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

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REVIEW OF THIS LITERATURE ARTICLE THAT DESCRIBED A RETROSPECTIVE ANALYSIS AND AN UMBRELLA SYSTEMATIC REVIEW WAS PERFORMED. THE AIM OF THE STUDY WAS TO EXPLORE THE DIFFERENCES IN CLINICAL OUTCOMES OF PATIENTS UNDERGOING MINIMALLY INVASIVE CHOLECYSTECTOMY USING LAPAROSCOPIC AND ROBOTIC APPROACHES AT A SINGLE ACADEMIC CENTER WITH A NEWLY ESTABLISHED ROBOTIC SURGERY PROGRAM. THE CONCLUSION OF THE STUDY FOUND THAT ROBOTIC CHOLECYSTECTOMY IS FEASIBLE AND SAFE IN AN ACADEMIC SETTING, WITH CLINICAL OUTCOMES COMPARABLE TO LAPAROSCOPIC CHOLECYSTECTOMY. THE STUDY OCCURRED FROM NOVEMBER 2020 AND JANUARY 2022. THE ARTICLE NOTED THAT THE STUDY EXAMINED CHOLECYSTECTOMY PROCEDURES PERFORMED BY A SINGLE SURGEON, INCLUDING 61 LAPAROSCOPIC CHOLECYSTECTOMIES (LC) AND 42 ROBOTIC CHOLECYSTECTOMIES (RC), WITH RC PATIENTS BEING OLDER AND HAVING A LOWER BMI COMPARED TO LC PATIENTS. COMPLICATIONS INCLUDED INTRA-ABDOMINAL ABSCESSES (3 CASES) AND A SURGICAL SITE INFECTION (1 CASE), WITH NO CONVERSIONS TO OPEN PROCEDURES, BILE LEAKS, SMALL BOWEL OBSTRUCTIONS, OR BLOOD TRANSFUSIONS NEEDED. THE ARTICLE DOCUMENTED THAT THERE WERE SEVERAL LIMITATIONS TO THIS STUDY. THESE INCLUDE ITS SINGLE-SURGEON SCOPE, MAKING IT

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 (LAR) PROCEDURE, THE HARMONIC ACE INSTRUMENT TIP BROKE. A FRAGMENT BROKE OFF FROM THE INSTRUMENT AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE USER COMPLETED THE PROCEDURE USING A BACKUP HARMONIC ACE INSTRUMENT WITH NO FURTHER ISSUE REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE FRAGMENT(S) WERE ALL CONFIRMED TO BE RETRIEVED THROUGH VISUALIZATION OF AN ENDOSCOPE BY THE SURGEON, NURSE, AND SURGICAL ASSISTANT. THERE WAS NO ADDITIONAL PROCEDURE OR POST-OPERATIVE TEST PERFORMED. THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO DAMAGE OBSERVED. THE INSTRUMENT WAS IN USE FOR HALF AN HOUR PRIOR TO BREAKING AND WHILE THE SURGEON WAS DISSECTING. THERE WAS NO ISSUE WITH FUNCTIONALITY OF THE INSTRUMENT AND NO INSTRUMENT COLLISION. THE INSTRUMENT WAS REMOVED DURING THE PROCEDURE PRIOR TO THE BREAKAGE BUT THERE WAS NO RESISTANCE UPON REMOVAL. UPON FINAL REMOVAL OF THE INSTRUMENT, THERE WAS NO RESISTANCE THROUGH THE CANNULA, NO DAMAGE TO THE CANNULA, AND NO FURTHER DAMAGE TO THE INSTRUMENT. THE PATI

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 TIP OF THE HARMONIC ACE INSTRUMENT WAS BROKEN. THE FRAGMENT FELL INSIDE THE PATIENT¿S CAVITY AND WAS RETRIEVED DURING THE SAME PROCEDURE. 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, AND NO DAMAGE WAS FOUND. AFTER THE CUSTOMER USED THE INSTRUMENT FOR 20 TO 30 MINUTES TO GRASP TISSUE, THE INSTRUMENT BROKE AND THE FRAGMENT(S) FELL INSIDE THE PATIENT. ALL THE FRAGMENTS WERE RETRIEVED DURING SAME PROCEDURE AND CONFIRMED BY MATCHING THE FRAGMENTS TO THE INSTRUMENT. POST-OPERATIVE TESTS WERE NOT PERFORMED. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT AND THE INSTRUMENT DID NOT COLLIDE WITH ANY HARD MATERIALS OR OTHER INSTRUMENTS. THE INSTRUMENT WAS NOT REMOVED DURING THE PROCEDURE (PRIOR TO THE BREAKAGE). UPON FINAL REMOVAL OF THE INSTRUMENT, THE INSTRUMENT'S WRIST WAS STRAIGHTENED, AND THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. NO OTHER

