ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED AFTER BLEEDING WAS NOTICED. SHORTLY AFTER, THE PATIENT DISPLAYED SUSPECTED PRESENCE OF STROKE AND/OR HEMATOMA.

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 OR JAW ON THE HARMONIC ACE INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE WHICH 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: A REVIEW OF THE ARTICLE WAS CONDUCTED WHICH AIMED TO EVALUATE THE FEASIBILITY, REPRODUCIBILITY, AND SAFETY OF ADRENALECTOMY PROCEDURES PERFORMED USING THE DA VINCI SINGLE-PORT (DV-SP) ROBOTIC SYSTEM. THE STUDY DESIGN WAS A SYSTEMATIC REVIEW AND POOLED ANALYSIS OF FIVE RETROSPECTIVE STUDIES INVOLVING 342 PATIENTS WHO UNDERWENT ROBOT-ASSISTED ADRENALECTOMY PROCEDURES BETWEEN 2018 AND 2024. DURING THESE DA VINCI SURGERIES, THE ARTICLE REPORTED MULTIPLE COMPLICATIONS. ONE PATIENT HAD A GRADE IIIB CLAVIEN¿DINDO COMPLICATION IDENTIFIED ON POSTOPERATIVE DAY #6. THE PATIENT DEVELOPED SEPSIS WITH A TRANSIENT IPSILATERAL URETEROPELVIC JUNCTION (UPJ) OBSTRUCTION DUE TO EDEMA NEAR THE UPJ, WHICH REQUIRED THE PLACEMENT OF A URETERAL STENT FOR 6 WEEKS. ANOTHER PATIENT IN THE DA VINCI MULTI-PORT (MP) GROUP, DEVELOPED A CLAVIEN¿DINDO IIIB COMPLICATION CONSISTING OF PNEUMOPERITONEUM WHICH REQUIRED A SURGICAL DRAIN PLACEMENT. CONVERSION TO LAPAROSCOPY WAS REQUIRED IN ONLY TWO CASES AMONG PATIENTS UNDERGOING SINGLE-PORT ROBOT-ASSISTED ADRENALECTOMY (SA RAA), WHILE AN ADDITIONAL PORT FOR LIVER RETRACTION WAS NEEDED IN THE ONLY TRANSPERITONEAL DV-SP RAA CASE. NO DEVICE MALFUNCTIONS WERE REPORTED, AND 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 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.

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

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. A FRAGMENT FELL INSIDE THE PATIENT WHILE THE SURGEON WAS DISSECTING. THE FRAGMENT WAS SUCCESSFULLY RETRIEVED USING AN ENDOSCOPIC INSTRUMENT, AND IT WAS CONFIRMED THAT ALL FRAGMENTS WERE RETRIEVED AS ONLY ONE FRAGMENT HAD BROKEN OFF. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT, NOR WERE ANY POST-OPERATIVE TESTS LIKE X-RAYS OR ULTRASOUNDS PERFORMED TO CHECK FOR REMAINING FRAGMENTS. TO COMPLETE THE PROCEDURE, A NEW HARMONIC ACE INSTRUMENT WAS REINSERTED. THERE WAS NO INJURY TO THE PATIENT, AND THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO ANY POST-SURGICAL COMPLICATIONS.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT FOLLOWING A SPINAL SURGERY, THE PATIENT WAS INITIALLY DOING WELL, BUT LATER DEVELOPED PROGRESSIVELY WORSENING LOW BACK PAIN (LEFT GREATER THAN RIGHT) AND LEFT LOWER-EXTREMITY PAIN OVER SEVERAL MONTHS. SYMPTOMS INCLUDED PAIN, PARESTHESIA'S, WEAKNESS, AND OCCASIONAL SENSATION OF LEFT-SIDED FOOT DROP; NO BOWEL OR BLADDER INCONTINENCE WAS REPORTED. PAIN WAS CONSTANT TO SOME DEGREE AND WORSENED WITH PROLONGED POSITIONING, RESEMBLING SYMPTOMS PRIOR TO THE PATENT'S ORIGINAL BERTOLOTTI'S FUSION. IT WAS SUGGESTED THAT MICROMOTION AT THE LEFT BERTOLOTTI'S JOINT POSSIBLY CONTRIBUTED TO SYMPTOMS, WITH RESIDUAL HARDWARE ALSO CONSIDERED AS A POTENTIAL FACTOR. THE PATIENT UNDERWENT A LEFT-SIDED BERTOLOTTI JOINT RESECTION AND REMOVAL OF RIGHT-SIDED INSTRUMENTATION AT L6/S1.POST-OPERATIVELY, LOW BACK AND LOWER EXTREMITY SYMPTOMS RESOLVED.

