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.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: VERIFICATION FAILED AND SUBSEQUENT AUTO ARM TEST ALSO FAILED. CABLE AND CAMERA CLEANED. ROBOT RESTARTED SEVERAL TIMES. ROBOT REPOSITIONED AND CAMERA ANGLE CHANGED. THE SURGERY WAS CANCELLED AND THE NEXT SURGERY IN THE OPERATING ROOM TOOK PLACE APPROXIMATELY ONE HOUR AFTER WE STARTED THE FAILED REGISTRATION OF 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: 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

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PATIENT HAD SHOWN SOME IMPROVEMENT SINCE THE SURGERY. THE SUSPECTED CAUSE WAS A PATIENT SHIFT DUE TO LEANING WHILE DRILLING, LEADING TO THE SKIVE.

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.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative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

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.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS ORIGINALLY REPORTED BY MPS: "PATIENT STARTED WITH 6 DEGREES OF VARUS. MAKO SAID HIS FINAL LIMB ALIGNMENT WAS 1 DEGREE OF VALGUS BUT THE PATIENT IS NOW IN 5 DEGREES OF VALGUS. SURGEON WANTS TO UNDERSTAND WHY. CASE TYPE / APPLICATION: TKA 2.0" ADDITIONAL INFORMATION: SURGERY ORIGINALLY PERFORMED (B)(6) 2025. ON (B)(6) 2025, MPS WAS MADE AWARE THAT THE PATIENT WAS 'NOW IN 5 DEGREES OF VALGUS' AND THAT THERE WERE PATIENT COMPLAINTS: PATIENT HAS FUNCTIONAL WEAKNESS AND ANKLE/FOOT PAIN.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: NO NEW 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 RELINE MAS REDUCTION SCREWS WERE UTILIZED WITH THE ROBOT FOR THIS CASE. BLACK EXCELSIUS ARRAY WITH AN ADAPTER WAS UTILIZED. TWO EXCELSIUS ARRAYS WERE SET UP WITH MAS REDUCTION DRIVERS AND VERIFICATION OF THESE ARRAYS WAS CHALLENGING. THE CAMERA WAS HAVING A HARD TIME SEEING THESE ARRAYS. SPHERES WERE MANIPULATED MULTIPLE TIMES AND BOTH DRIVER ARRAYS WERE TRIED. ONCE THE CAMERA WAS ABLE TO SEE THE ARRAYS, IT TOOK MULTIPLE VERIFICATION ATTEMPTS AND MANIPULATION.

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

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 COMPARISON OF SINGLE-PORT VERSUS MULTI-PORT ROBOTIC RADICAL PROSTATECTOMY IN ELDERLY PATIENTS, FOCUSING ON PERIOPERATIVE OUTCOMES AND POSTOPERATIVE COMPLICATIONS WAS PERFORMED. THE STUDY RETROSPECTIVELY ANALYZED 338 PATIENTS UNDERGOING ROBOT-ASSISTED RADICAL PROSTATECTOMY (SINGLE-PORT (SP-RARP)OR MULTI-PORT (MP-RARP) BETWEEN JANUARY 2018 AND DECEMBER 2023. ONE RECTAL INJURY OCCURRED IN THE MP GROUP, WHILE THE SP GROUP HAD TWO EVENTS (RECTAL AND BLADDER INJURY). IN ELDERLY PATIENTS, THE MP GROUP HAD TWO COMPLICATIONS (RECTAL INJURY AND CONVERSION TO OPEN SURGERY DUE TO HEMODYNAMIC INSTABILITY), WHEREAS THE SP GROUP HAD SIX COMPLICATIONS (RECTAL INJURY, BLADDER INJURY, OBTURATOR NERVE INJURY, AND PERSISTENT PNEUMOPERITONEUM); ALL WERE MANAGED INTRAOPERATIVELY. POSTOPERATIVE CLAVIEN¿DINDO GRADE 3 COMPLICATIONS INCLUDED PARALYTIC ILEUS AND LYMPHOCELES REQUIRING DRAINAGE IN THE MP GROUP AND LYMPHOCELES IN THE SP GROUP. ONE PATIENT IN THE MP GROUP DIED DUE TO POSTOPERATIVE UROSEPSIS (CLAVIEN¿DINDO GRADE 5); HOWEVER, THE REPORT DOES NOT CLEARLY DESCRIBE THE CLINICAL SEQUENCE OR ESTABLISH WHETHER THIS OUTCOME WAS DIRECTLY ATTRIBUTABLE TO A SPECIFIC

