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 APPROXIMATELY 25-30 MINUTES INTO A DA VINCI-ASSISTED SIMPLE PROSTATECTOMY PROCEDURE, THE PATIENT EXPERIENCED HEMODYNAMIC INSTABILITY WITH A DROP IN BLOOD PRESSURE AND HYPOXIA. THE CARDIAC ANESTHESIOLOGIST PERFORMED A TRANSESOPHAGEAL ECHOCARDIOGRAM AND A CO2 GAS EMBOLUS WAS OBSERVED IN THE RIGHT VENTRICLE. THE SURGICAL FELLOW REPORTED THAT THE PATIENT WAS IN A TRENDELENBURG POSITION OF APPROXIMATELY 10 DEGREES AND THE 3RD PARTY INSUFFLATION DEVICE PRESSURE WAS SET TO 12 MMHG. THE PROCEDURE WAS ABORTED; THEY WERE AT THE PROSTATE ENUCLEATION STEP WITH APPROXIMATELY ANOTHER 15-20 MINUTES REMAINING IN THE PROCEDURE. THE PATIENT DECOMPENSATED A SECOND TIME IN THE INTENSIVE CARE UNIT AND EXPIRED ABOUT 4-5 HOURS POST-OPERATIVELY. THE PATIENT HAD A HISTORY OF CARDIAC COMORBIDITIES. THE REPORTED CAUSE OF DEATH WAS CO2 EMBOLUS AND MYOCARDIAL INFARCTION. THE FELLOW STATED THAT THE EVENT WAS NOT CAUSED BY ANY DA VINCI PRODUCT; IT WAS A COMBINATION OF THE PRE-EXISTING CARDIAC CONDITION AND ABSORPTION OF CO2 GAS.

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, DISLODGED TIPS AND WHITE LOOSE PART ON SYNCHOSEAL/EAGLE WAS NOTED. 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: WHEN FIRING THE ROBOTIC STAPLING DEVICE IT JAMMED AND LAID DOWN STAPLES, BUT DID NOT CUT THE BOWEL. THE AREA HAD TO BE RESECTED CAUSING SLIGHTLY INCREASED MARGINS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE THAT THE SINGLE PORT (SP) MONOPOLAR CURVED SCISSORS (MCS) TIP COVER CAME OFF WHEN DISSECTING A PEDICLE. THE SP MCS TIP COVER HAD A GAP BETWEEN THE INSTRUMENT TIP AND SHEATH. THE RUBBER REPORTEDLY CAME OFF, BUT THE BLADE SET STAYED ON. THE SURGEON SPENT 15 MINUTES FINDING THE SP TIP COVER. REPORTEDLY WHEN THE SURGEON HAD EXPERIENCED A LOOSE SP MCS TIP COVER, THE INSTRUMENT WAS REPLACED WITH A NEW SP MCS INSTRUMENT AND TIP COVER. 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: A REVIEW OF A LITERATURE ARTICLE CONCERNING A DA VINCI ROBOTIC NIPPLE SPARING MASTECTOMY AND IMMEDIATE BREAST RECONSTRUCTION (RNSMIBR) WITH GEL IMPLANT WAS PERFORMED. THE AIM OF THE STUDY WAS TO ANALYZE THE EFFECT OF THE DA VINCI ROBOT IN NIPPLE-PRESERVING AREOLA-PRESERVING IMMEDIATE PROSTHETIC BREAST RECONSTRUCTION. SURGERIES WERE REVIEWED BETWEEN THE TIME PERIOD OF SEPTEMBER 2022 TO MAY 2024 USING THE DA VINCI SI AND XI SYSTEMS. A TOTAL OF 116 FEMALE PATIENTS WERE INCLUDED. A TOTAL OF 14 PATIENTS UNDERWENT SURGERY USING THE DA VINCI SI SURGICAL SYSTEM AND 102 PATIENTS UNDERWENT SURGERY USING THE DA VINCI XI SURGICAL SYSTEM. THE ARTICLE STATED THERE WERE "TWO CASES OF IMPLANTS LOSS AND FIVE CASES OF HEAT STEAM-INDUCED SKIN DAMAGE." THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS REPORTED, AND NO INDICATION THAT ISI PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENT. IT WAS CONCLUDED THAT THE DA VINCI ROBOTIC NIPPLE-PRESERVING AREOLA IMMEDIATE PROSTHESIS BREAST RECONSTRUCTION SURGERY CAN PROVIDE GOOD COSMETIC RESULTS WITHOUT SERIOUS PERIOPERATIVE COMPLICATIONS. ALSO, RNSMIBR CAN PROVIDE BETTER OVERALL AESTHETIC RESULTS AND PATIENT SATISFACTION, AND MAY DECREASE THE RISK OF NIP