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, THE PLASTIC RING BECAME SEPARATED FROM THE SYNCHROSEAL INSTRUMENT. THE SURGEON NOTICED IT, REMOVED THE PIECE, ENSURED ALL PIECES WERE REMOVED, AND EXCHANGED FOR A NEW INSTRUMENT. 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 SURGICAL PROCEDURE, THE VIDEO FEED WAS FLICKERING AND A FRAGMENT FROM THE 30 DEGREE ENDOSCOPE PLUS FELL OFF INSIDE THE PATIENT. IT IS UNKNOWN IF THE FRAGMENT WAS RETRIEVED. THE PROCEDURE WAS DELAYED FOR GREATER THAN 30-MINUTES BUT 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 AFTER A DA VINCI-ASSISTED RADICAL CYSTECTOMY WITH NEOBLADDER PROCEDURE, THE PATIENT EXPERIENCED POST-OPERATIVE BLEEDING THAT REQUIRED AN ADDITIONAL PROCEDURE. THE EXACT SEQUENCE OF EVENTS LEADING TO THE BLEEDING REMAINS UNCLEAR, AND IT IS ALSO UNKNOWN WHETHER THE PATIENT HAD ANY UNDERLYING COAGULOPATHY OR WAS TAKING MEDICATIONS THAT MAY HAVE CONTRIBUTED. IMAGING REVEALED BLEEDING ORIGINATING FROM THE SITE WHERE THE SYNCHROSEAL INSTRUMENT HAD BEEN SUCCESSFULLY USED ON A VESSEL LESS THAN 5 MM IN DIAMETER. THE DEVICE WAS OPERATED IN SYNCH MODE, WITH A CONTINUOUS TONE DURING PEDAL ACTIVATION AND THREE ASCENDING AUDIBLE TONES CONFIRMING COMPLETION OF THE SEAL. ADDITIONALLY, THE SURGEON REPORTED SEALING BOTH SIDES OF THE VESSEL AFTER COMPLETING THE TRANSECTION. TO ADDRESS THE BLEEDING, A SUBSEQUENT PROCEDURE WAS PERFORMED, DURING WHICH HEMOSTASIS WAS ACHIEVED USING A HEMOSTATIC AGENT AND SUTURING. ALTHOUGH THE EXACT VOLUME OF BLOOD LOSS WAS NOT PROVIDED, THE PATIENT RECEIVED AN UNSPECIFIED NUMBER OF BLOOD TRANSFUSIONS. THE PATIENT HAS SINCE RECOVERED, AND THE SURGEON DOES NOT ANTICIPATE ANY LONG-TERM COMPLICATIONS AS A RESULT OF 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 MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY WAS FOUND BROKEN. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER NOTED THE TIP COVER WAS BROKEN AND AFTER INSPECTION, BEFORE USE, NO ABNORMALITY WAS FOUND. THE ANATOMICAL TISSUE WAS BEING DISSECTED. THE SURGEONS BELIEVED THAT THE QUALITY PROBLEM CAUSED THE TIP COVER TO RUPTURE, AND IT TOOK ABOUT 50 MINUTES BEFORE THE TIP COVER BROKE. THE SURGEON DIDN'T NOTICE ANYTHING WRONG WITH THE INSTRUMENT, AND IT DID NOT COLLIDE DURING THE OPERATION. NO FRAGMENT(S) FELL INTO THE PATIENT DURING A COLLISION, AND ALL WAS CORRECTED BEFORE REMOVING THE EQUIPMENT. THE OPERATOR FELT NO RESISTANCE WHEN REMOVING THE INSTRUMENT. THE WRIST OF THE INSTRUMENT IS STRAIGHT. THERE WAS NO RESISTANCE WHEN THE OPERATOR REMOVED THE INSTRUMENT. THERE WAS NO DAMAGE TO THE INSTRUMENT CHANNEL. THE OPERATOR DID NOT FIND ANY DAMAGE TO THE INSTRUMENT, AND ALL THE FRAGMENTS WERE RECOVERED AND CONFIRMED BY THE OBSERVATION OF THE OPERATING PERSONNEL. THE ASSISTANT RETRIEVED THE FRAGMENTS

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 DIFFERENCES IN EFFICIENCY, SAFETY, AND HOSPITAL COSTS BETWEEN THREE-ARM AND FOUR-ARM ROBOTIC-ASSISTED PARTIAL NEPHRECTOMY (RAPN) WAS PERFORMED. THE RETROSPECTIVE STUDY ANALYZED THE CLINICAL DATA OF 91 PATIENTS UNDERGOING RAPN BETWEEN JANUARY 2021 TO DECEMBER 2023. ONE PATIENT FROM EACH OF THE TWO GROUPS DEVELOPED A CLAVIEN-DINDO GRADE 3 COMPLICATION OF POST-OPERATIVE BLEEDING, REQUIRING ANGIOEMBOLIZATION. TWO PATIENTS IN THE FOUR-ARM GROUP DEVELOPED DEEP VEIN THROMBOSIS, REQUIRING PLACEMENT OF AN INFERIOR VENA CAVA FILTER, AND THREE PATIENTS EXPERIENCED POST-OPERATIVE WOUND INFECTIONS. THERE WERE NO DA VINCI DEVICE MALFUNCTIONS REPORTED, AND NO INDICATION THAT INTUITIVE SURGICAL, INC. (ISI) PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENT. ISI MADE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO INFORMATION HAS BEEN OBTAINED AT THE TIME 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 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, "PATIENT-REPORTED SYMPTOMS SUGGESTIVE OF VESICOURETERAL REFLUX AFTER ROBOTIC URETERAL REIMPLANTATION IN ADULTS" WAS PERFORMED. A RETROSPECTIVE REVIEW OF 95 PATIENT FROM A MULTI-INSTITUTIONAL DATABASE OF COLLABORATIVE OF RECONSTRUCTIVE ROBOTIC URETERAL SURGERY (CORRUS) CONCERNING ROBOTIC URETERAL RECONSTRUCTION WAS PERFORMED. THE MEDIAN AGE AT TIME OF SURGERY WAS 56.0 YEARS WITH A MEDIAN BODY MASS INDEX (BMI) OF 27.3 KG/M2 (23.6-30.0). MOST OF THE PATIENTS WERE FEMALE (61/95, 64.2%). THE ARTICLE NOTED THAT DURING THE DA VINCI SURGERIES, 3 PATIENTS SUFFERED INTRAOPERATIVE COMPLICATIONS; 2 PATIENTS HAD A POSTOPERATIVE COMPLICATION OF CLAVIEN-DINDO GRADE >2 WITHIN 30 DAYS OF SURGERY WITH NO OTHER DETAILS. THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS REPORTED, AND NO INDICATION THAT INTUITIVE SURGICAL, INC. (ISI) PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENT. ISI HAS MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, AS OF THE DATE OF THIS REPORT, NO NEW INFORMATION HAS BEEN OBTAINED.

