da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A PATIENT WHO WAS ENROLLED IN A STUDY UNDERWENT A DA VINCI-ASSISTED NIPPLE SPARING MASTECTOMY (NSM) SURGICAL PROCEDURE AND WAS DISCHARGED THE SAME DAY. THE PATIENT EXPERIENCED POSTOPERATIVE SUBJECTIVE SWELLING OF THE LEFT BREAST AND SELF-REPORTED TO THE EMERGENCY DEPARTMENT ON POSTOPERATIVE DAY 0 OVERNIGHT. SHE WAS EVALUATED IN THE EMERGENCY DEPARTMENT AND THERE WERE NO SIGNS OR SYMPTOMS OF SWELLING, BLEEDING, INFECTION, WOUND ISSUES. SHE WAS DISCHARGED TO HOME ON THE SAME EVENING. SHE WAS SEEN IN FOLLOW-UP CLINIC THE NEXT DAY AND THE CONTRALATERAL (RIGHT) BREAST WAS NOTED TO HAVE BREAST SWELLING AND SIGNIFICANT CHANGE IN SIZE SINCE BEING SEEN IN THE EMERGENCY DEPARTMENT. ADDITIONALLY, THE RIGHT BREAST DRAIN HAD STOPPED DRAINING AND THE DRAIN OUTPUT WAS NOTED TO BE MORE SANGUINOUS IN NATURE. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION AND KEPT NOTHING BY MOUTH (NPO). INITIALLY, BREAST COMPRESSION WAS ATTEMPTED BUT HER DRAIN OUTPUT CONTINUED TO BE SANGUINOUS IN NATURE AND WAS ONGOING AND THEREFORE THE DECISION WAS MADE TO RETURN TO THE OPERATING ROOM FOR EVACUATION OF HEMATOMA. INTRAOPERATIVELY, THE TISSUE EXPANDER WAS REMOVED, THE BREAST POCKET WAS IRRIGATED, 30 CC OF

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT THERE WAS OVER RESECTION ON BOTH THE DISTAL FEMORAL AND PROXIMAL TIBIAL RESECTIONS, WITH A NET OVER RESECTION OF 4MM. THE CALIPER OF BONE MATCHED VALIDATED CUTS. PLANNED POLY WAS 10MM, RESULTING IN 13MM POLY WITH ADDITIONAL SOFT TISSUE RELEASES. THERE IS NO ADDITIONAL 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: 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: NO NEW 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 NIPPLE SPARING MASTECTOMY SURGICAL PROCEDURE. A SMALL SUPERFICIAL BURN WAS NOTED ON THE LEFT AREOLA PRIOR TO INCISION CLOSURE. CAREFUL INSPECTION OF THE FLAPS WAS PERFORMED IN ORDER TO ENSURE THAT THIS WAS NOT A THERMAL INJURY FROM THE DISSECTION AND THIS WAS CONFIRMED. THIS APPEARED TO BE A MILD SUPERFICIAL DESQUAMATION BURN MEASURING APPROXIMATELY 4 X 4 MM IN SIZE. AFTER THE COMPLETION OF THE OPERATION, A SMALL DRESSING WAS PLACED AT THIS SITE. THERE WAS NO REPORT OF A DA VINCI DEVICE MALFUNCTION. THE STUDY INVESTIGATOR REPORTED THAT THE EVENT WAS MILD IN SEVERITY, WAS POSSIBLY RELATED TO THE NIPPLE SPARING MASTECTOMY PROCEDURE AND A DA VINCI STUDY DEVICE, AND THAT IT OCCURRED AFTER THE UNDOCKING OF THE DA VINCI SYSTEM. ON 04-MAR-2025, THE FOLLOWING INFORMATION WAS RECEIVED FROM THE PHYSICIAN: THE CAUSE OF THE BURN IS UNCLEAR. HOWEVER, THE PHYSICIAN BELIEVES THE COMPLICATION WAS LIKELY FROM AN INADVERTENTLY PLACED INSTRUMENT ON THE PATIENT DURING THE PLASTIC SURGERY PORTION OF THE OPERATION. THE BURN WAS CONFIRMED TO NOT BE PRESENT AT THE COMPLETION OF THE ROBOTIC PORTION OF THE OPERATION AND AGAIN CONFIRMED TO

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 LABEL FROM A STERILE DRAPE SOMEHOW ATTACHED TO AN UNIDENTIFIED INSTRUMENT AND WAS INSERTED THROUGH A CANNULA AND INTO THE PATIENT. THE CUSTOMER WAS ABLE TO RETRIEVE THE LABEL DURING THE SAME SURGICAL PROCEDURE AND WITH NO ISSUE TO THE PATIENT. THE PROCEDURE WAS COMPLETED ROBOTICALLY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY PROCEDURE, THE CUSTOMER WAS GETTING LINES LIKE AN OLD TV. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ASKED IF IT WAS WHEN FIRING ENERGY, ANOTHER PERSON CAME ON THE LINE AND SAID NO ITS INDEPENDENT OF THE ENERGY AND ITS ONLY HORIZONTAL GREEN LINES AND MULTI-COLORS IN THE LEFT EYE. THE TSE VIEWED LOGS AND DID NOT SEE ANYTHING; THEY RECOMMENDED THAT THE CUSTOMER RE-SEAT THE ENDOSCOPE. WHEN RESEATING THE ENDOSCOPE, THE TSE COULD HEAR AN ERROR TONE AND SAW AN ERROR IN THE LOGS, INDICATING THAT THE CUSTOMER WOULD HAVE TO REPLACE THE ENDOSCOPE. THE CUSTOMER SAID THEY'D CALL BACK AND ENDED THE CALL ABRUPTLY. THE STAFF CONFIRMED THEY REPLACED THE ENDOSCOPE, AND THE SYSTEM RETURNED TO NORMAL FUNCTIONALITY. THE CUSTOMER STATED THAT THE SURGEON CONVERTED TO OPEN.

