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 PARTIAL NEPHRECTOMY PROCEDURE, THE PATIENT HAD A LOT OF BLEEDING. THE PROCEDURE WAS ABORTED AND CONVERTED TO OPEN SURGERY. DURING THE PROCEDURE, A THIRD-PARTY GOLD SCANLAN BULLDOG CLAMP WAS USED VIA A SEPARATE PORT SITE. THE USE OF THE SCANLAN BULLDOG CLAMP WAS A REQUIRED STEP FOR THE PROCEDURE, THIS WAS USED TO CLAMP THE RENAL ARTERY. THE SURGEON REPORTED THAT THE SCANLAN BULLDOG CLAMP DID NOT HAVE A STRONG ENOUGH GRIP TO CLAMP THE PATIENT'S STIFF RENAL ARTERY WHICH CAUSED A LOT OF BLEEDING. THE BLEEDING COULD NOT BE CONTROLLED, AND THE PROCEDURE WAS CONVERTED TO OPEN. THE PATIENT WAS REPORTED TO BE STABLE AND REMAINS HOSPITALIZED. THE SURGEON REPORTED THAT THERE WAS NOT AN ISSUE WITH THE SINGLE PORT PLATFORM BUT RATHER, WITH THE THIRD-PARTY INSTRUMENTATION CLAMPING PRESSURE.

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, THE ENTIRE TIP FROM THE HARMONIC ACE INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT THE ENTIRE PIECE WAS RETRIEVED AND ACCOUNTED FOR DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO PATIENT INJURY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A REVIEW WAS CONDUCTED OF A LITERATURE ARTICLE COMPARING DA VINCI-ASSISTED ROBOTIC PARTIAL PANCREATODUODENECTOMY (RPD) WITH OPEN PARTIAL PANCREATODUODENECTOMY (OPD) SURGICAL PROCEDURES AT A HIGH-VOLUME PANCREATIC CENTER, HIGHLIGHTED FINDINGS OF A RANDOMISED CONTROLLED TRIAL (RCT) WITH TWO PARALLEL STUDY ARMS. THE STUDY INCLUDED 81 PATIENTS (41 ROBOTIC AND 40 OPEN) OVER A PERIOD OF APPROXIMATELY 1 1/2 YEARS AND COMPARED THE OUTCOMES OF THE RPD PATIENTS VERSUS THOSE OF THE OPD PATIENTS. DESCRIBED OUTCOMES INCLUDED POST-PANCREATECTOMY HEMORRHAGES (4 VERSUS 1), MAJOR BILIARY LEAKS (5 VERSUS 3), DELAYED GASTRIC EMPTYING (10 VERSUS 2), AND MAJOR CHYLE LEAKS (2 VERSUS 1). ALSO, IN THE RPD GROUP, 4 PATIENTS REQUIRED RE-OPERATION, 5 PATIENTS REQUIRED READMISSION, 15 PATIENTS REQUIRED NON-SURGICAL REINTERVENTION, 20 PATIENTS REQUIRED CT-GUIDED DRAIN PLACEMENT, 4 PATIENTS REQUIRED ANGIOGRAPHY, AND 7 PATIENTS REQUIRED UNSPECIFIED REINTERVENTION. BLOOD LOSS AND THE NUMBER OF PATIENTS WITH INTRAOPERATIVE BLOOD TRANSFUSIONS DID NOT DIFFER RELEVANTLY BETWEEN BOTH GROUPS. THE STUDY INDICATED THAT IN THE SETTING OF A VERY HIGH-VOLUME CENTER, BOTH RPD AND OPD CAN BE CONSIDERED SAFE TECHNIQUES. THERE

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, AFTER THE PATIENT WAS UNDER ANESTHESIA, A NON-RECOVERABLE FAULT 319 OCCURRED ON THE PATIENT SIDE MANIPULATOR (PSM) 1. THE CUSTOMER PERFORMED HARD POWER CYCLE OF THE SYSTEM, BUT THE SAME ISSUE PERSISTED. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY WITH NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON, AND THE SYSTEM INITIALIZED WITHOUT ERROR. THE CUSTOMER IDENTIFIED THE ISSUE AFTER PORTS PLACEMENT. THERE WERE NO INTRA-OPERATIVE OR POST-OPERATIVE COMPLICATIONS IDENTIFIED. IT WAS UNKNOWN IF THE CONVERSION RESULTED IN INCREASING PORT SIZE INCISION OR ADDING ADDITIONAL PORTS.

