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

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

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE THAT A NON-RECOVERABLE FAULT OCCURRED. THE CUSTOMER POWER-CYCLED THE SYSTEM MULTIPLE TIMES; HOWEVER, THE ERROR RETURNED. THE CUSTOMER UNDOCKED AND POWER CYCLED THE SYSTEM AGAIN. THE ERROR RETURNED. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ASKED THE CALLER TO HARD POWER CYCLE THE SYSTEM AND PERFORM AN EMERGENCY POWER OFF (EPO) OF THE PATIENT SIDE CART (PSC). THE SYSTEM POWERED UP AND AN ERROR AGAINST PATIENT SIDE MANIPULATOR (PSM) #2 WAS PRESENT. THE TSE HAD THE CALLER PERFORM A HARD POWER CYCLE AND PERFORM AN EPO AGAIN, KEEPING THE SYSTEM OFF LONGER. THE ERROR(S) RETURNED. THE TSE ADVISED TO CONTINUE TO PERFORM HARD CYCLES TO SEE IF THE ERROR WOULD CLEAR, AND ALSO ADVISED THAT THE ERRORS COULD RETURN. THE PROCEDURE WAS ULTIMATELY ABORTED AFTER ANESTHESIA HAD BEEN ADMINISTERED TO THE PATIENT AND PORTS HAD BEEN PLACED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: Intraoperative complications consisted of five vaginal injuries and one small bowel serosa injury requiring simple suturing. Vaginal injuries occurred in three patients in the FR group and two in the SR group (P = 0.7) and were closed in two layers; the mesh was trimmed to avoid the repaired site. The FR group had one grade 3 complication, a small bowel obstruction caused by an adhesion and released by laparotomy.The author responded and reported that there were no complications mentioned in the article that were caused/contributed by an Intuitive product and no da Vinci device malfunctions.

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 IN THE MATERNITY OPERATING ROOM, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY SLIPPED AND ENDED UP IN THE PATIENT'S INTRAPERITONEAL CAVITY, WHICH THE SURGEON SUBSEQUENTLY REMOVED. THE MCS AND SHEATH WERE REPLACED, BUT THE SECOND MCS TIP COVER ACCESSORY ALSO SLIPPED FROM THE SECOND PAIR, AND IT WAS OBSERVED BY SEVERAL PEOPLE IN THE OPERATING ROOM. UPON VERIFICATION, IT WAS FOUND THAT BOTH SHEATHS HAD THE SAME LOT NUMBER. THE MCS INSTRUMENT DID NOT EXPERIENCE ANY ISSUES DURING USE. THE INCIDENT RESULTED IN PROLONGED SURGERY AND INCREASED STRESS FOR THE SURGEON. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT AND TIP COVER WERE INSPECTED BEFORE USE, AND THERE WAS NOTHING UNUSUAL NOTED. THE TIP COVER FELL DURING DISSECTION. IT WAS RETRIEVED USING GRASPING FORCEPS AND IT WAS REMOVED THROUGH THE CANNULA WITHOUT DIFFICULTY. THERE WAS NO COLLISION. THE MCS INSTRUMENT DID NOT EXPERIENCE ANY FUNCTIONALITY ISSUES. THE TIP COVER APPEARED TO BE PROPERLY INSTALLED; A FOUR EYES CHECK HAD BEEN PERFORMED TO VERIFY PROPER INSTALLATION. THE ORANGE SURFACE WAS NOT VISIBLE, AND THE TIP

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 HYSTERECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY CAME OFF THE MCS INSTRUMENT INTRAOPERATIVELY. DURING THE EXCHANGE BETWEEN 2 INSTRUMENTS ON ARM #3, THE CUSTOMER NOTICED THAT THE MCS TIP COVER ACCESSORY WAS MISSING FROM THE MCS INSTRUMENT. THE CUSTOMER FOUND THE MCS TIP COVER ACCESSORY STUCK IN THE PERITONEAL WALL. LONGER ANESTHESIA TIME AND WIDENING OF THE INCISION WERE REQUIRED TO FIND/REMOVE THE MCS TIP COVER ACCESSORY.