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 NEPHROURETERECTOMY PROCEDURE THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY INSTALLED ON AN MCS INSTRUMENT FELL OFF INSIDE THE PATIENT'S BODY. THE EVENT OCCURRED WHEN THE CUSTOMER WAS ATTEMPTING TO EXCHANGE A FORCEPS INSTRUMENT. THE MCS TIP COVER ACCESSORY WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE AND DISCARDED. A NEW MCS TIP COVER ACCESSORY WAS ATTACHED TO THE SAME MCS INSTRUMENT TO PROCEED WITH THE PROCEDURE. NO POST-OPERATIVE TESTS SUCH AS AN X-RAY OR ULTRASOUND WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. AT AN UNSPECIFIED TIME LATER IN THE CASE, THE CUSTOMER IDENTIFIED AN UNSPECIFIED BROKEN CABLE ON THE MCS INSTRUMENT (PART #470179-19, LOT #K12240118-0090). IT IS UNCLEAR WHAT ACTIONS THE CUSTOMER TOOK AS A RESULT OF THE BROKEN CABLE ISSUE WITH THE MCS INSTRUMENT. HOWEVER, A REVIEW OF THE SITE'S SYSTEM LOGS REVEAL THE CUSTOMER REPLACED THE MCS INSTRUMENT WITH ANOTHER MCS INSTRUMENT LOT #K12241003-0253). THE PROCEDURE WAS COMPLETED ROBOTICALLY. 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE THE TIP OF THIS HARMONIC ACE INSTRUMENT SUDDENLY BROKE AND A FRAGMENT FELL INSIDE THE PATIENT. THE BROKEN PART WAS REMOVED FROM THE PATIENT'S BODY DURING THE SAME SURGICAL PROCEDURE. THE NURSE REPORTED THAT NO INSTRUMENTS COLLIDED WITH EACH OTHER DURING THE OPERATION.

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, A FRAGMENT FROM THE HARMONIC ACE BROKE OFF AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE. NO ISSUES WERE NOTED DURING THE INSPECTION OF THE INSTRUMENT PRIOR TO USE. IT WAS VISUALLY CHECKED THAT NO FRAGMENTS WERE LEFT BEHIND INSIDE THE PATIENT. THE ISSUE WAS NOTED AFTER 30 MINUTES OF USE OF THE INSTRUMENT. NO RESISTANCE WAS NOTED WHILE REMOVING THE INSTRUMENT THROUGH THE CANNULA. NO OTHER DAMAGES WERE NOTED UPON THE FINAL REMOVAL OF THE INSTRUMENT. THERE WERE NO INJURIES OR COMPLICATIONS TO THE PATIENT. THE PROCEDURE WAS COMPLETED ROBOTICALLY.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE, AN IMAGE GUIDED L4-5 TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF). IT WAS REPORTED THAT THERE WAS A CONCERNING INCREASE IN SPINE SURGICAL SITE INFECTIONS (SSIS) ASSOCIATED WITH THE GUIDANCE SYSTEM ROBOT. THE INFECTION RATE HAD TRIPLED COMPARED TO FISCAL YEAR 2024, WITH SEVEN FUSION INFECTIONS REPORTED IN FY2025, FIVE OF WHICH INVOLVED PROCEDURES UTILIZING THE GUIDANCE SYSTEM ROBOT. IT WAS NOTED THAT THE INSTRUMENT WAS NOT PROPERLY CLEANED AFTER STERILIZATION, AS OBSERVED USING A BORESCOPE DOWN THE CANNULA INSERTER. IN RESPONSE TO THESE FINDINGS, THE USE OF THE GUIDANCE SYSTEM ROBOT FOR SPINE SURGERIES WAS TEMPORARILY SUSPENDED EFFECTIVE MAY 19, 2025, WHILE FURTHER INVESTIGATION AND MITIGATION EFFORTS WERE UNDERTAKEN. IT WAS NOTED THE PATIENT WAS DISCHARGED HOME WITH OUTPATIENT INFUSION FOR ANTIBIOTICS. THE PATIENT REPORTED A FEVER OF 100.3 AND THEIR WHITE BLOOD COUNT WAS 11.4. THERE WERE 3 LONGITUDINAL INCISIONS, 1 MIDLINE AND 1 ON EITHER SIDE OF THE SPINE. THE LEFT-SIDED INCISION HAD AN AREA ABOUT 2 CENTIMETER (CM) IN DIAMETER WITH MILD PALPABLE FLUCTUATION, SOME OVERLYING ERYTHEMA, A

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 HEAD OF THE HARMONIC ACE INSTRUMENT BROKE. A FRAGMENT FELL INTO THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE SURGICAL TEAM USED THE GUIDANCE SYSTEM TO INSTALL THE S2 SCREW. THE L5 SCREW WAS SET UP WITH A SCREW BY USING A FREE HAND. THE S2 SCREW DISLODGED INTO THE PELVIS WHEN A COMPUTED TOMOGRAPHY (CT) SCAN WAS TAKEN. L5 ALSO DEVIATED, AND THE PHYSICIAN'S OPINION WAS THAT THE PATIENT'S NEUROLOGICAL SYMPTOMS AFTER SURGERY WERE CAUSED BY THE DEVIATION OF THE L5 SCREW, NOT THE S2 SCREW. THE PATIENT EXPERIENCED HEALTH DAMAGE AND THE PROCEDURE WAS EXTENDED BY LESS THAN ONE-HOUR. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AS A SYMPTOM. THE TRAJECTORIES FOR THE S2 SCREW WERE DEVIATED BETWEEN 3.5 AND 10 MILLIMETERS (MM). THE TRAJECTORY DEVIATION FOR THE L5 SCREW WAS ASKED BUT UNKNOWN.

