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 SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSOR (MCS) TIP COVER SLIPPED OFF OF THE MCS INSTRUMENT AND FELL 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 MONOPOLAR CURVED SCISSORS (MCS) AND THE MCS TIP COVER ACCESSORY WERE INSPECTED PRIOR TO USE, AND NO DAMAGE OR ANYTHING OUT OF THE ORDINARY WAS FOUND. THE MCS TIP COVER ACCESSORY WAS RETRIEVED WITH A LAPAROSCOPIC GRASPER. THE ISSUE WAS IDENTIFIED DURING A TISSUE RETRACTION TASK. THE SURGEON WAS UNSURE OF THE CAUSE OF THE ACCESSORY SLIPPING OFF. THE MCS INSTRUMENT WAS IN USE FOR ABOUT HALF AN HOUR, AND NO ISSUES WITH ITS FUNCTIONALITY WERE NOTICED DURING THE PROCEDURE. THERE WERE NO COLLISIONS WITH OTHER INSTRUMENTS, AND THE TIP COVER APPEARED TO BE PROPERLY INSTALLED, WITH NO PART OF THE ORANGE SURFACE VISIBLE. THE INSTALLATION TOOL WAS USED, AND NO LUBRICANT WAS APPLIED. A REDUCER WAS NOT USED, AND THERE WAS NO DIFFICULTY IN REMOVING THE INSTRUMENT AND TIP COVER. THE INSTRUMENT WRIST WAS S

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 PULMONARY SEGMENTECTOMY PROCEDURE, A RIB FRACTURE OCCURRED FOLLOWING THE REMOVAL OF A CANNULA. THIS RESULTED IN MINOR BLEEDING, WHICH WAS RESOLVED USING AN UNSPECIFIED CAUTERIZING INSTRUMENT. SPECIFIC DETAILS REGARDING THE RIB FRACTURE, INCLUDING WHETHER IT WAS AN ANTICIPATED COMPLICATION OF THE PROCEDURE AND WHAT MEDICAL INTERVENTION WAS RENDERED DUE TO THE COMPLICATION, REMAIN UNKNOWN. ALTHOUGH THE SURGEON ATTRIBUTED THE FRACTURE TO THE MOVEMENT OF THE CANNULA, THE SURGEON ALSO NOTED THAT CERTAIN PATIENT FACTORS, SUCH AS ADVANCED AGE, MAY INCREASE SUSCEPTIBILITY TO RIB FRACTURES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED ROBOTICALLY, AND IT IS UNKNOWN WHETHER THE PATIENT EXPERIENCED ANY POSTOPERATIVE 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 CUSTOMER REPORTED A FEELING A SHOCK OR PINCH WHILE MOVING THE PATIENT SIDE CART (PSC). THE CUSTOMER INSPECTED THE PSC AND FOUND A CHIP ON THE SIDE OF THE "ARM HANDLE." THE FOLLOWING INFORMATION IS UNKNOWN: THE CAUSE AND SEVERITY OF THE COMPLICATION, AND WHAT MEDICAL INTERVENTION (IF ANY) WAS RENDERED DUE TO THE SHOCK OR PINCH. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO GATHER ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT; HOWEVER, NO RESPONSE HAS BEEN RECEIVED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM, T10-L2 OPEN FUSION INSTRAOP MERGE WITH E3D, T10/T11/T12 WERE ALL MEDIAL/LATERAL MISSED SCREWS, T12 RIGHT AND LUMBAR SCREWS WERE PERFECT. T10 BILATERAL AND T11 RIGHT WERE REMOVED AND REPLACED AFTER THE SECOND E3D SPIN.