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 PATIENT EXPERIENCED BREATHING DIFFICULTIES AND NODAL TACHYCARDIA. AN ELECTROCARDIOGRAM (ECG) AND A CORONARY ANGIOGRAM (CAG) WERE PERFORMED; THE ECG SHOWED SINUS TACHYCARDIA AND ST-ELEVATION, INDICATING A POSSIBLE ANTERIOR WALL INJURY. THE PATIENT WAS ADMINISTERED NITROGLYCERIN, "STATINS" AND OTHER HEART RATE LOWERING MEDICATIONS. TWO DAYS LATER, THE PATIENT'S SYMPTOMS HAD RESOLVED AND AFTER AN ADDITIONAL TWO DAYS MORE, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND HAS SINCE NOT RETURNED. IT WAS REPORTED THAT THE BREATHING DIFFICULTIES ARE BELIEVED TO BE UNRELATED TO ANY MALFUNCTION OF THE DA VINCI SYSTEM, INSTRUMENTS, OR ACCESSORIES OCCUR DURING THE 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: REFER TO H10/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: IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNEVENTFUL DA VINCI ASSISTED LOW ANTERIOR RESECTION FOR COLORECTAL CANCER. THE SURGEON STATED THAT THE ANASTOMOSIS WAS END-TO-END, CREATED WITH AN ETHICON ILS 29 CIRCULAR STAPLER. TESTING OF THE ANASTOMOSIS WAS PERFORMED DURING THE OPERATION AND NO LEAKAGE WAS FOUND. THE PATIENT EXPERIENCED COMPLICATIONS POSTOPERATIVELY AND EXPIRED APPROXIMATELY 69 DAYS POST-PROCEDURE. THERE WAS NO REPORT OF ANY ISSUES WITH THE DAVINCI PRODUCTS. ON POST-OPERATIVE DAY 4 (POD) THE PATIENT'S BLOOD PRESSURE SIGNIFICANTLY DROPPED AND CT SCANS SHOWED PNEUMOPERITONEUM. ANASTOMOSIS LEAKAGE, PERITONITIS, AND SEPSIS WERE SUSPECTED AND AN EMERGENT RE-OPERATION WAS PERFORMED. THE PATIENT REQUIRED POST-OPERATIVE CIRCULATORY AND OXYGEN SUPPORT VIA VENO-ARTERIAL AND VENO-VENO EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) AND VASOPRESSORS DUE TO RESPIRATORY FAILURE AND SEPTIC SHOCK. ON POD 7 THE CIRCULATORY SUPPORT WAS CHANGED TO VENO-VENOUS ECMO ONLY, WHICH WAS REMOVED FIVE DAYS LATER AFTER THE PATIENT WAS HEMODYNAMICALLY STABLE. THE PATIENT WAS TREATED WITH ANTIBIOTICS FOR ILEOSTOMY AND WOUND INFECTIONS. THE PATIENT'S HAND BECAME CYANOTIC FROM THE ECMO TREATMENT REQUIRI

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DR. (B)(6) WAS DOING A T3-T12 PEDIATRIC SCOLIOSIS PATIENT. SIGNIFICANT CORONAL AND SAGITTAL DEFORMITY AT MULTIPLE LEVELS. WE WERE USING A 12INCH C-ARM. MERGE FAILED AFTER MULTIPLE ATTEMPTS OF HAVING THE X-RAY TECH WAG THE C-ARM IN LATERAL, RAINBOW IN A/P, AND TRY OBLIQUE IN LATERAL AT HIGH LEVELS. TRIED MULTIPLE LATERALS AND A/P WITH NO AVAIL. SURGEON WAS VERY PATIENT AND GAVE US THE TIME BUT EVENTUALLY BAILED ON THE ROBOT. HE PROCEEDED WITH DOING THE CASE FREE HAND.