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 THE RIGHT PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, THE CAMERA SHEATH SHREDDED, AND A PIECE WAS HANGING. THE CUSTOMER WAS UNABLE TO ACCESS THE SHEATH INITIALLY DUE TO THE CLAP TIME. THE CUSTOMER PERFORMED AN X-RAY, AND IT WAS CONFIRMED THAT THERE WERE NO FRAGMENTS IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

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 (VIA MEDSUN UF/IMPORTER REPORT # (B)(4)) THAT AFTER THE MONARCH BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A PNEUMOTHORAX.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A REVIEW OF A LITERATURE ARTICLE TITLED, ¿LAPAROSCOPIC VERSUS ROBOTIC LATERAL PELVIC LYMPH NODE DISSECTION IN LOCALLY-ADVANCED RECTAL CANCER: A COHORT STUDY COMPARING PERIOPERATIVE MORBIDITY AND SHORT-TERM ONCOLOGICAL OUTCOMES,¿ WAS PERFORMED. THE GOAL OF THE STUDY NOTED IN THE ARTICLE WAS TO EVALUATE THE OUTCOMES OF ROBOTIC AND LAPAROSCOPIC LATERAL PELVIC LYMPH NODE DISSECTION (LPLND) IN PATIENTS WITH LATERAL PELVIC NODE-POSITIVE LOCALLY ADVANCED RECTAL CANCER (LARC) WITH REFERENCE TO INTRAOPERATIVE SAFETY, POSTOPERATIVE MORBIDITY, PATHOLOGICAL INDICES INCLUDING NODAL YIELD AND NODE POSITIVITY RATES, LATERAL PELVIC RECURRENCE RATES, AND SHORT-TERM EVENT-FREE AND OVERALL SURVIVAL. THIS WAS A RETROSPECTIVE SINGLE-CENTER STUDY THAT EVALUATED 115 PATIENTS BETWEEN 2014 AND 2023. THE ARTICLE NOTED THAT THAT DURING THESE DA VINCI-ASSISTED SURGERIES, IN THE IMMEDIATE POSTOPERATIVE PERIOD, FOUR PATIENTS (TWO FROM EACH GROUP) REQUIRED RE-EXPLORATION FOR ISSUES INCLUDING DISTAL MARGIN POSITIVITY, FASCIAL DEHISCENCE WITH EVISCERATION, AND ACUTE INTESTINAL OBSTRUCTION DUE TO EMPTY-PELVIS SYNDROME OR PORT-SITE HERNIA. THESE OCCURRED AT A MEDIAN OF 10 DAYS POST-SURGERY (RANGE: 6¿21 DAYS). CLINIC

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE TIP OF HARMONIC ACE INSTRUMENT BROKE AND A FRAGMENT FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED 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 HARMONIC ACE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGE WAS NOTED. WHEN THE EVENT OCCURRED, THE SURGEON WAS PERFORMING DISSECTION AND THE INSTRUMENT HAD BEEN IN USE FOR LESS THAN AN HOUR. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. UPON FINAL REMOVAL OF THE HARMONIC ACE INSTRUMENT, THE INSTRUMENT'S WRIST WAS STRAIGHTENED AND THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE REMOVING THE INSTRUMENT THROUGH THE CANNULA. THERE WAS NO DAMAGE NOTED TO THE CANNULA AFTER THE EVENT OCCURRED. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE, AND IT WAS CONFIRMED VISUALLY THAT NO FRAGMENTS WERE LEFT BEHIND. NO ADDITIONAL SURGICAL PROCEDURE WAS RE

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, A SYNCHROSEAL INSTRUMENT BROKE AND A SMALL PIECE OF PLASTIC FROM THE WRISTED PORTION FELL OFF INSIDE THE PATIENT. THE PIECE WAS SUCCESSFULLY REMOVED DURING THE SAME SURGICAL PROCEDURE. THERE WAS A SLIGHT DELAY IN PROCEDURAL TIME. THE CUSTOMER REPLACED THE SYNCHROSEAL INSTRUMENT WITH ANOTHER SYNCHROSEAL INSTRUMENT. THE PROCEDURE WAS COMPLETED ROBOTICALLY. THE SYNCHROSEAL INSTRUMENT WAS INSPECTED PRIOR TO USE, AND NOTHING WAS NOTED. THE EVENT OCCURRED WHILE THE SURGEON WAS GRASPING AND DISSECTING UNSPECIFIED TISSUE. THE INSTRUMENT BROKE IN THE MIDDLE OF THE CASE. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIALS DURING THE SURGICAL PROCEDURE. THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. THERE WAS NO DAMAGE TO THE CANNULA AFTER THE EVENT OCCURRED. THE FRAGMENT WAS RETRIEVED WITH A LAPAROSCOPIC GRASPER. ALL FRAGMENTS WERE RETRIEVED AND THE PIECE THAT BROKE WAS SEEN RIGHT AWAY. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE 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: A LITERATURE ARTICLE DESCRIBED A CASE OF PUBIC OSTEOMYELITIS FOLLOWING DA VINCI-ASSISTED RADICAL PROSTATECTOMY. THE PATIENT INITIALLY UNDERWENT DA VINCI SURGERY FOR PROSTATE CANCER. ONE MONTH AFTER SURGERY, THE PATIENT DEVELOPED LOWER ABDOMINAL PAIN AT REST AND HAD AN ELEVATED CRP LEVEL. THE PATIENT HAD DIFFICULTY WALKING AND WAS ADMITTED TO THE HOSPITAL URGENTLY. ON ADMISSION, X-RAYS AND PLAIN CT SCANS SHOWED SEPARATION OF THE PUBIC SYMPHYSIS. MRI SHOWED BONE MARROW EDEMA, SO POSTOPERATIVE PUBIC INFECTION WAS SUSPECTED. BLOOD CULTURES WERE NEGATIVE, BUT E. COLI WAS DETECTED IN A PUBIC PUNCTURE SPECIMEN. ANTIBIOTIC TREATMENT WITH CEFTRIAXONE AND ST COMBINATION WAS INITIATED. CRP GRADUALLY DECREASED AND BECAME NEGATIVE AFTER APPROXIMATELY SIX MONTHS. CONSERVATIVE FOLLOW-UP SHOWED THAT THE PUBIC SYMPHYSIS DISTANCE HAD INCREASED TO 10.8 MM SIX MONTHS AFTER THE START OF TREATMENT AND THE PAIN HAD DISAPPEARED. NO RESIDUAL SYMPTOMS WERE OBSERVED. THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS REPORTED, NOR DID THE AUTHOR ALLEGE THAT ISI PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENT. INTUITIVE SURGICAL INC. (ISI) HAS MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION; HOWE