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 MALIGNANT HYSTERECTOMY PROCEDURE, THE PATIENT WAS TRAPPING CO2 AND HAD TO BE REPOSITIONED TO RESOLVE THE ISSUE. THE ANESTHESIOLOGIST HAD DIFFICULTY OXYGENATING THE PATIENT DUE TO THIS EVENT AND WERE NOT ABLE TO PROPERLY VENTILATE THE PATIENT. THE CUSTOMER REPORTED THAT THEY BELIEVE THIS EVENT WAS CAUSED BY THE DA VINCI INSUFFLATOR EVACUATION PORT. THE CUSTOMER INDICATED THAT THE PATIENT WAS TRAPPING CO2 AND THAT THE INSUFFLATOR PRESSURE MAY HAVE BEEN PREVENTING THE STAFF FROM OXYGENATING THE PATIENT. THE PATIENT WAS REPORTEDLY FINE POST-OPERATIVELY AND WAS ONLY OBSERVED LONGER THAN PLANNED DUE TO THIS EVENT.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ETIGUNTA, S. K., WALKER, C. T., GAUSPER, A., GALOUSTIAN, N., LIU, A., GOWD, A. K., CHAN, V., ANAND, N., NOMOTO, E., PERRY, T. G., SODHA, S., JOHNSON, J. P., SKAGGS, D. L., KIM, T. (2025). DECREASED ROBOT-RELATED COMPLICATIONS FOLLOWING THE DEVELOPMENT AND ADOPTION OF A STANDARDIZED SAFETY PROTOCOL. JOURNAL OF BONE AND JOINT SURGERY, 108(1), 45¿50. HTTPS://DOI.ORG/10.2106/JBJS.25.00406 SUMMARY: BACKGROUND: ROBOT-ASSISTED SPINE SURGERY (RASS) ENABLES PRECISE PEDICLE SCREW INSERTION VIA PRE-PLANNED TRAJECTORIES, AND YET COMPLICATIONS REMAIN A NOTABLE CONCERN. PRIOR WORK SUGGESTS THAT OSSEOUS PEDICLE WALL BREACHES FROM INSTRUMENTATION AND ENSUING COMPLICATIONS RELATED TO ROBOTIC SURGERY MAY BE FROM SHIFTING OF THE REFERENCE FRAME OR IMPROPER METHODOLOGY. IN THIS STUDY, WE HYPOTHESIZED THAT THE INTRODUCTION OF STANDARDIZED INSTITUTIONAL GUIDELINES FOR RASS WOULD REDUCE COMPLICATIONS ASSOCIATED WITH ROBOTIC SCREW PLACEMENT. METHODS: THIS RETROSPECTIVE COHORT STUDY INCLUDED PATIENTS WHO UNDERWENT RASS USING 2 ROBOTIC SYSTEMS AT A SINGLE INSTITUTION. WE ANALYZED THE CASES OF 264 PATIENTS IN A HISTORICAL COHORT BEFORE, AND 290 PATIENTS AFTER, THE IMPLEMENTATION OF A STANDARDIZED INSTITUTION

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 SIGMOID COLECTOMY PROCEDURE, THE ENTRY GUIDE MANIPULATOR (EGM) INADVERTENTLY MADE CONTACT WITH THE PATIENT'S FACE. IT WAS SPECULATED THAT THE PITCH LIMIT MAY HAVE NOT BEEN INITIALLY CONFIGURED. AS A RESULT, WHEN THE SURGEON ROTATED FROM THE COLON TO THE PELVIS TO MOBILIZE THE COLON, THE EGM MOVED BEYOND THE INTENDED RANGE OF MOTION AND STRUCK THE PATIENT'S FACE. THERE WAS NO INJURY, BLEEDING, OR HARM TO THE PATIENT FROM THIS INCIDENT, NOR WERE ANY UNPLANNED MEDICAL OR SURGICAL INTERVENTIONS REQUIRED. ANY BLEEDING OBSERVED DURING THE PROCEDURE WAS EXPECTED. THE AMOUNT OF BLOOD LOSS WAS NOT PROVIDED. THE SURGEON IDENTIFIED THE CAUSE OF THE EVENT AS THE NEED FOR GREATER RANGE OF MOVEMENT DUE TO THE TASK BEING PERFORMED AND DID NOT ATTRIBUTE THE INCIDENT TO THE DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORIES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED ROBOTICALLY, AND THERE WAS NO INJURY TO THE PATIENT'S FACE. THERE WERE NO POST-OPERATIVE 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 TO AN INTUITIVE SENIOR SURGICAL APPLICATIONS ENGINEER BY THE SURGEON THAT THE TIP OF THE SINGLE PORT (SP) MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT HAD COME OFF DURING A GYNECOLOGIC PROCEDURE. HE SAID THAT HE HAD BEEN ABLE TO RETRIEVE THE TIP DURING THE SAME PROCEDURE. IT TOOK A LONG TIME (UP TO 30 MINUTES) FOR THE OPERATING ROOM (OR) STAFF TO GET A NEW TIP AND PUT IT IN THE INSTRUMENT. THE DATE OF THE EVENT AND NAME OF THE PROCEDURE ARE UNKNOWN. THE REPRESENTATIVE THEN OBSERVED TWO CASES, AND THE SP MCS TIP SEEMED TO BE CORRECTLY INSTALLED BY THE SCRUB TECH WITH NO ISSUES NOTED.