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 A REVIEW OF A CLINICAL LITERATURE ARTICLE THAT COMPARED SURVIVAL AND PERIOPERATIVE OUTCOMES OF OPEN VERSUS ROBOTIC RETROPERITONEAL LYMPH NODE DISSECTION (RPLD), THE FOLLOWING COMPLICATIONS WERE DOCUMENTED. A TOTAL OF 178 PATIENTS UNDERWENT PRIMARY RPLD IN ONE SINGLE INSTITUTION BETWEEN 1990 AND 2022, 137 PATIENTS UNDERWENT OPEN-RPLD AND 41 PATIENTS UNDERWENT ROBOTIC-RPLD. AFTER PROPENSITY SCORE MATCHING (PSM), 38 PATIENTS IN THE OPEN-RPLD WERE MATCHED WITH 26 PATIENTS IN THE ROBOTIC-RPLD GROUP. ROBOTIC-RPLD WAS ASSOCIATED WITH LOWER BLOOD LOSS AND STATISTICALLY SHORTER LENGTH OF STAY, COMPARED TO THE OPEN-RPLD GROUP. THE OPERATIVE TIME WAS SIGNIFICANTLY LONGER FOR THE ROBOTIC APPROACH, BUT DECREASED AS SURGEON'S EXPERIENCES GAINED. THERE WERE NO INTRA-OPERATIVE COMPLICATIONS OR DA VINCI DEVICE MALFUNCTION OCCURRED IN ANY OF THE PROCEDURES ACCORDING TO THE ARTICLE AUTHOR. THERE WERE TEN (24%) POST-OPERATIVE COMPLICATIONS OCCURRED IN ROBOTIC-RPLD GROUP COMPARED TO 31 (23%) COMPLICATIONS IN THE OPEN-RPLD GROUP. IN THE ROBOTIC-RPLD GROUP, ONE (2.4%) COMPLICATION OF ASCITES THAT REQUIRED PARACENTESIS WAS REPORTED AS CLAVIDEN-DINDO IIIA, WHILE THE REST OF THE COMPLICATIONS WERE CL

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A PNEUMOTHORAX IN THE RIGHT LUNG. A CHEST TUBE WAS PLACED AND PATIENT WAS HOSPITALIZED. THE FOLLOWING DAY THE CHEST TUBE WAS REMOVED AND THE PATIENT WAS RELEASED. THE PHYSICIAN STATED THAT THE SCOPE APPEARED TO BE KINKED AND THE PHYSICIAN ELECTED TO ABORT THE CASE.

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.

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 REPORTED THAT THE NAVIGATION WAS NOT MATCHING UP WITH THE CIOS SPIN AND WAS ~30MM OFF FROM THE TARGET BUT THE CASE WAS COMPLETED SUCCESSFULLY. A PNEUMOTHORAX WAS DISCOVERED POST-OP AND THE PATIENT WAS NOT ADMITTED BUT A CHEST TUBE WAS PLACED. CHEST TUBE WAS REMOVED SAME DAY AND THE PATIENT WENT HOME SAME DAY. THERE WERE NO FAULTS OR ISSUES REPORTED WITH THE MONARCH SYSTEM AND THE PHYSICIAN IS NOT ATTRIBUTING THE EVENT TO THE MONARCH.

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.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE MERGE OF L4-5 LEVELS FOR SINGLE POSITION LATERAL SURGERY SHOWED A SHIFT. WE TOOK NEW SHOTS OF EACH INDIVIDUAL LEVEL AND ADDED L3 AND S1 TO HELP WITH THE MERGE. THE SURGEON WAS UNHAPPY WITH THE MERGE AS THERE WAS SLIGHT MOVEMENT VISIBLE ON THE L4 AND L5 A/P AND LATERAL VIEWS. THE SINGLE POSITION LATERAL CASE WAS ABORTED AND CONVERTED TO AN OPEN PRONE TLIF. PLEASE NOTE THE BED WAS ADJUSTED TO HELP ACCOMMODATE THE ILIAC CREST PRIOR TO ROBOTIC X RAYS BEING TAKEN.