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 Robot-assisted Partial Nephrectomy (RAPN) surgery, the patient experienced an accidental massive hemorrhage and hypotension due to sudden iatrogenic rupture of the IVC. The procedure was converted to open nephrectomy. The patient was transferred to the Intensive Care Unit on Synchronized Intermittent Mandatory Ventilation (SIMV) ventilator mode.The patient remained hemodynamically stable and was extubated and subsequently discharged from the hospital on postoperative day 7.Intuitive Surgical Inc. (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: IT WAS REPORTED THAT IN THE MATERNITY OPERATING ROOM, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY SLIPPED AND ENDED UP IN THE PATIENT'S INTRAPERITONEAL CAVITY, WHICH THE SURGEON SUBSEQUENTLY REMOVED. THE MCS AND SHEATH WERE REPLACED, BUT THE SECOND MCS TIP COVER ACCESSORY ALSO SLIPPED FROM THE SECOND PAIR, AND IT WAS OBSERVED BY SEVERAL PEOPLE IN THE OPERATING ROOM. UPON VERIFICATION, IT WAS FOUND THAT BOTH SHEATHS HAD THE SAME LOT NUMBER. THE MCS INSTRUMENT DID NOT EXPERIENCE ANY ISSUES DURING USE. THE INCIDENT RESULTED IN PROLONGED SURGERY AND INCREASED STRESS FOR THE SURGEON. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT AND TIP COVER WERE INSPECTED BEFORE USE, AND THERE WAS NOTHING UNUSUAL NOTED. THE TIP COVER FELL DURING DISSECTION. IT WAS RETRIEVED USING GRASPING FORCEPS AND IT WAS REMOVED THROUGH THE CANNULA WITHOUT DIFFICULTY. THERE WAS NO COLLISION. THE MCS INSTRUMENT DID NOT EXPERIENCE ANY FUNCTIONALITY ISSUES. THE TIP COVER APPEARED TO BE PROPERLY INSTALLED; A FOUR EYES CHECK HAD BEEN PERFORMED TO VERIFY PROPER INSTALLATION. THE ORANGE SURFACE WAS NOT VISIBLE, AND THE TIP

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 REPORTED THE FOLLOWING ADVERSE EVENT. ONE PATIENT DEVELOPED A TRACHEAL MICRO-PERFORATION AT BERRY¿S LIGAMENT A WEEK AFTER SURGERY, WHICH WAS SUCCESSFULLY MANAGED WITH COMPRESSION DRESSING AND CONSERVATIVE TREATMENT, ACHIEVING TRACHEAL HEALING WITHOUT INFECTION.

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

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT PRIOR TO THE START - POST ANESTHESIA DA VINCI-ASSISTED RENAL TUMORECTOMY PROCEDURE, THE SURGEON SIDE CONSOLE (SSC) WOULD NOT POWER ON, DESPITE BEING POWERED DURING SYSTEM INSTALLATION. THE PORTS WERE IN PLACE WHEN THE PROBLEM WAS DISCOVERED. VARIOUS TROUBLESHOOTING STEPS WERE TAKEN, INCLUDING CHANGING THE POWER CORD LOCATION MULTIPLE TIMES, TOGGLING THE SSC SWITCH BREAKER, SWAPPING THE POWER CORD LOCATION WITH A KNOWN WORKING ONE, WIGGLING THE POWER CORD, AND ENSURING THE POWER CORD WAS PROPERLY SEATED IN THE CONSOLE. THE CUSTOMER HAD ONLY ONE SSC, AND IT WAS DETERMINED THAT A REPLACEMENT OF THE CONSOLE POWER CORD WAS NOT POSSIBLE BY THE BIOMED OR ELECTRICAL DEPARTMENT. SUBSEQUENTLY, A SALES REPRESENTATIVE CALLED TO REQUEST AN UPDATE, AND IT WAS CONFIRMED THAT ON SITE TROUBLESHOOTING WITH SPARE PART REPLACEMENT WAS NECESSARY TO RESOLVE THE ISSUE. THE PROCEDURE WAS ABORTED POST-ANESTHESIA AND PORT PLACEMENT, AND IT WAS UNKNOWN IF OR WHEN THE PROCEDURE WOULD BE RESCHEDULED.