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 LOW ANTERIOR RESECTION PROCEDURE, AN ABDOMINAL SURGICAL WOUND INFECTION WAS IDENTIFIED 22 DAYS POST-OPERATIVELY. THE NURSE OBSERVED REDNESS, SWELLING, HEAT, AND PAIN AROUND THE WOUND. THE RESIDENT PHYSICIAN EXAMINED THE WOUND, REMOVED ONE STITCH, AND EXPRESSED A LARGE AMOUNT OF FOUL-SMELLING PUS. A WOUND CULTURE WAS TAKEN, AND INSTRUCTIONS WERE GIVEN FOR WOUND PACKING AND DRAINAGE CARE EVERY 8 HOURS. BLOOD TESTS WERE SCHEDULED, AND A BLOOD CULTURE WAS PERFORMED. THE NEXT DAY, A DRAINAGE TUBE WAS PLACED IN THE LEFT ABDOMEN TO DRAIN AN ABDOMINAL ABSCESS. ONE WEEK LATER, THE LEFT ABDOMINAL DRAINAGE TUBE (DRAINAGE FLUID <2ML) WAS REMOVED. THE ATTENDING PHYSICIAN EXAMINED THE SUBJECT AND THE ABDOMINAL WOUND, AND IT WAS NOTED THAT THE SUBJECT COULD BE DISCHARGED IN 2-3 DAYS WITH CONTINUED OBSERVATION. ONE WEEK LATER, THE PATIENT WAS IN GOOD SPIRITS AND WITH GOOD ENERGY. THE WOUND IN THE RIGHT ABDOMEN HAD HEALED WITHOUT FURTHER PUS FORMATION, AND THERE WAS NO FEVER, SO DISCHARGE WAS APPROVED FOR THE SAME DAY. THERE IS NO REPORT THAT A DA VINCI DEVICE MALFUNCTIONED OR CAUSED OR CONTRIBUTED 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: A LITERATURE ARTICLE DESCRIBED A RETROSPECTIVE ANALYSIS BETWEEN JANUARY 2021 AND AUGUST 2023 OF 69 PATIENTS THAT UNDERWENT DA VINCI SINGLE PORT (SP) ASSISTED ROBOTIC HYSTERECTOMY WITH CONCOMITANT SACROCOLPOPEXY FOR PELVIC ORGAN PROLAPSE (POP) AT TWO TERTIARY CARE CENTERS, PERFORMED BY FIVE TRAINED SURGEONS. THE STUDY WAS CONDUCTED TO EVALUATE THE SHORT-TERM OUTCOMES OF THE PATIENTS UNDERWENT SP ASSISTED HYSTERECTOMY WITH CONCOMITANT SACROCOLPOPEXY POP. THE PROCEDURES WERE ALL COMPLETED EXCEPT FOR ONE CASE OF CONVERSION TO OPEN SURGERY. THE MEDIAN OPERATIVE TIME WAS 209 MINUTES, MEDIAN ESTIMATED BLOOD LOSS WAS 100ML. ONE PATIENT EXPERIENCED A MAJOR VASCULAR INJURY DURING PRESACRAL DISSECTION AND REQUIRED CONVERSION TO LAPAROTOMY. FIVE POST-OPERATIVE COMPLICATIONS WERE MENTIONED IN THE ARTICLE WHICH INCLUDED TWO CASES OF SMALL BOWEL OBSTRUCTION, ONE OF THEM WAS RESOLVED BY CONSERVATIVE MANAGEMENT, AND ONE REQUIRED SURGICAL MANAGEMENT. A PATIENT EXPERIENCED PELVIC HEMATOMA REQUIRING A BLOOD TRANSFUSION, AND 1 CASE OF VENTRAL HERNIA THAT REQUIRED SUBSEQUENT REPAIR. ONE PATIENT HAD VAGINAL MESH EXPOSURE, AND THE PATIENT ELECTED TO UNDERGO SURGICAL EXCISION. THERE WAS NO MENTION OF ANY D

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 GASTRECTOMY PROCEDURE, WHILE USING THE HARMONIC ACE CURVED SHEARS INSTRUMENT, AN INSTRUMENT BLADE BROKE OFF AND FELL INSIDE THE PATIENT. THE BROKEN BLADE WAS REMOVED WITH AN UNKNOWN FORCEPS INSTRUMENT DURING THE SAME SURGICAL PROCEDURE. IT WAS CONFIRMED THAT THE FALLEN BLADE WAS NOT CHIPPED AFTER REMOVAL. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS. THE PROCEDURE WAS COMPLETED ROBOTICALLY AS PLANNED.

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 AFTER A DA VINCI ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE PERFORMED, THE PATIENT EXPERIENCED BLOODY STOOLS ON THE SAME DAY POST-SURGERY. ON POST-OPERATIVE DAY ONE, A COLONOSCOPY FOUND BLEEDING AT THE ANASTOMOSIS SITE. HEMOSTATIC CLIPS WERE APPLIED, AND THE BLEEDING WAS RESOLVED. THERE WERE NO ABNORMAL BOWEL MOVEMENTS AFTER EATING, AND THE SUBJECT WAS DISCHARGED ON POST-OPERATIVE DAY SEVEN. ON POST-OPERATIVE DAY NINE, THE PATIENT RETURNED TO THE EMERGENCY DEPARTMENT WITH COMPLAINTS OF BLOODY STOOLS, DIZZINESS, AND RESPIRATORY DISCOMFORT. TREATMENT INCLUDED FASTING, ADMINISTRATION OF HEMOSTATIC INJECTIONS, INTRAVENOUS DRIP, AND BLOOD TRANSFUSION. A FEVER WAS IDENTIFIED, AND BLOOD CULTURES WERE DRAWN. A CONSULTATION WITH THE COLORECTAL DEPARTMENT RECOMMENDED CONTINUING THE PREVIOUS TREATMENT AND ARRANGING FOR HOSPITALIZATION. ON POST-OPERATIVE DAY 10, THE PATIENT WAS ADMITTED TO THE WARD AND CONTINUED WITH FASTING, HEMOSTATIC INJECTIONS, ANTIBIOTICS AND A BLOOD TRANSFUSION. ON POST-OPERATIVE DAY 11, THE PATIENT WAS STILL EXPERIENCING BLOODY STOOLS, AND THE PHYSICIAN STATED THERE WAS NO NEED FOR FURTHER SURGERY AT THE MOMENT, AS THE ANASTOMOSIS SITE IS HE