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 THE ARTICLE WAS CONDUCTED WHICH AIMED TO ASSESS THE SAFETY, FEASIBILITY, AND ONCOLOGIC OUTCOMES OF COMBINING TRANSANAL TOTAL MESORECTAL EXCISION (TATME) WITH A SINGLE-PORT ROBOTIC ABDOMINAL APPROACH (RSPA) FOR LOW RECTAL CANCER. THE STUDY WAS A RETROSPECTIVE REVIEW AND ANALYZED 10 PATIENTS UNDERGOING COMBINED TATME WITH RSPA APPROACH BETWEEN MAY 2022 AND AUGUST 2024. ONE PATIENT EXPERIENCED ANEMIA REQUIRING TRANSFUSION, A URINARY TRACT INFECTION REQUIRING ANTIBIOTICS, AND A STROKE. NO DEVICE MALFUNCTIONS WERE REPORTED, AND THE AUTHORS DID NOT REPORT ANY EVENTS CAUSED BY THE DA VINCI SINGLE-PORT ROBOTIC SYSTEM. ADDITIONAL INFORMATION RECEIVED FROM THE AUTHOR STATES "NONE OF THE COMPLICATIONS [ARE] RELATED TO THE SP ROBOT, THESE WERE ALL COMPLICATIONS THAT CAN HAPPEN AFTER ANY SUCH ABDOMINAL 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: A REVIEW OF THE ARTICLE WAS CONDUCTED WHICH AIMED TO ASSESS THE SAFETY, FEASIBILITY, AND ONCOLOGIC OUTCOMES OF COMBINING TRANSANAL TOTAL MESORECTAL EXCISION (TATME) WITH A SINGLE-PORT ROBOTIC ABDOMINAL APPROACH (RSPA) FOR LOW RECTAL CANCER. THE STUDY WAS A RETROSPECTIVE REVIEW AND ANALYZED 10 PATIENTS UNDERGOING COMBINED TATME WITH RSPA APPROACH BETWEEN MAY 2022 AND AUGUST 2024. ONE PATIENT EXPERIENCED PELVIC SEROMA WHICH WAS TREATED WITH A DRAIN, AND INFERIOR MESENTERIC VEIN (IMV) THROMBUS, NO INFORMATION PROVIDED ON HOW IT WAS MANAGED. NO DEVICE MALFUNCTIONS WERE REPORTED, AND THE AUTHORS DID NOT REPORT ANY EVENTS CAUSED BY THE DA VINCI SINGLE-PORT ROBOTIC SYSTEM. ADDITIONAL INFORMATION RECEIVED FROM THE AUTHOR STATES "NONE OF THE COMPLICATIONS [ARE] RELATED TO THE SP ROBOT, THESE WERE ALL COMPLICATIONS THAT CAN HAPPEN AFTER ANY SUCH ABDOMINAL 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: A REVIEW OF THE ARTICLE WAS CONDUCTED WHICH AIMED TO ASSESS THE SAFETY, FEASIBILITY, AND ONCOLOGIC OUTCOMES OF COMBINING TRANSANAL TOTAL MESORECTAL EXCISION (TATME) WITH A SINGLE-PORT ROBOTIC ABDOMINAL APPROACH (RSPA) FOR LOW RECTAL CANCER. THE STUDY WAS A RETROSPECTIVE REVIEW AND ANALYZED 10 PATIENTS UNDERGOING COMBINED TATME WITH RSPA APPROACH BETWEEN MAY 2022 AND AUGUST 2024. ONE PATIENT EXPERIENCED AN ABSCESS TREATED WITH ANTIBIOTICS, AND A SMALL BOWEL OBSTRUCTION WHICH WAS MANAGED CONSERVATIVELY. NO DEVICE MALFUNCTIONS WERE REPORTED, AND THE AUTHORS DID NOT REPORT ANY EVENTS CAUSED BY THE DA VINCI SINGLE-PORT ROBOTIC SYSTEM. ADDITIONAL INFORMATION RECEIVED FROM THE AUTHOR STATES "NONE OF THE COMPLICATIONS [ARE] RELATED TO THE SP ROBOT, THESE WERE ALL COMPLICATIONS THAT CAN HAPPEN AFTER ANY SUCH ABDOMINAL 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: A REVIEW OF THE ARTICLE WAS CONDUCTED WHICH AIMED TO ASSESS THE SAFETY, FEASIBILITY, AND ONCOLOGIC OUTCOMES OF COMBINING TRANSANAL TOTAL MESORECTAL EXCISION (TATME) WITH A SINGLE-PORT ROBOTIC ABDOMINAL APPROACH (RSPA) FOR LOW RECTAL CANCER. THE STUDY WAS A RETROSPECTIVE REVIEW AND ANALYZED 10 PATIENTS UNDERGOING COMBINED TATME WITH RSPA APPROACH BETWEEN MAY 2022 AND AUGUST 2024. ONE PATIENT EXPERIENCED DEEP VEIN THROMBOSIS WHICH WAS TREATED WITH ANTICOAGULATION. NO DEVICE MALFUNCTIONS WERE REPORTED, AND THE AUTHORS DID NOT REPORT ANY EVENTS CAUSED BY THE DA VINCI SINGLE-PORT ROBOTIC SYSTEM. ADDITIONAL INFORMATION RECEIVED FROM THE AUTHOR STATES "NONE OF THE COMPLICATIONS ARE RELATED TO THE SP ROBOT, THESE WERE ALL COMPLICATIONS THAT CAN HAPPEN AFTER ANY SUCH ABDOMINAL 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: A REVIEW OF THE ARTICLE WAS CONDUCTED WHICH AIMED TO ASSESS THE SAFETY, FEASIBILITY, AND ONCOLOGIC OUTCOMES OF COMBINING TRANSANAL TOTAL MESORECTAL EXCISION (TATME) WITH A SINGLE-PORT ROBOTIC ABDOMINAL APPROACH (RSPA) FOR LOW RECTAL CANCER. THE STUDY WAS A RETROSPECTIVE REVIEW AND ANALYZED 10 PATIENTS UNDERGOING COMBINED TATME WITH RSPA APPROACH BETWEEN (B)(6) 2022 AND (B)(6) 2024. ONE PATIENT EXPERIENCED AN ILEUS WHICH WAS MANAGED CONSERVATIVELY, AND AN ACUTE KIDNEY INJURY, WHICH WAS MANAGED WITH HYDRATION. NO DEVICE MALFUNCTIONS WERE REPORTED, AND THE AUTHORS DID NOT REPORT ANY EVENTS CAUSED BY THE DA VINCI SINGLE-PORT ROBOTIC SYSTEM. ADDITIONAL INFORMATION RECEIVED FROM THE AUTHOR STATES "NONE OF THE COMPLICATIONS [ARE] RELATED TO THE SP ROBOT, THESE WERE ALL COMPLICATIONS THAT CAN HAPPEN AFTER ANY SUCH ABDOMINAL 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: A CLINICAL ARTICLE WAS REVIEWED AND THE GOAL OF THE STUDY WAS TO PERFORM A COMPARATIVE ANALYSIS OF ROBOT-ASSISTED VERSUS LAPAROSCOPIC LADD'S PROCEDURE ON PERI AND POSTOPERATIVE OUTCOMES. THE STUDY EVALUATED 95 PEDIATRIC PATIENTS, OF WHOM 57 UNDERWENT ROBOT ASSISTED SURGERY USING THE DA VINCI XI SYSTEM AND 38 UNDERWENT LAPAROSCOPIC SURGERY. ALL LADD¿S PROCEDURES PERFORMED ON PATIENTS AGED UP TO 18 YEARS OLD BETWEEN JANUARY 2020 AND DECEMBER 2023. POSTOPERATIVE COMPLICATIONS OCCURRED IN BOTH GROUPS, WITH A LOWER OVERALL COMPLICATION RATE IN THE ROBOTIC COHORT (3.5%) COMPARED TO THE LAPAROSCOPIC COHORT (18.4%). WITHIN THE ROBOT ASSISTED GROUP, TWO POSTOPERATIVE COMPLICATIONS WERE REPORTED: CHYLOUS ASCITES AND ADHESIVE BOWEL OBSTRUCTION, WITH ONE PATIENT REQUIRING SECONDARY SURGERY DUE TO THE OBSTRUCTION. THE ARTICLE DID NOT REPORT ANY INTRAOPERATIVE DEVICE MALFUNCTIONS OR SYSTEM ERRORS RELATED TO THE DA VINCI SYSTEM. ALL ROBOTIC PROCEDURES WERE COMPLETED WITHOUT CONVERSION TO OPEN SURGERY. THE SURGERY CASE IN THE ROBOTIC GROUP WAS ASSOCIATED WITH POSTOPERATIVE ADHESIVE OBSTRUCTION. THE ARTICLE NOTES THAT THE CAUSE MAY BE RELATED TO LACK OF TACTILE FEEDBACK IN ROBOTIC SURGERY, WHICH LE

