FELL INTO THE PATIENT AND WAS RETRIEVED DURING THE SAME 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: REFER TO 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 PATIENT WHO WAS ENROLLED IN A STUDY UNDERWENT A DA VINCI-ASSISTED CHOLECYSTECTOMY. THE SURGERY WAS PERFORMED SUCCESSFULLY, AND THE PATIENT WAS DISCHARGED THE NEXT DAY. AT HOME, THE PATIENT EXPERIENCED UMBILICAL WOUND PAIN WITH PURULENT DISCHARGE. AFTER EVALUATION, A PLASTIC SURGEON RECOMMENDED DEBRIDEMENT AND WOUND REPAIR. ONE WEEK LATER, THE PATIENT WAS HOSPITALIZED FOR UMBILICAL WOUND REPAIR AND DEBRIDEMENT SURGERY. THERE WAS NO REPORT THAT A DA VINCI DEVICE MALFUNCTIONED DURING THE SURGERY. THE STUDY INVESTIGATOR REPORTED THAT THE EVENT WAS UNLIKELY RELATED TO THE DA VINCI DEVICE AND UNLIKELY RELATED TO THE PROCEDURE. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING INFORMATION. THE SITE CONFIRMED THAT THE EVENT IS RELATED TO A WOUND INFECTION AND AMPICILLIN AND SULBACTAM, CURAM WERE PRESCRIBED. THE PATIENT WAS DISCHARGED WITH NO OTHER COMPLAINTS. THERE WERE NO DA VINCI DEVICE MALFUNCTIONS AND A DA VINCI DEVICE DID NOT CAUSE OR CONTRIBUTE 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 DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER HAD AN IMAGE ORIENTATION ISSUE. THE CAMERA HAD ROTATED, THE ENTRY GUIDE MANIPULATOR (EGM) REPOSITIONED VERTICALLY, AND THE ISSUE REOCCURRED. NO FURTHER DETAILS WERE AVAILABLE AND THERE WERE NO ERRORS TO INDICATE FAILURE. THE PROCEDURE WAS CONVERTED TO MULTI-PORT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ENDOSCOPE MOVED FREELY WITH UNCONTROLLED MOTION. HOWEVER, THE IMAGE WAS NOT INVERTED. THE EVENT DID NOT INVOLVE A REVERSED CONTROL OF THE SYSTEM ARMS. IT WAS EXPLAINED THAT WHEN TH SURGEON MOVED FORWARD WITH THE SP CAMERA, THE ENTIRE BOOM RELOCATED TO ANOTHER POSITION. THE SURGEON CONFIRMED THAT THE DESIRED ORIENTATION WAS OBTAINED WHEN THE ENDOSCOPE WAS INSTALLED. THE HORIZON WAS REPORTEDLY YELLOW AND DID NOT SHOW THE SURGEON IF HE WAS LEVEL. THE SURGEON ELECTED TO COMPLETE THE CASE VIA A MULTI-PORT 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: STAPLER WAS CLAMPED ONTO STOMACH TISSUE AND FROZE - IT WOULD NOT FIRE, IT WOULD NOT RELEASE. THE EMERGENCY BUTTON WAS PUSHED AND STAPLER REMOVED MANUALLY.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A REVIEW OF AN ARTICLE WAS PERFORMED THAT EVALUATED OUTCOMES OF ROBOTIC INGUINAL HERNIA REPAIR (RIHR) IN A SINGLE INSTITUTION STUDY COMPARING SURGEONS WITH VARYING ROBOTIC EXPERIENCE. THE STUDY ANALYZED 297 PATIENTS UNDERGOING ROBOTIC INGUINAL HERNIA REPAIR BETWEEN JULY 2016 AND SEPTEMBER 2021. ONE PATIENT DIED WITHIN 30 DAYS POST SURGERY DUE TO ASPIRATION PNEUMONIA LEADING TO CARDIAC ARREST. NO DEVICE MALFUNCTIONS WERE REPORTED, AND THE AUTHORS DID NOT REPORT ANY EVENTS CAUSED BY ANY ISI DEVICE. INTUITIVE SURGICAL INC, (ISI) CONTACTED THE AUTHOR WHO REPORTED THAT THERE WERE NO ISSUES SEEN OR RECORDED WITH THE DA VINCI SYSTEM DURING THE STUDY. THE SYSTEM ITSELF DID NOT CONTRIBUTE TO THE DEATH IN THE STUDY WHICH WAS RELATED TO THE PATIENTS CO MORBIDITY AND NOT THE SURGERY ITSELF.