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 RETROSPECTIVE STUDY THAT ASSESSED THE INTRAOPERATIVE AND SURGICAL OUTCOMES OF 200 PATIENTS BY A SINGLE SURGEON THAT UNDERWENT SINGLE PORT ROBOTIC-ASSISTED SACROCOLPOPEXY (SCP) TO TREAT PELVIC ORGAN PROLAPSE FROM APRIL 2020 TO AUGUST 2023 IN ONE INSTITUTION. ALL PROCEDURES WERE COMPLETED WITHOUT CONVERSIONS TO LAPAROSCOPY OR LAPAROTOMY. INTRAOPERATIVE COMPLICATIONS WERE NOTED AS FIVE INTRAOPERATIVE CYSTOTOMIES; TWO OF THEM OCCURRED DURING THE DISSECTION OF THE VESICOVAGINAL SPACE, AND ALL OF THEM WERE REPAIRED SUCCESSFULLY. THERE WERE 2 CASES OF BOWEL INJURIES, 4 VAGINAL WALL TEAR, AND 1 SACRAL VESSEL INJURY THAT WERE REPAIRED INTRA-OPERATIVELY. POST-OPERATIVELY, FOUR PATIENTS WERE FOUND WITH UMBILICAL WOUND HERNIAS WITH ONE ELECTING SURGICAL REPAIR. A PATIENT WAS FOUND WITH MESH EXPOSURE AND WAS MANAGED CONSERVATIVELY WITH TOPICAL ESTROGEN. THERE WAS NO DA VINCI DEVICE MALFUNCTIONS OR ISSUES MENTIONED IN THE ARTICLE. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION FROM THE DESIGNATED AUTHOR WERE MADE, 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: 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 TIP FRACTURED. THE USER COMPLETED THE PROCEDURE ROBOTICALLY WITH USING A BACKUP HARMONIC ACE INSTRUMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO DAMAGE OBSERVED. THERE WAS NO INSTRUMENT COLLISION. A FRAGMENT FELL INSIDE OF 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 LITERATURE DESCRIBED A STUDY AIMED TO EVALUATE SEXUAL AND REPRODUCTIVE OUTCOMES OF 22 PATIENTS FOLLOWING POST-CHEMOTHERAPY ROBOT-ASSISTED RETROPERITONEAL UNILATERAL LYMPH NODE DISSECTION (PC-RRPLND) FOR NON-SEMINOMATOUS GERM CELL TUMORS (NSGCTS) AT A HIGH-VOLUME CANCER CENTER. AMONG THE PATIENTS INCLUDED IN THE STUDY, AN INTRAOPERATIVE COMPLICATION (VENA CAVA INJURY) WAS RECORDED, WITHOUT NEEDING PERIOPERATIVE BLOOD TRANSFUSION. NONE OF THE PATIENTS EXPERIENCED LATE POST-OPERATIVE COMPLICATIONS. RETROGRADE EJACULATION IS CONFIRMED TO BE ONE OF THE MOST COMMON COMPLICATIONS OF PC-RRPLND. THERE WERE NO DA VINCI DEVICE ISSUES REPORTED IN THE ARTICLE. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION FROM THE DESIGNATED AUTHOR WERE MADE, 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: 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 PROCEDURE USING A HARMONIC ACE INSTRUMENT, THE BLADE BROKE, RESULTING IN POOR CUTTING AND A FRAGMENT FALLING INSIDE THE PATIENT. THE SURGEON WAS CUTTING THE LIVER PARENCHYMA WHEN A PIECE OF THE INSTRUMENT'S BLADE BROKE OFF INSIDE THE PATIENT. THE BLADE PIECE WAS RETRIEVED WITH A LAPAROSCOPIC FORCEPS. THE PROCEDURE WAS CONTINUED WITH A BACKUP HARMONIC ACE INSTRUMENT. THE STAFF CONFIRMED ALL PIECES WERE RETRIEVED BY CHECKING THE FRAGMENT OF THE DAMAGED BLADE AND ALIGNING IT WITH THE HARMONIC ACE INSTRUMENT BODY. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO REPORT OF INJURY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SUBTOTAL GASTRECTOMY SURGICAL PROCEDURE, THE HARMONIC ACE BLADE FRACTURED. IT WAS CONFIRMED THAT THE FRACTURED PART WAS COMPLETELY REMOVED, AND NO FRAGMENT REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED USING A BACKUP HARMONIC ACE INSTRUMENT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE ENERGY CABLE WAS UNABLE TO TRANSMIT ENERGY. THE USER CONVERTED TO OPEN SURGERY WITH A PROCEDURE DELAY GREATER THAN 30 MINUTES. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

