Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE CLINICAL SPECIALIST REPORTED THAT DURING THE PROCEDURE, THE LIVE CAMERA VIEW ON THE SCOPE SUDDENLY BECAME STATIC AND FUZZY, LEADING TO A LOSS OF VIEW. THE USER SWITCHED SCOPES AND SUCCESSFULLY NAVIGATED TO THE LESION. HOWEVER, WHILE BIOPSYING, AN FAULT OCCURRED, INDICATING DISCONNECTION OF THE SCOPE AND DISABLING OF ROBOTIC FUNCTIONS. DESPITE ATTEMPTS, THE USER COULDN'T TURN THE CAMERA BACK ON OR CLEAR THE ERROR. THE CLINICAL SPECIALIST MENTIONED THAT THE ISSUE RECURRED WITH THE SECOND SCOPE DURING BIOPSYING. CONSEQUENTLY, THE PHYSICIAN DECIDED TO END THE PROCEDURE WITHOUT FURTHER BIOPSIES. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT BECAUSE OF THE SCOPE ISSUES.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE CLINICAL SPECIALIST REPORTED THAT DURING THE PROCEDURE, THE LIVE CAMERA VIEW ON THE SCOPE SUDDENLY BECAME STATIC AND FUZZY, LEADING TO A LOSS OF VIEW. THE USER SWITCHED SCOPES AND SUCCESSFULLY NAVIGATED TO THE LESION. HOWEVER, WHILE BIOPSYING, AN FAULT OCCURRED, INDICATING DISCONNECTION OF THE SCOPE AND DISABLING OF ROBOTIC FUNCTIONS. DESPITE ATTEMPTS, THE USER COULDN'T TURN THE CAMERA BACK ON OR CLEAR THE ERROR. THE CLINICAL SPECIALIST MENTIONED THAT THE ISSUE RECURRED WITH THE SECOND SCOPE DURING BIOPSYING. CONSEQUENTLY, THE PHYSICIAN DECIDED TO END THE PROCEDURE WITHOUT FURTHER BIOPSIES. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT BECAUSE OF THE SCOPE ISSUES.

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

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UNILATERAL INGUINAL HERNIA REPAIR SURGICAL PROCEDURE, THE SURGEON FELT A SHOCK PULSING SENSATION IN HIS FOOT WHEN PRESSING THE FOOT PEDAL. THE SURGEON REPORTED WHEN HE PRESSED THE COAGULATION PEDAL, AN IMMEDIATE INTENSE PULSATING SHOCK SENSATION FROM HIS RIGHT GREAT TOE TO HIS HIP, WHEN RELEASING THE PEDAL, IT WOULD STOP WITH NO LINGERING SENSATION AT ALL, OCCURRING APPROXIMATELY 4-5 TIMES DURING THE PROCEDURE. (CLOG SLIP-ON SHOES WERE WORN). THE PROCEDURE WAS CONTINUED WITH THE FENESTRATED BIPOLAR FORCEPS AND NOT THE COAGULATION BUTTON FOR THE REMAINDER OF THE PROCEDURE. THERE IS NO INJURY FROM THIS EVENT AND THE PROCEDURE WAS COMPLETED AS PLANNED.

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

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 CLINICAL ARTICLE WAS CONDUCTED BASED ON A RETROSPECTIVE STUDY EVALUATING THE SAFETY AND FEASIBILITY OF MINIMALLY INVASIVE GASTRECTOMY IN PATIENTS WITH ADVANCED GASTRIC CANCER WHO HAD UNDERGONE PREOPERATIVE CHEMOTHERAPY. THE STUDY, WHICH ANALYZED 150 CASES FROM JANUARY 2009 TO MARCH 2022, FOCUSED ON BOTH DA VINCI ROBOTIC AND LAPAROSCOPIC GASTRECTOMY APPROACHES. THE RESULTS DEMONSTRATED THAT MINIMALLY INVASIVE PROCEDURES, PARTICULARLY ROBOTIC GASTRECTOMY, WERE FEASIBLE AND SAFE, WITH MINIMAL BLOOD LOSS (72 GRAMS) AND MANAGEABLE COMPLICATIONS. NOTABLY, CONVERSION SURGERY WAS PERFORMED IN 41 CASES (27.3%), AND PANCREATIC FISTULA WAS THE MOST COMMON COMPLICATION, OCCURRING IN 11 PATIENTS. POSTOPERATIVE COMPLICATIONS (GRADE > OR = 3A) WERE OBSERVED IN 18 PATIENTS. THE STUDY ACKNOWLEDGED LIMITATIONS, INCLUDING ITS RETROSPECTIVE DESIGN, SMALL SAMPLE SIZE, AND SHORT FOLLOW-UP PERIOD. OVERALL, ROBOTIC GASTRECTOMY SHOWED POTENTIAL FOR IMPROVED SURGICAL SAFETY, ESPECIALLY IN COMPLEX CASES INVOLVING SPLENECTOMY, AND FURTHER INVESTIGATION IS NEEDED TO REFINE TREATMENT STRATEGIES AND ASSESS LONG-TERM OUTCOMES. THE RESEARCHERS DID NOT REPORT ANY SPECIFIC MALFUNCTIONS OR INJURIES RELA

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING A DIAGNOSTIC MONARCH BRONCHOSCOPY, THE PHYSICIAN BIOPSIED SAMPLES AT THE RIGHT UPPER LOBE (RUL) 3CM FROM THE TARGET. AS THE PHYSICIAN REPOSITIONED THE BRONCHOSCOPE, A ROBOTIC ARM FAULT STATE OCCURRED. THE PHYSICIAN WAS NOT ABLE TO GET ALL OF HIS BIOPSIES DUE TO THIS FAULT CONDITION AND ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT BECAUSE OF THE SYSTEM ISSUES.

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

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT THE PATIENT EXPERIENCED A PNEUMOTHORAX MEDIASTINAL. NO MEDICAL INTERVENTION WAS REQUIRED. HOWEVER, THE PATIENT WAS HOSPITALIZED DUE TO OTHER MEDICAL ISSUES, FOR OBSERVATION ONLY UNRELATED TO MONARCH DEVICE. THERE WERE NO FAULTS OR ISSUES REPORTED WITH THE MONARCH SYSTEM AND THE PHYSICIAN IS NOT ATTRIBUTING THE EVENT TO THE MONARCH.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PROCEDURE WAS A L3-5 OPEN/MIDLINE RIGHT TLIF USING A PRE-OP CT WORKFLOW. 9' FLOURO FIXTURE WAS USED WITH A OEC 9900 ELITE C ARM. SURGEON IDENTIFIED A MEDIAL BREACH OF THE RIGHT L3 SCREW.