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 GASTRIC BYPASS (ROUX-EN-Y) SURGICAL PROCEDURE, THE CUSTOMER REPORTED AN ISSUE WITH THE VESSEL SEALER EXTEND (VSE). THE VSE FAILED AND RESULTED IN AN ABORT TO OPEN. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE LOGS BUT FOUND NO RELATED ISSUE. THE CUSTOMER HAD NO ADDITIONAL DETAILS ABOUT THE ISSUE AS FAR AS THE ARM IT WAS INSTALLED IN, WHETHER THE VSE WAS USED IN THE E100/IESU, OR HOW EXACTLY THE VSE FAILED BUT THE CUSTOMER HAS INDICATED SOMETHING WAS WRONG AND WAS NOT GOING TO PERFORM SURGERY WITHOUT THE SYSTEM BEING CHECKED. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WIDMANN, R. F., WISCH, J. L., TRACEY, O. C., ZUCKER, C. P., FEDDEMA, T., MILLER, F., LINDEN, G. S., ERICKSON, M., & HEYER, J. H. (2024). ANALYSIS OF 5,070 CONSECUTIVE PEDICLE SCREWS PLACED UTILIZING ROBOTICALLY ASSISTED SURGICAL NAVIGATION IN 334 PATIENTS BY EXPERIENCED PEDIATRIC SPINE DEFORMITY SURGEONS: SURGICAL SAFETY AND EARLY PERIOPERATIVE COMPLICATIONS IN PEDIATRIC POSTERIOR SPINAL FUSION. SPINE DEFORMITY. HTTPS://DOI.ORG/10.1007/S43390-024-00854-7 PURPOSE: THIS STUDY EVALUATES THE INTRAOPERATIVE AND SHORT-TERM COMPLICATIONS ASSOCIATED WITH ROBOTICALLY ASSISTED PEDICLE SCREW PLA CEMENT IN PEDIATRIC POSTERIOR SPINAL FUSION (PSF) FROM THREE SURGEONS AT TWO DIFERENT INSTITUTIONS. METHODS: WE RETROSPECTIVELY REVIEWED 334 PEDIATRIC PATIENTS WHO UNDERWENT PSF WITH ROBOTIC-ASSISTED NAVIGATION AT 2 INSTITUTIONS OVER 3 YEARS (2020¿2022). FIVE THOUSAND SEVENTY ROBOTICALLY PLACED SCREWS WERE EVALUATED. DATA COLLECTION FOCUSED ON INTRAOPERATIVE AND EARLY POSTOPERATIVE COMPLICATIONS WITH MINIMUM 30-DAY FOLLOW-UP. PATIENTS UNDERGOING REVISION PROCEDURES WERE EXCLUDED. RESULTS: INTRAOPERATIVE COMPLICATIONS INCLUDED 1 DUROTOMY, 6 PATIENTS WITH NEUROMONITORING ALERTS NOT RELATED TO SCREW PLAC

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, THE CASE WAS ABORTED AND THEN FREE HANDED.

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, WITH SUBSEQUENT DURAL TEAR THAT WAS REPAIRED.

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.

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 WAS CONDUCTED OF A CLINICAL ARTICLE THAT ASSESSED THE EFFECTIVENESS AND FEASIBILITY OF ROBOTIC PORTAL RESECTION (RPR) FOR MEDIASTINAL TUMORS AND THE FOLLOWING COMPLICATIONS WERE NOTED: (B)(4) PATIENTS WITH MEDIASTINAL TUMORS BETWEEN (B)(6) 2018 AND (B)(6) 2023 WERE ENROLLED IN THE STUDY. MOST PATIENTS WERE ASYMPTOMATIC ((B)(4)), AND NO MYASTHENIA GRAVIS WAS IDENTIFIED IN THE ENTIRE COHORT. ONE PATIENT EXPERIENCED AN INTRA-OPERATIVE LEFT INNOMINATE VEIN INJURY. THE INJURY WAS SUTURED USING A ROBOTIC PROCEDURE AND WITHOUT THE NEED FOR A CONVERSION TO THORACOTOMY. ALTHOUGH THE BLOOD LOSS DUE TO THE INJURY WAS NOT PROVIDED, IT WAS MENTIONED THAT THE MEDIAN BLOOD LOSS WAS 20 ML WITH THE RANGE OF 5.0¿30.0 ML FOR THE ENTIRE COHORT. (B)(4) PATIENTS UNDERWENT ACTIVE CONVERSION TO STERNOTOMY BECAUSE THE TUMORS WERE FOUND TO INVOLVE THE LEFT INNOMINATE VEIN DURING SURGERY. POSTOPERATIVE COMPLICATIONS WERE DEVELOPED IN (B)(4) PATIENTS, INCLUDING (B)(4) PATIENT WITH CHYLOTHORAX. THE POSTOPERATIVE CHYLOTHORAX WAS TREATED WITH CONSERVATIVE THERAPY (I.E. FASTING AND TOTAL PARENTERAL NUTRITION (TPN)) TO SUPPORT THE PATIENT. THE CHYLOTHORAX WAS RESOLVED AFTER 4 DAYS OF CARE. NO PERIOPERATIV

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 WAS CONDUCTED OF A CLINICAL ARTICLE THAT ASSESSED THE SAFETY AND FEASIBILITY OF MINIMALLY INVASIVE CYTOREDUCTIVE PROSTATECTOMIES (CRP) OF SINGLE-PORT (SP) OR MULTI-PORT (MP) ROBOTIC SYSTEMS, AND THE FOLLOWING COMPLICATIONS WERE MENTIONED. TWENTY-FOUR PATIENTS THAT UNDERWENT ROBOTIC-ASSISTED CRP IN ONE SINGLE INSTITUTION BETWEEN 2015 TO 2022 WERE ENROLLED IN THE STUDY. OF THE 24 MEN WITH A MEDIAN PROSTATE SPECIFIC ANTIGEN (PSA) OF 32 NG/ML WHO UNDERWENT CRP, 17 (71%) WERE DONE USING THE MP ROBOTIC SYSTEMS AND 7 (29%) WERE USING THE SP SYSTEMS. THE OVERALL MAJOR COMPLICATION RATE WAS 8%. IN THE MULTI-PORT GROUP, ONE PATIENT DEVELOPED A SMALL BOWEL OBSTRUCTION REQUIRING SURGICAL DECOMPRESSION (GRADE III), AND ANOTHER EXPERIENCED A LYMPHOCELE THAT REQUIRED PERCUTANEOUS INTERVENTION (GRADE III). TWO PATIENTS IN THE MULTI-PORT GROUP WERE REPORTED AS EXPERIENCING AN ANASTOMOTIC LEAK, BUT NO MEDICAL INTERVENTION NOR THE SEVERITY WERE PROVIDED IN THE ARTICLE. THERE WAS NO MENTION OF ANY DEVICE MALFUNCTIONS REPORTED DURING THE ROBOTIC ASSISTED SURGERIES IN THE ARTICLE. ADDITIONAL INFORMATION WAS REQUESTED FROM THE AUTHORS, BUT NO RESPONSE HAS BEEN RECEIVED.