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

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

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY THAT WAS INSTALLED ON AN MCS INSTRUMENT, FELL INSIDE THE PATIENT'S PELVIS. THE MCS TIP COVER ACCESSORY WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE WHICH WAS COMPLETED ROBOTICALLY AND THE CUSTOMER CONFIRMED ALL PIECES WERE RETRIEVED BY A VISUAL INSPECTION. THE MCS INSTRUMENT AND MCS TIP COVER ACCESSORY WILL NOT BE RETURNED FOR FAILURE ANALYSIS EVALUATION. 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: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

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

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A LITERATURE ARTICLE DESCRIBED A STUDY THAT AIMED TO ANALYZE THE OUTCOMES OF 29 PATIENTS THAT UNDERWENT ROBOTIC-ASSISTED REVISIONAL ROUX-EN-Y GASTRIC BYPASS (RRYGB) SURGERIES FROM JANUARY 2016 TO FEBRUARY 2023 IN ONE SINGLE INSTITUTION. THE ARTICLE NOTED THAT AMONG THESE SURGERIES, ONE PATIENT EXPERIENCED A POST-OPERATIVE COMPLICATION OF JEJUNOJEJUNAL STENOSIS AND WAS RESOLVED BY REDOING THE JEJUNO-JEJUNAL ANASTOMOSIS LAPAROSCOPICALLY. THERE WERE NO POSTOPERATIVE ANASTOMOTIC LEAKS OR INCIDENCE OF HEMORRHAGE. THERE WERE NO DA VINCI DEVICE ISSUES REPORTED IN THE ARTICLE NOR ANY MORTALITY IN THE COHORT. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A LITERATURE ARTICLE DESCRIBED AN OBSERVATIONAL COHORT STUDY WHICH WAS TO ASSESS THE IMPACT OF A PROFICIENCY-BASED PROGRESSION TRAINING CURRICULUM ON PERI-OPERATIVE AND SURVIVAL OUTCOMES FOR ENDOMETRIAL CANCER. THE STUDY OCCURRED FROM 2015 TO 2022 AND INCLUDED 594 WOMEN DIAGNOSED WITH PRIMARY ENDOMETRIAL CANCER TREATED WITH ROBOT-ASSISTED LAPAROSCOPIC SURGERY, WHICH TYPICALLY INVOLVED HYSTERECTOMY AND SALPINGO-OOPHORECTOMY ALONG WITH SOME FORM OF PELVIC LYMPH NODE DISSECTION. THE ARTICLE STATED MANY INTRAOPERATIVE COMPLICATIONS, WHICH WERE SLIGHTLY LOWER IN THE NON-TRAINING GROUP AT 4.8% COMPARED TO 7.7% IN THE TRAINING GROUP. GRADES 3A AND 3B COMPLICATIONS OCCURRED AT SIMILAR LOW FREQUENCIES ACROSS BOTH GROUPS, WHILE GRADE 4A COMPLICATIONS WERE EQUALLY RARE AT 0.7% IN BOTH GROUPS. READMISSION RATES WITHIN 30 DAYS WERE LOWER IN THE TRAINING GROUP (3.8%) COMPARED TO THE NON-TRAINING GROUP (6.0%). RETURNS TO THE THEATER WERE INFREQUENT IN BOTH GROUPS, OCCURRING AT 1.0% IN THE TRAINING GROUP AND 1.7% IN THE NON-TRAINING GROUP. LYMPHOEDEMA RATES WERE ALSO COMPARABLE, NOTED AT 8.4% IN THE TRAINING GROUP VERSUS 11.3% IN THE NON-TRAINING GROUP. THERE WERE NO DA VINCI DEVICE ISSUES MENTION

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 PROSTATECTOMY SURGICAL PROCEDURE, THE PATIENT DEVELOPED A PULMONARY EMBOLISM (PE) ALONG WITH RIGHT VENTRICULAR STRAIN ON POSTOPERATIVE DAY ONE AND WAS IN CRITICAL CONDITION. THE PATIENT'S CURRENT STATUS IS UNKNOWN. THE INITIAL PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO REPORTED INTRAOPERATIVE COMPLICATIONS OR MALFUNCTION OF THE DA VINCI SYSTEM. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, AS OF THE DATE OF THIS REPORT, NO FURTHER DETAILS HAVE 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: A RETROSPECTIVE, COHORT STUDY WHICH DESCRIBED A COMPARISON BETWEEN ROBOTIC SINGLE-SITE (RSS) AND MULTIPORT LAPAROSCOPIC (MPL) SURGERY, WAS SUMMARIZED IN A LITERATURE ARTICLE. THE AIM OF THE STUDY WAS TO COMPARE RSS SURGERY TO MULTIPORT LAPAROSCOPIC SURGERY IN TERMS OF SURGICAL OUTCOMES AND OVERALL SURVIVAL FOR PATIENTS WITH EARLY ENDOMETRIAL CANCER. THE STUDY OCCURRED FROM MARCH 2014 TO DECEMBER 2022 AND INCLUDED A TOTAL OF 421 PATIENTS OF WHICH 146 UNDERWENT RSS SURGERY WITH A MEDIAN AGE OF APPROXIMATELY 51.95 YEARS AND A MEDIAN BMI OF 24.82. ALL PATIENTS WERE FEMALE AS THE STUDY INVOLVED ENDOMETRIAL CANCER PATIENTS. THE ARTICLE NOTED THAT DURING THESE SURGERIES, PERIOPERATIVE COMPLICATIONS OCCURRED INCLUDING: ONE CASE OF AN INCISIONAL HERNIA, ONE CASE OF LYMPHOCELE, ONE CASE OF RECTUM TEAR, ONE OCCURRENCE OF VAGINAL CUFF BLEEDING, ONE CASE OF VAGINAL CUFF DISRUPTION, AND ONE CASE OF VAGINAL CUFF INFECTION. THERE WERE NO REPORTS OF ANY DA VINCI DEVICE MALFUNCTIONS NOR WERE THERE ANY ALLEGATIONS THAT ANY INTUITIVE SURGICAL, INC. (ISI) PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENT. ADDITIONAL INFORMATION WAS REQUESTED FROM THE DESIGNATED AUTHOR; HOWEVER, NO RESPONSE WAS RECEIV