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, A MONOPOLAR CURVED SCISSORS (MCS) TIP COVER FELL OFF WHILE INSTALLED ON AN MCS INSTRUMENT. THE CUSTOMER WAS ABLE TO SAFELY REMOVE THE MCS TIP COVER ACCESSORY FROM THE PATIENT AND PLACED A NEW ONE ON THE MCS INSTRUMENT. THE PROCEDURE WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGEON WAS DOING A HYSTERECTOMY. THE MCS INSTRUMENT AND MCS TIP COVER ACCESSORY WERE INSPECTED AS USUAL. NO DAMAGE WAS NOTED. THE MCS TIP COVER ACCESSORY WAS INSTALLED CORRECTLY WITH NO LUBRICANT USED. THE UTERUS WAS VERY LARGE AND DIFFICULT TO MOVE AROUND. THE PROCEDURE WAS 2.5 HOURS LONGS AND THE MCS INSTRUMENT WAS USED THE ENTIRE CASE. THE ENTIRE MCS TIP COVER ACCESSORY WAS REMOVED WITHOUT DIFFICULTY. NO FRAGMENT WAS NOTED TO BE LEFT IN THE PATIENT. THERE WAS NO ISSUE WITH THE USE OF THE SCISSORS. THE MCS INSTRUMENT AND A TENACULUM FORCEPS INSTRUMENT WERE ON THE SAME SIDE OF THE PATIENT. THE MCS TIP COVER ACCESSORY WAS DISPOSED OF AND THE MCS INSTRUMENT IS STILL IN USE. NO PHOTOS WERE TAKEN.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A PORTION OF THE BLACK RUBBER ON THE TROCAR CAPS BREAKING OFF AND FALLING INSIDE OF THE PATIENT. NO FURTHER INFORMATION WAS AVAILABLE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE; WHILE USING THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT, THE PATIENT SUSTAINED A BLADDER BURN. PRIOR TO ACTIVATION, THE MCS TIP COVER ACCESSORY APPEARED TO BE PROPERLY INSTALLED. THE GROUNDING PAD WAS CONFIRMED TO BE CORRECTLY PLACED AND FREE OF DEFECTS. THE ERBE GENERATOR WAS IN USE AT THE TIME, WITH THE COAGULATION MODE SET TO SWIFT: 4. THE INJURY OCCURRED WHILE THE MCS INSTRUMENT WAS ACTIVELY DELIVERING ENERGY FOR DISSECTION OF THE BLADDER NECK. AT THE TIME OF ACTIVATION, THE INSTRUMENT¿S JAWS WERE NEITHER IMMERSED IN FLUID NOR CONTAMINATED WITH CARBONIZED TISSUE OR OTHER BIOLOGICAL DEBRIS. THE MCS TIP COVER ACCESSORY WAS OBSERVED TO HAVE COME INTO CONTACT WITH BLADDER TISSUE, RESULTING IN A THERMAL INJURY. THE BURN WAS ADDRESSED WHILE PERFORMING THE VESICOURETHRAL ANASTOMOSIS. NO ADDITIONAL TISSUE RESECTION WAS REQUIRED, AND THERE WAS NO BLEEDING AS A RESULT OF THE INJURY. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER WAS CONSULTED AND SUGGESTED THE POSSIBILITY OF A SHORT CIRCUIT DUE TO COMPROMISED INSULATION. THIS MAY HAVE CAUSED ENERGY TO BE REDIRECTED TO THE INSTRUMENT¿S SHAFT OR MCS 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NIPPLE SPARING MASTECTOMY SURGICAL PROCEDURE, THE PATIENT SUFFERED A BURN. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE THERMAL DAMAGE TO OCCUR OR THE EXTENT OF THE INJURY. THE PROCEDURE WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT BROKE. THE BROKEN PART WAS REMOVED AND IT WAS NOTED THAT NO FRAGMENTS REMAINED IN THE PATIENT. HOWEVER, IT IS UNCLEAR IF ANY FRAGMENTS ACTUALLY FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED ROBOTICALLY 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: A PATIENT WHO WAS ENROLLED IN A STUDY UNDERWENT A DA VINCI ASSISTED BILATERAL NIPPLE SPARING MASTECTOMY SURGICAL PROCEDURE. INTRA-OPERATIVELY, A SKIN BURN/THERMAL INJURY WAS OBSERVED ON THE LEFT BREAST BY THE CASE SUPPORT ENGINEER. THERE WAS NO REPORTED CAUSE OF THE BURN. THE PHYSICIAN REPORTED THE SEVERITY AS MILD, POSSIBLY RELATED TO THE STUDY DEVICE AND NOT RELATED TO THE RECONSTRUCTION PROCEDURE AND NOT RELATED TO THE PATIENT'S PRE-EXISTING CONDITION. THE TREATMENT WAS REPORTED AS XEROFORM DAILY TO THE BURNS AND THE EVENT OUTCOME IS DOCUMENTED AS ONGOING. THE PATIENT WAS DISCHARGED THE DAY AFTER SURGERY. THERE WERE NO DEVICE MALFUNCTIONS ASSOCIATED WITH 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 DISTAL PANCREATECTOMY PROCEDURE, THE KNIFE HEAD ON A HARMONIC ACE INSTRUMENT SUDDENLY BROKE. IT WAS REPORTED THAT NO RESIDUE WAS LEFT IN THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. IT IS UNCLEAR IF A FRAGMENT FELL INSIDE THE PATIENT AND WAS RETRIEVED.