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 AN ARTICLE THAT EVALUATED THE OUTCOMES OF ROBOTIC INGUINAL HERNIA REPAIR (RIHR) IN A SINGLE-INSTITUTION STUDY COMPARING SURGEONS WITH VARYING ROBOTIC EXPERIENCE. THE STUDY ANALYZED 297 PATIENTS UNDERGOING ROBOTIC INGUINAL HERNIA REPAIR BETWEEN JULY 2016 AND SEPTEMBER 2021. THERE WERE 6 (2%) INTRAOPERATIVE COMPLICATIONS, INCLUDING 5 (1.7%) SEROSAL TEARS AND 1 (0.3%) FULL THICKNESS ENTEROTOMY. TWO CASES (0.7%) REPORTED CONVERSION TO OPEN PROCEDURES. ONE CASE INVOLVED A CHRONICALLY INCARCERATED SIGMOID COLON THAT COULD NOT BE REDUCED VIA A MINIMALLY INVASIVE APPROACH. THE SECOND CASE INVOLVED A RECURRENT HERNIA WITH SIGNIFICANT ADHESIONS AROUND A PRIOR PLUG REPAIR. ALL INTRAOPERATIVE INJURIES WERE CAUGHT AT THE TIME OF SURGERY AND DID NOT REQUIRE TAKEBACKS OR CAUSE SIGNIFICANT UNDUE HARM TO THE PATIENT. 28 PATIENTS (9.4%) PRESENTED TO THE ED WITH 30 DAYS OF THEIR SURGERIES WITH 20 PATIENTS (6.7%) RECEIVING ABDOMINAL IMAGING AND 13 PATIENTS (4.4%) BEING READMITTED. THERE WERE 8 TOTAL (2.7%) COMPLICATIONS INCLUDING 2 (0.7%) COMPLICATED SEROMAS, 4 HEMATOMAS (1.3%), AND 1 (0.3%) PATIENT WITH URINARY RETENTION. 30 DAY COMPLICATIONS WERE ALSO LARGELY MINOR WITH ONE PATIENT REQUI

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 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, THERE WAS A DAMAGED VALVE ON THE CANNULA SEAL ACCESSORY. A FRAGMENT FELL INSIDE OF THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND ADDITIONAL INFORMATION WAS OBTAINED ABOUT THE COMPLAINT: A FRAGMENT FELL INTO THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE, ALL FRAGMENTS WERE RETRIEVED BY USING LAPAROSCOPIC FORCEPS. A BLACK PIECE WAS FOUND IN THE SURGICAL FIELD, AND UPON CHECKING THE UNIVERSAL SEAL IT WAS FOUND TO BE DAMAGED. THERE WAS NO RAPID LOSS OF INSUFFLATION AS A RESULT OF THE BREAKAGE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DAVINCI XI SHUT DOWN MID PROCEDURE DUE TO OVERHEATING, NO WARNING NOTED DURING OPERATION.