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 WHILE DRIVING IN THE RIGHT UPPER LOB (RUL), AND 25MM OUT FROM THE TARGET, USER DECIDED TO DO A SPIN TO CONFIRM HE WAS IN LINE WITH THE LESION AND GET READY TO PLACE A DYED COIL. THE SPIN WAS DONE AND THE SCOPE WAS OBSERVED TO BE THROUGH THE LUNG AND INTO THE PLEURAE WHILE THE SYSTEM WAS SHOWING THEY WERE 25MM OUT, RESULTING IN A PNEUMOTHORAX.

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 DURING A PEDIATRIC SCOLIOSIS SURGERY, THE SURGEON PLANNED A T3-L2 SCAN AND PLAN WORKFLOW AND THE SURGEON EXPOSED T2-L3. AFTER EXPOSURE, THE SURGEON FREEHANDED THE LEFT L2 SCREW AND PLACED A FIDUCIAL MARKER IN LAMINA AT T10 (LAMINA IS A TECHNIQUE THE SURGEON USES TO HELP VERIFY ACCURACY). THE SPINOUS PROCESS CLAMP WAS ATTACHED ON THE SPINOUS PROCESS OF L2 AND CONNECTED THE SURGICAL ARM TO THE PATIENT WITH A STANDARD BRIDGE. THE AIRFRAME WAS PLACED WITH A DOUBLE SPINOUS PROCESS CLAMP AT T3 AND T4. A 3DEFINE SCAN SNAPSHOT WITH NAVIGATION AIRFRAME WAS THEN PERFORMED. THE STAR MARKER WAS PLACED AND A SUCCESSFUL IMAGING SPIN WAS TAKEN. THE SPIN WAS TRANSFERRED TO THE GUIDANCE SYSTEM VIA THUMB DRIVE. THE SURGEON ASSISTED WITH SCREW PLANNING ¿ IT WAS PLANNED AT T8-L1 ON THE LEFT SIDE (L2 WAS PLACED FREEHAND PRIOR) AND PLANNED T8-L2 ON THE RIGHT. THE SURGEON STARTED PLACING SCREWS ROBOTICALLY AT LEFT L1 AND WORKING CRANIALLY TO T8. THEY WERE PERIODICALLY CHECKING THE ROBOTIC AND NAVIGATION ACCURACY ON PATIENT'S ANATOMY, THE DIVOT ON THE ARM GUIDE, AND ROBOTICALLY BY SENDING

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PHAM, M. H., HERNANDEZ, N. S., & STONE, L. E. (2024). PREOPERATIVE ROBOTICS PLANNING FACILITATES COMPLEX CONSTRUCT DESIGN IN ROBOT-ASSISTED MINIMALLY INVASIVE ADULT SPINAL DEFORMITY SURGERY¿A PRELIMINARY EXPERIENCE. JOURNAL OF CLINICAL MEDICINE, 13(7), 1829. HTTPS://DOI.ORG/10.3390/JCM13071829. BACKGROUND: THE CORRECTION OF ADULT SPINAL DEFORMITY (ASD) CAN REQUIRE LONG, COMPLEX CONSTRUCTS WITH MULTIPLE RODS WHICH TRAVERSE IMPORTANT BIOMECHANICAL LEVELS TO ACHIEVE MULTI-PELVIC FIXATION. MINIMALLY INVASIVE (MIS) PLACEMENT OF THESE CONSTRUCTS HAS HISTORICALLY BEEN DIFFICULT. ADVANCED TECHNOLOGIES SUCH AS SPINAL ROBOTICS PLATFORMS CAN FACILITATE THE DESIGN AND PLACEMENT OF THESE CONSTRUCTS AND FURTHER ENABLE THESE SURGICAL APPROACHES IN MIS DEFORMITY SURGERY. METHODS: A RETROSPECTIVE STUDY WAS PERFORMED ON A SERIES OF ASD PATIENTS UNDERGOING MIS DEFORMITY CORRECTION WITH =EIGHT FUSION LEVELS TO THE LOWER THORACIC SPINE WITH PREOPERATIVE ROBOTIC CONSTRUCT PLANNING AND ROBOT-ASSISTED PEDICLE SCREW PLACEMENT. RESULTS: THERE WERE 12 PATIENTS (10 FEMALE, MEAN AGE 68.6 YEARS) WITH A DIAGNOSIS OF EITHER DEGENERATIVE SCOLIOSIS (8 PATIENTS) OR SAGITTAL IMBALANCE (4 PATIENTS). ALL UNDERWENT PREO