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

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 PROCEDURE, A PLASTIC PART OF THE SYNCHROSEAL INSTRUMENT FELL INSIDE THE PATIENT. THE CUSTOMER WAS ABLE TO RETRIEVE THE FRAGMENT DURING THE SAME PROCEDURE. THE CUSTOMER USED AN UNSPECIFIED BACKUP INSTRUMENT TO CONTINUE COMPLETING THE PROCEDURE AS PLANNED.

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

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) HAS REVIEWED AN ARTICLE THAT COMPARED THE FEASIBILITY AND SAFETY OF THE REVO-I ROBOT SYSTEM TO DA VINCI SURGICAL SYSTEMS FOR ROBOT-ASSISTED PANCREATICODUODENECTOMIES (RPD) AND THE FOLLOWING COMPLICATIONS WERE MENTIONED: A TOTAL OF 10 PATIENTS UNDERWENT REVO-I ROBOT ASSISTED RPD AND A TOTAL OF 37 PATIENTS UNDERWENT DA VINCI ASSISTED RPD BETWEEN MARCH 2017 AND AUGUST 2020. THERE WAS NO STATISTICAL DIFFERENCE IN THE INTRAOPERATIVE BLOOD LOSS BETWEEN THE TWO GROUPS, BUT THERE WAS ONE CASE OF INTRA-OPERATIVE TRANSFUSION REQUIRED IN THE DA VINCI GROUP. THE DA VINCI GROUP HAD TWO CASES OF CLAVIEN-DINDO GRADE IIIB COMPLICATIONS THAT REQUIRED REOPERATION. ONE PATIENT WAS READMITTED DUE TO INTESTINAL OBSTRUCTION AND UNDERWENT ADHESIOLYSIS AND BYPASS SURGERY, WHILE THE OTHER PATIENT HAD A DRAINAGE CATHETER ISSUE THAT REQUIRED FOREIGN BODY REMOVAL UNDER GENERAL ANESTHESIA. THERE WAS NO SIGNIFICANT DIFFERENCE IN THE POSTOPERATIVE PANCREATIC FISTULA (POPF) RATE BETWEEN THE TWO GROUPS. SEVEN PATIENTS IN THE DA VINCI GROUP WERE READMITTED, INCLUDED THE ONE PATIENT PREVIOUSLY MENTIONED AS REQUIRING REOPERATION, ONE PATIENT WITH EPIGASTRIC DISCOMFORT, AND FIVE PATIENTS

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 DIAGNOSTIC MONARCH BRONCHOSCOPY PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY WHILE DRIVING THROUGH THE BRONCHIAL ANATOMY TO THE TARGET LOCATION IN THE RIGHT UPPER LOBE (RUL). THE PATIENT ANATOMY REQUIRED THE BRONCHOSCOPE TO MANEUVER THROUGH A DIFFICULT/TIGHT SHARP TURN. THE MONARCH SYSTEM PRODUCED MULTIPLE FAULT CODES. THE PHYSICIAN WAS NOT ABLE TO REACH THE TARGET AND ELECTED TO ABORT THE DIAGNOSTIC PROCEDURE. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT BECAUSE OF THE SYSTEM ISSUES.

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

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 SUMMARIZED THE PRELIMINARY EXPERIENCE OF USING THE DA VINCI SURGICAL SYSTEM FOR ROBOT BREAST SURGERY (RBS) WAS PERFORMED. THE STUDY ANALYZED 151 PATIENTS UNDERGOING RBS BETWEEN SEPTEMBER OF 2022 TO JANUARY OF 2025. A TOTAL OF 40 PATIENTS UNDERWENT BREAST SURGERY USING THE DA VINCI SI SURGICAL SYSTEM AND 137 PATIENTS UNDERWENT BREAST SURGERY USING THE DA VINCI XI SURGICAL SYSTEM. A TOTAL OF 10 PATIENTS EXPERIENCED COMPLICATIONS INCLUDING THE FOLLOWING: 1 PATIENT EXPERIENCED AN INFECTION DUE TO SKIN BURNS AND LOST THE PROSTHESIS, 7 PATIENTS HAD PERIOPERATIVE SKIN REDNESS AND SWELLING WHICH IMPROVED AFTER TOPICAL NITROGLYCERIN OINTMENT WAS ADMINISTERED, AND 2 PATIENTS WERE DISCHARGED FROM THE HOSPITAL WITHOUT DISINFECTION AND DRESSING CHANGE OF THE DRAINAGE TUBE, RESULTING IN THE LOSS OF THE RETROGRADE INFECTION PROSTHESIS. NO DEVICE MALFUNCTIONS WERE REPORTED, AND THE AUTHORS DID NOT REPORT ANY EVENTS CAUSED BY ANY INTUITIVE SURGICAL, INC. (ISI) DEVICE. ISI FOLLOWED UP WITH THE INITIAL REPORTER TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO RESPONSE HAS BEEN RECEIVED AT THE TIME 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 RADICAL TONSILLECTOMY SURGICAL PROCEDURE THAT A YELLOW CIRCLE OCCURRED WHEN INSTALLING THE CAMERA. THE CALLER STATED THAT THEY REMOVED THE CAMERA TO PERFORM A CERTAIN PART OF THE CASE, AND WHEN REINSTALLING THE CAMERA IN THE PATIENT SIDE CART (PSC), THE IMAGE HAD A YELLOW CIRCLE. THE INTUITIVE TECHNICAL SUPPORT ENGINEER (TSE) FOUND NO RELATED ERRORS IN THE SYSTEM LOGS. THE ISI TSE SUGGESTED TO RESEAT THE STERILE ADAPTER. THE CALLER STATED THEY ALREADY PERFORMED THAT. THE ISI TSE SUGGESTED TO REPLACE THE CAMERA, AND IF NO CHANGE, TO RE-DRAPE OR HARD POWER CYCLE THE SYSTEM. THE CALLER STATED THAT THE SURGEON WAS GOING TO BE DONE WITH THE SYSTEM AND WOULD BE COMPLETING THE CASE MANUALLY. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY. 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 TRANSTHORACIC ESOPHAGECTOMY - CHEST ANASTOMOSIS SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT WAS FOUND TO HAVE A BROKEN TIP. THE CUSTOMER USED A SPARE INSTRUMENT TO CONTINUE WITH THE PROCEDURE. A FRAGMENT FROM THE INSTRUMENT REPORTEDLY FELL INSIDE THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. INTUITIVE SURGICAL, INC (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE INSTRUMENT FUNCTIONALITY WAS INSPECTED BEFORE USE WITH NOTHING FOUND OUT OF THE ORDINARY. THE EVENT OCCURRED WHILE THE SURGEON WAS DISSECTING AND AFTER ACTIVATING THE HARMONIC ACE INSTRUMENT TO ONCE. THE SURGEON DID NOT NOTICE FUNCTIONALITY ISSUES DURING THE SURGICAL PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR HARD MATERIAL. THE INSTRUMENT WAS NOT REMOVED BEFORE BRAKEAGE. THE WRIST WAS STRAIGHTENED. THE STAFF DID NOT FEEL RESISTANCE DURING REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. THERE WAS NO DAMAGE NOTED TO THE CANNULA. ALL FRAGMENTS WERE CONFIRMED TO BE RETRIEVED VISUALLY IN THE SAME PROCEDURE. NO ADDITIONAL SURGICAL PROCEDURES WERE DONE TO REMOVE