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 TO AN INTUITIVE SENIOR SURGICAL APPLICATIONS ENGINEER BY THE SURGEON THAT THE TIP OF THE SINGLE PORT (SP) MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT HAD COME OFF DURING A GYNECOLOGIC PROCEDURE. HE SAID THAT HE HAD BEEN ABLE TO RETRIEVE THE TIP DURING THE SAME PROCEDURE. IT TOOK A LONG TIME (UP TO 30 MINUTES) FOR THE OPERATING ROOM (OR) STAFF TO GET A NEW TIP AND PUT IT IN THE INSTRUMENT. THE DATE OF THE EVENT AND NAME OF THE PROCEDURE ARE UNKNOWN. THE REPRESENTATIVE THEN OBSERVED TWO CASES, AND THE SP MCS TIP SEEMED TO BE CORRECTLY INSTALLED BY THE SCRUB TECH WITH NO ISSUES NOTED.

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 WAS FOUND BROKEN ON THE HARMONIC ACE INSTRUMENT. A FRAGMENT FELL INTO THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RIGHT HEMICOLECTOMY PROCEDURE, THE BLADE OF THE HARMONIC ACE INSTRUMENT BROKE WHILE DISSECTING. A FRAGMENT FELL INSIDE THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE BY THE ASSISTANT. THE SURGEON CONFIRMED ALL FRAGMENTS WERE RETRIEVED. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED AND NO POST-OPERATIVE IMAGING WAS PERFORMED. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH A BACK-UP HARMONIC ACE INSTRUMENT. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO ANY POST-SURGICAL COMPLICATIONS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO 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 WHILE USING THE EXCELSIUS GPS SYSTEM, THERE WAS AN ISSUE WITH THE END EFFECTOR AND ACCURACY, AND THERE WAS ALSO AN ISSUE WITH REHOMING AFTER INITIAL ACCURACY CONCERNS. WE PLANNED LEVELS L4, L5, AND S1 BUT ONLY COMPLETED THE LEVELS L4, L5 DURING THE PROCEDURE. ALL 4 SCREWS WERE NOT PLACED AS PLANNED; THEY WERE ALL CONSIDERED LOWER THAN THE INITIAL PLAN THE SURGEON CREATED. THEN WE DID X-RAYS AND CONFIRMED THE SCREWS WERE OUT OF PLACEMENT. ROBOT WAS REMOVED FROM THE PROCEDURE ARE BUT STILL IN THE OR UNTIL THE CASE WAS COMPLETED.

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 THERE WAS A RADIAL ERROR OF GREATER THAN 1.5MM AT MULTIPLE TRAJECTORIES. THE RIGHT OF ELECTRODE WAS REMOVED AND NO OTHER ELECTRODE WAS PLACED ALONG THIS PLANNED TRAJECTORY. NO FURTHER REVISION IS NEEDED.