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 ¿INCORRECT CUTS WERE MADE¿ WHILE USING THE ROBOTIC-ASSISTED SOLUTION SATELLITE STATION DEVICE. ACCORDING TO THE REPORT, THE SURGEON INITIALLY CUT FOR A SIZE 6 FEMUR AND WANTED TO RECUT TO A SIZE 5 FEMUR TO OPEN FLEXION SPACE. THE REPORTER STATED THAT THE ROBOT WAS SET TO ¿ANTERIOR REFERENCING¿, SO THE SURGEON CHANGED TO A SIZE 5 AND RECUT FEMUR. IT WAS REPORTED THAT THE CUTS WERE OFF BY OVER ¿ONE FULL SIZE AND THE CHAMFER CUTS WERE ANGLED WAY OFF.¿ THE REPORTER STATED THAT THE SURGEON DID NOT OBSERVE PIN OR ARRAY MOVEMENT, BUT IT COULD HAVE HAPPENED. THE SURGEON SWITCHED FROM PRESS FIT TO CEMENTED CRS REVISION FEMUR WITH 30MM STEM AND A RP REVISION TIBIA WITH A CONSTRAINED CRS FEMUR DUE TO CUTS NOT MATCHING. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT STARTED WITH 15 DEGREES OF FLEXION CONTRACTURE. AFTER THE INITIAL CUTS, THE PATIENT HYPER EXTENDED BY 15 DEGREES AND WAS ANOTHER REASON TO USE CRS REVISION COMPONENTS. IT WAS REPORTED THAT THERE WAS A SURGICAL DELAY OF 35 MINS. THERE WAS PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BE

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE DOCTOR WAS DOING AN INTRA-OP ROBOT CASE AT LEVELS L3-L5. WE PLACED SCREWS ON THE RIGHT SIDE FOLLOWED BY THE LEFT. WE ALSO DID A CHECK WITH THE VERIFICATION PROBE TO ENSURE TRAJECTORY AND CONFIRMATION OF SCREWS. EVERYTHING LOOKED GOOD THUS FAR. AFTER THE PLACEMENT OF SCREWS AND RODS, WE PROCEEDED TO TAKE A 2ND SPIN TO CONFIRM SCREW AND ROD PLACEMENTS. WE THEN DISCOVERED THE SCREW AT L4R HAD SHIFTED A BIT LATERAL OF THE PEDICLE.

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.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: EGPS PERFORMED A CASE PERFECTLY TODAY THEN WAS POWERED DOWN. 45 MINUTES LATER IT WAS POWERED BACK UP TO LOAD A SCAN BUT WOULD NOT POWER UP. BATTERY LIGHT WAS CYCLING ,YELLOW INFORMATION RING WAS ON, NO SYNC MONITOR WARNING COMES UP BUT NOTHING APPEARED ON THE SCREEN. WE HAVE REBOOTED MULTIPLE TIMES CHANGED POWER SUPPLY POINT MULTIPLE TIME AND FRANCESCO BELIEVES IT TO BE A COMPUTER FAILURE AND THAT THE COMPUTER NEEDS TO BE REPLACED.

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.

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 THERE WAS AN ALLEGED SCREW DEVIATION IN A SCAN AND PLAN CASE. THE MANUFACTURER REPRESENTATIVE (REP) REPORTED THAT THE PATIENT WAS HAVING MULTIPLE SCREWS PLACED FROM THE THORACIC TO THE LUMBAR VERTEBRAE FOR A SCOLIOSIS PROCEDURE. THE REP REPORTED THAT MULTIPLE ACCURACY CHECKS WERE PERFORMED, HOWEVER, WHEN T4 ON THE RIGHT SIDE WAS DRILLED, THE PATIENT'S MOTOR WAS TESTED AND WAS ABSENT. WHEN A POST SURGICAL SCAN WAS PERFORMED, THE SCREW PLACED IN T5 WAS POTENTIALLY DEVIATED BY 1-2 MILLIMETERS (MM), BUT PER THE REP, THE SURGEON BELIEVED THAT THE T4 DRILL WAS ACCURATE AND THAT THE PEDICLE FRACTURED ON THE RIGHT SIDE. ALL OTHER SCREWS PLACED IN THE LEFT AND RIGHT VERTEBRAE APPEARED ACCURATE IN THE SOFTWARE. THERE WAS NO SURGICAL DELAY TIME AND THE PATIENT WAS AFFECTED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ROBOTIC MEGA SUTURE CUT NEEDLE DRIVER'S WIRES BROKE WHILE INSIDE PATIENT. SURGEON AWARE. NO VISIBLE SIGNS OF ANY PIECES LEFT INSIDE PATIENT. INSTRUMENT REMOVED FROM SERVICE AND GIVEN TO RISK MANAGER.