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 02/26/2024, INTUITIVE SURGICAL, INC. (ISI) RECEIVED MW5151229 STATING: "SMALL SCREW FROM DAVINCI SYNCHROSEAL FELL OFF INSIDE PATIENT. SURGEON REMOVED SCREW IMMEDIATELY. DAVINCI REP MADE AWARE. DEVICE REMOVED FROM THE FIELD."

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AFTER MAKING TRACKS IN L4-R, L3-R, L2-R AND L1-R, SURGEON WAS ABOUT TO USE BUR IN T12-R AND HE OBSERVED THAT THE BUR POSITION IS NOT RIGHT AS PER THE ANATOMY AND THE PLANNED TRAJECTORY WHILE THE POSITIONING OF THE ARM WAS GOOD ON THE SCREEN. WE ASKED SURGEON TO CHECK THE ACCURACY BY USING AN INSTRUMENT AND T10-T12 LEVELS WERE NOT ACCURATE WHILE THE LUMBER AREA WAS ACCURATE. THERE WAS NOT ANY DRB/SURVEILLANCE SHIFT WARNING ON THE SYSTEM.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A PATIENT WHO WAS ENROLLED IN A CLINICAL STUDY UNDERWENT A DA VINCI ASSISTED LOW ANTERIOR RESECTION WHICH A TEMPORARY ILEOSTOMY WAS PLACED IN THE LOWER RIGHT ABDOMEN. THE PROCEDURE WAS COMPLETED WITHOUT ANY REPORTED DA VINCI DEVICE MALFUNCTIONS OR ANY COMPLICATIONS. NO SIGNS OR SYMPTOMS OF BOWEL OBSTRUCTIONS HAVE BEEN REPORTED. THE PATIENT WAS FOUND WITH NARROWING OF THE ANUS THREE MONTHS LATER, AND AN OUTPATIENT PROCEDURE WAS PERFORMED. TWO MONTHS LATER, THE PATIENT WAS SCHEDULED FOR AN ILEOSTOMY TAKEDOWN BUT WAS FOUND WITH ANASTOMOSIS SITE NARROWING FROM THE PRE-PROCEDURAL COLOSCOPY. A SPHINCTEROTOMY WAS PERFORMED FOR THE ANAL STENOSIS ON AND THE PATIENT HAS BEEN REPORTED AS DOING WELL POST-PROCEDURALLY. THE STUDY INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE DA VINCI DEVICES NOR 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 DA VINCI-ASSISTED NIPPLE AREOLAR SKIN SPARING MASTECTOMY, SENTINEL LYMPH NODE BIOPSY, AND LEFT BREAST RECONSTRUCTION WITH DEEP INFERIOR EPIGASTRIC PERFORATOR FLAP PROCEDURES, THE PATIENT PRESENTED WITH SYMPTOMS OF INFECTION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITH NO COMPLICATIONS ON POSTOPERATIVE DAY 6. ON POSTOPERATIVE DAY 9, THE PATIENT PRESENTED WITH A FEVER OF 38 DEGREES CELSIUS OR HIGHER, SWELLING, HEAT, AND REDNESS IN THE LEFT BREAST, AND AN INCREASE IN THE AMOUNT OF DRAINAGE BY 3 TIMES WITH THE JACKSON-PRATT (JP) DRAIN. INTRAVENOUS (IV) ANTIBIOTICS WERE ADMINISTERED AFTER BLOOD, DRAINAGE FLUID, AND URINE CULTURES WERE PERFORMED IN THE EMERGENCY ROOM (ER) UNDER SUSPICION OF A POSTOPERATIVE INFECTION; MODERATE STAPHYLOCOCCUS AUREUS BACTERIA WERE FOUND IN THE DRAINAGE FLUID, AND NO BACTERIA WERE IDENTIFIED IN THE BLOOD OR URINE. THE INFECTION WAS CONFIRMED VIA A CHEST COMPUTED TOMOGRAPHY (CT), AND THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH A WOUND INFECTION IN THE LEFT BREAST. IN ADDITION TO IV ANTIBIOTICS, THE PATIENT ALSO UNDERWENT A HEMATOMA EVACUATION SURGERY AT THIS TIME; THE HEMATOMA WAS LOCATED BELOW THE NIPPLE OF THE LEFT BREAST.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: HELLO, THIS IS CONCERNING A DEFECTIVE MEDICAL DEVICE. THE DEVICE: THE MONARCH. MY PULMONOLOGIST USED IT AS HE HAD DONE WITH THE OTHER 300 PATIENTS BEFORE ME, TO PLACE A MARKER IN MY LUNG. I HAVE A POSSIBLE MALIGNANT NODULE. THE SURGEON WENT IN TO TAKE OUT THE NODULE BUT COULD NOT FIND IT. THE MARKER WAS IN THE WRONG PLACE!!! MY PULMONOLOGIST CALLED MONARCH BUT GOT NOWHERE. HE DID FIND OUT THEY HAD RECENTLY DID A SOFTWARE UPDATE. SOMETHING WAS DEFECTIVE IN THE MONARCH DEVICE USED. MY DOCTOR PUT IN A COMPLAINT WITH THE FDA. ANOTHER PROVIDER AT THE LUNG CLINIC, ALSO HAD A MALFUNCTION WITH THE MONARCH ON A RECENT PATIENT. HE ALSO REPORTED TO THE FDA. MY PULMONOLOGIST AND IS GROUP WILL BE TALKING WITH THE HOSPITAL ABOUT THIS DEVICE AND IF THEY SHOULD CONTINUE TO USE IT OR CHANGE TO SOMETHING ELSE. THE MONARCH MALFUNCTION HAS DERAILED EVERYTHING WITH MY CARE REGARDING GETTING THIS NODULE REMOVED. I HAVE SO MUCH INFLAMMATION SINCE THE SURGERY THAT I MUST WAIT UNTIL JUNE FOR ANOTHER CT (COMPUTED TOMOGRAPHY) TO CHECK ON THE NODULE. OVER (B)(6) IN DOCTOR BILLS AND A SURGERY THAT I SHOULD NOT HAVE HAD BECAUSE OF THE DEFECT. **PROCEDURE OCCURRED AT (B)(6) OPERATING ROOM. THANK YOU, (B)(6). I H