VELYS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHEN VERIFYING THE CUTS ON THE FEMUR, IT APPEARED THAT THE LATERAL POSTERIOR CUT HAD BEEN OVER RESECTED BY 1MM WHEN USING VELYS. WHEN SURGEON PUT TRIALS ON, HE NOTICED CONSIDERABLE 1-2MM GAPS BETWEEN BONE AND TRIAL FEMUR FOR THE: POSTERIOR, ANTERIOR, ANTERIOR CHAMFER AND DISTAL. LEFT TKR USING VELYS ATTUNE PS FB CONSTRUCT.

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

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WHEN ASSEMBLING THE A/O DRIVER AND ELECTRODE CLAMP GUIDE TUBE, IT WAS NOTED THAT THE SURGEON WAS ABLE TO SPIN THE E.C GUIDE TUBE. HOWEVER, THE E.C. GT APPEARED TO BE ASSEMBLED AS EXPECTED.

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 UNILATERAL INGUINAL HERNIA PROCEDURE, THE CANNULA SEAL ACCESSORY RIPPED WHILE THE CUSTOMER WAS INSERTING MESH INSIDE THE PATIENT WITH A GRASPER INSTRUMENT. DURING INSERTION OF THE GRASPER, THE CUSTOMER SAW A BLUE FRAGMENT/PIECE INSIDE THE PATIENT. THE CANNULA SEAL WAS INSPECTED, AND IT WAS NOTED TO BE TORN. IT IS UNKNOWN IF THERE WAS AN INSTRUMENT/ACCESSORY COLLISION. THE INSTRUMENT WRIST WAS STRAIGHTENED DURING REMOVAL. THE FRAGMENT WAS RETRIEVED USING A BACK-UP INSTRUMENT DURING THE SAME PROCEDURE WHICH WAS COMPLETED ROBOTICALLY. THERE ARE NO PHOTOGRAPHIC IMAGES 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT HAD A RECOGNITION ISSUE AND A FRAGMENT DETACHED FROM THE INSTRUMENT. THE FRAGMENT FELL INSIDE THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC (ISI) FOLLOWED UP WITH A NURSE FROM THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE INSTRUMENT WAS INSPECTED BEFORE USE WITH NOTHING FOUND OUT OF THE ORDINARY. IT IS UNKNOWN WHAT SURGICAL TASK WAS BEING PERFORMED WHEN THE FRAGMENT FELL INSIDE THE PATIENT. THE SURGEON DOES NOT KNOW WHAT CAUSED THE ISSUE. THE ISSUE WITH THE INSTRUMENT OCCURRED ABOUT 10 MINUTES AFTER THE PROCEDURE STARTED. THE SURGEON DID NOT NOTICE FUNCTIONALITY ISSUES DURING THE SURGICAL PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR HARD MATERIAL. THE INSTRUMENT WAS NOT REMOVED BEFORE BRAKEAGE AND THE WRIST WAS STRAIGHTENED. THE STAFF DID NOT FEEL RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. THERE WAS NO DAMAGE NOTED TO THE CANNULA. ALL FRAGMENTS WERE CONFIRMED TO BE RETRIEVED BY VISUAL INSPECTION. NO ADDITIONAL SURGICAL P

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

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY PROCEDURE, THE SCRUB TECH NOTICED WHILE LOOKING INSIDE OF THE PELVIS OF THE PATIENT THAT A BLACK PIECE OF THE RUBBER PART OF THE UNIVERSAL SEAL FELL OFF INTO THE PATIENT. A GRASPER WAS UTILIZED TO REMOVE THE FRAGMENT FROM THE PATIENT. NO FRAGMENT WAS LEFT BEHIND INSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS NO NOTED DAMAGE PRIOR TO USE OF THE CANNULA SEAL. THE SURGEON WAS UNSURE WHEN THE FRAGMENT FELL INSIDE THE PATIENT. HOWEVER, THE SURGEON SUSPECTED IT MAY HAVE BEEN OCCURRED WHEN INSERTING AN INSTRUMENT ONTO AN ARM AND THROUGH THE CAP OF THE CANNULA SEAL. THE PROCEDURE HAD BEEN IN PROGRESS FOR APPROXIMATELY 45 MINUTES WHEN THE EVENT OCCURRED. 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. IT WAS REPORTED THAT AN INSTRUMENT DID NOT BREAK. THE CANNULA SEAL WAS REMOVED AND REPLACED. THE AREA OF CANNULA SEAL WAS NOTED TO

