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 PANCREATODUODENECTOMY SURGICAL PROCEDURE, THE PATIENT EXPERIENCED POSTOPERATIVE BLEEDING AND REQUIRED AN ANGIOGRAM. THE INITIAL ROBOTIC PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATIONS. THERE WAS NO EXCESSIVE INTRAOPERATIVE BLEEDING NOTED. THE VESSEL SEALER CURVED INSTRUMENT WAS USED ON THE INFERIOR PANCREATIC DUODENAL BRANCH OFF THE SUPERIOR MESENTERIC ARTERY, WHERE THE BLEEDING WAS IDENTIFIED POSTOPERATIVELY. THE VESSEL WAS APPROXIMATELY 2MM IN DIAMETER. THE BLEEDING WAS CONTROLLED BY THE ANGIOGRAM; NO FURTHER INTERVENTION WAS REQUIRED, AND THE PATIENT DID NOT HAVE TO BE TAKEN BACK TO THE OPERATING ROOM.

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

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY PROCEDURE, THE MONOPOLAR ENERGY CABLE BURNED THROUGH THE SURGEON¿S GOWN. AS A RESULT, THE SURGEON'S ARM WAS ALSO REPORTEDLY BURNED WHILE AT THE BEDSIDE. THE CABLE WAS REPLACED AND THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO REPORTED INJURY TO THE PATIENT. THE SURGEON REPORTEDLY TREATED THE BURN INJURY WITH BURN CREAM/OINTMENT.

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 SURGICAL PROCEDURE, THE JAW OF THE HARMONIC ACE INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE WHICH WAS COMPLETED ROBOTICALLY. A SURGICAL DELAY OF GREATER THAN 30 MINUTES WAS 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: REFER TO H11 FOR FOLLOW-UP INFORMATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSOR (MCS) TIP INSTURMENT GUARD BROKE IN TWO. THE SCISSORS REMAINED COMPLETELY ATTACHED TO THE INSTRUMENT, ONLY THE BLUNT PLASTIC PART FELL INTO THE ABDOMINAL CAVITY. THE FOREIGN BODY WAS REMOVED WITHOUT COMPLICATIONS, AND THERE WERE NO ADDITIONAL INJURIES TO THE PATIENT OR DELAYS TO THE OPERATION. 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 BENIGN HYSTERECTOMY PROCEDURE, THE CUSTOMER ENCOUNTERED A NON-RECOVERABLE FAULT INVOLVING THE ERBE GENERATOR, PROMPTING THE SURGEON TO CONVERT TO THE PROCEDURE TO A CONVENTIONAL VAGINAL APPROACH. THE CUSTOMER INSPECTED THE GENERATOR BEFORE USE AND NO UNUSUAL FINDINGS WERE SEEN. A SELF-TEST WAS PERFORMED AND NO ERROR MESSAGES WERE OBSERVED. ACCORDING TO THE CUSTOMER, THE GENERATOR HAD BEEN SHOWING AN ERROR INTERMITTENTLY WHICH EVENTUALLY BECAME CONSTANT WHEN FIRING MONOPOLAR OR BIPOLAR INSTRUMENTS. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ADVISED THE CUSTOMER TO CHANGE THE BIPOLAR SETTING, BUT THE ERROR PERSISTED. AS A RESULT, THE SURGEON ELECTED TO CONVERT THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE WELL AND NO ADVERSE COMPLICATIONS 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 MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY, INSTALLED ON AN MCS INSTRUMENT, FELL OFF INSIDE THE PATIENT. THE MCS TIP COVER ACCESSORY 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 PRIOR TO THE START OF A DA VINCI-ASSISTED LEFT NEPHROURETERECTOMY SURGICAL PROCEDURE, THE CUSTOMER CONTACTED A INTUITIVE SURGICAL INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THAT THE ENERGY SHIELD MONITOR (ESM) WOULD NOT LIGHT UP AND A MESSAGE ON THE MONITOR INDICATED THAT THE ENERGY SHIELD COULD NOT BE DETECTED. THE TSE INSTRUCTED THE CUSTOMER TO CHECK ALL THE CABLES ON THE BACK OF THE ESM TO ENSURE THEY WERE FULLY SEATED, WHICH THEY WERE. THE CUSTOMER ALSO CHECKED THE CABLES ON THE OTHER END, WHICH WERE ALSO FULLY SEATED. THE CUSTOMER MENTIONED A SCREEN MESSAGE INDICATING THAT THE VIDEO PROCESSOR (VP) WAS NOT DETECTED. UPON CHECKING, THE GRAY FIBER WAS FOUND TO BE MISSING, SO THE CUSTOMER USED A FIBER FROM ANOTHER SYSTEM TO CONNECT THE VP TO THE CORE. THE TSE ALSO HAD THE CUSTOMER CHECK THE ROCKER SWITCH TO ENSURE IT WAS IN THE ON POSITION. A HARD POWER CYCLE OF THE SYSTEM WAS PERFORMED, BUT THE ESM STILL DID NOT LIGHT UP. THE ERBE WAS ON, WITH MONOPOLAR AND NEUTRAL PAD CONNECTIONS PLUGGED IN. THE CUSTOMER NOTED THAT ANOTHER SYSTEM HAD ISSUES WITH ARM 1 AND THAT TWO CASES WERE SCHEDULED FOR NEXT WEEK. THE CUSTOMER REQUESTED THAT THE FIELD SERVICE