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

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

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A REVIEW OF A LITERATURE ARTICLE DESCRIBING A RETROSPECTIVE ANALYSIS OF ALL PATIENTS UNDERGOING DA VINCI-ASSISTED ROBOTIC DISTAL PANCREATECTOMY (DP) AND PANCREATICODUODENECTOMY (PD) PROCEDURES PERFORMED BY A SINGLE SURGEON, WAS COMPLETED. THE STUDY EVALUATED THE SAFETY AND FEASIBILITY OF INSTITUTING A ROBOTIC PANCREATECTOMY PROGRAM. THE STUDY INCLUDED SURGERIES FROM MAY 2014 TO DECEMBER 2020, DURING WHICH 62 PATIENTS UNDERWENT ROBOTIC PANCREATECTOMY, 34 PATIENTS WERE IN THE PD GROUP AND 28 PATIENTS WERE IN DP GROUP. 13 PATIENTS REQUIRED CONVERSION TO OPEN SURGERY IN PD GROUP DUE TO VEIN RESECTION, BILIOPANCREATIC RESECTION OR DIFFICULT DISSECTION. POST-OPERATIVELY, IN THE PANCREATICODUODENECTOMY (PD) GROUP, NINE PATIENTS (26.5%) EXPERIENCED CLAVIEN-DINDO GRADE III OR MORE COMPLICATIONS COMPARED TO 5 PATIENTS (17.9%) IN THE DISTAL PANCREATECTOMY (DP) GROUP. OF THE 5 GRADE B/C POSTOPERATIVE PANCREATIC FISTULA (POPF) IN THE PD GROUP, 4 PATIENTS REQUIRED OPERATIVE INTERVENTION WHILST ALL OF THOSE IN THE DP GROUP WERE MANAGED EITHER ENDOSCOPICALLY OR WITH PROLONGED USE OF SURGICAL DRAINS. THREE PATIENTS EXPERIENCED POST-PANCREATECTOMY HEMORRHAGE IN PD GROUP WHILE 1 PATIENT IN DP GROUP.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE SURGEON USED THE NS INSTRUMENTATION TO MARK PLACEMENT OF THE BURR HOLES. THE PATIENT AND EGPS WERE DRAPED AND THE IGEE WAS VERIFIED BY THE SCRUB TECH. THE EGPS WAS PUSHED IN WITH THE O-ARM STILL IN SCAN POSITION TO ALLOW FOR EVALUATION SHOTS. ONCE THE INCISION/APPROACH WAS COMPLETED, THE ARM WAS BROUGHT IN ALONG THE VIM R TRAJECTORY. AS THE SURGEON PLACED THE CANNULA IN THE CENTRAL TRAJECTORY, THE ENTRY POINT APPEARED TO BE CLOSE TO THE POSTERIOR EDGE OF THE BURR HOLE COVER. AS THE SURGEON INSERTED THE CANNULA, HE BOVIED THE CANNULA WHICH CAUSED THE EGPS SCREEN TO TEMPORARILY BLACK OUT DURING THE BOVIE USAGE WHEN THE CANNULA WAS SEATED, AN O-ARM SPIN WAS PERFORMED TO CHECK CANNULA PLACEMENT. THE CANNULA TRAJECTORY WAS OFF WITH THE ENTRY POINT POSTERIOR AND THE TRAJECTORY POINTING ANTERIOR. THE TIP OF THE CANNULA (PLANNED FOR 10MM ABOVE TARGET) PRESENTED A DEVIATION OF E/ 11.5 AND E/1.4. LANDMARK CHECKS WERE PERFORMED AGAIN AND IT APPEARED THAT THE CENTER OF THE BURR HOLE SHOWED ANTERIOR OF THE PLANNED TRAJECTORY ON THE SCREEN. A STERILE REGISTRATION WAS THEN PERFORMED BUT FOLLOWING THE TRANSFER OF THE SPIN AND CONFIRMATION OF THE FIDUCIALS, THE EGPS PRESENTED AN ERROR STATING T