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WAS A SLIGHT DEVIATION BETWEEN THE NAVIGATION PLAN AND THE MIDAS DRILL. THE SURGEON ATTEMPTED TO INSERT A SCREW BUT FELT THAT THE AREA WAS BREACHED, LEADING TO THE DECISION TO HOLD OFF ON THE SCREW INSERTION. A NEW REGISTRATION WAS ATTEMPTED, WHICH PASSED SUCCESSFULLY, AND THE SURGEON FELT THAT NAVIGATION WAS ACCURATE FOR THE REMAINDER OF THE CASE. IT WAS NOTED THAT THE PATIENT WAS IMPACTED POST-SURGERY. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE PATIENT HAS HAD ONGOING NEUROLOGICAL ISSUES SINCE THE CASE. THE ONLY DELAY IN THE CASE WAS SWITCHING FROM CT-FLUORO TO SCAN AND PLAN REGISTRATION. THE AMOUNT OF DELAY WAS UNKNOWN. THE SURGEON STATED THE DEVIATION WAS 3 MM, HOWEVER THEY WERE COMPARING THE SCAN AND PLAN TRAJECTORY TO THE CT-FLUORO TRAJECTORY, BUT THE PLANNED TRAJECTORY WAS NOT THE SAME. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE SYSTEM FUNCTIONS AS INTENDED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT SURGICAL DELAY WAS LESS THAN ONE-HOUR.

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 THE ARTICLE WAS CONDUCTED WHICH AIMED TO ASSESS THE SAFETY, FEASIBILITY, AND ONCOLOGIC OUTCOMES OF COMBINING TRANSANAL TOTAL MESORECTAL EXCISION (TATME) WITH A SINGLE-PORT ROBOTIC ABDOMINAL APPROACH (RSPA) FOR LOW RECTAL CANCER. THE STUDY WAS A RETROSPECTIVE REVIEW AND ANALYZED 10 PATIENTS UNDERGOING COMBINED TATME WITH RSPA APPROACH BETWEEN MAY 2022 AND AUGUST 2024. ONE PATIENT EXPERIENCED SMALL BOWEL OBSTRUCTION WHICH WAS TREATED CONSERVATIVELY. NO DEVICE MALFUNCTIONS WERE REPORTED, AND THE AUTHORS DID NOT REPORT ANY EVENTS CAUSED BY THE DA VINCI SINGLE-PORT ROBOTIC SYSTEM. ADDITIONAL INFORMATION RECEIVED FROM THE AUTHOR STATES "NONE OF THE COMPLICATIONS [ARE] RELATED TO THE SP ROBOT, THESE WERE ALL COMPLICATIONS THAT CAN HAPPEN AFTER ANY SUCH ABDOMINAL 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 SURGICAL PROCEDURE, THE TIP OF THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT GOT STUCK IN THE FENESTRATION OF A BIPOLAR FORCEPS INSTRUMENT. WHILE THE SURGEON WAS TRYING TO UNTWIST AND UNTANGLE THE INSTRUMENTS, THE MCS TIP BROKE OFF INSIDE THE PATIENT. THE MCS TIP WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE AND DISCARDED. THE MCS INSTRUMENT WAS INSPECTED AND NO DAMAGE WAS FOUND. A NEW MCS TIP WAS INSTALLED. 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, A MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY SLIPPED OFF THE MCS INSTRUMENT DURING A PROCEDURE IN THE MORNING. THE MCS TIP COVER ACCESSORY FELL INTO THE PATIENT AND WAS RECOVERED. 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 RECTAL RESECTION PROCEDURE, THE UNIVERSAL SEAL WAS DAMAGED. A FRAGMENT FELL INSIDE THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. IT IS UNKNOWN WHAT SURGICAL TASK WAS BEING PERFORMED WHEN THE FRAGMENT HAD FALLEN INTO THE PATIENT. THE FRAGMENT WAS RETRIEVED USING A LAPAROSCOPIC FORCEPS. NO ADDITIONAL PROCEDURE WAS PERFORMED TO RETRIEVE THE FRAGMENT. THE PROCEDURE WAS COMPLETED ROBOTICALLY, AND THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT. THE UNIVERSAL SEAL WILL BE RETURNED. NO PHOTOGRAPHIC IMAGES ARE AVAILABLE FOR ISI 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 DURING A DA VINCI-ASSISTED NIPPLE-SPARING MASTECTOMY, THE CUSTOMER RECEIVED A "REPLACE INSTRUMENT SHEATH" MESSAGE WHEN USING MONOPOLAR ENERGY. THE SHEATH, TIP, CAUTERY CABLE AND GROUND PAD WERE REPLACED, AND THE ISSUE WAS RESOLVED TEMPORARILY, HOWEVER, THE ERROR OCCURRED SEVERAL TIMES. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO PATIENT ISSUE REPORTED. HOWEVER, ON THE SURGERY DATE, NECROSIS OF THE BREAST TISSUE WAS NOTED. THE SURGEON DOES NOT THINK AN INTUITIVE SURGICAL, INC. (ISI) PRODUCT CAUSED OR CONTRIBUTED TO THE NECROSIS, BUT DOES THINK THAT THE CAUSE OF THE SHEATH MESSAGING WAS A SYSTEM/INSTRUMENT ISSUE. INSTEAD, THE SURGEON THINKS THE CAUSE OF THE NECROSIS WAS A "SURGICAL ISSUE." ONLY THE MONOPOLAR ENERGY INSTRUMENT EXPERIENCED ISSUES. THERE WAS NO REPORT OF ARCING.