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 H11 FOR FOLLOW-UP INFORMATION.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A REVIEW OF THE CLINICAL ARTICLE WAS CONDUCTED, WHICH SUMMARIZED THE CLINICAL EXPERIENCE AND OUTCOMES OF TRANSORAL ROBOTIC SURGERY (TORS) IN THE TREATMENT OF HYPOPHARYNGEAL CARCINOMA. THE RETROSPECTIVE MULTICENTER STUDY ANALYZED 28 PATIENTS (ALL MALE, AGED 47- 82 YEARS) UNDERGOING TRANSORAL ROBOTIC SURGERY USING THE DA VINCI SI OR XI SURGICAL SYSTEM BETWEEN SEPTEMBER 2017 AND MARCH 2024. THE ARTICLE REPORTED TWO POSTOPERATIVE DEATHS WITHIN ONE MONTH OF SURGERY WITHOUT ANY OTHER DETAILS. NO DEVICE MALFUNCTIONS WERE REPORTED, AND THE AUTHORS DID NOT REPORT ANY EVENTS CAUSED BY THE DA VINCI SURGICAL SYSTEM. REQUESTS FOR ADDITIONAL INFORMATION WERE MADE TO THE CORRESPONDING AUTHOR, BUT NO RESPONSE 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 AFTER A DA VINCI-ASSISTED BILATERAL INGUINAL HERNIA SURGICAL PROCEDURE, THE PATIENT'S SKIN WAS SINGED SLIGHTLY AT THE PORT SITE WITH THE MONOPOLAR CURVED SCISSORS (MCS.) THE SINGED SKIN WAS EXCISED MINIMALLY DURING CLOSURE. INSPECTION OF THE TIP COVER ACCESSORY REVEALED NO DEFECTS BY STAFF. NO COLLISIONS OF INSTRUMENTS WERE REPORTED. THE PATIENT IS REPORTEDLY DOING WELL. 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: REFER TO 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 PATIENT WHO WAS ENROLLED IN A STUDY UNDERWENT A DA VINCI-ASSISTED NIPPLE SPARING MASTECTOMY (NSM) SURGICAL PROCEDURE AND WAS DISCHARGED THE SAME DAY. THE PATIENT EXPERIENCED POSTOPERATIVE SUBJECTIVE SWELLING OF THE LEFT BREAST AND SELF-REPORTED TO THE EMERGENCY DEPARTMENT ON POSTOPERATIVE DAY 0 OVERNIGHT. SHE WAS EVALUATED IN THE EMERGENCY DEPARTMENT AND THERE WERE NO SIGNS OR SYMPTOMS OF SWELLING, BLEEDING, INFECTION, WOUND ISSUES. SHE WAS DISCHARGED TO HOME ON THE SAME EVENING. SHE WAS SEEN IN FOLLOW-UP CLINIC THE NEXT DAY AND THE CONTRALATERAL (RIGHT) BREAST WAS NOTED TO HAVE BREAST SWELLING AND SIGNIFICANT CHANGE IN SIZE SINCE BEING SEEN IN THE EMERGENCY DEPARTMENT. ADDITIONALLY, THE RIGHT BREAST DRAIN HAD STOPPED DRAINING AND THE DRAIN OUTPUT WAS NOTED TO BE MORE SANGUINOUS IN NATURE. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION AND KEPT NOTHING BY MOUTH (NPO). INITIALLY, BREAST COMPRESSION WAS ATTEMPTED BUT HER DRAIN OUTPUT CONTINUED TO BE SANGUINOUS IN NATURE AND WAS ONGOING AND THEREFORE THE DECISION WAS MADE TO RETURN TO THE OPERATING ROOM FOR EVACUATION OF HEMATOMA. INTRAOPERATIVELY, THE TISSUE EXPANDER WAS REMOVED, THE BREAST POCKET WAS IRRIGATED, 30 CC OF