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ROBOT DOES NOT RECOGNIZE WHEN THE POWER CORD IS PLUGGED IN. WORKED FINE FOR A CASE LAST NIGHT, BUT WHEN TURNING ON TODAY TO DO A CASE IT WOULD NOT CHARGE THE BATTERY AND WAS RUNNING SOLELY OFF THE BATTERY WHEN TURNED ON. THINK A FUSE IS BLOWN IN THE ROBOT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A RETROSPECTIVE REVIEW OF PATIENTS WHO UNDERWENT ELECTIVE LAPAROSCOPIC OR ROBOT-ASSISTED LAPAROSCOPIC HIATAL HERNIA (HH) REPAIR BETWEEN JANUARY 2020 AND DECEMBER 2022 WAS CONDUCTED TO EVALUATE THE CLINICAL EFFECTS OF ROBOT-ASSISTED LAPAROSCOPIC SURGERY (RALS) AND CONVENTIONAL LAPAROSCOPIC SURGERY (CLS) IN TREATING HH IN CHILDREN. FIFTY-FOUR PATIENTS WERE INITIALLY ENROLLED IN THE STUDY; HOWEVER, NINE PATIENTS WERE EXCLUDED DUE TO FACTORS SUCH AS GASTROESOPHAGEAL REFLUX (GER), SERIOUS DISEASES, AND INCOMPLETE CLINICAL DATA. ULTIMATELY, 46 PATIENTS MET THE INCLUSION CRITERIA, WITH 25 (54.3%) UNDERGOING CLS (GROUP 1) AND 21 UNDERGOING RALS (GROUP 2). THE AVERAGE AGE FOR GROUP 1 WAS 2.2 YEARS, WHILE FOR GROUP 2, IT WAS 3.3 YEARS. THE MEAN FOLLOW-UP PERIOD WAS 18 MONTHS FOR GROUP 1 AND 13 MONTHS FOR GROUP 2. POSTOPERATIVE COMPLICATIONS WERE ASSESSED, WITH PNEUMONIA BEING THE MOST COMMON IN BOTH GROUPS¿OCCURRING IN 5 PATIENTS (20%) IN GROUP 1 AND 2 PATIENTS (9.5%) IN GROUP 2. EACH GROUP HAD ONE PATIENT READMITTED DUE TO REPEATED VOMITING WITHIN ONE MONTH POST-OPERATION, BOTH OF WHOM RECOVERED WITH CONSERVATIVE TREATMENT. ADDITIONAL COMPLICATIONS INCLUDED ONE CASE OF PNEUMOTHORAX IN GROUP

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE ROBOT IS DISPLAYING A BLACK SCREEN WITH WHITE LETTERS ON BOOT UP SAYING "REBOOT AND SELECT PROPER BOOT DEVICE OR INSERT BOOT MEDIA IN SELECTED BOOT DEVICE AND PRESS A KEY".

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: (B)(6), LLIF L2-5 (FLUOROSCOPY WORKFLOW), PLDF L2-ILIUM (PREOP/INTRAOP WORKFLOW). FOR LLIF PORTION OF PROCEDURE FLUOROSCOPY WORKFLOW USED. L3/4 AND L4/5 REGISTERED AND L4/5 INSTRUMENTED FIRST. SURGEON STATED CAGE ENDED UP MORE POSTERIOR THAN PLANNED. L2/3 AND L3/4 REGISTERED AGAIN AND AGAIN, SURGEON STATED CAGE WAS PLACED MORE POSTERIORLY THAN NAVIGATION STATED. SURGEON DECLINED TO REGISTER L2/3 AGAIN AND CAGE PLACED. IN THE END, SURGEON STATED ALL CAGES WERE PLACED MORE POSTERIORLY THAN HE EXPECTED BASED ON THE NAVIGATION SHOWING HIM PLACING CAGES ANTERIOR TO FINAL POSITION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MY MOTHER SUFFERED SERIOUS COMPLICATIONS DURING A FUNDOPLICATION SURGERY USING THE DA VINCI ROBOT MADE MY INTUITIVE SURGICAL. A PRIMARY BLOOD VESSEL TO HER STOMACH WAS SEVERED CAUSING THE ORGAN TO DIE. SHE HAS CONTINUED TO HAVE ISSUES WITH PERFUSION TO HER INTESTINES REQUIRING MULTIPLE FOLLOW UP PROCEDURES TO REMOVE MORE NECROTIC TISSUE. AT THIS POINT WE ARE UNSURE IF SHE WILL SURVIVE AND IF SHE DOES SHE WILL BE DEPENDENT ON OTHERS FOR HER CARE FOR THE REMAINDER OF HER LIFE. SHE WAS PREVIOUSLY AN ACTIVE 65 YO GRANDMOTHER. THIS MATTER NEEDS TO BE INVESTIGATED FULLY. THE PROCEDURE WAS DONE BY DR (B)(6) AT (B)(6) HOSPITAL IN (B)(6). PROCEDURE DATE IS (B)(6) 2023.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED DUE TO ROBOTIC ERROR.