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, ONE SIDE OF THE HARMONIC ACE INSTRUMENT JAW BROKE WHILE THE SURGEON WAS DISSECTING AND A FRAGMENT FELL INSIDE THE PATIENT. THE FRAGMENT WAS SUCCESSFULLY RETRIEVED DURING THE SAME PROCEDURE AND WAS VISUALLY CONFIRMED TO HAVE BEEN FULLY RECOVERED. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED FOR REMOVAL OF THE FRAGMENT AND NO POST-OPERATIVE TESTS WERE CONDUCTED TO CHECK FOR REMAINING FRAGMENTS. THE PROCEDURE WAS COMPLETED ROBOTICALLY USING A BACKUP HARMONIC ACE INSTRUMENT. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO 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: A review of an article was performed that presented a retrospective review of experiences with robotic lymphadenectomy procedures. The article noted one man was diagnosed with inguinal panniculitis (on the side of radical inguinal lymph node dissection (rILND)), which was managed successfully with a 14-day course of cefditoren.The corresponding author was contacted and stated that the reported postoperative lymphoceles were not caused by, nor attributed to, any Intuitive Surgical device. They represent well-recognized complications following inguinal lymph node dissection. No da Vinci system or instrument malfunctions occurred during any of the procedures reported in the manuscript. Consequently, no corrective actions or interventions related to device malfunction were required. The patients were adult males undergoing robotic inguinal lymphadenectomy for penile cancer. No additional patient-specific information can be provided due to privacy regulations.

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 SURGICAL PROCEDURE, THE TIP WAS BENT, AND A PIECE OF THE BLACK PART FELL INSIDE THE PATIENT, BUT THE DOCTOR RETRIEVED IT. 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 AN ARTICLE THAT EVALUATED THE PERIOPERATIVE, ONCOLOGIC, AND FUNCTIONAL OUTCOMES OF SALVAGE TRANSORAL ROBOTIC SURGERY (TORS) WITH SUBMENTAL ISLAND FLAP RECONSTRUCTION FOR RECURRENT OROPHARYNGEAL SQUAMOUS CELL CARCINOMA (OPSCC) WAS PERFORMED. THE RETROSPECTIVE STUDY ANALYZED 8 PATIENTS UNDERGOING SALVAGE TORS WITH SUBMENTAL ISLAND FLAP RECONSTRUCTION BETWEEN DECEMBER 2019 AND FEBRUARY 2024. TWO PATIENTS EXPERIENCED POSTOPERATIVE COMPLICATIONS, INCLUDING NECK HEMATOMA REQUIRING INTERVENTION AND DEHYDRATION/FAILURE TO THRIVE REQUIRING READMISSION. TWO DEATHS WERE OBSERVED DURING LONG-TERM FOLLOW-UP (AT 4 MONTHS AND 27 MONTHS POSTOPERATIVELY), ACKNOWLEDGED BY THE AUTHORS AS PART OF OVERALL SURVIVAL OUTCOMES. NO DEVICE MALFUNCTIONS WERE REPORTED, AND THE AUTHORS DID NOT ATTRIBUTE ANY ADVERSE EVENTS TO AN INTUITIVE SURGICAL, INC. (ISI) DEVICE. FOLLOW-UP WITH THE AUTHOR PROVIDED THE FOLLOWING INFORMATION: "THOSE WERE ANTICIPATED ONCOLOGIC OUTCOMES, INDEPENDENT OF THE ROBOT. THERE WERE NO MALFUNCTIONS."

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 an article was performed that presented a retrospective review of experiences with robotic lymphadenectomy procedures. The article noted four patients developed clinically evident lymphoceles, with one case requiring temporary percutaneous drainage under local anesthesia due to the risk of cutaneous ulceration.Intuitive Surgical, Inc. (ISI) followed up with the initial reporter and obtained the following additional information: The reported postoperative lymphoceles were not caused by, nor attributed to, any Intuitive Surgical device. They represent well-recognized complications following inguinal lymph node dissection. No da Vinci system or instrument malfunctions occurred during any of the procedures reported in the manuscript. Consequently, no corrective actions or interventions related to device malfunction were required. The patients were adult males undergoing robotic inguinal lymphadenectomy for penile cancer. No additional patient-specific information can be provided due to privacy regulations.