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE SURGEON WAS CHECKING THE FIRST TRAJECTORY OF A BILATERAL ANTERIOR NUCLEUS OF THE THALAMUS DEEP BRAIN STIMULATION CASE. THE TRAJECTORY DEVIATED FROM THE PLAN BY AT LEAST 2.5MM, SLIGHTLY MORE DEVIATED AT THE TARGET THAN THE ENTRY POINT. THE SURGEON CONTINUED ON TO THE SECOND TRAJECTORY. WHEN THE SECOND TRAJECTORY (RIGHT) POSITIONING WAS CHECKED WITH AN O-ARM SPIN, IT WAS NOTED THE FIRST TRAJECTORY (LEFT) WAS SHALLOWER AND EXTREMELY DEVIATED INTO THE VENTRICLE. THE SURGEON TRIED TO PLACE THE ELECTRODE BACK IN POSITION, DRIVING TO THE LEFT TRAJECTORY AGAIN. THE SURGEON ALSO TRIED TWO DIFFERENT TRAJECTORIES, ONE IN THE LATERAL HOLE OF THE STARDRIVE MICRODRIVE BEN-GUN AND ANOTHER NEW ROSA TRAJECTORY. THE FINAL TRAJECTORY WAS STILL DEVIATED FROM THE INTENDED TARGET BUT SURGEON CONTINUED ON AND CLOSED UP. THE SURGEON HAS SINCE DECIDED TO REPLACE THE LEFT ELECTRODE AT A LATER DATE. CASE END WAS DELAYED SEVERAL HOURS. SURGEON MENTIONED IT APPEARED THE CANNULA PUSHED THE BRAIN TO THE SIDE INSTEAD OF PIERCING THROUGH TISSUE AFTER GOING THROUGH THE LEFT VENTRICLE. THEN ONCE THE CANNULA WAS REMOVED THE ELECTRODE FLOATED INTO THE VENTRICLE. THE REVISION TO REPLACE THE LEFT ELECTRODE WAS PERFO

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) REVIEWED A JOURNAL ARTICLE THAT DESCRIBES A PROSPECTIVE SINGLE-CENTER COHORT STUDY THAT WAS PERFORMED. THE AIM OF THE STUDY WAS TO REVIEW THE FIRST 100 PATIENTS IN THE IMPLEMENTATION PHASE OF A NEW DA VINCI ROBOTIC LIVER SURGERY PROGRAM IN THEIR INSTITUTION TO ASSESS THE USE OF THE IWATE DIFFICULTY SCORES IN PREDICTING SURGICAL DIFFICULTY AND POSTOPERATIVE COMPLICATIONS. THE CONCLUSION OF THE STUDY FOUND THAT THE IWATE CATEGORIES HAD THE ABILITY TO PREDICT BOTH THE DIFFICULTY OF SURGERY AS WELL AS POSTOPERATIVE OUTCOMES WHEN ASSESSING THE COMPLEXITY OF ROBOTIC LIVER SURGERY, WHICH MAY AID IN APPROPRIATE PATIENT SELECTION. THE STUDY OCCURRED FROM NOVEMBER 2020 TO JANUARY 2023. THE ARTICLE NOTED THAT MAJOR LIVER RESECTIONS WERE PERFORMED IN 17% OF CASES, WHILE ATYPICAL RESECTIONS WERE THE MOST COMMON AT 49%, WITH THE REMAINING BEING ANATOMICAL SEGMENTECTOMIES (17%) AND LEFT LATERAL SECTIONECTOMIES (13%). THE MEDIAN BLOOD LOSS WAS 300 ML, AND 22 (22%) PATIENTS RECEIVED PERIOPERATIVE BLOOD TRANSFUSIONS. CONVERSION TO OPEN SURGERY OCCURRED IN 6% OF CASES DUE TO INTRAOPERATIVE BLEEDING TENDENCY (3 CASES), VASCULAR INFILTRATION (2 CASES), AND ADHESIONS (1 CA

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IN BETWEEN CASES SYSTEM FLAGGED ANOTHER "BUMP ERROR", THIS HAS HAPPENED 2 DAYS AFTER THE SITE HAD ANOTHER BUMP ERROR. THIS WAS RESOLVED VIA ACCURACY TEST PASS. SITE HAVE BEEN VIGILANT AND ASSURED ME THAT NO-ONE HAD IMPACTED THE CAMERA AND THE WARNING RANDOMLY APPEARED WHEN PREPPING FOR THE SECOND CASE.