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 HEMICOLECTOMY AND ABDOMINOPERINEAL RESECTION PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY FELL INSIDE THE PATIENT. THE NURSE REPORTED THAT THE SURGEON OBSERVED THE MCS TIP COVER ACCESSORY, SLIPPING OFF THE MCS INSTRUMENT AND REQUESTED STAFF TO REMOVE THE INSTRUMENT. UPON REMOVAL, IT WAS NOTED THAT THE MCS TIP COVER ACCESSORY WAS NO LONGER INSTALLED ON THE INSTRUMENT. AN INTUITIVE SURGICAL INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WAS CONSULTED AND ADVISED THAT THE MCS TIP COVER ACCESSORY IS RADIOLUCENT AND CANNOT BE DETECTED BY X-RAY OR MAGNETIC RESONANCE IMAGING (MRI). AS A RESULT, NO IMAGING WAS PERFORMED, AND THE SURGEON CHOSE TO PROCEED WITH THE CASE, PLANNING TO RETRIEVE THE MCS TIP COVER ACCESSORY LATER IN THE PROCEDURE. ULTIMATELY, DUE TO PATIENT-RELATED COMPLICATIONS, INCLUDING LONG-TERM STEROID USE AND FRIABLE TISSUE, THE PROCEDURE WAS CONVERTED TO OPEN SURGERY. THE MCS TIP COVER ACCESSORY WAS SUCCESSFULLY RETRIEVED, AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES. THE PATIENT DID NOT EXPERIENCE ANY POSTOPERATIVE 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: DURING ROUTINE MEDIA MONITORING, AN ARTICLE WAS IDENTIFIED REPORTING SEVERE COMPLICATIONS FOLLOWING A DA VINCI-ASSISTED PROSTATECTOMY. THE PATIENT STATED THAT THE PROSTATE WAS REMOVED USING THE DA VINCI ROBOTIC SURGICAL SYSTEM. POST-OPERATIVELY, SERIOUS COMPLICATIONS OCCURRED AS A RESULT OF THE SMALL INTESTINE BEING DAMAGED DURING THE PROCEDURE, NECESSITATING AN EMERGENCY SURGERY OVERNIGHT. AS A RESULT, THE PATIENT WAS IN A COMA FOR ONE WEEK AND REMAINED HOSPITALIZED FOR APPROXIMATELY THREE AND A HALF WEEKS. NO ALLEGATIONS WERE MADE REGARDING DEVICE MALFUNCTIONS OR DIRECT CAUSATION BY THE DA VINCI SYSTEM.

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 A SCOPE ISSUE AND DID NOT USE ANY ADDITIONAL SCOPES TO CONTINUE THE PROCEDURE. 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NEPHRECTOMY PROCEDURE, THE TIP OF THE HARMONIC ACE INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS VISIBLE ON THE SCREEN AND THE PROFESSOR GRASPED IT WITH THEIR LEFT HAND WHILE THE ASSISTANT RETRIEVED IT USING AN ENDOSCOPIC INSTRUMENT. IT WAS CONFIRMED THAT ALL FRAGMENTS WERE RETRIEVED BECAUSE THE FRAGMENT DID NOT SCATTER. THE TIP SIMPLY BROKE OFF AND REMAINED IN PLACE, ALLOWING IMMEDIATE CONFIRMATION. NO POST-OPERATIVE IMAGING TESTS, SUCH AS X-RAY OR ULTRASOUND, WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE PROCEDURE WAS COMPLETED ROBOTICALLY USING A BACKUP HARMONIC ACE INSTRUMENT. THE CUSTOMER STATED THAT PATIENT DEMOGRAPHIC INFORMATION CANNOT BE DISCLOSED.

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 PATIENT DEVELOPED A PNEUMOTHORAX. PATIENT WAS HOSPITALIZED AND CHEST TUBE WAS PLACED. THE PNEUMOTHORAX RESOLVED AND THE PATIENT WAS RELEASED ON (B)(6) 2025. NO DEVICE ISSUES WERE REPORTED.

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 BROKE OFF INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE WHICH WAS COMPLETED ROBOTICALLY WITH A BACKUP HARMONIC ACE INSTRUMENT.