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: A REVIEW OF AN ARTICLE THAT EVALUATED THE CLINICAL EFFECT OF CONTINUOUS IMPROVEMENT OF PERIOPERATIVE NURSING QUALITY IN PATIENTS WITH DA VINCI ROBOT-ASSISTED LAPAROSCOPIC RADICAL PROSTATECTOMY. A TOTAL OF SEVEN PATIENTS EXPERIENCED COMPLICATIONS, INCLUDING DEEP VEIN THROMBOSIS. NO DEVICE MALFUNCTIONS WERE REPORTED, AND THE AUTHORS DID NOT REPORT ANY EVENTS CAUSED BY ANY ISI DEVICE. MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE CORRESPONDING AUTHOR; HOWEVER, NO RESPONSE HAS BEEN RECEIVED.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AFTER BURRING THE AREA NEAR THE PROXIMAL INTERCONDYLAR EMINENCE OF THE TIBIA WITH MAKOPKA AND PLACING THE TRIAL, IT WAS DISCOVERED THAT THE INTERCONDYLAR EMINENCE HAD BEEN CUT DOWN BY ABOUT 5 MM (1/3) MORE THAN THE PLANNED LINE. THE ATTACHMENT SITE OF THE ACL HAD BECOME UNSTABLE, SO A BONE GRAFT WAS PERFORMED TO COMPLETE THE SURGERY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ADRENALECTOMY PROCEDURE, THE INTUITIVE SURGICAL, INC, (ISI) CLINICAL SALES REPRESENTATIVE (CSR) CONTACTED A TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THAT THE CONSOLE WOULD NOT POWER ON AFTER THE CUSTOMER HAD ALREADY DOCKED TO THE PATIENT. THE CSR CHECKED THE WALL POWER, MOVED THE POWER CORD TO ANOTHER OUTLET, AND VERIFIED THAT THE WALL POWER WAS GOOD. THE CONSOLE BREAKER WAS CHECKED AND CYCLED ON AND OFF, BUT THE CONSOLE STILL DID NOT POWER ON. THE SYSTEM LOGS INDICATED THAT NO CONSOLE WAS CONNECTED, SUGGESTING A POSSIBLE MEDICAL GRADE POWER SUPPLY (MGPS) FAILURE. THE ENTIRE SYSTEM WAS SWAPPED OUT, AND THE PROCEDURE WAS CONVERTED FROM A SINGLE PORT TO A MULTI-PORT PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A XI SYSTEM.

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 EXCELSIUSHUB SYSTEM, AN INTRA-OPERATIVE CORRECTION WAS REQUIRED FOR A MISPLACED IMPLANT.

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 THE PHYSICIAN STARTED THE CASE WITH ENDOBRONCHIAL ULTRASOUND (EBUS) AND THEN SWITCHED TO MONARCH. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED SYSTEM FAULT MESSAGES AND ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO 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 INGUINAL HERNIA BILATERAL SURGICAL PROCEDURE, AT THE END OF THE PROCEDURE, THEY NOTICED A PLASTIC PIECE FROM THE CANNULA SEAL HAD FALLEN INTO THE PATIENT. THE ITEM WAS RETRIEVED WITHOUT ANY HARM. THE PROCEDURE WAS COMPLETED.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY PROCEDURE, THE PHYSICIAN ENCOUNTERED NAVIGATION ISSUES AND ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY FELL INSIDE THE PATIENT. THE SURGEON DIDN'T REALIZE IT FELL UNTIL THEY FINISHED THE CASE AND WERE DOING THE COUNTING. THE PATIENT WAS STILL ON THE TABLE, SO A CT SCAN WAS DONE TO LOCATE THE MCS TIP COVER. THE CUSTOMER WAS ABLE TO RETRIEVE IT, HOWEVER, THEY SAID IT TOOK THEM A LONG TIME WHICH CAUSED A DELAY TO THE CASE. NOT SURE THE EXACT DELAY TIME BUT IT WAS LONG. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT AND THE MCS TIP COVER ACCESSORY WERE INSPECTED PRIOR TO USE AND NO DAMAGE WAS NOTED. THE SURGEON OPENED THE PATIENT AND FOUND THE MISSING MCS TIP COVER ACCESSORY. SURGERY WAS COMPLETED WHEN THE MCS TIP COVER WAS FOUND. THE SCRUB TECHNICIAN NOTICED A MISSING TIP COVER AT THE END OF THE CASE ONCE THE COUNT NUMBER WAS OFF ON THE MATERIALS USED IN THE CASE. IT IS UNKNOWN WHAT THE SURGEON BELIEVES WAS THE CAUSE OF THE INSTRUMENT ACCESSORY SLIP-OFF. THE MCS TIP COVERS ARE IN USE FOR 30 MINUTES. NO ISSUES WITH THE FUNCTIONALITY OF THE MCS INSTRUMENT