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

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

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A REVIEW OF AN ARTICLE THAT EVALUATED THE SAFETY AND PERIOPERATIVE OUTCOMES OF ROBOTIC-ASSISTED SINGLE-PORT VERSUS MULTI-PORT SURGICAL STAGING FOR APPARENT EARLY-STAGE ENDOMETRIAL CANCER WAS PERFORMED. THE RETROSPECTIVE, PROPENSITY-MATCHED STUDY ANALYZED 100 PATIENTS UNDERGOING ROBOTIC-ASSISTED HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY AND NODAL STAGING USING THE DA VINCI SURGICAL SYSTEM BETWEEN JANUARY 2021 AND DECEMBER 2024. A TOTAL OF 3 PATIENTS IN THE SINGLE-PORT GROUP EXPERIENCED POSTOPERATIVE COMPLICATIONS WITHIN 30 DAYS, INCLUDING SURGICAL SITE INFECTION AND ABDOMINAL PAIN REQUIRING READMISSION, AND HEMOPERITONEUM REQUIRING SURGICAL RE-INTERVENTION. NO DEVICE MALFUNCTIONS WERE REPORTED, AND THE AUTHORS DID NOT REPORT ANY EVENTS CAUSED BY ANY INTUITIVE SURGICAL, INC. (ISI) DEVICE. MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE AUTHOR. 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: A REVIEW OF THE ARTICLE REPORTED THE FOLLOWING ADVERSE EVENT. IN THE DA VINCI SP GROUP REASONS FOR READMISSION WERE: SURGICAL SITE INFECTION AND ABDOMINAL PAIN AND 1 PATIENT REQUIRED A BLOOD TRANSFUSIONS. IN THE DA VINCI XI GROUP REASONS FOR READMISSION WERE URETERAL FISTULA, URINARY TRACT INFECTION, AND ABDOMINAL PAIN. SEVERE COMPLICATIONS (GRADE 3 OR MORE) IN THE DA VINCI SP GROUP INCLUDED HEMOPERITONEUM REQUIRING SURGERY (N 1); WHILE IN THE DA VINCI XI GROUP INCLUDED HEMOPERITONEUM REQUIRING SURGERY (N = 1) AND URETERAL FISTULA (N = 1). ALL SEVERE COMPLICATIONS OCCURRED WITHIN 30 DAYS.

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 GASTRECTOMY PROCEDURE, A WHITE FRAGMENT FROM THE HARMONIC ACE INSTRUMENT FELL INSIDE THE PATIENT. WHEN THE EVENT OCCURRED, THE SURGEON WAS PERFORMING DISSECTION. THE FRAGMENT WAS NOT RETRIEVED AS IT COULD NOT BE FOUND. AN X-RAY WAS CONDUCTED POST-OPERATIVELY TO CHECK FOR FRAGMENTS. THE SURGERY WAS COMPLETED ROBOTICALLY, UTILIZING A BACKUP HARMONIC ACE INSTRUMENT. AFTERWARDS, IT WAS DISCOVERED THAT THE INSTRUMENT WAS WOBBLING. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, A PORTION OF THE BLACK RUBBER ON THE TROCAR CAPS BROKE OFF AND FELL INSIDE OF THE PATIENT. THE UNIVERSAL SEAL WAS IDENTIFIED WHEN THE SURGICAL TEAM NOTICED A DEVICE FRAGMENT IN THE PELVIS. THE CAUSE OF THE FRAGMENT'S DETACHMENT REMAINS UNKNOWN. THE FRAGMENT WAS RETRIEVED BY THE SURGICAL ASSISTANT USING A LAPAROSCOPIC GRASPER, AND ITS RETRIEVAL WAS CONFIRMED BY MATCHING IT TO THE INNER CAP SEAL. NO ADDITIONAL SURGICAL PROCEDURE WAS NEEDED FOR THE REMOVAL OF THE FRAGMENT, AND NO POST-OPERATIVE TESTS WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITHOUT THE USE OF A BACKUP INSTRUMENT. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BARIATRIC SURGICAL PROCEDURE, THE SURGEON DISCOVERED FRAGMENTS WERE BROKEN OFF FROM THE GASKET OF THE HARMONIC ACE INSTRUMENT. THE DEVICE FRAGMENT FELL INSIDE THE PATIENT WHILE GRASPING, WHICH THE SURGEON BELIEVES WAS CAUSED BY INTRAOPERATIVE CLEANING OR COLLISION. THE FRAGMENT WAS SUCCESSFULLY RETRIEVED BY THE FIRST ASSISTANT UNDER DIRECT VISUALIZATION USING LAPAROSCOPIC INSTRUMENTS, AND ITS RETRIEVAL WAS CONFIRMED BY THE SCRUB NURSE WHO MATCHED THE FRAGMENT TO THE INSTRUMENT'S BREAK POINT. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT, AND NO POST-OPERATIVE TESTS SUCH AS AN X-RAY OR ULTRASOUND WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE PROCEDURE WAS COMPLETED ROBOTICALLY. A BACKUP INSTRUMENT, THE HARMONIC SCALPEL, WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT. THE INSTRUMENT RECOGNITION ISSUE OCCURRED ON THE SAME HARMONIC ACE INSTRUMENT THAT HAD THE BROKEN FRAGMENT. THE INSTRUMENT IS AVAILABLE FOR RETURN TO ISI FOR EVALUATION; HOWEVER, THE FRAGMENT HAS BEEN DISCARDED AND WILL NOT BE RETURNE