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 THE PATIENT UNDERWENT INTRACRANIAL ELECTRODE PLACEMENT FOR MONITORING, AND DIFFICULTY OCCURRED WITH REMOVAL OF ONE STEREOELECTROENCEPHALOGRAPHY (SEEG) ELECTRODE IN THE RIGHT FRONTAL REGION. AFTER MONITORING CONCLUDED, DURING THE REMOVAL PROCEDURE UNDER LOCAL ANESTHESIA IN THE OPERATING ROOM, DIFFICULTY AROSE IN EXTRACTING ONE SEEG ELECTRODE PLACED IN THE RIGHT FRONTAL REGION. THE ELECTRODE STUMP WAS TEMPORARILY BURIED SUBCUTANEOUSLY. SUBSEQUENTLY, DURING A LEFT FOCAL RESECTION, THE RIGHT FRONTAL ELECTRODE INSERTION SITE WAS INCISED, AND THE ELECTRODE WAS REMOVED USING A DRILL. THE PATIENT RECOVERED WELL WITHOUT POSTOPERATIVE COMPLICATIONS AND WAS DISCHARGED. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

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

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

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

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION PROCEDURE, THE BLADE OF THE HARMONIC ACE INSTRUMENT BROKE. WHILE DISSECTING, AND A FRAGMENT FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED BY AN ASSISTANT AND CONFIRMED BY THE SURGEON, WITH NO ADDITIONAL SURGICAL PROCEDURE REQUIRED. NO POST-OPERATIVE IMAGING TESTS WERE PERFORMED, AND THE PROCEDURE WAS COMPLETED ROBOTICALLY USING A BACKUP INSTRUMENT OF THE SAME TYPE. THERE WAS NO INJURY TO THE PATIENT, AND THE PATIENT DID NOT RETURN TO THE HOSPITAL FOR COMPLICATIONS RELATED TO A RETAINED FOREIGN OBJECT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: 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 PULMONARY WEDGE RESECTION SURGICAL PROCEDURE, AN UNSPECIFIED INSTRUMENT WAS STUCK ON DRIVE 1 AND PRIOR TO CALLING, THE USER HAD UNDOCKED THE PATIENT SIDE CART (PSC) FROM THE PATIENT WITH THE INSTRUMENT INSTALLED. AFTER UNDOCKING, THE CUSTOMER WAS ABLE TO REMOVE THE INSTRUMENT. AN ERROR WAS OBSERVED IN THE LOGS ON DRIVE 1 INDICATING A LIKELY NOT FULLY SEATED/CONNECTED INSTRUMENT ON DRIVE 1. THE CUSTOMER INDICATED THAT THEY WOULD RETURN THE UNSPECIFIED INSTRUMENT. THE PROCEDURE WAS CONVERTED FROM SINGLE PORT (SP) TO LAPAROSCOPIC. 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 TRANSVERSE COLECTOMY SURGICAL PROCEDURE, IT IS UNCLEAR WHETHER THE METAL FRAGMENT (UNKNOWN COMPONENT) LEFT INSIDE THE PATIENT'S BODY DURING SURGERY WAS A DA VINCI PART. NO DAMAGE WAS FOUND TO THE EXTERIOR OF THE DA VINCI INSTRUMENTS. (FROM THE HOSPITAL) ENGINEERS AND QA RESPONDED THAT NO MATCHING PARTS WERE FOUND. INSTRUMENTS USED DURING PROCEDURE: 30DEG ENDOSCOPE PLUS, TIP-UP FENESTRATED GRASPER, MONOPOLAR CURVED SCISSORS, FENESTRATED BIPOLAR FORCEPS, LARGE NEEDLE DRIVER, MEDIUM-LARGE CLIP APPLIER. THE FRAGMENT WAS RETRIEVED. THE PROCEDURE WAS COMPLETED. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER USED A COVIDIEN LAPAROSCOPIC INSTRUMENT DURING THE PROCEDURE. THE PATIENT HAD AN APPENDECTOMY PROCEDURE ABOUT 60 YEARS AGO.