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 CHEST ANASTOMOSIS ESOPHAGECTOMY TRANSTHORACIC SURGICAL PROCEDURE THAT THE TIP OF THE HARMONIC ACE INSTRUMENT WAS FOUND TO BE LOOSE. REPORTEDLY A FRAGMENT FELL INTO THE PATIENT BUT WAS RETRIEVED DURING THE PROCEDURE. THE PROCEDURE WAS ABLE TO BE 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 LYMPHADENECTOMY PROCEDURE, A SMALL PIECE OF THE UNIVERSAL CANNULA SEAL BROKE OFF INTO THE PATIENT. THE CUSTOMER WAS ABLE TO SUCCESSFULLY RETRIEVE THE PIECE DURING THE SAME SURGICAL PROCEDURE WHICH WAS COMPLETED AS PLANNED.

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 THAT EVALUATED THE PREOPERATIVE FINDINGS AND SURGICAL RESULTS OF THYMIC CYSTS SURGICALLY TREATED WITH ROBOTIC APPROACH WAS REVIEWED. THE STUDY INCLUDED 57 PATIENTS THAT UNDERWENT ROBOTIC SURGERY FOR THYMIC CYSTS IN THREE ITALIAN THORACIC SURGERY CENTERS BETWEEN MARCH 2014 AND APRIL 2022. SURGICAL PROCEDURES WERE ROBOTIC APPROACH IN ALL CASE INCLUDING 35 TOTAL/EXTENDED THYMECTOMY AND 22 CYST RESECTION/PARTIAL THYMECTOMY 22. IN ALL CASES, THE CYSTS WERE COMPLETELY REMOVED USING THE ROBOTIC APPROACH, WITH NO INSTANCES REQUIRING CONVERSION TO THORACOTOMY OR STERNOTOMY, AND NO INTRAOPERATIVE COMPLICATIONS WERE OBSERVED. THREE POSTOPERATIVE COMPLICATIONS WERE MENTIONED IN THE ARTICLE. ONE CASE REQUIRED REOPERATION FOR THORACIC DUCT CLOSURE DUE TO CHYLOTHORAX, ANOTHER CASE OF POSTOPERATIVE ANEMIA WAS MANAGED CONSERVATIVELY THROUGH BLOOD TRANSFUSION, AND A THIRD CASE OF POSTOPERATIVE RESPIRATORY FAILURE WAS EFFECTIVELY TREATED WITH NON-INVASIVE VENTILATION. THERE WERE NO POSTOPERATIVE MORTALITIES OBSERVED. THERE WERE NO DA VINCI DEVICE ISSUES REPORTED IN THE ARTICLE. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION FROM THE DESIGNATED AUTHOR WERE MADE, BUT NO RESPONSE HAS

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

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PANCREATODUODENECTOMY SURGICAL PROCEDURE, ONE BRANCH BROKE ON THE HARMONIC ACE INSTRUMENT. 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 LIVER RESECTION SURGICAL PROCEDURE, THE HARMONIC ACE SHEATH BROKE, PREVENTING THE DEVICE USE DUE TO AN UNRECOVERABLE ERROR ON THE SYSTEM. DURING THE USE OF THE FIRST HARMONIC ACE INSTRUMENT, THE BURN AND BREAK OF ONE OF THE BRANCHES OF THE INSTRUMENT RESULTED IN A FRAGMENT FALLING INTO THE PATIENT'S ABDOMEN. THE FRAGMENT WAS PROMPTLY RETRIEVED THE CUSTOMER USED A SECOND HARMONIC ACE INSTRUMENT, AND THE COVER SHEATH BROKE, AGAIN PREVENTING THE DEVICE FROM USE AND AN UNRECOVERABLE ERROR ON THE SYSTEM WAS DISPLAYED. THERE IS NO FURTHER INFORMATION 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: A LITERATURE ARTICLE DESCRIBED A RETROSPECTIVE STUDY TO EVALUATE THE METHODOLOGIES AND SURGICAL OUTCOMES OF ROBOTIC SINGLE-SITE PLUS ONE-PORT MYOMECTOMY (RSOM) WITH ROBOTIC SINGLE-SITE PLUS ONE-PORT MYOMECTOMY (RSOM). 230 PATIENTS WHO HAD UNDERGONE RSOM AND 146 PATIENTS WHO HAD UNDERGONE RSTM BETWEEN SEPTEMBER 2020 AND SEPTEMBER 2021 AT A SINGLE INSTITUTION WERE REVIEWED, ALL WERE USING DA VINCI-X OR XI ROBOTIC SYSTEM. IN THE RSTM GROUP, THE POSTOPERATIVE COMPLICATIONS INCLUDED ONE CASE OF WOUND DEHISCENCE THAT THE LEFT SIDE TROCAR INCISION WAS REOPENED, AND RE-SUTURING WAS PERFORMED.; IN THE RSOM GROUP, THERE WAS ONE CASE OF REOPERATION REQUIRED REOPERATION ON POSTOPERATIVE DAY 1. IT WAS PROVIDED THAT AN EMERGENT LAPAROSCOPIC REOPERATION WAS PERFORMED DUE TO HEMOPERITONEUM RESULTING FROM BLEEDING AT THE UMBILICAL INCISION SITE. SUCTION AND IRRIGATION, HEMOSTASIS OF INCISION SITE, AND TRANSFUSION WERE PERFORMED, AND THE PATIENT RECOVERED WELL. ANOTHER PATIENT IN THE RSOM EXPERIENCED AN APPROXIMATELY 4-CM UMBILICAL HERNIA 4 MONTHS POST PROCEDURE, AND HERNIORRHAPHY WAS PERFORMED WITHOUT ANY COMPLICATION. NO CASE OF CONVERSION TO LAPAROTOMY OR ADDITIONAL TROCAR INSERTION WAS FOUND IN