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 THE ARTICLE WAS CONDUCTED WHICH AIMED TO EVALUATE THE SHORT-TERM CLINICAL AND LONG-TERM ONCOLOGICAL OUTCOMES OF ROBOT-ASSISTED TOTAL MESORECTAL EXCISION (R-TME) IN HIGH-VOLUME EUROPEAN CENTRES. THE STUDY, DESIGNED AS AN INTERNATIONAL MULTICENTRE RETROSPECTIVE COHORT ANALYSIS, EVALUATED 1390 PATIENTS UNDERGOING ROBOT-ASSISTED TOTAL MESORECTAL EXCISION BETWEEN JANUARY 2013 AND JANUARY 2022. THE ARTICLE NOTED THAT DURING THESE DV SURGERIES, INTRAOPERATIVE COMPLICATIONS WERE REPORTED IN 67 PATIENTS, WITH CONVERSION TO OPEN OR LAPAROSCOPIC SURGERY REQUIRED IN 52 CASES. TYPES OF INTRA-OPERATIVE COMPLICATIONS WERE BLEEDING IN 3 PATIENTS, PERFORATION IN 20 PATIENTS. POST OP COMPLICATIONS WITHIN 31 DAYS REPORTED IN 322 PATIENTS WHICH INCLUDED ILEUS REPORTED IN 132 PATIENTS, WOUND INFECTION IN 67 PATIENTS, BLEEDING IN 25 PATIENTS. READMISSION WITHIN 30 DAYS OCCURRED IN 189 PATIENTS, RE-INTERVENTION WITHIN 31 DAYS OCCURRED IN 144 PATIENTS. ANASTOMOTIC LEAKAGE OCCURRED IN 115 PATIENTS. THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS REPORTED, AND NO INDICATION THAT ISI PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENT. ISI HAS REACHED OUT TO THE AUTHOR; NO INFORMATION IS AVAI

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

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 A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE WHITE PART OF THE TIP OF THE SYNCHROSEAL INSTRUMENT REPORTEDLY BROKE OFF AND FELL INSIDE THE PATIENT. THE ROBOTICS AND THORACIC SURGERY SERVICE COORDINATOR, RN STATED A WHITE PIECE BROKE OFF THE TIP OF THE INSTRUMENT AND WAS SUCCESSFULLY RETRIEVED USING A GRASPER. THE FRAGMENT DETACHED WHILE THE SURGEON WAS DISSECTING THE DUODENUM. THE EXACT CAUSE OF THE FRAGMENT DETACHMENT IS UNKNOWN. IT WAS CONFIRMED THAT ALL FRAGMENTS WERE RETRIEVED DURING THE PROCEDURE. NO ADDITIONAL SURGICAL PROCEDURES WERE REQUIRED TO REMOVE THE FRAGMENT, AND NO POST-OPERATIVE TESTS, SUCH AS X-RAYS OR ULTRASOUNDS, WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE PROCEDURE WAS COMPLETED ROBOTICALLY. ANOTHER SYNCHROSEAL INSTRUMENT WAS OPENED AND USED TO COMPLETE THE CASE. THERE WAS NO INJURY TO THE PATIENT, AND THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO POST-SURGICAL COMPLICATIONS RELATED TO A RETAINED 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: A PATIENT WHO WAS ENROLLED IN A STUDY, UNDERWENT A DA VINCI-ASSISTED NIPPLE SPARING MASTECTOMY SURGICAL PROCEDURE. DURING THE PROCEDURE, AN AREA OF ISCHEMIA WAS OBSERVED ON THE LEFT BREAST INFERIOR TO THE NIPPLE AREOLA COMPLEX (NAC). THE AREA WAS COVERED WITH SILVADENE CREAM. THE SKIN ISCHEMIA WILL BE SUBJECT TO OBSERVATION AND THE PATIENT WAS CONNECTED WITH ANOTHER INSTITUTION FOR POSSIBLE TREATMENT WITH HYPERBARIC OXYGEN THERAPY. THE PATIENT WAS DISCHARGED THE SAME DAY, THE EVENT IS REPORTED AS ONGOING AND THE PATIENT WILL RETURN IN A FEW WEEKS FOR A RE-EVALUATION AND PROCEED WITH RECONSTRUCTION. THERE WAS NO REPORT OF A DA VINCI DEVICE MALFUNCTION DURING THE PROCEDURE. THE STUDY INVESTIGATOR INDICATED THAT THERE WERE NO INTRAOPERATIVE DEVICE MALFUNCTIONS AND THE INJURY WAS OBSERVED AFTER DOCKING OF THE SYSTEM. THE EVENT WAS REPORTED AS MODERATE SEVERITY, POSSIBLY RELATED TO THE DA VINCI SYSTEM, POSSIBLY RELATED TO THE NSM PROCEDURE, BUT NOT RELATED TO RECONSTRUCTION, AND NOT RELATED TO THE PATIENT'S PRE-EXISTING CONDITION. THE STUDY INVESTIGATOR STATED THERE WAS NO ARCING OR SPARKING COMING FROM ANY OF THE INSTRUMENTS AND THAT THE PATIENT WAS CONNECTED WITH ANOTHER FACILITY FOR

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 ABDOMINOPERINEAL RESECTION SURGICAL PROCEDURE, "ONE OF THE INSTRUMENT TIPS BROKE OFF INTO PIECES INSIDE THE PATIENT". WHILE ON THE CALL WITH THE TECHNICAL SUPPORT ENGINEER, THE FRAGMENT WAS RETRIEVED BY THE STAFF USING A DIFFERENT INSTRUMENT. THE LOGS DID NOT SHOW ANY SYSTEM ERRORS. THE PROCEDURE WAS CONTINUED.