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 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 PATIENT WHO WAS ENROLLED IN A STUDY, UNDERWENT A DA VINCI ASSISTED NIPPLE SPARING MASTECTOMY SURGICAL PROCEDURE. A SMALL SUPERFICIAL BURN WAS NOTED ON THE LEFT AREOLA PRIOR TO INCISION CLOSURE. CAREFUL INSPECTION OF THE FLAPS WAS PERFORMED IN ORDER TO ENSURE THAT THIS WAS NOT A THERMAL INJURY FROM THE DISSECTION AND THIS WAS CONFIRMED. THIS APPEARED TO BE A MILD SUPERFICIAL DESQUAMATION BURN MEASURING APPROXIMATELY 4 X 4 MM IN SIZE. AFTER THE COMPLETION OF THE OPERATION, A SMALL DRESSING WAS PLACED AT THIS SITE. THERE WAS NO REPORT OF A DA VINCI DEVICE MALFUNCTION. THE STUDY INVESTIGATOR REPORTED THAT THE EVENT WAS MILD IN SEVERITY, WAS POSSIBLY RELATED TO THE NIPPLE SPARING MASTECTOMY PROCEDURE AND A DA VINCI STUDY DEVICE, AND THAT IT OCCURRED AFTER THE UNDOCKING OF THE DA VINCI SYSTEM. ON 04-MAR-2025, THE FOLLOWING INFORMATION WAS RECEIVED FROM THE PHYSICIAN: THE CAUSE OF THE BURN IS UNCLEAR. HOWEVER, THE PHYSICIAN BELIEVES THE COMPLICATION WAS LIKELY FROM AN INADVERTENTLY PLACED INSTRUMENT ON THE PATIENT DURING THE PLASTIC SURGERY PORTION OF THE OPERATION. THE BURN WAS CONFIRMED TO NOT BE PRESENT AT THE COMPLETION OF THE ROBOTIC PORTION OF THE OPERATION AND AGAIN CONFIRMED TO

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 LABEL FROM A STERILE DRAPE SOMEHOW ATTACHED TO AN UNIDENTIFIED INSTRUMENT AND WAS INSERTED THROUGH A CANNULA AND INTO THE PATIENT. THE CUSTOMER WAS ABLE TO RETRIEVE THE LABEL DURING THE SAME SURGICAL PROCEDURE AND WITH NO ISSUE TO THE PATIENT. 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 DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY PROCEDURE, THE CUSTOMER WAS GETTING LINES LIKE AN OLD TV. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ASKED IF IT WAS WHEN FIRING ENERGY, ANOTHER PERSON CAME ON THE LINE AND SAID NO ITS INDEPENDENT OF THE ENERGY AND ITS ONLY HORIZONTAL GREEN LINES AND MULTI-COLORS IN THE LEFT EYE. THE TSE VIEWED LOGS AND DID NOT SEE ANYTHING; THEY RECOMMENDED THAT THE CUSTOMER RE-SEAT THE ENDOSCOPE. WHEN RESEATING THE ENDOSCOPE, THE TSE COULD HEAR AN ERROR TONE AND SAW AN ERROR IN THE LOGS, INDICATING THAT THE CUSTOMER WOULD HAVE TO REPLACE THE ENDOSCOPE. THE CUSTOMER SAID THEY'D CALL BACK AND ENDED THE CALL ABRUPTLY. THE STAFF CONFIRMED THEY REPLACED THE ENDOSCOPE, AND THE SYSTEM RETURNED TO NORMAL FUNCTIONALITY. THE CUSTOMER STATED THAT THE SURGEON CONVERTED TO OPEN.