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 PHYSICIAN ENCOUNTERED SYSTEM FAULT MESSAGES AND ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO 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: A PATIENT WHO WAS ENROLLED IN A STUDY UNDERWENT A DA VINCI ASSISTED NIPPLE SPARING MASTECTOMY SURGICAL PROCEDURE (MALIGNANT WITH ONE-STAGE IMPLANT RECONSTRUCTION) WITH CARBON DIOXIDE (CO2) INSUFFLATION. INTRA-OPERATIVELY, A SKIN BURN WAS OBSERVED ON THE LEFT BREAST. AFTER UNDOCKING THE ROBOT, TURNING LIGHTS ON AND INSPECTING SKIN FLAPS, THERE WERE THREE SITES NOTED (IN THE UPPER OUTER AND UPPER INNER QUADRANTS) WHERE A SUB CM BLISTER WAS NOTED, EVIDENCE OF THERMAL INJURY SUSTAINED DURING THE ROBOTIC ANTERIOR FLAP DISSECTION. AT THE END OF THE CASE, NITROPASTE AND XEROFORM GAUZE WERE APPLIED TO THESE AREAS TO ENHANCE PERFUSION AND MAINTAIN INTEGRITY OF THE SKIN FLAP, RESPECTIVELY. THE EVENT IS REPORTED AS ONGOING, NO FURTHER TREATMENT WAS PROVIDED, AND THERE WAS NO PROLONGED HOSPITALIZATION ATTRIBUTE TO THIS SPECIFIC EVENT. THE PATIENT WAS DISCHARGED ON POST-OPERATIVE DAY TWO. THERE WAS NO REPORT OF A DA VINCI DEVICE MALFUNCTION. THE STUDY INVESTIGATOR REPORTED THE EVENT AS MILD SEVERITY, NOT A SERIOUS ADVERSE EVENT (SAE), THERE WAS NO PROLONGED HOSPITALIZATION ATTRIBUTED TO THIS SPECIFIC EVENT, NOT RELATED TO A DA VINCI DEVICE, NOT RELATED TO THE RECONSTRUCTION PROCEDURE, NOT RELAT