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'S BLADE SUDDENLY BROKE. FRAGMENTS WERE REPORTED TO HAVE FALLEN INSIDE THE PATIENT AND WERE RETRIEVED DURING THE SAME PROCEDURE. THE CUSTOMER USED A SPARE INSTRUMENT TO COMPLETE THE PROCEDURE. 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.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ROBOT BROUGHT INTO ROOM AND TURNED ON WITHOUT ANY ISSUES. SCREEN WENT TO A BLUE SCREEN WITH MESSAGE "A START UP ERROR HAS OCCURRED". TRIED MULTIPLE RESTARTS AND ERROR STILL OCCURRED. CASE HAD TO BE ABORTED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING A DBS PROCEDURE AN IDENTICAL BILATERAL DEVIATION WAS NOTICED EVEN WITH 3 REGISTRATIONS. THE PATIENT HAD A BONE FIDUCIAL PLACED AND AN INITIAL NON-STERILE REGISTRATION WITH O ARM SET TO THE STEREOTAXY SETTINGS WAS PERFORMED AND ACCURACY CHECKS WERE PERFORMED. IT WAS NOTICED THAT THE INITIAL REGISTRATION FIT WAS NOT CENTERED ON ALL SPHERES AND REQUIRED A FAIR AMOUNT OF MANIPULATION TO GET INTO A GREEN FIT. ACCURACY CHECKS WERE PERFORMED, INCLUDING WITH THE BONE FIDUCIAL AND SHOWED AN ACCEPTABLE REGISTRATION. THE PATIENT WAS DRAPED AND ACCURACY CHECKS WERE PERFORMED AGAIN SHOWING NO CHANGE IN ACCURACY. THE BURR HOLES WERE CREATED AT WHICH POINT THE PATIENT COUGHED. I ADVISED TO PERFORM ADDITIONAL ACCURACY CHECKS TO THE BONE FIDUCIAL SHOWING A 2-3 MM SHIFT POSTERIOR. A STERILE ICT AND ARM WERE ATTACHED AND ANOTHER O ARM SCAN WITH THE SAME SETTING WAS PERFORMED. THERE WAS A SIMILAR REGISTRATION FIT WITH THIS REGISTRATION AS WELL. ACCURACY CHECKS WERE PERFORMED AND THE LEAD WAS PERFORMED ON THE RIGHT SIDE. AN EVALUATION SCAN WAS PERFORMED SHOWING A 3 MM POSTERIOR MEDIAL DEVIATION. THE LEAD WAS LEFT DUE TO RESPONSIVE TESTING. THE PATIENT COUGHED AGAIN AND ANOTHER REGISTRATION WAS P

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 TIP WAS BROKEN. A FRAGMENT FELL INSIDE THE PATIENT AND THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE HARMONIC ACE INSTRUMENT WAS INSPECTED BEFORE USE. THE INSTRUMENT DID NOT COLLIDE WITH OTHER INSTRUMENTS OR TOOLS.