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 WHILE USING THE NEW 5.1.1 SOFTWARE, THE NAVIGATION WAS SHOWING THE SCREW HIT THE BULLSEYE DEPTH, BUT THE SCREW WAS STILL PROUD. THE SURGEON CHECKED THE DEPTH WITH A PROBE AND BELIEVED IT WAS AT 40MM DEEP, INSTEAD OF 50 MM DEEP. THE SNAPSHOT WAS REDONE TO MAKE SURE ACCURACY WAS GOOD. THE SITE TOUCHED THE LAMINA WITH THE PASSIVE PLANAR PROBE AND THE SYSTEM SHOWED THAT IT WAS 5-10 MM PAST WHERE IT WAS LOCATED. AN ACCURACY CHECK ON THE DIVOT OF THE ARM GUIDE WAS MATCHING. THE REGISTRATION WAS REDONE AND THE SITE HAD TO AIRPLANE THE BED TO CONFIRM HOW DEEP THE SCREWS ACTUALLY WERE AND THEY WERE ABLE TO SEE THERE WAS PLENTY OF ROOM LEFT. WHEN AIRPLANING THE BED, THE SITE BELIEVED THE PATIENT ANATOMY SHIFTED SO THE ORIGINAL PILOT HOLE WAS INFERIOR AND MEDIAL. DURING THE LEFT L3 SEGMENT, THE SURGEON B REACHED THE INTERVERTEBRAL CANAL AND CENTRAL CANAL. NEUROMONITORING INDICATED SIGNAL LOSS ON THE LEFT SIDE. DESPITE THE CHALLENGES, THE PATIENT DID REGAIN THE ABILITY TO MOVE THEIR LEGS POST-OPERATION. DURING THE LEFT L3 PART, THE NAVIGATION SYSTEM INDICATED A 5 MM 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: THE STUDY ASSESSED THE IMPACT OF THE DA VINCI SURGICAL SYSTEM ON THYROID SURGERY BY ANALYZING 104 ROBOTIC THYROIDECTOMY CASES PERFORMED FROM MARCH 2018 TO JANUARY 2022. THE SURGERIES UTILIZED BOTH THE SI AND XI MODELS OF THE DA VINCI SURGICAL SYSTEM IN SEQUENCE. THE STUDY AIMED TO DETERMINE IF, AFTER AN INITIAL LEARNING CURVE, THE SYSTEM WOULD REDUCE OPERATIVE TIMES WHILE MAINTAINING LOW COMPLICATION RATES, THEREBY ENHANCING PATIENT CARE. RESULTS SHOWED A DECREASE IN TRANSIENT POSTOPERATIVE COMPLICATIONS, WITH THE INCIDENCE OF VOCAL CORD PALSY FALLING FROM 5.4% IN EARLY CASES TO 1.5% IN LATER CASES. THERE WERE NO REPORTED PERMANENT INJURIES TO THE RECURRENT LARYNGEAL NERVE OR CASES OF PERMANENT HYPOPARATHYROIDISM. EARLY-PHASE ISSUES INCLUDED RARE INSTANCES OF POSTOPERATIVE HEMORRHAGE AND TRACHEAL INJURY. NO ISI- PRODUCTS RELATED MALFUNCTIONS WERE MENTIONED IN THE ARTICLES. THE STUDY CONCLUDED THAT AS SURGEONS GAINED EXPERIENCE, ROBOTIC ASSISTANCE IMPROVED SURGICAL PRECISION AND LED TO CONSISTENT OUTCOMES. HOWEVER, IT NOTED LIMITATIONS SUCH AS THE SMALL SAMPLE SIZE, SHORT FOLLOW-UP DURATION, AND LACK OF COMPARISON WITH OTHER THYROIDECTOMY APPROACHES. ALTHOUGH SURGERY DURATION REDUCE

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: NAGATA, K., GUM, J. L., BROWN, M., DANIELS, C., HINES, B., CARREON, L. Y., GLASSMAN, S. D. (2024). RISK FACTORS FOR MEDIAL BREACH DURING ROBOTIC-ASSISTED CORTICAL BONE TRAJECTORY SCREW INSERTION. WORLD NEUROSURGERY, 184. HTTPS://DOI.ORG/10.1016/J.WNEU.2024.01.168 OBJECTIVE: WE DESCRIBE THE INCIDENCE OF, AND IDENTIFY THE RISK FACTORS FOR, A MEDIAL BREACH OF THE PEDICLE WALL DURING ROBOTIC-ASSISTED CORTICAL BONE TRAJECTORY (RA-CBT) SCREW INSERTION. METHOD: WE ANALYZED A CONSECUTIVE SERIES OF ADULT PATIENTS WHO UNDERWENT RA-CBT SCREW PLACEMENT FROM JANUARY 2019 TO JULY 2022. TO ASSESS THE PEDICLE WALL MEDIAL BREACH, POSTOPERATIVE COMPUTED TOMOGRAPHY (CT) IMAGES WERE ANALYZED. PATIENT DEMOGRAPHIC DATA AND SCREW DATA WERE COMPARED BETWEEN PATIENTS WITH AND WITHOUT A MEDIAL BREACH. THE HOUNSFIELD UNITS (HUS) ON THE L1 MIDVERTEBRAL AXIAL CT SCAN WAS USED TO EVALUATE BONE QUALITY. RESULT: OF 784 CBT SCREWS IN 145 PATIENTS, 30 (3.8%) HAD A MEDIAL BREACH IN 23 PATIENTS (15.9%). ONE SCREW WAS GRADE 2, AND THE OTHERS WERE GRADE 1. PATIENTS WITH A MEDIAL BREACH HAD A LOWER HU VALUE COMPARED WITH THE PATIENTS WITHOUT A MEDIAL BREACH (123.3 VS. 150.5; P [0.027). A MEDIAL BREACH WAS MORE COMMON IN

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

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING THE CLINICAL STUDY TRIAL CASE UNEXPECTED VIDEO QUALITY WAS OBSERVED ON URETEROSCOPE. THE UNEXPECTED VIDEO QUALITY CONSISTED OF BLURRINESS ON THE SYSTEM DISPLAY. THE BLURRY VISION WAS ONLY OBSERVED DURING MINI-PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE OF THE PRODUCT WORKFLOW, NAMELY DURING URETEROSCOPE DRIVING WITH THE LASER DRIVER COMPONENT CONNECTED. UPON REPLACEMENT OF THE URETEROSCOPE, NO FURTHER VIDEO ISSUES WERE OBSERVED AND THE USER COMPLETED THE CASE. UNDER PRELIMINARY INVESTIGATION THE URETEROSCOPE WAS EXAMINED UNDER MAGNIFICATION, AT WHICH TIME IT WAS DISCOVERED THAT THE TOP LAYER OF THE CAMERA LENS WAS MISSING. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT BECAUSE OF THE SYSTEM ISSUES.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY PROCEDURE THE SURGEON MENTIONED THE VESSEL SEALER INSTRUMENT (VSE) WAS NOT WORKING AT ALL. THE CIRCULATING NURSE TRIED TO TROUBLESHOOT THE ISSUE BY UNPLUGGING AND PLUGGING THE CORD OF THE VSE TO THE E100. WHEN SHE WENT TO DO THIS SHE SAW A SPARK AND FELT A SHOCK TO THE VERY PROXIMAL TIP OF THE FIRST DIGIT ON THE RIGHT HAND; ENERGY WAS NOT BEING DELIVERED TO THE VSE AT THIS TIME. AFTER PLUGGING THE CORD BACK INTO THE E100 THE VSE INSTRUMENT BEGAN TO FUNCTION AS NORMAL. THE PROCEDURE WAS COMPLETED AS PLANNED. THE NURSE DESCRIBED THE FEELING AS "A QUICK SHOCK WHEN YOU TOUCH A LIGHT SWITCH." A MARK WAS LEFT SMALLER THAN THE SIZE OF A PENCIL ERASER ON THE TIP/DISTAL PORTION OF FIRST DIGIT; NOW THE SKIN IS PEELING. SHE HAS NO PAIN. SHE DID NOT NEED TO SEE A PHYSICIAN OR MEDICAL TREATMENT DUE TO THE SHOCK EVENT. THE GENERATOR SETTINGS FOR THIS CASE ARE UNKNOWN. NO PHOTOS ARE 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 AN UNSPECIFIED DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT'S BLADE SUDDENLY BROKE AND FELL OFF. A FRAGMENT FROM THE INSTRUMENT FELL INSIDE THE PATIENT AND WAS RETRIEVED IN THE SAME PROCEDURE. THE CUSTOMER USED A SPARE INSTRUMENT TO CONTINUE WITH THE 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 SURGEON CAUSED A TEAR OF THE SPINAL MEMBRANE(DUROTOMY) DUE TO DEVIATED PLACEMENT OF THE LEFT PEDICLE SCREW. THE SURGEON FELT THE CAUSE OF THE DEVIATED SCREW PLACEMENT WAS DUE TO A MALFUNCTION WITH THE GUIDANCE SYSTEM. THE PATIENT'S SPINAL CORD MEMBRANE WAS TORN APART, RESULTING IN SIGNIFICANT PERMANENT INJURIES INCLUDING EPIDURAL HEMATOMA, INTRADURAL COMPRESSIVE FLUID COLLECTION, SEVERED LUMBAR NERVE ROOTS, LOSS OF USE OF LIMBS, FOOT DROP, INCONTINENCE, AND OTHER INJURIES CONSISTENT WITH CAUDA EQUINA SYNDROME. THE PATIENT HAS ALSO EXPERIENCED PAIN AND MENTAL ANGUISH.