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 THE MEDICAL CRUCIATE LIGAMENT WAS UNINTENTIONALLY CUT. IT WAS REPORTED THAT REVISION COMPONENTRY WAS REQUIRED. THE LIGAMENT WAS REPAIRED AND IMPLANTED COMPONENTS LOOKED GOOD. IT WAS REPORTED BY THE SURGEON THAT THE RETRACTORS SHOULD HAVE BEEN PLACED BETTER. IT WAS REPORTED THAT THE DEVICE WAS BEING USED WITH A ROBOTIC ASSISTED BASE STATION DEVICE. THERE WERE NO DELAYS IN THE PROCEDURE REPORTED. THERE WAS PATIENT INVOLVEMENT. 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: A STUDY TO EVALUATE THE ONCOLOGICAL OUTCOMES POST TRANSORAL ROBOTIC SURGERY (TORS) FOR HUMAN PAPILLOMAVIRUS (HPV)-ASSOCIATED OROPHARYNGEAL SQUAMOUS CELL CARCINOMA, WAS SUMMARIZED IN A LITERATURE ARTICLE DESCRIBING A RETROSPECTIVE ANALYSIS ON 184 PATIENTS THAT UNDERWENT DA VINCI-ASSISTED TRANSORAL ROBOTIC SURGERY (TORS) WITH NECK DISSECTION IN ONE SINGLE INSTITUTION PERFORMED BY TWO TRAINED SURGEONS. POST-OPERATIVE TORS-RELATED COMPLICATIONS OCCURRED IN 12 PATIENTS (6.5%). NINE PATIENTS (4.9%) HAD A SECONDARY POST-OPERATIVE BLEED, DEFINED AS BLEEDING OCCURRING GREATER THAN 24 HOURS FOLLOWING SURGERY, WITH ALL PATIENTS BEING SUCCESSFULLY MANAGED EITHER CONSERVATIVELY OR WITH OPERATIVE MANAGEMENT. SALIVARY FISTULA OCCURRED IN 2 PATIENTS (1.1%). PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) INSERTION FOR SWALLOWING DYSFUNCTION OCCURRED IN 10 PATIENTS (5.4%) WITH ONLY 2 PATIENTS (1.1%) REQUIRING FOR GREATER THAN 12 MONTHS. THERE WERE NO DA VINCI DEVICE ISSUES REPORTED IN THE ARTICLE. ATTEMPTS WERE MADE TO CONTACT THE ARTICLE AUTHOR, BUT NO RESPONSE HAS BEEN RECEIVED.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A LITERATURE ARTICLE DESCRIBED A RETROSPECTIVE ANALYSIS BETWEEN 2011-2022 OF 184 PATIENTS THAT UNDERWENT DA VINCI ASSISTED TORS SURGERY WITH NECK DISSECTION IN ONE SINGLE INSTITUTION, PERFORMED BY TWO TRAINED SURGEONS. THE STUDY WAS CONDUCTED TO EVALUATE THE ONCOLOGICAL OUTCOMES OF POST-TRANSORAL ROBOTIC SURGERY (TORS) FOR HPV-ASSOCIATED OROPHARYNGEAL SQUAMOUS CELL CARCINOMA. THE 3-YEAR AND 5-YEAR DISEASE-SPECIFIC SURVIVAL WERE 98.6% (95% CI 96.7¿100%) AND 94.4% (95% CI 89.9¿99.0%), RESPECTIVELY. THREE PATIENTS DIED FROM CAUSES UNRELATED TO DISEASE RECURRENCE. ONE PATIENT (0.5%) HAD AN EARLY POSTOPERATIVE HEMORRHAGE, DEFINED BY BLEEDING OCCURRING LESS THAN 24 HOURS FOLLOWING SURGERY, RESULTING IN DEATH FOUR DAYS LATER. ONE PATIENT DIED FROM CARDIOPULMONARY ARREST; ANOTHER PATIENT DIED FROM A SECOND TUMOR METASTASIS. THERE WERE NO DA VINCI DEVICE ISSUES REPORTED IN THE ARTICLE. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION FROM THE DESIGNATED AUTHOR WERE MADE, BUT NO RESPONSE HAS BEEN RECEIVED.

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

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, THE CASE WAS ABORTED AND THEN FREE HANDED TO PLACE SCREWS.

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 THE SAW BLADE DETACHED FROM SAW HAND PIECE WHILE CUTTING FEMUR, SAW BLADE STAYED EMBEDDED IN THE FEMUR. BLACK LIQUID WAS NOTED AROUND WHERE THE SAW BLADE ATTACHES TO THE SAW HAND PIECE. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? YES. IF YES, NUMBER OF MINUTES: 5.

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 BLADE OF THE HARMONIC ACE INSTRUMENT FRACTURED AS THE INSTRUMENT WAS ACTIVATED. THE SURGEON CLAIMED THAT HE DID NOT TOUCH ANY HARD OBJECTS WITH THE INSTRUMENT. THE FRACTURED PIECE FELL INSIDE THE PATIENT BUT WAS RETRIEVED DURING THE SAME PROCEDURE. 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 ANONYMOUSLY TO FDA THROUGH A MEDWATCH 3500A FORM THAT A PATIENT EXPERIENCED SERIOUS ADVERSE EFFECTS FOLLOWING SCREW PLACEMENT WITH THE GLOBUS SPINE ROBOT. IT WAS REPORTED THAT THE SCREW(S) WERE NOT PLACED TO PLAN BY THE USER.

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 PRIOR TO A TOTAL KNEE ARTHROPLASTY SURGICAL PROCEDURE, THE ROBOTIC-ASSISTED SOLUTION SAW HANDPIECE DEVICE WAS OPENED FOR THE PROCEDURE PRIOR TO THE PATIENT COMING INTO THE ROOM. THE DEVICE HAD A LEAK WHICH APPEARED TO BE OIL. IT WAS REPORTED THAT THE SAME WAS TRUE WITH THE SECOND HANDPIECE. THE HANDPIECES WERE RETURNED TO STERILE PROCESSING FOR CLEANING AND STERILIZATION. WHEN IN STERILE PROCESSING THE DEVICE WAS HAND WASHED AND IT WAS MADE SURE THAT ALL RESIDUE WAS REMOVED FROM BOTH HANDPIECES AND RE-STERILIZED. AFTER THE STERILIZED PACKAGES WERE RE-OPENED, THE OIL RE-APPEARED AND THE CASE HAD TO BE CANCELLED. IT WAS REPORTED THAT THE PATIENT RECEIVED A REGIONAL ANESTHETIC PRIOR TO THE PROCEDURE BEING CANCELLED. THERE WAS PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. THIS IS REPORT 2 OF 2 FOR (B)(4).