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SINGLE PORT EXTRAPERITONEAL RADICAL PROSTATECTOMY PROCEDURE, A PATIENT DEVELOPED A SUBCUTANEOUS EMPHYSEMA. THE SURGEON USED AN AIRSEAL AT A PRESSURE OF 10, AND HE INCREASED THE PRESSURE TO 14 AT TIMES DURING THE PROCEDURE. THE PATIENT REPORTEDLY FELT FINE; HOWEVER, THEY WERE KEPT ONE NIGHT IN THE CRITICAL CARE UNIT (CCU). INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE FOR ADDITIONAL INFORMATION; HOWEVER, AT THE TIME OF THIS REPORT, NO FURTHER DETAILS HAVE BEEN PROVIDED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED THYROIDECTOMY PROCEDURE, THE CUSTOMER OBSERVED THAT THE TIP OF THE HARMONIC ACE INSTRUMENT WAS BROKEN OFF. A FRAGMENT FELL INSIDE THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. THE INSTRUMENT WAS REMOVED AND REPLACED WITH A BACKUP. THE USER CONTINUED AND COMPLETED THE PROCEDURE ROBOTICALLY WITHOUT FURTHER 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: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A LITERATURE ARTICLE DESCRIBED A RETROSPECTIVE ANALYSIS OF PATIENTS WHO UNDERWENT TUMESCENT-FREE ROBOTIC NIPPLE SPARING MASTECTOMY (NSM) BETWEEN OCTOBER 2020 AND MARCH 2023 AT ONE SINGLE INSTITUTION. THE ARTICLE NOTED THAT AMONG 118 PATIENTS, THAT UNDERWENT ROBOTIC NSM, THIRTY-ONE PATIENTS EXPERIENCED AN ADVERSE EVENT, WITH 8 PATIENTS EXPERIENCING GRADE II OR HIGHER ADVERSE EVENTS, WHICH REQUIRED MORE THAN THE USUAL SYMPTOMATIC CARE. TWO PATIENTS HAD A HEMATOMA AT THE BREAST SURGERY SITE; ONE OF THESE PATIENTS RECEIVED BLEEDING CONTROL IN THE OPERATING ROOM UNDER GENERAL ANESTHESIA, AND THE OTHER PATIENT IMPROVED AFTER A BLOOD TRANSFUSION. TWO PATIENTS HAD NIPPLE-AREOLAR COMPLEX (NAC) NECROSIS, AND BOTH HAD TO UNDERGO NAC REMOVAL. ONE PATIENT HAD SKIN NECROSIS AND UNDERWENT DEBRIDEMENT UNDER LOCAL ANESTHESIA IN THE OPERATING ROOM. TWO PATIENTS EXPERIENCED INFECTION; 1 WAS LOCATED IN THE NAC AND THE OTHER IN THE AXILLA, BOTH OF WHICH IMPROVED AFTER ANTIBIOTIC TREATMENT. THERE WAS NO DA VINCI DEVICE MALFUNCTION MENTIONED IN THE ARTICLE. THE DESIGNATED AUTHOR WAS CONTACTED AND CONFIRMED THAT THERE WAS NO DEVICE MALFUNCTION OCCURRED IN ANY OF THE PROCEDURES, AND THE COMPLICATIONS WERE