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

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

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

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

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

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

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: 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 THE ARTICLE REPORTED THE FOLLOWING ADVERSE EVENT. URINARY LEAKAGE OCCURRED IN ONE PATIENT IN THE NONRENORRHAPHY GROUP AND TWO PATIENTS IN THE RENORRHAPHY GROUP; HOWEVER, THERE WAS NO STATISTICALLY SIGNIFICANT DIFFERENCE BETWEEN THE GROUPS (P=0.9399). IN THE NONRENORRHAPHY GROUP, ONE PATIENT DEVELOPED A URINOMA REQUIRING READMISSION. URINARY LEAKAGE DID NOT IMPROVE WITH URETERAL STENTING AND DRAINAGE BUT WAS ULTIMATELY RESOLVED AFTER FIBRIN INFUSION.

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 TRANSORAL THYROIDECTOMY PROCEDURE, THE WHITE PART OF THE TIP OF THE HARMONIC ACE INSTRUMENT FELL OFF. UPON INSPECTION, IT WAS FOUND THAT THE FRONT TIP WAS SLIGHTLY BROKEN, SO ANOTHER HARMONIC ACE INSTRUMENT WAS USED INSTEAD. THE PROCEDURE WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE TEFLON PAD ON THE HARMONICA ACE INSTRUMENT WAS DAMAGED AND COMPLETELY DETACHED FROM THE INSTRUMENT. THE INSTRUMENT WAS INSPECTED PRIOR TO USE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR TOOL DURING PROCEDURE. A FRAGMENT FELL INSIDE THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. THE PATIENT HAD NO RETURNED TO THE HOSPITAL DUE TO ANY POST-SURGICAL COMPLICATIONS. THE INSTRUMENT IS AVAILABLE FOR RETURN TO ISI FOR EVALUATION; HOWEVER, NO PHOTOS OR VIDEOS ARE AVAILABLE FOR REVIEW.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT BROKE AND FRAGMENTS FELL INSIDE THE PATIENT'S BODY. THERE WERE NO INSTRUMENT COLLISIONS DURING THE CASE. THE FRAGMENTS WERE RETRIEVED DURING THE SAME SURGICAL PROCEDURE WHICH WAS COMPLETED ROBOTICALLY 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 DISTAL PANCREATECTOMY PROCEDURE, THE TIP OF A HARMONIC ACE INSTRUMENT BROKE AND A PLASTIC FRAGMENT FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE WHICH WAS COMPLETED ROBOTICALLY USING A BACKUP 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: 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 "BENCH SURGERY WITH ROBOT-ASSISTED KIDNEY AUTO-TRANSPLANTATION FOR COMPLEX KIDNEY TUMORS: TECHNIQUE AND OUTCOMES FROM A SINGLE CENTER" WAS PERFORMED. FROM JANUARY 2018 TO MAY 2021, FOUR PATIENTS WITH SOLITARY KIDNEY TUMORS AND EIGHT WITH BILATERAL KIDNEY TUMORS UNDERWENT BENCH SURGERY (BENS) AND ROBOT-ASSISTED KIDNEY AUTO-TRANSPLANTATION (RAKAT). THE ARTICLE NOTED THAT THAT DURING THESE DV SURGERIES, "THREE PATIENTS PRESENTED GRADE IV POSTOPERATIVE COMPLICATIONS, AS FOLLOWS: ONE DEVELOPED SEPTIC SHOCK THAT RESOLVED WITH TREATMENT WITH BROAD-SPECTRUM ANTIBIOTICS AND SUPPORTIVE CARE IN THE INTENSIVE CARE UNIT. WHILE OTHER TWO OTHER DEVELOPED DELAYED GRAFT FUNCTION (DGF) THAT RESOLVED WITH TEMPORARY DIALYSIS." THE AUTHORS CONCLUDED THAT BENS WITH RAKAT IS AN ALTERNATIVE STRATEGY FOR THE TREATMENT OF HIGH-COMPLEXITY RENAL TUMORS THAT ARE UNSUITABLE FOR IN SITU PARTIAL NEPHRECTOMY (PN). LARGER PROSPECTIVE STUDIES WITH LONGER FOLLOW-UP ARE REQUIRED TO FURTHER ASSESS THE FINDINGS. THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS REPORTED, NOR DID THE AUTHOR ALLEGE THAT INTUITIVE SURGICAL, INC. (ISI) PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENT. 