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: TWO LASER FIBERS WERE IMPLANTED DURING THIS PROCEDURE: LEFT HIPPOCAMPUS AND LEFT ANTERIOR. LEFT ANTERIOR HAD A GOOD PLACEMENT THE FIRST TIME, BUT LEFT HIPPOCAMPUS WAS 13.1 MM OFF IN RADIAL ERROR DUE TO SKIVING. THE LASER FIBERS WAS REIMPLANTED UNDER A NEW INTRAOP PLAN, AND HAD A RADIAL ERROR OF 1.8 MM.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: E3D SPIN WITH AUTOMATIC REGISTRATION PERFORMED. SCREWS PLANNED, SURGEON MOVED ARM TO TRAJECTORY AND DEPTH OF BURR WAS SHOWING DEEP. SECOND E3D SPIN PERFORMED WITH AUTOMATIC REGISTRATION, SCREWS PLANNED, VERIFICATION PROBE SHOWED GOOD DEPTH. SURGEON PLACED T8-T12 SKIPPING T10 IN A SERPENTINE FASHION STARTING AT LT8. E3D BROUGHT IN FOR XRAY AND LT9 WAS SHOWN TO BE LATERAL OUTSIDE THE PEDICLE WHILE ALL OTHER SCREWS WERE GOOD. VERIFICATION PROBE USED TO CHECK NAVIGATION. NAVIGATION LOOKED INTACT. SURGEON ATTEMPTED TO PLACE LT9 AGAIN AND SCREW WAS AGAIN LATERAL. SURGEON REMOVED SCREW AND PLANNED SCREWS AT T7 BILATERALLY. SURGEON PLACED SCREWS AND LT7 WAS LATERAL, OUTSIDE THE PEDICLE AND RT7 LOOKED GOOD. SURGEON REMOVED LT7, ANOTHER CHECK PERFORMED BUT THIS TIME, BOTH ABOVE AND BELOW THE FRACTURE SITE, NAVIGATION WAS SHOWING LATERAL SHIFT TO THE LEFT. SCAN CONVERTED TO PREOP AND MERGE PERFORMED WITH E3D. MERGE GOOD ON FIRST ATTEMPT. SURGEON PLACED LT7 AND LT9 AND XRAY CONFIRMED GOOD PLACEMENT.

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 PRIOR TO A TOTAL KNEE ARTHROPLASTY SURGICAL PROCEDURE, THE ROBOTIC-ASSISTED SOLUTION SAW HANDPIECE DEVICE WAS OPENED FOR THE PROCEDURE PRIOR TO THE PATIENT COMING INTO THE ROOM. THE DEVICE HAD A LEAK WHICH APPEARED TO BE OIL. IT WAS REPORTED THAT THE SAME WAS TRUE WITH THE SECOND HANDPIECE. THE HANDPIECES WERE RETURNED TO STERILE PROCESSING FOR CLEANING AND STERILIZATION. WHEN IN STERILE PROCESSING THE DEVICE WAS HAND WASHED AND IT WAS MADE SURE THAT ALL RESIDUE WAS REMOVED FROM BOTH HANDPIECES AND RE-STERILIZED. AFTER THE STERILIZED PACKAGES WERE RE-OPENED, THE OIL RE-APPEARED AND THE CASE HAD TO BE CANCELLED. IT WAS REPORTED THAT THE PATIENT RECEIVED A REGIONAL ANESTHETIC PRIOR TO THE PROCEDURE BEING CANCELLED. THERE WAS PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. THIS IS REPORT 1 OF 2 FOR (B)(4).

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: IT WAS REPORTED THAT DURING A PLANNED DA VINCI-ASSISTED SP (SINGLE-PORT) PROSTATECTOMY PROCEDURE, AN ARM WAS NOT ACCEPTING STERILE ADAPTERS. THE STERILE ADAPTERS KEPT POPPING OFF ARM #3. AS A RESULT, THE CUSTOMER ELECTED TO CONVERT THE SURGICAL PROCEDURE TO A MULTI-PORT DA VINCI-ASSISTED PROSTATECTOMY 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 CUSTOMER HAD UNSPECIFIED PROBLEMS WITH A HARMONIC ACE INSTRUMENT. A FRAGMENT FROM THE INSTRUMENT FELL INSIDE THE PATIENT AND IT WAS UNKNOWN IF IT WAS RETRIEVED. 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: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REVIEW OF AN ARTICLE WAS COMPLETED OF A RANDOMIZED CONTROLLED TRIAL BASED ON DA VINCI-ASSISTED ROBOTIC PANCREATICODUODENECTOMY (RPD) WHERE THE AUTHORS COMPARED THE SHORT-TERM POSTOPERATIVE OUTCOMES OF RPD WITH THOSE OF OPEN PANCREATICODUODENECTOMY (OPD). THE TRIAL, CONDUCTED BETWEEN MARCH 5 AND DECEMBER 20, 2022, INCLUDED 164 PATIENTS RANDOMLY ASSIGNED TO EITHER THE RPD OR OPD GROUP. IN THE RPD GROUP, THERE WAS ONE IN-HOSPITAL DEATH (1%) WITHIN 90 DAYS AFTER THE OPERATION. SPECIFICALLY, ONE (1%) OF 81 PATIENTS IN THE RPD GROUP DEVELOPED POSTOPERATIVE PANCREATIC FISTULA RELATED HEMORRHAGE ON POSTOPERATIVE DAY 9, UNDERWENT TRANS-ARTERIAL EMBOLIZATION AND A SUBSEQUENT REOPERATION, BUT DIED OF SEPTIC SHOCK ON DAY 30. THERE WERE NO DA VINCI DEVICE MALFUNCTIONS REPORTED. THE OPD SUBSET ALSO HAD ONE PATIENT DEATH DUE TO A PULMONARY EMBOLISM ON POSTOPERATIVE 5. THE ARTICLE STATES THAT WHILE RPD SHOWED BENEFITS IN REDUCING HOSPITAL STAY, THE OVERALL CLINICAL BENEFIT REMAINS UNCLEAR, ESPECIALLY CONSIDERING THE EXTRA COSTS AND PATIENT PERCEPTIONS OF QUALITY OF LIFE AND RECOVERY AFTER DISCHARGE.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE REMOVAL OF THE NAIL WAS AN ADDITIONAL SURGERY.