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 PROCEDURE THE PHYSICIAN WAS UNABLE TO TURN THE BRONCHOSCOPE ON AFTER REMOVING THE SCOPE FROM THE PATIENT'S TRACHEA DUE TO THE CAMERA IMAGE BEING GRAINY AND ULTIMATELY GOING BLACK. THE PHYSICIAN 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 REVIEW OF A LITERATURE ARTICLE, "ONE HUNDRED AND FIFTY-TWO ROBOTIC HEPATECTOMIES AT A NORTH AMERICAN HEPATOBILIARY PROGRAM: EVOLUTION OF PRACTICE, LEARNING CURVE, APPRAISAL OF OUTCOMES, AND COST ANALYSIS" WAS PERFORMED. A RETROSPECTIVE ANALYSIS OF ALL HEPATECTOMIES (N=334) WAS PERFORMED AT AN INSTITUTION BETWEEN JANUARY 2018 TO JANUARY 2023. THIS INCLUDED 164 OPEN, 18 LAPAROSCOPIC, AND 152 ROBOTIC HEPATECTOMIES. THE ARTICLE NOTED THAT DURING THESE DA VINCI SURGERIES, THERE WAS 1 CASE IN THE ROBOTIC GROUP THAT WAS CONVERTED TO OPEN SURGERY DUE TO BLEEDING DURING A PARENCHYMAL TRANSECTION. THIS WAS A CONTROLLED CONVERSION WITH UPPER MIDLINE LAPAROTOMY AND THE PATIENT OTHERWISE RECOVERED UNEVENTFULLY AND WAS DISCHARGED HOME ON POST-OPERATIVE DAY 4. THERE WERE NO SPECIFIC DA VINCI MALFUNCTIONS REPORTED, NOR DID THE AUTHOR ALLEGE THAT INTUITIVE SURGICAL, INC. (ISI) PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENT. INTRA AND POST-OPERATIVE EVENT AND LENGTH OF STAY WERE SIGNIFICANTLY LOWER IN THE ROBOTIC GROUP. ROBOTIC HEPATECTOMY HAD SIGNIFICANTLY HIGHER TEXTBOOK OUTCOME AFTER LIVER SURGERY (TOLS) COMPARED TO OPEN HEPATECTOMY (85 PERCENT VERSUS 64 PERCENT, P LESS THAN 0.001).

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A REVIEW OF A LITERATURE ARTICLE TITLED, "LOBECTOMY FOR PRIMARY LUNG CANCER: A COMPARISON OF PERIOPERATIVE AND POSTOPERATIVE OUTCOMES BETWEEN ROBOT-ASSISTED THORACIC SURGERY AND VIDEO-ASSISTED THORACIC SURGERY," (VATS) WAS PERFORMED. THE ARTICLE DISCUSSED A RETROSPECTIVE COHORT STUDY THAT INCLUDED MALE PATIENTS WHO UNDERWENT ROBOT-ASSISTED THORACIC SURGERY (RATS) OR VATS AT A SINGLE CENTER BETWEEN APRIL 2018 AND MARCH 2022. A TOTAL OF 137 PATIENT WERE INCLUDED IN EACH GROUP, RATS AND VATS. THE ARTICLE NOTED THAT DURING THESE DA VINCI SURGERIES, THE INCIDENCE OF PROLONGED POSTOPERATIVE AIR LEAK WAS SIGNIFICANTLY HIGHER IN THE RATS GROUP THAN IN THE VATS GROUP. THERE WERE 13 POSTOPERATIVE AIR LEAKS IN THE RATS GROUP VERSUS 3 IN THE VATS GROUP, RESULTING IN A SIGNIFICANTLY LONGER DURATION OF CHEST TUBE PLACEMENT IN THE RATS GROUP. THE ARTICLE ALSO STATED THAT PULMONARY ARTERY INJURIES ACCOUNTED FOR HALF OF THE INTRAOPERATIVE INJURIES IN THE RATS GROUP AND THAT THE SINGLE CONVERSION TO THORACOTOMY WAS DUE TO PULMONARY ARTERY INJURY. PER THE AUTHOR, THE INJURIES WERE NOT DUE TO THE DA VINCI SYSTEM OR THE INSTRUMENTS, BUT DUE TO THE RATS PROCEDURE AND THAT THE VESSELS WERE SUSCEPTIBLE TO