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: REFER TO H11 FOR FOLLOW-UP INFORMATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE TIP WAS BROKEN AND THE TEFLON PAD WAS SCRATCHED. THE USER COMPLETED THE PROCEDURE USING A BACKUP HARMONIC ACE WITH NO FURTHER ISSUE REPORTED. 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 INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO DAMAGE OBSERVED. THERE WAS NO INSTRUMENT COLLISION DURING THE PROCEDURE. A FRAGMENT OF THE INSTRUMENT 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY INSTALLED ON AN MCS INSTRUMENT CAME OFF AS THE SURGICAL STAFF WAS REMOVING THE INSTRUMENT. THE STAFF WAS ABLE TO RECOVER THE MCS TIP COVER ACCESSORY DURING THE SAME SURGICAL PROCEDURE WHICH WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INITIAL REPORTER SAID THAT THE MCS TIP COVER ACCESSORY FELL INSIDE THE PATIENT WHEN THE CUSTOMER WAS TRYING TO REMOVE THE INSTRUMENT. THE TIP COVER WAS IMMEDIATELY RETRIEVED. THE MCS TIP COVER ACCESSORY WAS INSPECTED PRIOR TO USE AND NO DAMAGE OR NOTHING OUT OF ORDINARY WAS NOTED. THE MCS INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENT. THE MCS TIP COVER ACCESSORY WAS PROPERLY INSTALLED. THE INSTRUMENT TIP WAS STRAIGHTENED UPON REMOVAL. THERE WAS NO DAMAGE/HOLES NOTED ON THE MCS TIP COVER ACCESSORY. THE MCS INSTRUMENT WAS FUNCTIONING AS EXPECTED 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: A SYSTEMATIC LITERATURE SEARCH WAS CONDUCTED USING PUBMED/MEDLINE, EMBASE, WEB OF SCIENCE, AND SCOPUS TO IDENTIFY STUDIES PUBLISHED UP TO NOVEMBER 2024. A REVIEW OF THE LITERATURE ARTICLE, ¿RELIABILITY OF THE DA VINCI ROBOTIC SURGICAL SYSTEM: A SYSTEMATIC REVIEW AND POOLED ANALYSIS OF TECHNICAL FAILURES¿ WAS PERFORMED AND 3,308,134 PROCEDURES WERE REVIEWED WITH 1,799 REPORTED EVENTS FROM 25 STUDIES. ALL THE INCLUDED STUDIES WERE RETROSPECTIVE, COVERING PROCEDURES PERFORMED BETWEEN 2000 AND 2021. THE POOLED MALFUNCTION RATE WAS 1.0% (95% CI: 0.9-1.2%). THE POOLED RATE OF DEVICE MALFUNCTIONS WAS 0.1% (95% CI: 0.1%-0.1%); INSTRUMENT MALFUNCTIONS ACCOUNTED FOR 0.4% (95% CI: 0.3-0.5%). THE OVERALL MALFUNCTION-RELATED CONVERSION RATE WAS 0.09% (95%CI: 0.06-0.11%), WITH CONVERSION TO OPEN AND LAPAROSCOPIC SURGERY IN 0.1% AND 0.04% OF THE TOTAL PROCEDURES, RESPECTIVELY. THE POOLED RATE OF MALFUNCTION-RELATED INJURIES WAS 0.01% (95% CI: 0.01-0.02%), WITH NO SIGNIFICANT IMPACT ON PATIENT OUTCOMES. NINETEEN STUDIES REPORTED DATA ON TECHNICAL FAILURES OF THE DA VINCI ROBOTIC SYSTEM, INCLUDING COMPLETE INFORMATION ON THE TOTAL NUMBER OF SURGERIES PERFORMED AND THE CORRESPONDING MALFUNCTIONS OBS