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) PROCEDURE. DURING THE PROCEDURE, A BURN AREA ON THE LEFT BREAST WAS IDENTIFIED, SUPERIOR TO THE NIPPLE-AREOLA COMPLEX (NAC). THE AREA WAS THROUGH AND THROUGH, WITH DISCHARGE OF FLUID FROM WITHIN THE BREAST POCKET AND WAS EXCISED DUE TO SKIN NECROSIS IN ELLIPTICAL FULL THICKNESS THROUGH TO THE BREAST POCKET. THE LENGTH OF THE WOUND WAS 2 CM. IT WAS THEN REPAIRED WITH A 3-0 MONOCRYL SUTURE AND IN DEEP DERMAL INTERRUPTED FASHION, AND RUNNING SUBCUTICULAR FASHION. IT WAS THEN COVERED WITH SILVADENE CREAM. THE PATIENT WAS DISCHARGED THE SAME DAY AND THE EVENT HAS BEEN REPORTED AS RESOLVED AND THE PATIENT WILL RETURN IN A FEW WEEKS FOR A RE-EVALUATION AND PROCEED WITH RECONSTRUCTION. THERE WAS NO REPORT OF A DA VINCI DEVICE MALFUNCTION DURING THE PROCEDURE. THE STUDY INVESTIGATOR INDICATED THAT THERE WERE NO INTRAOPERATIVE DEVICE MALFUNCTIONS AND THE INJURY WAS OBSERVED AFTER DOCKING OF THE SYSTEM. THE EVENT WAS REPORTED AS SEVERE, POSSIBLY RELATED TO THE DA VINCI SYSTEM, POSSIBLY RELATED TO THE NSM PROCEDURE, BUT NOT RELATED TO RECONSTRUCTION, AND NOT RELATED TO THE PATIENT'S PRE-EXISTIN

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. DURING THE PROCEDURE AN AREA OF SKIN BURN INJURY/BLISTERING TO THE LEFT MASTECTOMY FLAP WERE NOTED WITHIN THE NAC INVOLVING MOST OF THE AREOLA INFERIOR TO THE PAPULE FROM 4:00 TO 7:00. THE AREA DID NOT BLANCH. NITRO PASTE WAS PLACED OVER THE NIPPLE-AREOLAR COMPLEX AND SEALED WITH TEGADERM. THE PATIENT WAS DISCHARGED OTHER SAME DAY AND WILL RETURN IN A FEW WEEKS FOR A RE-EVALUATION AND PROCEED WITH RECONSTRUCTION. THERE WAS NO REPORT OF A DA VINCI DEVICE MALFUNCTION DURING THE PROCEDURE. THE STUDY INVESTIGATOR INDICATED THAT THERE WERE NO INTRAOPERATIVE DEVICE MALFUNCTIONS AND THE INJURY WAS OBSERVED AFTER DOCKING OF THE SYSTEM. THE EVENT WAS REPORTED AS SEVERE, POSSIBLY RELATED TO THE DA VINCI SYSTEM, POSSIBLY RELATED TO THE NSM PROCEDURE, BUT NOT RELATED TO RECONSTRUCTION, AND NOT RELATED TO THE PATIENT'S PRE-EXISTING CONDITION. ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW-UP. THE STUDY INVESTIGATOR STATED THERE WAS NO ARCING OR SPARKING COMING FROM ANY OF THE INSTRUMENTS AND THE CAUSE OF THE BURN INJURY WAS THAT THE FLAP WAS TOO THIN.

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, "INITIAL EXPERIENCE WITH FULLY ROBOTIC BILATERAL LUNG TRANSPLANTATION" WAS PERFORMED. THE DA VINCI XI SURGICAL SYSTEM WAS USED DURING THE SURGERY. THE ARTICLE NOTED THAT ONE PATIENT, A 57-YEAR-OLD WOMAN WITH A HISTORY OF END-STAGE CHRONIC OBSTRUCTIVE PULMONARY DISEASE, DEVELOPED ATRIAL FIBRILLATION, ACUTE KIDNEY INJURY, PROLONGED AIR LEAK, AND PNEUMONIA (DONOR) AFTER THE PROCEDURE. THE AUTHORS CONCLUDED THAT INTRAOPERATIVELY, THERE WAS DECREASED CARDIAC DYSFUNCTION DURING HILAR EXPOSURE WITH DECREASED HEMODYNAMIC SHIFTS, AND LESS PAIN REPORTED BY THE PATIENT. THERE WAS ALSO AN INCREASED TOTAL ISCHEMIC TIME, WARM ISCHEMIC TIME, AND OVERALL OPERATIVE TIME. IT WAS DETERMINED THAT ROBOTIC TRANSPLANTATION AND FUTURE COMPARATIVE STUDIES WITH LARGER PATIENT COHORTS ARE NEEDED TO ASSESS THE TRUE RISKS AND BENEFITS OF ROBOTIC LUNG TRANSPLANTATION. PER THE AUTHOR, THE COMPLICATION HAD NOTHING TO DO WITH THE DA VINCI DEVICE. THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS 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 SINGLE-PORT (SP) RADICAL PROSTATECTOMY, A LOUD BANG WAS HEARD FOLLOWED BY THE ERBE GENERATOR DISPLAYING A CONSTANT ERROR. PRIOR TO CONTACTING AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOR ASSISTANCE, THE CUSTOMER RESTARTED THE ERBE GENERATOR BUT THE ISSUE WAS NOT RESOLVED. UPON REVIEWING THE LOGS, THE TSE CONFIRMED THAT THE ERROR INDICATED A DEFECTIVE ERBE GENERATOR UNIT. AT THE TIME OF THE INCIDENT, ANESTHESIA HAD ALREADY BEEN ADMINISTERED TO THE PATIENT; HOWEVER, IT IS UNCLEAR IF THE SINGLE PORT HAD ALREADY BEEN PLACED. THE CASE HAD REPORTEDLY BEEN IN PROGRESS FOR 1 HOUR AND 45 MINUTES WHEN THE EVENT OCCURRED. DUE TO THE CUSTOMER REPORTED ISSUE, THE CUSTOMER ELECTED TO CONVERT THE DA VINCI-ASSISTED SP SURGICAL PROCEDURE TO A DA VINCI-ASSISTED MULTI-PORT SURGICAL PROCEDURE.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CITATION: SULLIVAN, MARGARET L., ET AL. BOSTON, 2025. UNDERSTANDING TECHNICAL DIFFICULTIES AND RECOGNIZED ERRORS IN PEDIATRIC ROBOTIC SPINE SURGERY HYPOTHESIS: INTRA-OPERATIVE TECHNICAL CHALLENGES EXIST WITH ADOPTION OF ROBOTICS COUPLED WITH NAVIGATION (RCN), THESE CAN BE RECOGNIZED AND RESOLVED WITHOUT SIGNIFICANT CONSEQUENCES TO PATIENT CARE. STUDY DESIGN: LEVEL I: PROSPECTIVE MULTICENTER SURGICAL OUTCOMES REGISTRY INTRODUCTION: RCN IN POSTERIOR SPINAL FUSION IS INCREASING IN PREVALENCE, AND LITERATURE SUPPORTS ITS VALUE FOR SAFE AND ACCURATE PEDICLE SCREW PLACEMENT. THIS STUDY PRESENTS THE FIRST MULTI INSTITUTIONAL ANALYSIS OF TECHNOLOGICAL DIFFICULTIES IN PEDIATRIC ROBOTIC SPINE SURGERY. METHODS: DATA COLLECTED FROM A MULTICENTER PROSPECTIVE REGISTRY INCLUDED: PATIENT DEMOGRAPHICS, DISEASE ETIOLOGY, AND CLINICAL AND S URGICAL CHARACTERISTICS. THE DIFFICULTIES WERE CATEGORIZED AS: LOSS OF REGISTRATION, LOSS OF CALIBRATION, INABILITY TO PERFORM TRAJECTORY, SCREW MALPOSITION, AND SYSTEM MALFUNCTION. GENERALIZED E STIMATED EQUATIONS (GEE) WERE USED TO QUANTIFY RCN TECHNICAL DIFFICULTIES AND IDENTIFY ASSOCIATIONS WITH CLINICAL FACTORS AND PROCEDURAL METRICS. RESULTS: 553 PATIENTS WE