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: QUICENO, E., SOLIMAN, M. A., KHAN, A., MULLIN, J. P., POLLINA, J. (2025). HOW DO ROBOTICS AND NAVIGATION FACILITATE MINIMALLY INVASIVE SPINE SURGERY? A CASE SERIES AND NARRATIVE REVIEW. NEUROSURGERY, 96(3S). HTTPS://DOI.ORG/10.1227/NEU.0000000000003352 BACKGROUND AND OBJECTIVE: IMAGE GUIDANCE HAS TRANSFORMED MINIMALLY INVASIVE SPINE SURGERY (MISS), ALLOWING FOR SAFER PROCEDURES WITHOUT EXCESSIVE BONY EXPOSURE AND REDUCING RADIATION EXPOSURE FOR THE SURGICAL TEAM. ROBOTIC PLATFORMS HAVE ENHANCED THE BENEFITS OF NAVIGATION BY PROVIDING HIGH PRECISION AND ACCURACY. HERE WE DESCRIBE A CASE SERIES TO DEMONSTRATE THE ACCURACY AND LOW COMPLICATION RATES OF REAL-TIME IMAGE-GUIDED ROBOTIC-ASSISTED (RA) MISS AT A TERTIARY REFERRAL CENTER. IN ADDITION, WE PERFORMED A NARRATIVE REVIEW ONHOW ROBOTICS AND NAVIGATION FACILITATE MISS. METHODS: A RETROSPECTIVE CHART REVIEW WAS CONDUCTED TO OBTAIN DATA FOR PATIENTS WHO UNDERWENT RA LUMBAR FUSIONS WITH REAL-TIME NAVIGATION FOR DEGENERATIVE LUMBAR PATHOLOGY BETWEEN SEPTEMBER 1, 2021, AND JANUARY 1, 2024. THE MAZOR X STEALTH EDITION (MEDTRONIC) ROBOTIC PLATFORM WAS USED. THE ACCURACY OF SCREW PLACEMENT WAS DETERMINED ACCORDING TO GERTZBEIN-ROBBINS CLAS

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 SINGLE PORT (SP) ADRENALECTOMY, THE CUSTOMER CONTACTED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOR PHONE ASSISTANCE REGARDING AN INVALID CANNULA SYSTEM MESSAGE. PRIOR TO CONTACTING THE TSE, THE CUSTOMER ATTEMPTED TO RESEAT THE CANNULA AND CHANGE OUT THE CANNULA. THE TSE REQUESTED THAT A HARD RESTART BE PERFORMED, BUT THE REPORTED COMPLAINT REMAINED. THE ROBOTIC SINGLE PORT WAS ABORTED. THERE WAS A DELAY OF 40 MINUTES ATTRIBUTED TO TRYING TO TROUBLESHOOT THE SP SYSTEM, AND EVENTUALLY A DECISION WAS MADE TO TAKE THE SP SYSTEM OUT AND BRING THE MULTI-PORT XI SYSTEM IN. THE PROCEDURE WAS COMPLETED WITH A XI SYSTEM WITHOUT FURTHER INCIDENT.

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 A PIECE OF THE INSTRUMENT FELL INSIDE THE PATIENT. THE CUSTOMER RETRIEVED THE FRAGMENT USING A ROBOTIC GRASPER DURING THE SAME 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ENUCLEATION OF ESOPHAGEAL TUMOR SURGICAL PROCEDURE, THE JAWS OF THE HARMONIC ACE FELL OFF INTO THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS NOT INSPECTED MORE THOROUGHLY THAN USUAL. NOTHING ABNORMAL WAS NOTED. THE SURGICAL TASK BEING PERFORMED WHEN THE DEVICE FRAGMENTS FELL INSIDE THE PATIENT WAS DISSECTION. THE SURGEON DOES NOT KNOW HOW TO EXPLAIN THE BREAKAGE. HE THOUGHT THAT MANUFACTURING DEFECTS CONTRIBUTED TO THE INSTRUMENT BREAKAGE. THE INSTRUMENT WAS IN USE FOR ABOUT 30 TO 45 MINUTES. JUST BEFORE THE BREAKAGE, THE SURGEON NOTICED A NON-INTUITIVE MOVEMENT, AND THEN WHEN HE OPENED THE JAWS (IN THE AIR), THEY SLOWLY OPENED UNTIL THEY BROKE. THERE WASN¿T ANY SIGNIFICANT COLLISION DURING THE SURGERY. THE FRAGMENT DID NOT FALL INSIDE THE PATIENT DUE TO AN INSTRUMENT TIP OR ACCESSORY COLLISION. THE CUSTOMER COULD NOT RECALL IF THE INSTRUMENT WAS REMOVED PRIOR TO THE BREAKAGE, BUT THE FIRST ASSISTANT WAS HIGHLY EXPERIENCED, AND IT WAS NOT VERY LIKEL

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 FRAGMENT FROM A SYNCHROSEAL INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE WHICH WAS BEING 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY FELL OFF OF THE INSTRUMENT AND INTO THE PATIENT. THE MCS TIP COVER WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE MCS INSTRUMENT AND THE MCS TIP COVER ACCESSORY WERE INSPECTED PRIOR TO USE AND NO DAMAGE WAS NOTED. THE MCS TIP COVER ACCESSORY WAS RETRIEVED WITH A LAPAROSCOPIC GRASPER. IT IS UNKNOWN WHAT SURGICAL TASK WAS BEING PERFORMED WHEN THE MCS TIP COVER FELL INSIDE OF THE PATIENT. THE MCS INSTRUMENT WAS IN USE FOR APPROXIMATELY 30 MINUTES. THE SURGEON DID NOT NOTICE ANY ISSUES WITH FUNCTIONALITY OF THE INSTRUMENT DURING THE PROCEDURE. THE MCS TIP COVER INSTRUMENT DID NOT COLLIDE WITH ANY OTHER HARD MATERIAL OR INSTRUMENTS. IT DID APPEAR THAT THE MCS TIP COVER WAS INSTALLED PROPERLY DURING THE SURGICAL PROCEDURE. THERE WAS NO ORANGE SURFACE VISIBLE AFTER THE MCS TIP COVER WAS INSTALLED. THE COVER WAS NOT INSTALLED BEYOND THE ORANGE SURFACE. THE CUSTOMER INSTALLED THE TIP COVER WITH THE INSTALLATION TOOL. NO ELEC