VELYS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY SURGICAL PROCEDURE, IT WAS OBSERVED THAT WHILE USING THE ROBOTIC-ASSISTED SOLUTION SATELLITE STATION DEVICE IT WAS NOTICED THAT THE ANTERIOR CUT WAS OFF. IT WAS ALSO REPORTED THAT THE ROBOTIC ASSISTED BASE STATION DEVICE WAS TAKING A LONG TIME TO BOOT UP AND THE POWER CORD WOULD NOT STAY SECURELY ATTACHED TO THE BASE STATION. IT WAS REPORTED THAT THE SYSTEM WAS WORKING HOWEVER THE POWER CORD IS CAUSING FRUSTRATION WITH THE SYSTEM SHUTTING DOWN. THERE WERE NO DELAYS IN THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

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, THE TIP OF THE HARMONIC ACE INSTRUMENT BROKE. THE INSTRUMENT WAS REMOVED AND REPLACED WITH A BACKUP INSTRUMENT. FOLLOWING THIS, THE USER CONTINUED AND COMPLETED THE PROCEDURE WITH NO FURTHER ISSUES. IT IS UNKNOWN IF A FRAGMENT FELL INSIDE THE PATIENT DURING THE PROCEDURE. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE REPORTER CONFIRMED THAT THERE WAS NO PATIENT INJURY. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A POSSIBLE FOREIGN BODY. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH A BACKUP INSTRUMENT. THE REPORTER DID NOT KNOW IF A FRAGMENT FELL INTO THE PATIENT. THE PATIENT UNDERWENT AN X-RAY EXAMINATION, AND NO ISSUE WAS DETECTED. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND THERE WAS NO DAMAGE OR ANYTHING OBSERVED OUT OF THE ORDINARY. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE INSTRUMENT'S FUNCTIONALITY DURING THE SURGICAL PROCEDURE. THE REPORTER WAS NOT AWARE IF THE INSTRUMENT COLLIDED WITH OTHER INSTRU

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 RIGHT UPPER PULMONARY LOBECTOMY PROCEDURE, THERE WAS AN INSUFFICIENT SEAL AFTER USING THE SYNCHROSEAL INSTRUMENT AND BLEEDING OCCURRED. PRIOR TO SEALING THE ASCENDING BRANCH OF THE INTERLOBAR ARTERY TO THE UPPER LOBE (A2), THE "CENTER SIDE" OF THE VESSEL WAS CLIPPED. THEN USING THE SYNCHROSEAL INSTRUMENT TO LIGATE THE A2, A SEAL FUNCTION WAS PERFORMED, FOLLOWED BY A CUT FUNCTION. BLEEDING WAS THEN OBSERVED FROM THE PERIPHERY. THE SURGEON REPORTED WHEN USING THE SYNCHROSEAL FOR THE LIGATION, IT OCCURRED CLOSE TO A STAPLE LINE; AND THAT IT'S POSSIBLE THE INSUFFICIENT SEAL WAS CAUSED BY A METAL-LIKE OBJECT BETWEEN THE INSTRUMENT JAWS. THE BLEEDING WAS REPORTED AS A SMALL AMOUNT ON THE SPECIMEN SIDE, AND WAS RESOLVED BY SUTURE LIGATING THE VESSEL. THE PROCEDURE WAS COMPLETED AND THE PATIENT IS STILL IN THE HOSPITAL, BUT THERE HAVE BEEN NO POST-OPERATIVE COMPLICATIONS.

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 A SURGEON DECIDED TO BRING A PATIENT BACK TO REVISE TWO SCREWS. THE SCOPE WAS TO IMPLANT EIGHT SCREWS FROM L2 TO L5. THE SITE INITIALLY ATTEMPTED TO REGISTER USING CT TO FLUORO, BUT THAT REGISTRATION FAILED SIX TIMES DUE TO THREE TITANIUM CAGES BEING IN THE FIELD OF VIEW AND THE PATIENT BEING VERY LARGE. THE SURGEON EXPECTED TO FAIL THAT REGISTRATION DUE TO THE CAGES IN THE VIEW AND THE PATIENT BEING VERY LARGE. THE SURGEON HAD BEEN SUCCESSFUL IN ACQUIRING A PASSING REGISTRATION IN THIS CIRCUMSTANCE BEFORE WHICH IS WHY THEY KEPT TRYING TO GET A REGISTRATION. AFTER THE SURGEON FELT LIKE THEY HAD GIVEN CT TO FLUORO REGISTRATION A CHANCE, THE SITE RESORTED TO USING SCAN AND PLAN INSTEAD. SCAN AND PLAN REGISTRATION WAS SUCCESSFUL. THE SURGEON INSERTED THE EIGHT SCREWS AND COMPLETED THE CASE. THE SURGEON VERIFIED THE SCREW PLACEMENT AFTER THE CASE USING FLUORO. HOWEVER, THE SURGEON ORDERED A CT OF THE PATIENT AFTER THE CASE, WHICH MADE THEM REALIZE TWO OF THE EIGHT SCREWS WERE TOO SUPERIOR. THE TRAJECTORY WAS DEVIATED 3.5 MM TO 10MM. THE SURGEON THEN DECIDED TO SCHEDULE