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 SINGLE PORT (SP) DA VINCI-ASSISTED SURGICAL PROCEDURE, THE NURSE ENCOUNTERED AN ERROR. PRIOR TO CALLING, THE USER HAD ALREADY CONVERTED THE PROCEDURE TO LAPAROSCOPIC SURGERY. AT THE TIME OF THE CALL, THERE WAS NO ERROR PRESENT, AND THE SYSTEM HAD RETURNED TO NORMAL OPERATION. THE CUSTOMER WAS ASKED TO REBOOT THE SYSTEM TO CONFIRM ITS STATUS, AND IT POWERED ON NORMALLY. THE ERROR WAS EXPLAINED, AND THE SYSTEM WAS CONFIRMED TO BE READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON, AND THE SYSTEM INITIALLY POWERED ON WITHOUT ANY ERRORS. DURING THE PROCEDURE, TECHNICAL SUPPORT WAS CONTACTED FOR TROUBLESHOOTING; HOWEVER, WHEN THE SUPPORT TEAM WAS ENGAGED, THE SYSTEM APPEARED TO BE FUNCTIONING NORMALLY, AND A TECHNICAL SUPPORT ENGINEER (TSE) CONFIRMED ITS FUNCTIONALITY. DESPITE THE SYSTEM OPERATING AS EXPECTED AT THAT POINT, THE PROCEDURE WAS ULTIMATELY CONVERTED FROM SINGLE PORT TO LAPAROSCOPIC SURGERY. WHEN ASKED IF, DURING THIS CONVERSION TO TRADITIONAL LAPAROSCOPIC SURGERY, THE NUMBER OR SIZE OF PORT INCISIONS WAS INCREASED, IT WAS CONFIRMED THAT N

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

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

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: NO NEW INFORMATION.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE PLACING CRANIAL LEADS WITH THE EXCELSIUS GPS THE LEFT SIDE LEAD SHIFTED SUPERIOR AT THE VENTRICLE. THE SURGEON STATED THAT THE LEAD RAN ALONG THE SUPERIOR EDGE OF THE HIPPOCAMPUS BUT DECIDED TO PLACE THE LEAD AGAIN. THE EGPS WAS PUSHED BACK IN AFTER LMCS VERIFIED CONTINUED ACCURACY. THE EGPS ARM WAS ALIGNED TO THE LEFT TRAJECTORY AND THE PROCESS REPEATED. THE O-ARM WAS BROUGHT BACK IN AND THE SPIN WAS PERFORMED AND TRANSFERRED. THE LEAD WAS FOUND TO HAVE HIT THE VENTRICLE AND SHIFTED SUPERIOR AGAIN BUT WAS INFERIOR TO THE PREVIOUS LEAD PLACEMENT AND WAS THUS MORE ON TRAJECTORY. THE SURGEON WAS SATISFIED WITH THE PLACEMENT AND CLOSING BEGAN.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE THAT THE ENERGY CORD LED ON THE ENERGY SHIELD MONITOR (ESM) TURNED YELLOW, AND THE MONOPOLAR ENERGY COULD NOT BE USED. REPLACING THE ENERGY CORDS AND RESTARTING BOTH THE ESM AND THE SYSTEM DID NOT RESOLVE THE ISSUE. DUE TO THIS, THE USER DECIDED TO CONVERT THE SINGLE PORT PROCEDURE TO LAPAROSCOPIC. THERE WERE NO REPORTS OF PATIENT INJURY.

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 PLANNED SURGICAL TRAJECTORIES WERE HIGHER ON THE PATIENT THAN INTENDED (TOWARDS THE HEAD). AFTER ADJUSTING THE ANGLE OF THE C-ARM, THE SURGERY PROCEEDED. FOLLOWING THE INITIAL SURGERY, IT WAS DETERMINED THAT SCREWS HAD BEEN MISPLACED, AND THE PATIENT REQUIRED A RETURN TO SURGERY FOR MANUAL SCREW PLACEMENT (REVISION SURGERY). THE PATIENT REPORTED LEFT LEG PAIN AND WEAKNESS FOLLOWING THE INITIAL SURGERY, WHICH LESSENED AFTER THE REVISION SURGERY. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE TRAJECTORY DEVIATION WAS LIKELY IN THE 3.5-10 MILLIMETER (MM) RANGE.