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.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CAMERA BUMP WARNING AT (B)(6) MEDICAL CENTER NEED IMMEDIATE REPLACEMENT. MULTIPLE CASES ARE SCHEDULED FOR TUESDAY (B)(6) 2025. CURRENTLY ON: GMED 4.0 USING VEGA CAMERA.

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 A PATIENT UNDERWENT A DA VINCI-ASSISTED LOW ANTERIOR RESECTION (LAR) AND WAS ENROLLED IN A CLINICAL STUDY. THE PROCEDURE WAS COMPLETED WITH NO INTRA-OPERATIVE COMPLICATIONS. NO DEVICE MALFUNCTIONS WERE REPORTED. THE PATIENT WAS FOUND WITH AN INCISION SITE INFECTION EIGHT DAYS POST-OPERATIVELY AND DRAINAGE WAS PERFORMED. THERE WAS NO MENTION OF OTHER MEDICAL INTERVENTION OR MEDICATION GIVEN FOR THE INFECTION. THE PATIENT WAS DISCHARGED HOME THREE WEEKS AFTER THE PROCEDURE, BUT UNKNOWN IF THE INFECTION PROLONGED THE HOSPITALIZATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SINGLE-PORT (SP) SURGICAL PROCEDURE, THE SYSTEM DISPLAYED A MESSAGE INDICATING THAT THE VIO INTEGRATED ELECTROSURGICAL GENERATOR UNIT (IESU) WAS NOT CONNECTED AND HAD A DIRTY FIBER CABLE MESSAGE. THE CUSTOMER CHECKED THE CABLE CONNECTIONS TO THE IESU, SURGEON SIDE CONSOLES (SSC) AND THE PATIENT SIDE CART (PSC) PRIOR TO CALLING IN THE ISSUE. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) REVIEWED THE SYSTEM LOGS AND NOTED A 307 ERROR POINTING TO THE VIDEO PROCESSOR (VP). THE TSE HAD THE CUSTOMER POWER OFF THE SYSTEM AND ENSURE THAT THE FIBER CABLES WERE FULLY SEATED ON THE BACK OF THE CORE AND VP, RESEAT THE ORANGE FIBER CABLES, AND ENSURE THAT THE BREAKERS OF THE VP AND ENDOSCOPE CONTROLLER (EC) WERE ON. THE SYSTEM POWERED ON WITH NO OTHER ERRORS, BUT LATER THE ERRORS RETURNED. THE TSE HAD THE CUSTOMER POWER CYCLE THE COMPONENTS AGAIN AND RESEAT THE FIBER CABLES. THE VP FAULTED AGAIN AND INDICATED A RED FIBER CABLE STATUS ON THE CORE TO THE VP. THE CUSTOMER USED A FIBER CABLE FROM THE SIMULATOR AND THE ERRORS CLEARED AGAIN. THE CUSTOMER THEN CALLED LATER AND REPORTED THAT THE VP FAULT RETURNED AS A N

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WHILE PLACING RIGHT SI1 SCREW THE SURGEON NOTICED RIGHT AWAY THAT SOMETHING WAS OFF AND UPON FLUORO IMAGING THEY REALIZED THAT THE SCREW WAS PLACED MUCH FURTHER CRANIAL THAN PLANNED OR INTENDED. THIS SCREW APPEARS TO HAVE BEEN PLACED IN DIRECTION OF RIGHT L5 TRANSVERSE PROCESS. THE SCREW WAS REMOVED AND WERE ABOUT TO USE E3D TO REREGISTER PATIENT VIA CT SPINE. AT THIS TIME IT WAS BROUGHT TO DR. VASILAKIS' ATTENTION THAT PATIENT WAS SHOWING SIGNS OF CARDIOVASCULAR DISTRESS AND CASE WAS TERMINATED.

At 10:00 p.m. on February 22, 2024, an employee working as a machine operator for a landscape architectural service had been monitoring a production line (Line 1). The employee started his shift at 3:00 p.m. He was operating the conveyer that carries pallets loaded with landscape materials such as bags of mulch, decorative rocks, and soil. The employee works with a robotic arm that picks up landscape materials from the conveyor and places them on a pallet. When the pallet is full, it moves down the conveyer. A coworker who operates a forklift noticed a pallet was crooked and mentioned it to the employee before leaving the area to do his assigned work. After returning to the area, the coworker saw the employee inside the cage with the door closed. The employer stated that the employee must have entered across the conveyer causing the robot to pick the employee up thinking he was a pallet. The employee was caught within the cage under a robotic arm and died from crushing injuries to his chest.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING A CASE IT WAS IDENTIFIED DURING AN X-RAY THAT A SCREW WAS MISSED AT L3-R ON A T10-PELVIS. THE MERGE APPEARED FINE AND THE OTHER SCREW WERE TO PLAN. THE MISPLACED SCREW WAS TAKEN OUT AND THEN PUT BACK IN SUCCESSFULLY USING THE ROBOTIC ARM.