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A REVIEW OF A LITERATURE ARTICLE TITLED: ¿OPTIMIZING ONCOLOGICAL AND FUNCTIONAL OUTCOMES WITH WIDE RESECTION TECHNIQUES IN ROBOT-ASSISTED RADICAL PROSTATECTOMY FOR VERY HIGH-RISK PROSTATE CANCER: A SINGLE-INSTITUTION RETROSPECTIVE STUDY" WAS PERFORMED. THE ARTICLE HAD MINIMAL INFORMATION REGARDING A PATIENT THAT EXPERIENCED A DEEP VEIN THROMBOSIS (CLAVIEN¿DINDO GRADE III) IN THE POSTOPERATIVE PERIOD. TWO PATIENTS REQUIRED READMISSION, INCLUDING ONE WITH DEEP VEIN THROMBOSIS REQUIRING INFERIOR VENA CAVA FILTER PLACEMENT WITH ANTICOAGULANT THERAPY (GRADE IIIA). THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS REPORTED AND THE AUTHOR REPORTED THAT THE COMPLICATION DESCRIBED IN THE ARTICLE WAS NOT RELATED TO THE DA VINCI PLATFORM.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: I LIVE WITH THE CHIEF TECHNOLOGY OFFICER FOR (B)(4), A DISTRIBUTORSHIP IN THE SOUTHEAST, FOR ZB CORPORATE. I HAVE OVERHEARD BUSINESS CALLS OF HOW THERE IS A PROBLEM WITH THE SOFTWARE ON THE ROBOTS AND THEY HAVE BEEN MAKING INCORRECT CUTS AND INCORRECT PLACEMENT OF IMPLANTS INTO PATIENTS FOR MONTHS. IT¿S A SYSTEM WIDE PROBLEM NOT JUST A FEW ROBOTS, MANY ROBOTS THEY HAVE OVER THE US ARE MALFUNCTIONING AND THEY HAVE YET TO FIGURE OUT THE EXACT CAUSE. IT¿S GONE AS HIGH UP THE CHAIN AS THE CEO BUT NOTHING IS BEING DONE. THEY HAVEN¿T SHUT DOWN USE. THEY JUST KEEP DOING INCORRECT AND IMMORAL SURGERIES ON PATIENTS AND NOT INFORMING THE DOCTORS THAT THEIR ROBOTS ARE THE REASON FOR THE POOR SURGERIES AND RESULTS. THEY HAVE BEEN TRYING TO FIX THE ISSUE AND COVER IT UP SINCE ZB FIRST BECAME AWARE. AS OF RIGHT NOW IT¿S NOT FIXED AND THEY ARE LETTING SURGEONS CONTINUE TO MAKE HARMFUL, PAINFUL IMPLANTS INTO PATIENTS. THEY¿VE FIRED ANYONE THAT CAME CLOSE TO DISCOVERING THE ISSUE. I LIVE WITH THE CHIEF TECHNOLOGY OFFICER FOR (B)(4), THE DISTRIBUTORSHIP FOR ZIMMER BIOMET IN THE SOUTHEAST DIVISION. THE ROSA ROBOT SOFTWARE HAS BEEN MALFUNCTIONING AND MAKING MISCUTS CONSTANTLY AND CAUSING HARM TO PATIE

VELYS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: THE FRACTURE WAS CAUSED BY FAILURE TO CLEAR THE POSTERIOR ASPECT OF THE PS BOX. NETHER THE VELYS CUTS OR THE SAGITTAL SAW CUTS WERE THE BLAME.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: I LIVE WITH THE CHIEF TECHNOLOGY OFFICER FOR (B)(6), A DISTRIBUTORSHIP IN THE SOUTH EAST, FOR ZB CORPORATE. I HAVE OVERHEARD BUSINESS CALLS OF HOW THERE IS A PROBLEM WITH THE SOFTWARE ON THE ROBOTS AND THEY HAVE BEEN MAKING INCORRECT CUTS AND INCORRECT PLACEMENT OF IMPLANTS INTO PATIENTS FOR MONTHS. IT¿S A SYSTEM WIDE PROBLEM NOT JUST A FEW ROBOTS, MANY ROBOTS THEY HAVE OVER THE US ARE MALFUNCTIONING AND THEY HAVE YET TO FIGURE OUT THE EXACT CAUSE. IT¿S GONE AS HIGH UP THE CHAIN AS THE CEO BUT NOTHING IS BEING DONE. THEY HAVEN¿T SHUT DOWN USE. THEY JUST KEEP DOING INCORRECT AND IMMORAL SURGERIES ON PATIENTS AND NOT INFORMING THE DOCTORS THAT THEIR ROBOTS ARE THE REASON FOR THE POOR SURGERIES AND RESULTS. THEY HAVE BEEN TRYING TO FIX THE ISSUE AND COVER IT UP SINCE ZB FIRST BECAME AWARE. AS OF RIGHT NOW IT¿S NOT FIXED AND THEY ARE LETTING SURGEONS CONTINUE TO MAKE HARMFUL, PAINFUL IMPLANTS INTO PATIENTS. THEY¿VE FIRED ANYONE THAT CAME CLOSE TO DISCOVERING THE ISSUE. I LIVE WITH THE CHIEF TECHNOLOGY OFFICER FOR (B)(6), THE DISTRIBUTORSHIP FOR ZIMMER BIOMET IN THE SOUTHEAST DIVISION. THE ROSA ROBOT SOFTWARE HAS BEEN MALFUNCTIONING AND MAKING MISCUTS CONSTANTLY AND CAUSING HARM TO PATI