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 DURING AN EXCELSIUSGPS SURGERY THE FIRST SCREW LOOKED TO PLAN. THE SECOND SCREW, L4R, LOOKED LIKE IT WAS TO PLAN, BUT THE OFFSET WAS RED, AND DOC WAS WORRIED. THERE WERE NO NAV SHIFTS AFTER LANDMARK CHECK. HE DIDN'T LIKE, CAME BACK IN WITH DURA PRO, PUT IN SCREW AGAIN, BUT THIS TIME WAS LATERAL. HE DID A LANDMARK CHECK, EVERYTHING ACCURATE. HE DID THE SCREW FREEHAND NAV, WHICH WAS TO PLAN. THE L4L SCREW OFFSET WAS RED, AND SCREW LOOKED LATERAL, BUT DOC SAID THAT IT FELT GOOD TO HIM AND DURA PRO WAS GREEN AND RIGHT ON TRAJECTORY. THE SCREW WAS LATERAL. IT WAS POSSIBLY LATERAL DUE TO RETRACTOR, OR PATIENT MOVEMENT. THE DR. TOOK OUT SCREW, AND REPLACED SCREW FREEHAND WITHOUT NAVIGATION USING FLOUROSCOPY. ALL SCREWS TO PLAN AT END.

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 RECTOPEXY PROCEDURE, THE CUSTOMER INDICATED THAT THE ERBE GENERATOR MALFUNCTIONED AND THE SURGEON COULD NO LONGER CUT TISSUE. AS A RESULT, THE SURGEON ELECTED TO CONVERT THE CASE TO OPEN SURGERY. THE SURGEON EXPLAINED THAT THE REASON FOR THE CONVERSION TO OPEN SURGERY WAS THAT ROBOTIC ELECTROCOAGULATION WAS NO LONGER AVAILABLE AND A LAPAROSCOPIC INTRACORPOREAL ANASTOMOSIS WAS NOT A VIABLE OPTION FOR AN EXTENDED ILEOCECAL RESECTION. POST-OPERATIVELY, THE PATIENT EXPERIENCED NO 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 AN UNSPECIFIED DA VINCI-ASSISTED LIVER SURGICAL PROCEDURE, A PIECE BROKE OFF THE HARMONIC ACE INSTRUMENT AND 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 BUT WAS UNABLE TO OBTAIN ANY ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT.

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

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

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL CYSTECTOMY PROCEDURE, A PIECE FROM ONE OF THE JAWS OF THE HARMONIC ACE INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT. THE DEVICE FRAGMENT FELL INSIDE THE PATIENT WHILE THE SURGEON GRIPPING TISSUE AND AS THE DOCTOR WAS TAKING A TISSUE SAMPLE. THE FRAGMENT WAS RETRIEVED USING TWEEZERS AND IT WAS CONFIRMED VISUALLY THAT ALL FRAGMENTS WERE REMOVED. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED FOR FRAGMENT REMOVAL, AND NO POST-OPERATIVE TESTS SUCH AS X-RAYS OR ULTRASOUNDS WERE PERFORMED. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITHOUT ANY INJURY TO THE PATIENT. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO ANY POST-SURGICAL COMPLICATIONS.

Crash With

Passenger Car

SV Pre-Crash Movement

Proceeding Straight

SV Contact Area

Rear Right

SV Precrash Speed (MPH)

2

CP Pre-Crash Movement

Proceeding Straight

CP Contact Area

Front Right

Within ODD?

Yes

Automation System Engaged?

ADS

Roadway Type

Street

Weather

Cloudy, Rain

Investigating Agency

Los Angeles Police Department

Make

JAGUAR

Model

I-PACE

SV is the subject vehicle — the one whose operator filed the report. CP is the crash partner, the other party. Contact area is where each was struck. NHTSA requires a report for any crash involving the driving system regardless of fault.

On November [XXX], 2025 at 4:52 PM PT a Waymo Autonomous Vehicle ("Waymo AV") operating in Los Angeles, California was in a collision involving a passenger car on [XXX] at [XXX]. The Waymo AV was traveling northeastbound on [XXX], with its right turn signal activated, when it slowed to a stop for a stop sign at the intersection with [XXX]. The Waymo AV proceeded forward slowly as it was yielding to vehicles traveling southeastbound on [XXX] and preparing to turn right onto [XXX]. While the Waymo was proceeding forward, a passenger car traveling northeastbound on [XXX] approached the Waymo AV from behind and the front of the passenger car made contact with the rear of the Waymo AV. At the time of the impact, the Waymo AV's Level 4 ADS was engaged in autonomous mode. Both vehicles sustained damage. The passenger in the Waymo AV was not belted at the time of the collision. The passenger in the Waymo AV was transported to a hospital by an ambulance with unknown injuries. Waymo is reporting this crash under Request No. 1 of Standing General Order 2021-01 because an individual involved was transported from the scene to a hospital for medical treatment. Waymo may supplement or correct its reporting with additional information as it may become available.