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 NEPHROURETERECTOMY PROCEDURE THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY INSTALLED ON AN MCS INSTRUMENT FELL OFF INSIDE THE PATIENT'S BODY. THE EVENT OCCURRED WHEN THE CUSTOMER WAS ATTEMPTING TO EXCHANGE A FORCEPS INSTRUMENT. THE MCS TIP COVER ACCESSORY WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE AND DISCARDED. A NEW MCS TIP COVER ACCESSORY WAS ATTACHED TO THE SAME MCS INSTRUMENT TO PROCEED WITH THE PROCEDURE. NO POST-OPERATIVE TESTS SUCH AS AN X-RAY OR ULTRASOUND WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. AT AN UNSPECIFIED TIME LATER IN THE CASE, THE CUSTOMER IDENTIFIED AN UNSPECIFIED BROKEN CABLE ON THE MCS INSTRUMENT (PART #470179-19, LOT #K12240118-0090). IT IS UNCLEAR WHAT ACTIONS THE CUSTOMER TOOK AS A RESULT OF THE BROKEN CABLE ISSUE WITH THE MCS INSTRUMENT. HOWEVER, A REVIEW OF THE SITE'S SYSTEM LOGS REVEAL THE CUSTOMER REPLACED THE MCS INSTRUMENT WITH ANOTHER MCS INSTRUMENT LOT #K12241003-0253). THE PROCEDURE WAS COMPLETED ROBOTICALLY. 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 SURGICAL PROCEDURE THE TIP OF THIS HARMONIC ACE INSTRUMENT SUDDENLY BROKE AND A FRAGMENT FELL INSIDE THE PATIENT. THE BROKEN PART WAS REMOVED FROM THE PATIENT'S BODY DURING THE SAME SURGICAL PROCEDURE. THE NURSE REPORTED THAT NO INSTRUMENTS COLLIDED WITH EACH OTHER DURING THE OPERATION.

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 FRAGMENT FROM THE HARMONIC ACE BROKE OFF AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE. NO ISSUES WERE NOTED DURING THE INSPECTION OF THE INSTRUMENT PRIOR TO USE. IT WAS VISUALLY CHECKED THAT NO FRAGMENTS WERE LEFT BEHIND INSIDE THE PATIENT. THE ISSUE WAS NOTED AFTER 30 MINUTES OF USE OF THE INSTRUMENT. NO RESISTANCE WAS NOTED WHILE REMOVING THE INSTRUMENT THROUGH THE CANNULA. NO OTHER DAMAGES WERE NOTED UPON THE FINAL REMOVAL OF THE INSTRUMENT. THERE WERE NO INJURIES OR COMPLICATIONS TO THE PATIENT. 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 DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HEAD OF THE HARMONIC ACE INSTRUMENT BROKE. A FRAGMENT FELL INTO THE PATIENT AND WAS RETRIEVED DURING THE SAME 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 THE RIGHT PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, THE CAMERA SHEATH SHREDDED, AND A PIECE WAS HANGING. THE CUSTOMER WAS UNABLE TO ACCESS THE SHEATH INITIALLY DUE TO THE CLAP TIME. THE CUSTOMER PERFORMED AN X-RAY, AND IT WAS CONFIRMED THAT THERE WERE NO FRAGMENTS IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED 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: A REVIEW OF A LITERATURE ARTICLE TITLED, ¿LAPAROSCOPIC VERSUS ROBOTIC LATERAL PELVIC LYMPH NODE DISSECTION