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON 06-JUN-2025, INTUITIVE SURGICAL, INC. (ISI) RECEIVED MEDWATCH REPORT (MDR) WITH UF/IMPORTER REPORT # (B)(4) STATING: "PATIENT HERE FOR ROBOTIC PROSTATECTOMY RETROPUBIC RADICAL WITH NERVE SPARING BY DR. [REDACTED]. WHEN SCOPE WAS BEING PLACED THROUGH THE UNIVERSAL SEAL "TOILET SEAT" UPON FIRST ENTRY THEY NOTICED A BLACK PIECE OF RUBBER INSIDE THE PATIENT. THE PIECE OF RUBBER WAS REMOVED WITH THE PIECE FULLY INTACT, AND A METHODICAL SWEEP OF THE CAVITY WAS PERFORMED BY THE SURGEON WITH NO OTHER PIECES FOUND. SURGEON CONTINUED THE SURGERY WITHOUT ANY COMPLICATIONS. AFTER THE PROCEDURE THE PIECE OF RUBBER WAS COMPARED TO THE MISSING PIECE UNDER THE UNIVERSAL SEAL AND BOTH PIECES MATCHED WITH NO OTHER MISSING PARTS AND SURGEON CONFIRMED. THE COMPANY WAS NOTIFIED. PER REPORTING CONTACT, "PER REPORTING CONTACT, THE COMPANY WAS MADE AWARE OF THE ISSUE AND CAME INTO THE HOSPITAL THE NEXT DAY. THERE WAS NO PATIENT HARM, BUT WE CANNOT RETURN TO MFG [MANUFACTURER] BECAUSE THE PRODUCT WAS TOSSED OUT AFTER THE SURGEON EXAMINED THE PRODUCT INTO A SHARPS CONTAINER."

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 "SURGICAL OUTCOMES OF ROBOTIC HYSTERECTOMY FOR LARGE UTERUS WEIGHING MORE THAN 1000 G: A RETROSPECTIVE STUDY FROM A HIGH-VOLUME CENTER" WAS PERFORMED. THIS RETROSPECTIVE STUDY DATA FROM THE HOSPITAL WAS REVIEWED BETWEEN JANUARY 2014 TO DECEMBER 2023 AND AIMED TO INVESTIGATE THE IMPACT OF VARIOUS RISK FACTORS ON SURGICAL OUTCOMES AND TO IDENTIFY THE MOST EFFECTIVE SURGICAL APPROACH FOR PERFORMING RADICAL HYSTERECTOMIES ON UTERI GREATER THAN 1000 G IN BENIGN CONDITIONS. A TOTAL OF 86 PATIENTS WERE INCLUDED IN THE ANALYSIS, AND THE AVERAGE AGE OF THE STUDY POPULATION WAS 47.1 +/- 4.5 YEARS, WITH A MEAN BODY MASS INDEX OF 25.1 +/- 4.0 KG/M2. THE ARTICLE DESCRIBES SOME SPECIFIC INTRA-OPERATIVE COMPLICATIONS WITH MINIMAL DETAILS. A SMALL PERCENTAGE OF PATIENTS (4.7%) REQUIRED CONVERSION TO OPEN SURGERY. A TOTAL OF 4 INCIDENTS OF ORGAN INJURIES WERE RECORDED; ONE PATIENT EXPERIENCED A BLADDER INJURY, AND THREE PATIENTS EXPERIENCED VAGINAL LACERATIONS, ALL OF WHICH REQUIRED INTRAOPERATIVE REPAIR WITHOUT SUBSEQUENT COMPLICATIONS. ADDITIONALLY, SIX CASES NECESSITATED INTRAOPERATIVE BLOOD TRANSFUSIONS. POST-OPERATIVELY, ONE PATIENT SUFFERED A CUFF INFECTION AN