Crash With

Passenger Car

SV Pre-Crash Movement

Stopped

SV Contact Area

Rear Right

SV Precrash Speed (MPH)

0

CP Pre-Crash Movement

Proceeding Straight

CP Contact Area

Front Right

Within ODD?

Yes

Automation System Engaged?

ADS

Roadway Type

Intersection

Weather

Clear

Investigating Agency

San Francisco Police Department

Make

JAGUAR

Model

I-PACE

SV is the subject vehicle — the one whose operator filed the report. CP is the crash partner, the other party. Contact area is where each was struck. NHTSA requires a report for any crash involving the driving system regardless of fault.

On November [XXX], 2025 at 10:09 AM PT a Waymo Autonomous Vehicle ("Waymo AV") operating in San Francisco, California was in a collision involving a passenger car on [XXX] at [XXX]. The Waymo AV was stopped in the right lane on [XXX], southwestbound for a red light at the intersection with [XXX]. While the Waymo AV remained stopped, a passenger car that was initially stopped directly behind the Waymo AV proceeded forward, and the front of the passenger car made contact with the rear of the Waymo AV. At the time of the impact, the Waymo AV's Level 4 ADS was engaged in autonomous mode. Neither vehicle sustained damage. The driver of the passenger car was transported from the scene to a hospital with unknown injuries. Waymo is reporting this crash under Request No. 1 of Standing General Order 2021-01 because an individual involved was transported from the scene to a hospital for medical treatment. Waymo may supplement or correct its reporting with additional information as it may become available.

Crash With

Motorcycle

SV Pre-Crash Movement

Proceeding Straight

SV Contact Area

Left

SV Precrash Speed (MPH)

1

CP Pre-Crash Movement

Proceeding Straight

CP Contact Area

Front Right

Within ODD?

Yes

Automation System Engaged?

ADS

Roadway Type

Intersection

Weather

Clear

Investigating Agency

Miami Police Department

Make

TOYOTA

Model

Highlander

SV is the subject vehicle — the one whose operator filed the report. CP is the crash partner, the other party. Contact area is where each was struck. NHTSA requires a report for any crash involving the driving system regardless of fault.

A Zoox retrofitted test vehicle (Vehicle 1) in autonomous mode was stopped, yielding to cross-traffic, on westbound [XXX] at [XXX] in Miami while waiting for an opportunity to proceed through the intersection and continue west on [XXX]. The Zoox vehicle inched forward and then stopped again for cross-traffic. The Zoox vehicle operator then disengaged from autonomous mode and proceeded to begin to cross [XXX]. While crossing, a motorcyclist traveling northbound on [XXX] at a high rate of speed collided with the driver's side front fender and door of the Zoox vehicle. The motorcycle and its operator fell to the ground. After the collision, the Zoox vehicle operator cleared the intersection and pulled over. Both the Zoox vehicle and the motorcycle sustained damage. Police and EMT personnel arrived at the scene, but the motorcycle operator was not transported from the scene.

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 NON-RECOVERABLE FAULT 48250. THE CUSTOMER TRIED REBOOTING THE SYSTEM AND REPLACING THE ENDOSCOPE BEFORE CALLING, WITH NO SUCCESS. THE CUSTOMER PERFORMED MULTIPLE HARD REBOOTS ON THE VISION TOWER AND CYCLED THE EC ROCKER SWITCH, BUT THE ERROR PERSISTED AT STARTUP. THE SURGEON CONFIRMED THE EC LED IS ILLUMINATED BLUE. THE SURGEON ALSO CONFIRMED THAT PROCEDURE WAS ABORTED POST ANESTHESIA AND POST PORT PLACEMENT AS THEY ONLY HAD ONE SP SYSTEM.