IN LOCALLY-ADVANCED RECTAL CANCER: A COHORT STUDY COMPARING PERIOPERATIVE MORBIDITY AND SHORT-TERM ONCOLOGICAL OUTCOMES,¿ WAS PERFORMED. THE GOAL OF THE STUDY NOTED IN THE ARTICLE WAS TO EVALUATE THE OUTCOMES OF ROBOTIC AND LAPAROSCOPIC LATERAL PELVIC LYMPH NODE DISSECTION (LPLND) IN PATIENTS WITH LATERAL PELVIC NODE-POSITIVE LOCALLY ADVANCED RECTAL CANCER (LARC) WITH REFERENCE TO INTRAOPERATIVE SAFETY, POSTOPERATIVE MORBIDITY, PATHOLOGICAL INDICES INCLUDING NODAL YIELD AND NODE POSITIVITY RATES, LATERAL PELVIC RECURRENCE RATES, AND SHORT-TERM EVENT-FREE AND OVERALL SURVIVAL. THIS WAS A RETROSPECTIVE SINGLE-CENTER STUDY THAT EVALUATED 115 PATIENTS BETWEEN 2014 AND 2023. THE ARTICLE NOTED THAT THAT DURING THESE DA VINCI-ASSISTED SURGERIES, IN THE IMMEDIATE POSTOPERATIVE PERIOD, FOUR PATIENTS (TWO FROM EACH GROUP) REQUIRED RE-EXPLORATION FOR ISSUES INCLUDING DISTAL MARGIN POSITIVITY, FASCIAL DEHISCENCE WITH EVISCERATION, AND ACUTE INTESTINAL OBSTRUCTION DUE TO EMPTY-PELVIS SYNDROME OR PORT-SITE HERNIA. THESE OCCURRED AT A MEDIAN OF 10 DAYS POST-SURGERY (RANGE: 6¿21 DAYS). CLINIC

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 TIP OF HARMONIC ACE INSTRUMENT BROKE AND A FRAGMENT FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE WHICH 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 NO DAMAGE WAS NOTED. WHEN THE EVENT OCCURRED, THE SURGEON WAS PERFORMING DISSECTION AND THE INSTRUMENT HAD BEEN IN USE FOR LESS THAN AN HOUR. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. UPON FINAL REMOVAL OF THE HARMONIC ACE INSTRUMENT, THE INSTRUMENT'S WRIST WAS STRAIGHTENED AND THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE REMOVING THE INSTRUMENT THROUGH THE CANNULA. THERE WAS NO DAMAGE NOTED TO THE CANNULA AFTER THE EVENT OCCURRED. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE, AND IT WAS CONFIRMED VISUALLY THAT NO FRAGMENTS WERE LEFT BEHIND. NO ADDITIONAL SURGICAL PROCEDURE WAS RE

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 THYMECTOMY PROCEDURE, A SYNCHROSEAL INSTRUMENT BROKE AND A SMALL PIECE OF PLASTIC FROM THE WRISTED PORTION FELL OFF INSIDE THE PATIENT. THE PIECE WAS SUCCESSFULLY REMOVED DURING THE SAME SURGICAL PROCEDURE. THERE WAS A SLIGHT DELAY IN PROCEDURAL TIME. THE CUSTOMER REPLACED THE SYNCHROSEAL INSTRUMENT WITH ANOTHER SYNCHROSEAL INSTRUMENT. THE PROCEDURE WAS COMPLETED ROBOTICALLY. THE SYNCHROSEAL INSTRUMENT WAS INSPECTED PRIOR TO USE, AND NOTHING WAS NOTED. THE EVENT OCCURRED WHILE THE SURGEON WAS GRASPING AND DISSECTING UNSPECIFIED TISSUE. THE INSTRUMENT BROKE IN THE MIDDLE OF THE CASE. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIALS DURING THE SURGICAL PROCEDURE. THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. THERE WAS NO DAMAGE TO THE CANNULA AFTER THE EVENT OCCURRED. THE FRAGMENT WAS RETRIEVED WITH A LAPAROSCOPIC GRASPER. ALL FRAGMENTS WERE RETRIEVED AND THE PIECE THAT BROKE WAS SEEN RIGHT AWAY. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE 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: A LITERATURE ARTICLE DESCRIBED A CASE OF PUBIC OSTEOMYELITIS FOLLOWING DA VINCI-ASSISTED RADICAL PROSTATECTOMY. THE PATIENT INITIALLY UNDERWENT DA VINCI SURGERY FOR PROSTATE CANCER. ONE MONTH AFTER SURGERY, THE PATIENT DEVELOPED LOWER ABDOMINAL PAIN AT REST AND HAD AN ELEVATED CRP LEVEL. THE PATIENT HAD DIFFICULTY WALKING AND WAS ADMITTED TO THE HOSPITAL URGENTLY. ON ADMISSION, X-RAYS AND PLAIN CT SCANS SHOWED SEPARATION OF THE PUBIC SYMPHYSIS. MRI SHOWED BONE MARROW EDEMA, SO POSTOPERATIVE PUBIC INFECTION WAS SUSPECTED. BLOOD CULTURES WERE NEGATIVE, BUT E. COLI WAS DETECTED IN A PUBIC PUNCTURE SPECIMEN. ANTIBIOTIC TREATMENT WITH CEFTRIAXONE AND ST COMBINATION WAS INITIATED. CRP GRADUALLY DECREASED AND BECAME NEGATIVE AFTER APPROXIMATELY SIX MONTHS. CONSERVATIVE FOLLOW-UP SHOWED THAT THE PUBIC SYMPHYSIS DISTANCE HAD INCREASED TO 10.8 MM SIX MONTHS AFTER THE START OF TREATMENT AND THE PAIN HAD DISAPPEARED. NO RESIDUAL SYMPTOMS WERE OBSERVED. THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS REPORTED, NOR DID THE AUTHOR ALLEGE THAT ISI PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENT. INTUITIVE SURGICAL INC. (ISI) HAS MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION; HOWE

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, "ONE HUNDRED AND FIFTY-TWO ROBOTIC HEPATECTOMIES AT A NORTH AMERICAN HEPATOBILIARY PROGRAM: EVOLUTION OF PRACTICE, LEARNING CURVE, APPRAISAL OF OUTCOMES, AND COST ANALYSIS" WAS PERFORMED. A RETROSPECTIVE ANALYSIS OF ALL HEPATECTOMIES (N=334) WAS PERFORMED AT AN INSTITUTION BETWEEN JANUARY 2018 TO JANUARY 2023. THIS INCLUDED 164 OPEN, 18 LAPAROSCOPIC, AND 152 ROBOTIC HEPATECTOMIES. THE ARTICLE NOTED THAT DURING THESE DA VINCI SURGERIES, THERE WAS 1 CASE IN THE ROBOTIC GROUP THAT WAS CONVERTED TO OPEN SURGERY DUE TO BLEEDING DURING A PARENCHYMAL TRANSECTION. THIS WAS A CONTROLLED CONVERSION WITH UPPER MIDLINE LAPAROTOMY AND THE PATIENT OTHERWISE RECOVERED UNEVENTFULLY AND WAS DISCHARGED HOME ON POST-OPERATIVE DAY 4. THERE WERE NO SPECIFIC DA VINCI MALFUNCTIONS REPORTED, NOR DID THE AUTHOR ALLEGE THAT INTUITIVE SURGICAL, INC. (ISI) PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENT. INTRA AND POST-OPERATIVE EVENT AND LENGTH OF STAY WERE SIGNIFICANTLY LOWER IN THE ROBOTIC GROUP. ROBOTIC HEPATECTOMY HAD SIGNIFICANTLY HIGHER TEXTBOOK OUTCOME AFTER LIVER SURGERY (TOLS) COMPARED TO OPEN HEPATECTOMY (85 PERCENT VERSUS 64 PERCENT, P LESS THAN 0.001).