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, ¿ROBOTIC-ASSISTED LEFT ATRIAL APPENDAGE OCCLUSION: AN IMPORTANT COMPLEMENTARY OPTION IN THE SURGICAL MANAGEMENT OF ATRIAL FIBRILLATION,¿ WAS PERFORMED. PER THE ARTICLE, THE OBJECTIVE OF THE OBSERVATIONAL, RETROSPECTIVE, MULTICENTRE STUDY WAS TO DEMONSTRATE SAFETY, FEASIBILITY, AND EFFICACY OF LEFT ATRIAL APPENDAGE OCCLUSION (LAAO) PERFORMED BY A ROBOTIC-ASSISTED APPROACH. THE STUDY PERIOD WAS BETWEEN AUGUST 2019 AND JUNE 2024 AND INCLUDED 194 PATIENTS WHO UNDERWENT LAAO THROUGH LEFT THORACOSCOPY USING THE DA VINCI X OR XI SURGICAL SYSTEM AT TWO SITES. WITHIN THIS COHORT, 155 PATIENTS UNDERWENT CONCOMITANT EPICARDIAL ABLATION AS PART OF A HYBRID ATRIAL FIBRILLATION (AF) TREATMENT. THE ARTICLE NOTED THAT DURING THESE DA VINCI SURGERIES, FOUR PATIENTS IN THE FIRST PHASE EXPERIENCED POSTOPERATIVE LEFT HEMIDIAPHRAGM PARALYSIS REQUIRING SURGICAL APPLICATION IN THREE CASES. SPONTANEOUS RESOLUTION WAS OBSERVED IN THE FOURTH CASE. FOUR PATIENTS AMONG THOSE UNDERGOING ROBOTIC ASSISTED HYBRID ABLATION WITH A SUBXIPHOID ACCESS DEVELOPED A SUBXIPHOID INCISIONAL HERNIA WHICH REQUIRED SURGICAL REPAIR. ONE PATIENT REQUIRED THORACOSCOPIC REVISION DUE TO CHES

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 DISTAL PANCREATECTOMY PROCEDURE, THE HARMONIC ACE INSTRUMENT WAS BEING USED FOR DISSECTION AND THE ROOT OF THE BLADE BROKE. THE BLADE FELL INSIDE THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. NO ADDITIONAL SURGICAL PROCEDURE WERE REQUIRED TO REMOVE THE BLADE/FRAGMENT. NO POST-OPERATIVE TESTS, SUCH AS AN X-RAY OR ULTRASOUND, WERE PERFORMED TO CHECK FOR REMAINING BLADE/FRAGMENTS. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH A BACKUP HARMONIC ACE INSTRUMENT. THERE WAS NO REPORTED INJURY TO THE PATIENT AND THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A BLADE/FRAGMENT 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 SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP BROKE INSIDE OF THE PATIENT. A FRAGMENT FELL INTO THE PATIENT. 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 AND NOTHING UNUSUAL WAS NOTED; THE TIP WAS PROPERLY MOUNTED AND FUNCTIONED NORMALLY WHEN TESTED FOR MOVEMENT. THE INSTRUMENT WAS NOT MOVING PROPERLY SO THE ARM WAS WITHDRAWN. AT THAT POINT, THE TIP HAD ALREADY SEPARATED AND REMAINED INSIDE OF THE PATIENT WHEN THE ARM WAS REMOVED. IT IS UNKNOWN WHAT THE SURGEON BELIEVED WAS THE CAUSE OF THE INSTRUMENT'S BREAKING. THE CUSTOMER DID NOT RECALL HOW LONG THE INSTRUMENT WAS IN USE FOR BUT STATED THAT IT WAS NOT USED FOR A LONG TIME. THE SURGEON RECOGNIZED THAT THE TIP HAD SEPARATED AND REMAINED INSIDE OF THE PATIENT. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIALS DURING THE SURGICAL PROCEDURE. THE FRAGMENT DID NOT FALL INSTEAD OF THE PATIENT DURING AN INSTRUMENT TIP COLLISION. THE MCS TIP BECAME DISLODGED DURING THE INSTRUMENT REMOVAL. IT IS UNKNOWN

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WAS A MEDIAL PUNCTURE ON THE RIGHT VERTEBRAE LEVEL. THE PATIENT NOW SUFFERS FOR LOWER BACK PAIN, FORWARD LEANING OF THE TRUNK, GAIT DISTURBANCE, AND HEARTBURN. THE PROCEDURE WAS COMPLETED WITH A NAVIGATION AND IMAGING SYSTEM. THERE WAS NO DELAY. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THERE WAS NO DEVIATION WITH THE TRAJECTORIES.