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 HYSTERECTOMY SURGICAL PROCEDURE, THE USER OBSERVED AN INSTRUMENT RECOGNITION ISSUE WITH THE HARMONIC ACE INSTRUMENT. THE INSTRUMENT WAS REMOVED AND REPLACED WITH A BACKUP. FOLLOWING THIS, THE USER CONTINUED AND COMPLETED THE PROCEDURE. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE REPORTER CONFIRMED THAT A FRAGMENT OF THE TEFLON PAD PIECE WAS FOUND AND RETRIEVED. AN X-RAY TEST WAS PERFORMED TO CHECK FOR REMAINING FRAGMENTS INSIDE THE PATIENT. THERE WAS NO INSTRUMENT COLLISION.

Mini vacuum sweeper — USB charged robotic vacuum cleaner, with dimensions 88x88x70 mm Hazard (Chemical, Environment): The solders in the product have an excessive concentration of lead (measured value up to 54.2% by weight). In addition, the plastic material of the cable has an excessive concentration of bis(2-ethylhexyl) phthalate (DEHP) (measured value up to 0.43% by weight) and an excessive concentration of short chain chlorinated paraffins (SCCPs) (measured value up to 4.2 % by weight). Lead poses a risk to th...

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED VENTRAL HERNIA TRANSABDOMINAL PRE-PERITONEAL (TAPP) SURGICAL PROCEDURE, THE UNIVERSAL SEAL INSUFFLATION PORT BROKE OFF DURING CASE. A FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAD BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: 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 LIVER RESECTION SURGICAL PROCEDURE, THE SYNCHROSEAL INSTRUMENT SLEEVE ON THE JOINT CAME OFF IN THE PATIENT AND WAS RETRIEVED IN 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: 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 SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY, INSTALLED ON AN MCS INSTRUMENT, FELL OFF INSIDE THE PATIENT. THE MCS TIP COVER ACCESSORY WAS RETRIEVED DURING SAME PROCEDURE AND THE CUSTOMER MOVED ON TO ANOTHER MCS INSTRUMENT TO CONTINUE THE PROCEDURE. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) INQUIRED IF THE MCS TIP COVER ACCESSORY WAS CORRECTLY INSTALLED, BUT THE CUSTOMER WAS NOT ABLE TO VERIFY.

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.

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

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A STUDY WHICH COMPARED ROBOT-ASSISTED VERSUS LAPAROSCOPIC LYMPH NODE DISSECTION PROCEDURES IN PATIENTS WITH GYNECOLOGIC MALIGNANCIES, WAS SUMMARIZED IN A LITERATURE ARTICLE. THE ARTICLE COMPARES THE SURGICAL OUTCOMES AND COMPLICATIONS FOR PELVIC LYMPH NODE DISSECTION (PLND) PERFORMED THROUGH CONVENTIONAL LAPAROSCOPIC SURGERY (CLS) VERSUS ROBOT-ASSISTED SURGERY (RAS) IN PATIENTS WITH GYNECOLOGIC MALIGNANCIES OVER A PERIOD OF APPROXIMATELY EIGHT YEARS. THERE WERE 731 PATIENTS WITH GYNECOLOGIC MALIGNANCIES WHO UNDERWENT TRANSPERITONEAL PLND, INCLUDING 460 AND 271 IN THE CLS AND RAS GROUPS, RESPECTIVELY. THE BLOOD LOSS, AND NUMBER OF RESECTED LYMPH NODES WERE 110 +/- 88 ML, AND 45 +/- 17, RESPECTIVELY, IN THE RAS GROUP AND 89 +/- 78 ML, AND 38 +/- 16, RESPECTIVELY, IN THE CLS GROUP. IT WAS CONSIDERED THAT THE DIFFERENCE IN BLOOD LOSS (APPROXIMATELY 20 ML) WAS WITHIN A CLINICALLY ACCEPTABLE RANGE AND RAS RESULTS IN THE RESECTION OF A GREATER NUMBER OF PELVIC LYMPH NODES. THE RATE OF CLAVIEN-DINDO GRADE >/= III COMPLICATIONS WAS 6.3% AND 8.7% IN THE RAS AND CLS GROUPS, RESPECTIVELY. ONE PATIENT IN THE RAS GROUP, COMPARED WITH 4 IN THE CLS GROUP, HAD AN INTRAOPERATIVE VASCULAR COMPLICATIO