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE PATIENT WAS SCHEDULED FOR A LUMBAR FUSION WITH SPINAL INSTRUMENTATION USING COMPUTER NAVIGATION AND ROBOTIC ASSISTANCE USING THE GLOBUS MEDICAL EXCELSIUS 3D IMAGING SYSTEM. I HAD BEEN NOTIFIED BY THE GLOBUS REPRESENTATIVE ON THE MORNING OF SURGERY THAT THERE WAS A POTENTIAL PROBLEM WITH THE BATTERY SUPPLY OF THE GLOBUS IMAGING SYSTEM BUT THAT IT HAD BEEN ADDRESSED BY THE ENGINEERS AND THERE SHOULD BE NO PROBLEM. I WAS TOLD THAT EVEN IF THERE WAS A BATTERY ISSUE THE SYSTEM COULD RUN FROM ELECTRICAL POWER FROM THE WALL. ONCE THE PATIENT WAS ASLEEP AND THE EXPOSURE TO THE SPINE WAS COMPLETE, THE GLOBUS IMAGING SYSTEM WAS BROUGHT IN FOR OBTAINING THE IMAGES. IT IMMEDIATELY SHUT DOWN AND COULD NOT BE RESTARTED. AS A RESULT I WAS UNABLE TO PROCEED WITH THE COMPUTER NAVIGATION OR ROBOTIC ASSISTANCE THAT I HAD EXPLAINED TO THE PATIENT. MY OPTIONS WERE TO EITHER CANCEL THE SURGERY AND CLOSE THE WOUND TO RETURN ANOTHER DAY ONCE THE SYSTEM WAS WORKING OR PROCEED WITHOUT THE NAVIGATION AND ROBOTIC ASSISTANCE. I CHOOSE TO PROCEED WITH THE SURGERY USING THE TRADITIONAL APPROACH WITHOUT NAVIGATION OR ROBOTICS. FORTUNATELY THE SURGERY WENT WELL WITHOUT COMPLICATIONS. I WAS ABLE TO CONTINUE WIT

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE PATIENT WAS SCHEDULED FOR A LUMBAR FUSION WITH SPINAL INSTRUMENTATION USING COMPUTER NAVIGATION AND ROBOTIC ASSISTANCE USING THE GLOBUS MEDICAL EXCELSIUS 3D IMAGING SYSTEM. I HAD BEEN NOTIFIED BY THE GLOBUS REPRESENTATIVE ON THE MORNING OF SURGERY THAT THERE WAS A POTENTIAL PROBLEM WITH THE BATTERY SUPPLY OF THE GLOBUS IMAGING SYSTEM BUT THAT IT HAD BEEN ADDRESSED BY THE ENGINEERS AND THERE SHOULD BE NO PROBLEM. I WAS TOLD THAT EVEN IF THERE WAS A BATTERY ISSUE THE SYSTEM COULD RUN FROM ELECTRICAL POWER FROM THE WALL. ONCE THE PATIENT WAS ASLEEP AND THE EXPOSURE TO THE SPINE WAS COMPLETE, THE GLOBUS IMAGING SYSTEM WAS BROUGHT IN FOR OBTAINING THE IMAGES. IT IMMEDIATELY SHUT DOWN AND COULD NOT BE RESTARTED. AS A RESULT I WAS UNABLE TO PROCEED WITH THE COMPUTER NAVIGATION OR ROBOTIC ASSISTANCE THAT I HAD EXPLAINED TO THE PATIENT. MY OPTIONS WERE TO EITHER CANCEL THE SURGERY AND CLOSE THE WOUND TO RETURN ANOTHER DAY ONCE THE SYSTEM WAS WORKING OR PROCEED WITHOUT THE NAVIGATION AND ROBOTIC ASSISTANCE. I CHOOSE TO PROCEED WITH THE SURGERY USING THE TRADITIONAL APPROACH WITHOUT NAVIGATION OR ROBOTICS. FORTUNATELY THE SURGERY WENT WELL WITHOUT COMPLICATIONS. I WAS ABLE TO CONTINUE WIT

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE PATIENT WAS SCHEDULED FOR A LUMBAR FUSION WITH SPINAL INSTRUMENTATION USING COMPUTER NAVIGATION AND ROBOTIC ASSISTANCE USING THE GLOBUS MEDICAL EXCELSIUS 3D IMAGING SYSTEM. I HAD BEEN NOTIFIED BY THE GLOBUS REPRESENTATIVE ON THE MORNING OF SURGERY THAT THERE WAS A POTENTIAL PROBLEM WITH THE BATTERY SUPPLY OF THE GLOBUS IMAGING SYSTEM BUT THAT IT HAD BEEN ADDRESSED BY THE ENGINEERS AND THERE SHOULD BE NO PROBLEM. I WAS TOLD THAT EVEN IF THERE WAS A BATTERY ISSUE THE SYSTEM COULD RUN FROM ELECTRICAL POWER FROM THE WALL. ONCE THE PATIENT WAS ASLEEP AND THE EXPOSURE TO THE SPINE WAS COMPLETE, THE GLOBUS IMAGING SYSTEM WAS BROUGHT IN FOR OBTAINING THE IMAGES. IT IMMEDIATELY SHUT DOWN AND COULD NOT BE RESTARTED. AS A RESULT I WAS UNABLE TO PROCEED WITH THE COMPUTER NAVIGATION OR ROBOTIC ASSISTANCE THAT I HAD EXPLAINED TO THE PATIENT. MY OPTIONS WERE TO EITHER CANCEL THE SURGERY AND CLOSE THE WOUND TO RETURN ANOTHER DAY ONCE THE SYSTEM WAS WORKING OR PROCEED WITHOUT THE NAVIGATION AND ROBOTIC ASSISTANCE. I CHOOSE TO PROCEED WITH THE SURGERY USING THE TRADITIONAL APPROACH WITHOUT NAVIGATION OR ROBOTICS. FORTUNATELY THE SURGERY WENT WELL WITHOUT COMPLICATIONS. I WAS ABLE TO CONTINUE WIT

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THERE IS A RED LIGHT ON THE ROBOT, AND THE SYSTEM CAMERA REPORTED BING BUMPED.