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY FELL OFF OF THE INSTRUMENT AND INTO THE PATIENT. THE MCS TIP COVER WAS RETRIEVED DURING THE SAME PROCEDURE. 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 MCS TIP COVER ACCESSORY WAS REMOVED WITH A LAPAROSCOPIC GRASPER. IT IS UNKNOWN WHAT SURGICAL TASK WAS BEING PERFORMED AT THE TIME OF THE MCS TIP COVER ACCESSORY FALLING INTO THE PATIENT. THE MCS INSTRUMENT WAS IN USE APPROXIMATELY FOR 30 MINUTES WHEN THE ISSUE OCCURRED. THE SURGEON DID NOT NOTICE ANY ISSUE WITH THE FUNCTIONALITY OF THE MCS INSTRUMENT DURING THE SURGICAL PROCEDURE. THE MCS INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS DURING THE PROCEDURE. THE MCS TIP COVER ACCESSORY APPEARED TO BE PROPERLY INSTALLED DURING THE SURGICAL PROCEDURE. THE ORANGE SURFACE WAS NOT VISIBLE AFTER THE MCS CHEAP ACCESSORY WAS INSTALLED. THE MCS TIP COVER ACCESSORY WAS NOT INSTALLED BEYOND THE ORANGE SURFACE. 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 SURGICAL PROCEDURE, A REPEATED NON-RECOVERABLE ERROR OCCURRED. THE SITE RECEIVED PHONE ASSISTANCE FROM AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE). THE SITE POWER CYCLED THE SYSTEM, BUT THE ERROR WAS NOT RESOLVED. THE TSE HAD THE SITE PERFORM A HARD POWER CYCLE OF THE SYSTEM, BUT A SYSTEM MESSAGE APPEARED STATING THAT THE PATIENT SIDE CART (PSC) WAS RUNNING ON BATTERY. THE TSE HAD THE SITE MOVE THE POWER CORDS AND VERIFY POWER. THE SITE CONFIRMED THAT THE OUTLET HAD POWER AND MOVED THE POWER CORD AGAIN; HOWEVER, ANOTHER ERROR APPEARED AFTER THAT. THE SURGEON CONVERTED TO LAPAROSCOPIC SURGERY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PORT WAS PLACED ON THE PATIENT WHEN THE ISSUE WAS IDENTIFIED. SINCE THE PROCEDURE WAS A SINGLE PORT, THE CONVERSION RESULTED IN INCREASING PORT SIZE INCISION, AND ADDITIONAL PORTS WERE ADDED.

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 RECTAL RESECTION AND AMPUTATION PROCEDURE, BLACK DEBRIS WAS FOUND INSIDE THE PATIENT'S BODY. AFTER REMOVAL OF A FORCEPS INSTRUMENT, IT WAS DISCOVERED THAT A PART OF THE UNIVERSAL SEAL WAS DAMAGED. THE CUSTOMER STATED TWO BLACK OBJECTS WERE FOUND IN THE PATIENT'S BODY CAVITY AND WERE RETRIEVED DURING THE SAME SURGICAL PROCEDURE. A BACKUP UNIVERSAL SEAL WAS USED TO PROCEED WITH THE PROCEDURE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED CHOLECYSTECTOMY PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY FELL INSIDE OF THE PATIENT. A PATIENT HAD UNDERGONE A CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2025. THE PROCEDURE WENT GREAT WITHOUT ANY ISSUES. THE PATIENT WAS RELEASED FROM THE HOSPITAL AFTER THE PROCEDURE. ABOUT A WEEK LATER, THE PATIENT CAME BACK COMPLAINING OF NAUSEA AND VOMITING. MAGNETIC RESONANCE IMAGING (MRI) WAS PERFORMED, AND A MCS TIP COVER ACCESSORY WAS IDENTIFIED. THE SURGEON PERFORMED A LAPAROSCOPIC PROCEDURE AND WAS ABLE TO REMOVE THE TIP COVER. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INITIAL REPORTER HAS SPOKEN WITH THE SURGEON ABOUT THIS TO UNDERSTAND MORE. NO ROBOTIC MSC INSTRUMENT WAS USED DURING THIS CASE AS NONE WERE AVAILABLE ON THAT DATE; HOWEVER, PER THE PREFERENCE CARD THE TEAM OPENED A MSC TIP COVER ACCESSORY EXPECTING TO HAVE AN MCS AVAILABLE. THE ONLY ROBOTIC INSTRUMENTS CAPTURED AS HAVING BEEN USED WERE THE PERMANENT CAUTERY HOOK (PCH), CADIERE FORCEPS, LARGE CLIP APPLIER, ENDOSCOPE, AND A GRASPER. LAPAROSCOPIC SCISSORS WERE USED DURING THE CASE.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: BIRCH, C., WELCH, N., COOK, D., HEDEQUIST, D. (2025). INSTRUMENTATION USING ROBOTICS COUPLED WITH NAVIGATION IN PEDIATRIC SP INE DEFORMITY SURGERY: A TECHNICAL REPORT OF SACROPELVIC INSTRUMENTATION. SPINE DEFORMITY. HTTPS://DOI.ORG/10.1007/S43390-025-01047-6. PURPOSE: THIS TECHNICAL REPORT PRESENTS THE INTRAOPERATIVE EXPERIENCE OF USING ROBOTIC ASSISTED NAVIGATION (RAN) FOR SACRO-PELVIC INSTRUMENTATION IN PEDIATRIC SPINE DEFORMITY SURGERY. METHODS: A RETROSPECTIVE REVIEW OF PATIENTS WHO UNDERWENT SURGERY USING RAN FOR SACROPELVIC INSTRUMENTATION AT A SINGLE INSTITUTION FROM 2019 TO 2022 WAS CONDUCTED. IN CASES WITH SCREW CONFIRMATION IMAGING, SCREWS WERE EVALUATED USING THE GERTZBEIN AND ROBBINS CLASSIFICATION SCALE. RESULTS: 52 CASES WERE INCLUDED. AVERAGE AGE AT SURGERY WAS 14.1 YEARS AND 67.3% OF PATIENTS WERE FEMALE. THE MOST COMMON DIAGNOSIS WAS SPONDYLOLISTHESIS (48.1%). THE AVERAGE MAJOR CURVE IN SCOLIOSIS CASES WAS 77°. A SCHANZ PIN IN THE POSTERIOR SUPERIOR ILIAC SPINE WAS PLACED IN 98.1% OF SURGERIES COMPARED TO 1 CASE WITH A SPINOUS PROCESS CLAMP. INTRAOPERATIVE 3D IMAGING SCANS (SCAN/PLAN) WERE USED FOR 69.2% OF THE ROBOTIC REGISTRATIONS TO THE PATIENT AND INTRAOPERATIV