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 HEMICOLECTOMY PROCEDURE, THE PROCEDURE WAS CONVERTED TO AN OPEN SURGERY DUE TO BLEEDING FROM THE ACCESSORY RIGHT COLIC VEIN WHICH WAS CAUSED BY FORCE BEING APPLIED WHEN LIFTING THE INTESTINES THROUGH A SMALL INCISION. THE PATIENT, DIAGNOSED WITH ADVANCED CANCER AND LYMPH NODE ENLARGEMENT, INITIALLY HAD A SURGICAL PLAN INVOLVING THE UNDOCKING OF THE SP SYSTEM, FOLLOWED BY THE PLACEMENT OF AN ACCESS PORT KIT AND THE ELEVATION OF THE INTESTINES THROUGH A SMALL INCISION FOR A SEMI-OPEN (HYBRID) PROCEDURE. HOWEVER, AFTER TREATING THE ILEOCOLIC ARTERY (ICA) AND ILEOCOLIC VEIN (ICV), DIFFICULTIES AROSE DURING DISSECTION AROUND THE SURGICAL TRUNK, LEAVING THE SUPERIOR MESENTERIC VEIN (SMV) AND ACCESSORY RIGHT COLIC VEIN UNTREATED. THE SURGEON EXPLAINED THAT UPON REMOVAL OF THE DA VINCI SP PORT AND WHILE ATTEMPTING TO PROCEED WITH THE SEMI-OPEN OPERATION, THE "EXTERNAL PASSIVE FORCE" WAS INADEQUATE. THIS INADEQUACY LED TO EXCESSIVE FORCE BEING APPLIED WHEN LIFTING THE INTESTINES THROUGH THE SMALL INCISION, CAUSING INJURY TO THE ACCESSORY RIGHT COLIC VEIN. THE RESULTING INJURY LED TO SIGNIFICANT BLEEDING, WITH AN ESTIMATED BLOOD LOSS OF 4

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 RADICAL EXTRAPERITONEAL PROSTATECTOMY WITH LYMPHADENECTOMY PROCEDURE, THE INSTRUMENT DRIVE ON PATIENT SIDE MANIPULATOR (PSM) #2 WAS NOT HOLDING THE STERILE ADAPTER (SA). THE ISSUE WAS IDENTIFIED WHILE THE OPERATING ROOM (OR) STAFF WAS SETTING UP FOR THE PROCEDURE. THE CUSTOMER HAD ALREADY RE-DRAPED BUT THE ISSUE REMAINED WITH A NEW DRAPE. WHEN THE CUSTOMER ENGAGED THE SA, IT SEEMED LIKE IT WOULD INITIALLY ENGAGE, BUT WHEN THEY TOUCHED THE SA ON PSM #2, IT FELL OFF. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) RECOMMENDED CHECKING THE WHEELS/DISK AND POGO PINS ON PSM #2. THE CALLER STATED ALL OF THE WHEELS AND THE POGO PINS SEEMED LIKE THEY WERE FREE TO MOVE AND SPONGY. THE CUSTOMER PRESSED THE INSTRUMENT RELEASE BUTTON ON THE PSM #2 AND THEN TRIED TO RE-ENGAGE THE SA ON THE PSM #2 WITH NO CHANGE. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. AT THIS TIME, IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE WAS NOTED AFTER ANESTHESIA WAS ALREADY ADMINISTERED AND PORTS HAD BEEN PLACED. THERE WAS NO 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 VAGINAL PROLAPSE REPAIR PROCEDURE THE MONOPOLAR CURVES SCISSORS (MCS) TIP COVER ACCESSORY THAT WAS INSTALLED ON AN MCS INSTRUMENT FELL OFF INSIDE THE PATIENT'S ABDOMEN. THE MCS TIP COVER ACCESSORY WAS RETRIEVED DURING THE SAME PROCEDURE WHICH WAS COMPLETED ROBOTICALLY.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER A SUCCESSFUL ROBOTIC BRONCHOSCOPY PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX. A VALVE WAS PLACED AND PATIENT WAS HOSPITALIZED. NO DEVICE ISSUES WERE 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 MONOPOLAR CURVED SCISSORS (MCS) TIP COVER DETACHED FROM THE MCS INSTRUMENT DURING SURGERY. "DELAY IN PATIENT CARE OR EXTENSION OF HOSPITALIZATION DISRUPTION OF DEPARTMENT OPERATIONS OR INTERDEPARTMENTAL RELATIONS" WERE EXPERIENCED. THE MCS TIP COVER WAS EXCHANGED AFTER RETRIEVAL FROM THE ABDOMEN. 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: WHILE PERFORMING A ROBOTIC RIGHT INGUINAL HERNIA REPAIR THE BIPOLAR FORCEPS SUPERFICIALLY SNAGGED THE PATIENT'S BOWEL INTESTINE. THE DOCTOR REMOVED THE BIPOLAR FORCEPS AND STITCHED THE BOWEL. UPON REMOVAL OF THE INSTRUMENT, IT WAS NOTED TO BE BROKEN. THE INSTRUMENT HAD BEEN USED 12 TIMES AND THIS WAS THE 13TH TIME, AND HAD TWO REPROCESSES 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 DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER DETACHED FROM THE MCS INSTRUMENT DURING SURGERY. "DELAY IN PATIENT CARE OR EXTENSION OF HOSPITALIZATION DISRUPTION OF DEPARTMENT OPERATIONS OR INTERDEPARTMENTAL RELATIONS" WERE EXPERIENCED. THE MCS TIP COVER WAS EXCHANGED AFTER RETRIEVAL FROM THE ABDOMEN. THE PROCEDURE WAS COMPLETED.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER A SUCCESSFUL ROBOTIC BRONCHOSCOPY PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX. A CHEST TUBE WAS PLACED. NO SYSTEM ISSUES WERE 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: A REVIEW OF AN ARTICLE THAT EVALUATED THE INITIAL EXPERIENCES AND ASSESSMENTS OF THE FEASIBILITY AND SAFETY OF ROBOTIC GASTRECTOMY FOR GASTRIC CANCER USING THE DA VINCI SP SYSTEM (DVSP) WAS PERFORMED. THE SINGLE-CENTER RETROSPECTIVE STUDY ANALYZED 20 PATIENTS UNDERGOING ROBOTIC GASTRECTOMY BETWEEN MARCH 2023 AND APRIL 2024. THE MEDIAN AGE OF THE PATIENTS WAS 74 YEARS. OF THESE PATIENTS, TUMORS IN THE MIDDLE TO LOWER STOMACH WERE OBSERVED. EIGHTEEN OF THE PATIENTS HAD CLINICAL STAGE 1 CANCER AND TWO PATIENTS HAD CLINICAL STAGE II CANCER. ONE PATIENT EXPERIENCED AFFERENT LOOP SYNDROME (CLAVIEN-DINDO IIIA). THE ARTICLE DID NOT PROVIDE THE FOLLOWING INFORMATION: THE CAUSE OF THE COMPLICATION AND WHAT MEDICAL INTERVENTION (IF ANY) WAS RENDERED DUE TO THE COMPLICATION. NO REOPERATIONS OR SURGICAL MORTALITY WERE REPORTED. ADDITIONALLY, NO DEVICE MALFUNCTIONS WERE REPORTED. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO GATHER ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT; HOWEVER, NO RESPONSE HAS BEEN RECEIVED.