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, IT WAS OBSERVED THAT THE UNIVERSAL SEAL FAILED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: IT WAS CONFIRMED THAT A FRAGMENT FELL INTO THE PATIENT AND WAS ABLE TO BE RECOVERED DURING THE SAME SURGICAL PROCEDURE. THE FRAGMENT WAS ABLE TO BE REMOVED BY USING THE RAPALLO SURGICAL FORCEPS. THE CUSTOMER WAS ABLE TO CONFIRM THAT ALL FRAGMENTS WERE RETRIEVED BY CONFIRMING THE BROKEN AREA OF THE CANNULA SEAL WITH THE FRAGMENT. NO POST-OPERATIVE TESTS WERE CONDUCTED TO CHECK FOR REMAINING FRAGMENTS. THERE WAS NO PATIENT INJURY OR HARM.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION SURGICAL PROCEDURE, THE BLADE ON A HARMONIC ACE INSTRUMENT WAS BROKEN. THE CUSTOMER USED A SPARE INSTRUMENT TO COMPLETE THE PROCEDURE. A FRAGMENT REPORTEDLY FELL INSIDE THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE WHICH 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 PROCEDURE, THE SCRUB TECHNICIAN NOTICED AS THEY WERE LOOKING INSIDE THE PELVIS OF THE PATIENT THAT A BLACK PIECE OF THE RUBBER PART OF THE UNIVERSAL SEAL HAD BROKEN OFF AND FELL INSIDE THE PATIENT. IT WAS UNKNOWN IF THE FRAGMENT WAS RETRIEVED OR NOT. THE PROCEDURE WAS COMPLETED ROBOTICALLY. ACCORDING TO THE INITIAL REPORTER, THE EVENT DATE WAS BETWEEN THE DATES OF 11-DEC-2023 AND 15-DEC-2023. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS NO DAMAGE TO THE CANNULA SEAL PRIOR TO USE. THE SURGEON WAS UNSURE HOW THE PIECE ENDED UP INSIDE OF THE PATIENT BUT SUSPECTS IT MAY HAVE BEEN WHEN AN INSTRUMENT WAS BEING INSTALLED THROUGH THE CAP. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE UNSPECIFIED INSTRUMENT DURING THE SURGICAL PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIALS DURING THE SURGICAL PROCEDURE. THE INSTRUMENT WAS NOT BROKEN. HOWEVER, THE SURGICAL STAFF FELT RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. THE CANNULA SEAL WAS REMOVED AND REPLACED. THERE WAS NO ADDITIONAL

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 AFTER THE SCREW INSERTIONS AND DURING DECOMPRESSION, THE SURGEON NOTICED A DURAL TEAR DUE TO A SCREW BEING INSERTED TOO MEDIALLY. THE SURGEON REINSERTED THE SCREW WITHOUT USING THE GUIDANCE SYSTEM. THE SURGEON ALLEGED THE TEAR WAS CAUSED BY THE MEDIAL SCREW AND THAT THE SCREW WAS NOT INSERTED ACCORDING TO THE PLAN. ALL SCREWS WERE PLACED CORRECTLY EXCEPT FOR THE LAST SCREW, WHICH WAS ON L1. THE DEVIATION WAS LESS THAN 3.5MM. THE SCREW WAS REPOSITIONED VIA FREEHAND. THE PATIENT EXPERIENCED WEAKNESS IN BOTH LEGS, BUT IS GETTING BETTER. THE PROCEDURE WAS NOT DELAYED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IN REVIEWING THE LITERATURE ARTICLE, A RETROSPECTIVE STUDY WAS CONDUCTED BASED ON COLLECTED CLINICOPATHOLOGICAL DATA OF A CONSECUTIVE SERIES OF MEN WITH LOCALIZED PROSTATE CANCER WHO UNDERWENT ROBOTIC-ASSISTED RADICAL PROSTATECTOMY (RARP) AT A SINGLE CENTER BETWEEN APRIL 2004 AND SEPTEMBER 2017. THE PRIMARY AIM OF THE STUDY WAS TO ASSESS LYMPH NODE (LN) YIELD, STRATIFIED BY SIDE AND ANATOMICAL REGION. THE SECONDARY OBJECTIVES WERE TO EXAMINE METASTATIC PATTERNS, COMPLICATION RATES, AND THE POTENTIAL THERAPEUTIC BENEFIT OF REMOVING REGIONAL METASTATIC LNS IN INDIVIDUALS WITH NODE-POSITIVE DISEASE. THE STUDY FOUND THAT AMONG PATIENTS WHO UNDERWENT EXTENDED PELVIC LYMPH NODE DISSECTION (EPLND) USING THE DA VINCI ROBOT ASSISTED APPROACH, SYMPTOMATIC LYMPHOCELES OCCURRED IN 2.1% OF CASES, WITH NONE OBSERVED IN MEN WHO DID NOT UNDERGO EPLND. THE STUDY ALSO REPORTED THAT CLAVIEN-DINDO GRADE IIIA AND GRADE IIIB COMPLICATIONS WERE 1.6% AND 3.3%, RESPECTIVELY, COMPARED TO 0.3% AND 1.1% IN PATIENTS WITHOUT PLND. FURTHERMORE, THE OVERALL COMPLICATION RATES (GREATER THAN OR EQUAL TO CLAVIEN-DINDO GRADE IIIA) INCREASED OVER TIME AMONG EPLND PATIENTS, WITH A TOTAL RATE OF 4.8%. NOTABLY, SIGNIFICA

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 WAS PERFORMED WHICH IS BASED ON A RETROSPECTIVE STUDY INVOLVING 144 PATIENTS WITH TYPE I¿IV HIATAL HERNIAS WHO UNDERWENT ELECTIVE DA VINCI-ASSISTED HERNIA REPAIR FROM 2016 TO 2019. THE STUDY AIMED TO ASSESS THE OUTCOMES OF A NOVEL TECHNIQUE FOR APPROXIMATING THE HIATUS USING V-LOCTM SUTURES, FOCUSING ON LENGTH OF STAY, READMISSION, AND RECURRENCE RATES. THE STUDY CONCLUDED THAT ROBOTIC REPAIR METHOD IS SAFE AND EFFECTIVE, WITH RESULTS COMPARABLE TO NATIONALLY PUBLISHED DATA ON LAPAROSCOPIC HIATAL HERNIA REPAIRS. THE AVERAGE PATIENT AGE WAS 61, WITH A MAJORITY BEING FEMALE. THE MOST COMMON COMPLICATION WAS CAPNOTHORAX (11%), WHICH REQUIRED PIGTAIL CATHETER PLACEMENT. NINETY-FIVE PERCENT OF PATIENTS WERE DISCHARGED HOME, AND 7% WERE READMITTED WITHIN 30 DAYS FOR VARIOUS ISSUES, INCLUDING DYSPHAGIA, EMESIS, MEDIASTINAL COLLECTION, INCISIONAL HERNIA, MALFUNCTIONING J-TUBE (A 3RD-PARTY MANUFACTURER PRODUCT), SUBCUTANEOUS EMPHYSEMA, AND SURGICAL SITE INFECTION. SIX RECURRENCES REQUIRED REOPERATION, PRIMARILY DUE TO SYMPTOMATIC RE-HERNIATION OR HIATUS ENLARGEMENT. THE STUDY CONCLUDED THAT ELECTIVE ROBOTIC HIATAL HERNIA REPAIR WITH FUNDOPLICATION AND PRIMAR

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