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 INSTRUMENT FRACTURED AND A FRAGMENT FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. AT THE TIME THE EVENT OCCURRED, THE SURGEON WAS PERFORMING SEPARATION. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT AND NO POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRASOUND WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH A BACKUP HARMONIC ACE INSTRUMENT. 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 H11 FOR FOLLOW-UP INFORMATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE INSTRUMENT ON THE UNIVERSAL SURGICAL MANIPULATOR (USM) 3 WAS NOT RECOGNIZED. THE CUSTOMER INFORMED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) THAT USM 3 HAD A CAUTERY SPATULA THAT WAS IN USE WHEN THE USM ERRORED WITH THE MESSAGE "INSTRUMENT NOT RECOGNIZED". THE CUSTOMER MADE MULTIPLE ATTEMPTS TO RESEAT THE INSTRUMENT WITH NO CHANGE. THE STAFF THEN SWAPPED THE INSTRUMENT WITH A SPARE SPATULA, BUT THE ISSUES REMAINED. THE CUSTOMER STATED THAT THE ROBOTIC PROCEDURE WAS ALMOST COMPLETE BUT OPTED TO CONVERT TO OPEN TO COMPLETE THE CASE. THE TSE REVIEWED MULTIPLE ERRORS ON USM 3 AND ASKED IF THE STAFF RESEATED THE STERILE ADAPTER. THE CUSTOMER WAS NOT SURE ABOUT THE COMPLETE TROUBLESHOOTING STEPS TAKEN AND REQUESTED A FOLLOW-UP FROM THE FIELD SERVICE ENGINEER (FSE). THE CUSTOMER CONTINUED WITH AN OPEN 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: INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA MEDWATCH REPORT (MDR) WITH MDR REPORT #MW5165586 STATING: ROBOTIC HARMONIC INSTRUMENT BROKE INSIDE THE PATIENT'S ABDOMEN DURING PROCEDURE. THE PIECE THAT BROKE OFF WAS LOCATED AND REMOVED FROM THE PATIENT. THERE WERE NO NOTED INJURIES. ROBOTIC HARMONIC WAS REPLACED.

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.

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

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 PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, A SMALL GREY PIECE OF MATERIAL WAS NOTICED IN THE PATIENT. THE FRAGMENT WAS REMOVED DURING THE SAME PROCEDURE. AFTER UNDOCKING THE ROBOT, ALL UNIVERSAL SEALS WERE INSPECTED. ONE UNIVERSAL SEAL WAS MISSING A PIECE THAT MATCHED THE MATERIAL THAT WAS RETRIEVED. ALL OTHER SEALS WERE INTACT. NO HARM WAS DONE TO THE PATIENT. THE PROCEDURE WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE. THE PIECE OF MATERIAL WAS NOTICED INSIDE OF THE PATIENT. THE FRAGMENT WAS REMOVED IMMEDIATELY WITH A GRASPER INSTRUMENT THROUGH THE ASSISTANT PORT. THE UNIVERSAL SEAL WAS USED FOR ABOUT 30 MINUTES TO AN HOUR WHEN THE ISSUE OCCURRED. THERE WERE NO FUNCTIONAL ISSUES WITH THE SEAL. THERE WAS NO COLLUSION WITH ANY OTHER INSTRUMENTS OR HARD MATERIALS. INSTRUMENTS WERE EXCHANGED A FEW TIMES THROUGH THE UNIVERSAL SEAL DURING THE PROCEDURE. THE INSTRUMENTS' WRISTS WERE ALWAYS STRAIGHTENED AND NO RESISTANCE FELT. UPON FINAL REMOVAL OF THE INSTRUMENT, THE WRIST WAS STRAIGHTENED. THERE WAS N

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.

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 FROM A SOCIAL MEDIA POST THAT DURING AT LEAST THREE DA VINCI-ASSISTED SURGICAL PROCEDURES, A FRAGMENT FROM A UNIVERSAL CANNULA SEAL FELL INSIDE THE PATIENT. IT IS UNKNOWN IF THE FRAGMENT WAS ALL 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 PROCTECTOMY PROCEDURE, THE 30 DEGREE ENDOSCOPE PLUS WAS LEFT ON THE PATIENT WITH THE LIGHT TURNED ON, CAUSING A 2CM DIAMETER CIRCULAR BURN ON THE PATIENT'S THIGH. THE ENDOSCOPE REMAINED ON THE PATIENT FOR APPROXIMATELY 15-20 MINUTES WHILE NOT IN USE, CAUSING THE DRAPE COVERING THE PATIENT TO MELT AND INFLICTING A 1ST TO 2ND DEGREE BURN. THE BURN WAS NOTED WITHOUT CHARRING, BRUISING, OR BLEEDING. THE ONLY MEDICAL TREATMENT ADMINISTERED WAS THE APPLICATION OF BURN OINTMENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT DID NOT EXPERIENCE ANY POST-OPERATIVE COMPLICATIONS.