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 DOCKING FOR A DA VINCI ASSISTED SURGICAL PROCEDURE, THE PATIENT EXPERIENCED A BURN AROUND THE CAMERA PORT SITE. THE NURSE CALLED A TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT THAT THE SURGEON WAS USING A CAMERA IN AN XI CANNULA AND A THIRD-PARTY NONMETAL CANNULA WHEN THE BURN OCCURRED. THE TSE INFORMED THE NURSE THAT CAPACITIVE COUPLING MAY HAVE BEEN THE CAUSE OF THE BURN. INFORMATION REGARDING WHAT TASK WAS BEING PERFORMED WHEN THE EVENT OCCURRED, IF ANY MEDICAL INTERVENTIONS WERE PERFORMED, HOW THE ISSUE WAS RESOLVED, OR THE PATIENT'S STATUS ARE ALL UNKNOWN. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, AS OF THE DATE OF THIS REPORT, NO FURTHER DETAILS HAVE BEEN RECEIVED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE, THE ERBE GENERATOR HAD AN ERROR M-02 ISSUE. PRIOR TO CONTACTING AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOR ASSISTANCE, THE CALLER POWER CYCLED THE ERBE GENERATOR WHICH DID NOT SOLVE THE PROBLEM. THE TSE ASKED THE CALLER TO DISCONNECT THE INSTRUMENT ACTIVATION CABLES, REMOVE THE POWER PLUG FROM THE ERBE GENERATOR, AND PUSH THE POWER BUTTON AT THE FRONT. AFTER RESTORING THE POWER AND WITHOUT INSTRUMENTS CONNECTED, THE ERROR CAME BACK IMMEDIATELY. THE TSE ASKED THE CALLER IF THEY COULD USE THE VISION SIDE CART (VSC) FROM THE XI SYSTEM OR IF THEY HAD A FORCETRIAD GENERATOR. THE CALLER STATED THE XI SYSTEM WAS IN USE AND THEY DID NOT HAVE A FORCETRIAD GENERATOR. THE SURGEON DECIDED TO ABORT THE PLANNED PROCEDURE AFTER PORTS HAD ALREADY BEEN PLACED ON 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 ESOPHAGECTOMY SURGICAL PROCEDURE, THE SYNCHROSEAL SHEATHING TORE AND A SMALL SCREW FELL INTO THE PATIENT. THE SCREW WAS RETRIEVED SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE FOLLOWED UP AND OBTAINED ADDITIONAL INFORMATION. THE PATIENT WAS NOT HARMED. THE INSTRUMENT HAS BEEN CHECKED BEFORE USE. NO DEFECTS NOR DAMAGE WERE FOUND. PREPARATION WAS CARRIED OUT. THE INSTRUMENT HAD BEEN IN USE FOR SEVERAL HOURS. NO PROBLEMS WITH FUNCTIONALITY WERE DETECTED DURING THE PROCEDURE. THERE WAS NO COLLISION. THE INSTRUMENT WAS REMOVED SEVERAL TIMES DURING THE PROCEDURE. THE WRIST WAS STRAIGHTENED EACH TIME. NO RESISTANCE WAS FELT DURING REMOVAL. THERE WAS NO CANNULA DAMAGE. THE FOREIGN OBJECT COULD BE REMOVED DURING THE PROCEDURE SO THAT THE PATIENT DID NOT HAVE TO BE READMITTED.

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

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A PATIENT, WHO WAS ENROLLED IN A STUDY, UNDERWENT A DA VINCI-ASSISTED LOW ANTERIOR RESECTION (LAR) PROCEDURE. APPROXIMATELY THREE MONTHS LATER, THE PATIENT RETURNED TO THE HOSPITAL FOR A PLANNED ILEOSTOMY TAKEDOWN SURGICAL PROCEDURE AND WAS DISCHARGED ON POST-OPERATIVE DAY #4. ON POST-OPERATIVE DAY #11, DURING A FOLLOW-UP VISIT, THE PATIENT COMPLAINED OF UPPER ABDOMINAL PAIN WITH TENDERNESS UPON PALPATION. IT IS UNKNOWN IF THE PATIENT WAS ABLE TO PASS STOOL. A KUB X-RAY SHOWED INTESTINAL GAS. GASTRIC MEDICATION WAS PRESCRIBED AND SCHEDULED A FOLLOW-UP IN A WEEK. DUE TO PERSISTENT ABDOMINAL PAIN AND COLD SWEATS, THE PATIENT VISITED THE EMERGENCY ROOM IN THE SAME EVENING. THE ABDOMEN WAS SOFT BUT PAINFUL UPON PRESSURE. BLOOD TESTS SHOWED ELEVATED WBC AND CRP, AND LOW POTASSIUM. KUB AND ABDOMINAL CT SCANS INDICATED GAS AND FLUID IN THE UPPER ABDOMEN, SUGGESTING A MINOR ANASTOMOTIC LEAK. THE RECTAL DEPARTMENT WAS CONSULTED AND RECOMMENDED FASTING, IV FLUIDS, ANTIBIOTICS, MONITORING VITAL SIGNS, AND HOSPITAL ADMISSION. THE NEXT DAY, THE PATIENT WAS ADMITTED TO THE HOSPITAL, RECEIVING ANTIBIOTICS AND NUTRITIONAL IV, AND FASTING. ON POST-OPERATIVE DAYS #13 THROUGH #17, THE PATIENT REPORTE

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 HARMONIC ACE INSTRUMENT SHEARS FRACTURED. NO FRAGMENTS FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A BACKUP INSTRUMENT, WITH NO REPORTS OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE FOLLOWING ADDITIONAL INFORMATION VIA FOLLOW UP: THE SHEAR OF THE HARMONIC ACE INSTRUMENT WAS BROKEN. THE INSTRUMENT WAS INSPECTED PRIOR TO USE. A LEFT HEMICOLECTOMY PROCEDURE WAS BEING PERFORMED WHEN THE ISSUE OCCURRED. THERE WERE NO INSTRUMENT COLLISIONS DURING THE PROCEDURE. A FRAGMENT DID FALL INSIDE OF THE PATIENT; IT WAS RETRIEVED DURING THE SAME PROCEDURE. THE INSTRUMENT IS AVAILABLE FOR RETURN. THE REPORTED FRAGMENT IS NOT AVAILABLE FOR RETURN.