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 TITLED, "LOBECTOMY FOR PRIMARY LUNG CANCER: A COMPARISON OF PERIOPERATIVE AND POSTOPERATIVE OUTCOMES BETWEEN ROBOT-ASSISTED THORACIC SURGERY AND VIDEO-ASSISTED THORACIC SURGERY," (VATS) WAS PERFORMED. THE ARTICLE DISCUSSED A RETROSPECTIVE COHORT STUDY THAT INCLUDED MALE PATIENTS WHO UNDERWENT ROBOT-ASSISTED THORACIC SURGERY (RATS) OR VATS AT A SINGLE CENTER BETWEEN APRIL 2018 AND MARCH 2022. A TOTAL OF 137 PATIENT WERE INCLUDED IN EACH GROUP, RATS AND VATS. THE ARTICLE NOTED THAT DURING THESE DA VINCI SURGERIES, THE INCIDENCE OF PROLONGED POSTOPERATIVE AIR LEAK WAS SIGNIFICANTLY HIGHER IN THE RATS GROUP THAN IN THE VATS GROUP. THERE WERE 13 POSTOPERATIVE AIR LEAKS IN THE RATS GROUP VERSUS 3 IN THE VATS GROUP, RESULTING IN A SIGNIFICANTLY LONGER DURATION OF CHEST TUBE PLACEMENT IN THE RATS GROUP. THE ARTICLE ALSO STATED THAT PULMONARY ARTERY INJURIES ACCOUNTED FOR HALF OF THE INTRAOPERATIVE INJURIES IN THE RATS GROUP AND THAT THE SINGLE CONVERSION TO THORACOTOMY WAS DUE TO PULMONARY ARTERY INJURY. PER THE AUTHOR, THE INJURIES WERE NOT DUE TO THE DA VINCI SYSTEM OR THE INSTRUMENTS, BUT DUE TO THE RATS PROCEDURE AND THAT THE VESSELS WERE SUSCEPTIBLE TO

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 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 SINGLE PORT (SP) ADRENALECTOMY, THE CUSTOMER CONTACTED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOR PHONE ASSISTANCE REGARDING AN INVALID CANNULA SYSTEM MESSAGE. PRIOR TO CONTACTING THE TSE, THE CUSTOMER ATTEMPTED TO RESEAT THE CANNULA AND CHANGE OUT THE CANNULA. THE TSE REQUESTED THAT A HARD RESTART BE PERFORMED, BUT THE REPORTED COMPLAINT REMAINED. THE ROBOTIC SINGLE PORT WAS ABORTED. THERE WAS A DELAY OF 40 MINUTES ATTRIBUTED TO TRYING TO TROUBLESHOOT THE SP SYSTEM, AND EVENTUALLY A DECISION WAS MADE TO TAKE THE SP SYSTEM OUT AND BRING THE MULTI-PORT XI SYSTEM IN. THE PROCEDURE WAS COMPLETED WITH A XI SYSTEM WITHOUT FURTHER INCIDENT.

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 BROKE AND A PIECE OF THE INSTRUMENT FELL INSIDE THE PATIENT. THE CUSTOMER RETRIEVED THE FRAGMENT USING A ROBOTIC GRASPER DURING THE SAME SURGICAL 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 ENUCLEATION OF ESOPHAGEAL TUMOR SURGICAL PROCEDURE, THE JAWS OF THE HARMONIC ACE FELL OFF INTO THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS NOT INSPECTED MORE THOROUGHLY THAN USUAL. NOTHING ABNORMAL WAS NOTED. THE SURGICAL TASK BEING PERFORMED WHEN THE DEVICE FRAGMENTS FELL INSIDE THE PATIENT WAS DISSECTION. THE SURGEON DOES NOT KNOW HOW TO EXPLAIN THE BREAKAGE. HE THOUGHT THAT MANUFACTURING DEFECTS CONTRIBUTED TO THE INSTRUMENT BREAKAGE. THE INSTRUMENT WAS IN USE FOR ABOUT 30 TO 45 MINUTES. JUST BEFORE THE BREAKAGE, THE SURGEON NOTICED A NON-INTUITIVE MOVEMENT, AND THEN WHEN HE OPENED THE JAWS (IN THE AIR), THEY SLOWLY OPENED UNTIL THEY BROKE. THERE WASN¿T ANY SIGNIFICANT COLLISION DURING THE SURGERY. THE FRAGMENT DID NOT FALL INSIDE THE PATIENT DUE TO AN INSTRUMENT TIP OR ACCESSORY COLLISION. THE CUSTOMER COULD NOT RECALL IF THE INSTRUMENT WAS REMOVED PRIOR TO THE BREAKAGE, BUT THE FIRST ASSISTANT WAS HIGHLY EXPERIENCED, AND IT WAS NOT VERY LIKEL

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 FRAGMENT FROM A SYNCHROSEAL INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE WHICH WAS BEING COMPLETED AS PLANNED.