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A PATIENT WHO WAS ENROLLED IN A STUDY UNDERWENT A DA VINCI ASSISTED NIPPLE SPARING MASTECTOMY PROCEDURE. DURING SURGERY, THE PATIENT EXHIBITED CREPITUS IN THE ARMS ALONG WITH FACIAL AND NECK SWELLING; END-TIDAL CO2 AND ALL VITAL SIGNS REMAINED STABLE. INSUFFLATION PRESSURE, WHICH HAD BRIEFLY BEEN INCREASED FROM 10 MMHG TO 12 MMHG TO IMPROVE WORKING SPACE, WAS REDUCED BACK TO 10 MMHG, AND THE PROCEDURE WAS COMPLETED ROBOTICALLY WITHOUT ANY COMPROMISE TO THE PATIENT¿S HEMODYNAMIC STATUS. THE POST-PROCEDURE CHEST X-RAY NOTED A SMALL TO MODERATE RIGHT PNEUMOTHORAX. THE NEXT DAY, REPEAT CHEST X-RAY SHOWED A MODERATE SIZED RIGHT PNEUMOTHORAX, PNEUMOMEDIASTINUM, AND PNEUMOPERITONEUM IN THE SETTING OF EXTENSIVE SUBCUTANEOUS EMPHYSEMA. THE PATIENT DENIED DYSPNEA AND REMAINED HEMODYNAMICALLY STABLE WITH NORMAL OXYGEN SATURATION ON ROOM AIR. NO CHEST TUBE WAS PLACED AND THE PATIENT REMAINED HOSPITALIZED FOR OBSERVATION ONLY. A CHEST CT SCAN AND SERIAL CHEST X-RAYS SHOWED STABILITY OF THE SIZE OF THE PNEUMOTHORAX, PNEUMOMEDIASTINUM AND PNEUMOPERITONEUM. THE PATIENT REMAINED STABLE ON ROOM AIR WITH NO DYSPNEA AND WAS DISCHARGED HOME THREE DAYS POST-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: 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 THYMECTOMY PROCEDURE, THE TIP OF THE HARMONIC ACE INSTRUMENT BROKE AND A FRAGMENT FELL INSIDE THE PATIENT. THE INSTRUMENT BROKE WHILE THE SURGEON WAS DISSECTING. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE, WHICH WAS VISUALLY CONFIRMED. THE PROCEDURE WAS COMPLETED ROBOTICALLY, USING A BACKUP HARMONIC ACE INSTRUMENT. NO ADDITIONAL SURGICAL PROCEDURE OR POST-OPERATIVE TESTS WERE PERFORMED. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO ANY POST-SURGICAL COMPLICATIONS RELATED TO A RETAINED FOREIGN OBJECT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AT THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, WITH THE PATIENT ON THE TABLE, THE MONOPOLAR ENERGY WAS NOT WORKING. TECHNICAL SUPPORT WAS CONTACTED, BUT THE ISSUE WAS NOT RESOLVED OVER THE PHONE. THE SURGEON ELECTED TO ABORT THE PROCEDURE DUE TO THE LACK OF MONOPOLAR ENERGY.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PAI, M., SRINIVASA, V., THIRUGNANAM, B., SONI, A., KASHYAP, A., VIDYADHARA, A., RAO, S. K. (2025). ROBOTIC-ASSISTED CERVICAL PEDICLE SCREW FIXATION WITH CUSTOM INSTRUMENTS. CLINICAL SPINE SURGERY. HTTPS://DOI.ORG/10.1097/BSD.0000000000001841 STUDY DESIGN: PROSPECTIVE STUDY OBJECTIVE: THIS STUDY AIMS TO DESCRIBE A WORKFLOW AND CUSTOM INSTRUMENTS FOR ROBOTIC-ASSISTED CERVICAL PEDICLE SCREW PLACEMENT USING THE MAZORX STEALTH EDITION. SUMMARY OF BACKGROUND DATA: POSTERIOR CERVICAL SPINAL INSTRUMENTATION USING PEDICLE SCREWS OFFERS BIOMECHANICAL ADVANTAGES BUT CARRIES RISKS OF INJURY TO THE VERTEBRAL ARTERY AND NERVE ROOTS. FLUOROSCOPIC AND NAVIGATION AIDS EXIST, YET ROBOTIC ASSISTANCE FOR CERVICAL PEDICLE SCREW PLACEMENT LACKS A DEFINED WORKFLOW. WHILE PREVIOUS GENERATIONS OF SPINE ROBOTS HAVE BEEN USED IN PLACING PEDICLE SCREWS, THERE ARE NO PAPERS IN LITERATURE THAT DESCRIBED THE USE OF THIRD-GENERATION SPINE ROBOTS IN PLACING THEM. METHODS: TWENTY-TWO PATIENTS UNDERGOING CERVICAL PEDICLE SCREW PLACEMENT WITH CUSTOM INSTRUMENTS AND ROBOTIC ASSISTANCE WERE INCLUDED. SCREW TRAJECTORIES WERE PLANNED AND EXECUTED BY THE ROBOTIC ARM, WITH POSTOPERATIVE O-ARM SCANS ASSESSING ACCURACY. CLIN

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: BURN OCCURRED TO SMALL AREA OF TISSUE NEXT TO ONE OF THE METAL ROBOT TROCARS. BURN OCCURRED 2 INCHES UP THE INSTRUMENT SHAFT.