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 THAT ASSESSED THE EFFECTIVENESS AND SAFETY OF ROBOTIC SECTIONECTOMY (RS) VERSUS ROBOTIC (EXTENDED) HEMIHEPATECTOMY (RH) FOR THE TREATMENT OF LIVER TUMORS WAS REVIEWED. THE STUDY INCLUDED 30 PATIENTS BETWEEN MARCH 2021 AND JULY 2023 THAT UNDERWENT HEPATECTOMIES IN ONE SINGLE INSTITUTION. A TOTAL OF 16 PATIENTS UNDERWENT RS, AND 14 PATIENTS UNDERWENT RH. AMONG THE 30 PATIENTS, ONE PATIENT IN EACH STUDY GROUP WAS CONVERTED TO OPEN HEPATECTOMY DUE TO ONCOLOGICAL SAFETY (ONE PATIENT WITH A BISMUTH TYPE IIIB PERIHILAR CHOLANGIOCARCINOMA WHO WAS ADMITTED FOR LEFT HEPATECTOMY BUT UNDERWENT EXTENDED LEFT HEPATECTOMY) AND DUE TO MULTIPLE ADHESIONS (ONE PATIENT WITH RECURRENT COLORECTAL LIVER METASTASES AFTER NON-ANATOMIC SEGMENT II RESECTION WHO WERE ADMITTED FOR LEFT LATERAL SECTIONECTOMY). THERE WAS NO INTRAOPERATIVE COMPLICATIONS MENTIONED IN THE ARTICLE. POST-OPERATIVELY, A TRANSIENT POSTHEPATECTOMY LIVER FAILURE, WHICH WAS ASSESSED AS INTERNATIONAL STUDY GROUP OF LIVER SURGERY(ISGLS) GRADE A, WAS REPORTED IN ONE PATIENT AFTER AN EXTENDED RIGHT HEPATECTOMY. POSTHEPATECTOMY BILE LEAKS (ISGLS GRADE B) WERE OBSERVED IN ONE PATIENT IN THE RH GROUP AND THREE PATIENTS IN THE

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 TRANSTHORACIC ESOPHAGECTOMY WITH NECK ANASTOMOSIS PROCEDURE, THE TIP OF THE HARMONIC ACE INSTRUMENT WAS FOUND TO BE BROKEN. AN UNSPECIFIED RADIOLOGICAL TEST WAS PERFORMED TO CHECK THE PATIENT AND NO FOREIGN BODY WAS FOUND. THE PROCEDURE WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED NIPPLE SPARING MASTECTOMY, A SEROMA WAS NOTED ON THE RIGHT ON POST-OPERATIVE DAY 34. AN ASPIRATION CULTURE OF THE SEROMA INDICATED A SERRATIA BACTERIAL INFECTION WHICH WAS TREATED WITH ORAL ANTIBIOTICS. NO OTHER MEDICAL INTERVENTION WAS REQUIRED, AND THE SEROMA WAS NOT YET RESOLVED. THERE WAS NO REPORT OF DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY MALFUNCTIONED 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: A LITERATURE ARTICLE DESCRIBED A RETROSPECTIVE STUDY TO COMPARE THE OUTCOMES OF 96 PATIENTS UNDERGOING ROBOTIC-ASSISTED RADICAL CYSTECTOMY (RARC) WITH URINARY DIVERSION FOR BLADDER CANCER. THE STUDY AIMED TO EVALUATE THE POSTOPERATIVE OUTCOMES AND ANALGESIC REQUIREMENTS OF SINGLE-PORT (SP) VS MULTIPORT ROBOTIC-ASSISTED RADICAL CYSTECTOMY (MP RARC). IN THE SP COHORT, THERE WERE SEVEN CLAVIEN IV COMPLICATIONS (TWO CARDIAC ARRHYTHMIAS AND SHOCK, THREE SEPTIC SHOCKS, ONE RESPIRATORY FAILURE, AND ONE BOWEL PERFORATION), AND FOUR CLAVIEN III COMPLICATIONS (ONE INCISIONAL HERNIA REPAIR, ONE GASTRIC TUBE PLACEMENT FOR CANCER RECURRENCE, ONE HYDRONEPHROSIS WITH ASSOCIATED ACUTE KIDNEY INJURY REQUIRING A NEPHROSTOMY TUBE, AND ONE INTRAABDOMINAL ABSCESS REQUIRING DRAIN PLACEMENT) WERE NOTED. THE STUDY CONCLUDED THAT THE SP ROBOTIC PLATFORM OFFERS A SAFE ALTERNATIVE TO THE MP ROBOTIC PLATFORM IN PERFORMING RARC WITH URINARY DIVERSION. NO CLINICALLY SIGNIFICANT DIFFERENCE WAS DEMONSTRATED IN PERIOPERATIVE OR ONCOLOGIC OUTCOMES. THERE WERE NO DA VINCI DEVICE MALFUNCTIONS REPORTED, NOR DID THE AUTHORS ALLEGE THAT ANY INTUITIVE PRODUCTS CAUSED OR CONTRIBUTED TO THE INJURIES. THE DESIGNATED AUTHOR

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PANCREATODUODENECTOMY SURGICAL PROCEDURE, THE PAD ON THE HARMONIC ACE INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT. IT WAS CONFIRMED THAT THE PAD WAS COMPLETELY REMOVED USING A LAPAROSCOPIC INSTRUMENT AND NO FRAGMENT REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED ROBOTICALLY.