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 BILATERAL NIPPLE SPARING MASTECTOMY FOLLOWED BY A NON-ROBOTIC IMMEDIATE BREAST RECONSTRUCTION. IT WAS REPORTED THAT THE PATIENT'S LEFT BREAST SHOWED ERYTHEMA AND SWELLING APPROXIMATE THREE MONTHS LATER, AND EXTENDED TO THE ENTIRE BREAST IN A PATCHY PATTERN. THE PATIENT WAS PLACED ON A TRIPLE IV ANTIBIOTIC REGIMEN AND THE LEFT BREAST ERYTHEMA WAS NOTED TO HAVE IMPROVED. THERE WAS NO MENTION OF MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING 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 HEPATECTOMY SURGICAL PROCEDURE, THE SLEEVE ON THE JOINT CAME OFF A SYNCHROSEAL INSTRUMENT AND FELL INSIDE THE PATIENT. THE SLEEVE JOINT WAS RETRIEVED INTRAOPERATIVELY DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED USING A BACKUP INSTRUMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO FURTHER DETAILS WERE AVAILABLE REGARDING THE REPORTED 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 RADICAL PROSTATECTOMY W/ LYMPHADENECTOMY SURGICAL PROCEDURE, USING AN DA VINCI SINGLE PORT SYSTEM, APPROXIMATELY 10 MINUTES AFTER INITIALIZATION, THE SYSTEM DISPLAYED RECOVERABLE ERROR CODE 307 ON PATIENT SIDE MANIPULATOR (PSM) 2. TROUBLESHOOTING WAS PERFORMED. THE SYSTEM WAS RESTARTED, AND A DISABLED ARM PROMPT WAS DISPLAYED. FURTHER TROUBLESHOOTING THROUGH A HARD SYSTEM POWER CYCLE CLEARED THE SYSTEM PROMPT; HOWEVER, WITHIN 1 MINUTE, THE ERROR APPEARED AGAIN. THE SURGEON ELECTED TO CONVERT TO FROM DA VINCI SINGLE PORT SYSTEM TO THE MULTI-PORTS SYSTEM. THERE WAS NO REPORTED PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM OPERATED NORMALLY AFTER INITIALIZATION.

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 GENERAL SURGICAL PROCEDURE, SP SYSTEM HAD A UNCOVERABLE FAULT ASSOCIATED WITH THIRD INSTRUMENT DRIVE. THE SURGEON DESCRIBED THE EVENT AS THE INSTRUMENT ¿FREEZING¿. THE SURGEON CONVERTED TO DV XI TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS CONVERTED TO ANOTHER DV SYSTEM WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE WAS IDENTIFIED PRIOR TO START OF PROCEDURE. THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING UP AND IT INITIALLY DID POWER ON WITHOUT ERRORS. THE TROUBLESHOOTING WAS NOT COMPLETED, AND IT WAS A NON-RECOVERABLE FAULT THAT REQUIRED A FIELD TECH TO COME OUT. PATIENT WAS ALREADY UNDER ANESTHESIA, SO THE XI SYSTEM WAS BROUGHT IN TO CONTINUE. THE PROCEDURE WAS ROBOTICALLY COMPLETED WITH THE XI SYSTEM. ADDITIONAL PORTS WERE PLACED TO COMPLETE THE PROCEDURE. THE PATIENT DID TOLERATE THE CHANGE AND NO PATIENT INJURY OCCURRED.

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 DURING A MONARCH BRONCHOSCOPY PROCEDURE AN E-STOP ERROR OCCURRED. THE PHYSICIAN WAS UNABLE TO CLEAR THE E-STOP ERROR AND ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT BECAUSE OF THE SYSTEM ISSUES.

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, PHYSICAL DAMAGE WAS OBSERVED ON THE HARMONIC ACE INSTRUMENT. THE INITIAL REPORTER INDICATED THAT THE INSTRUMENT HAD AN "INTERRUPTED TOOTH" AND A FRAGMENT FELL FROM THE INSTRUMENT FELL INSIDE THE PATIENT. THE INITIAL REPORTER ALSO INDICATED THAT THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE WHICH WAS COMPLETED ROBOTICALLY USING A BACKUP HARMONIC ACE INSTRUMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INITIAL REPORT INDICATED THAT NO DEVICE LANDED INSIDE THE PATIENT; HOWEVER, A FRAGMENT WAS REMOVED ENDOSCOPICALLY. THERE WERE NO REPORTED COMPLICATIONS.