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, THE CUSTOMER OBSERVED THE LOSS OF THE TIP OF THE MONOPOLAR CURVED SCISSORS (MCS) IN THE ABDOMINAL CAVITY. IT WAS IMMEDIATELY FOUND AND REMOVED. AT THE END OF THE SURGERY, IT WAS DETECTED THAT THERE WAS A PARTIAL OPENING IN THE RING TO WHICH THE MCS WERE ATTACHED, WHICH COULD HAVE CAUSED THE DISENGAGEMENT. A BACKUP DA VINCI INSTRUMENT OF THE SAME KIND WAS USED. THE PROCEDURE WAS COMPLETED WITH NO DELAY. THE REPORTER CONFIRMED THAT THE SURGICAL TASK, WHICH WAS BEING PERFORMED, WHEN THE DEVICE FRAGMENT FELL INSIDE THE PATIENT WAS MOVING THE INSTRUMENT. THE INSTRUMENT WAS IN USE ABOUT 30 MINUTES PRIOR TO THE ISSUE. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. THE INSTRUMENT WAS NOT REMOVED DURING THE PROCEDURE (PRIOR TO THE BREAKAGE). THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. THE FRAGMENT WAS RETRIEVED WITH A FORCEPS. THERE WAS NOT AN ADDITIONAL SURGICAL PROCEDURE REQUIRED TO REMOVE TH

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

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A PATIENT IN A STUDY UNDERWENT A DA VINCI-ASSISTED NIPPLE SPARING MASTECTOMY (NSM) PROCEDURE. DURING THE 14-DAY POST-OPERATIVE VISIT, IT WAS OBSERVED THAT THE PATIENT HAD DEVELOPED MILD ISCHEMIC CHANGES OF THE LEFT NIPPLE AREOLA COMPLEX (NAC), PRESENTING AS ERYTHEMA ON AND AROUND THE COMPLEX AND BLEEDING AT THE NIPPLE TIP THAT SUBSEQUENTLY FORMED A SCAB. THE PATIENT WAS TREATED WITH CIPROFLOXACIN AND SILVADENE CREAM. ON PHYSICAL EXAM DATED TEN DAYS AFTER THE ISCHEMIC CHANGES WERE OBSERVED, THE EVENT WAS EVALUATED AND DEEMED RESOLVED. IT WAS REPORTED THAT THE REASON FOR THE ISCHEMIC CHANGES WAS A DISRUPTION OF VASCULAR SUPPLY TO THE NAC WHICH WAS TRANSIENT. THERE WAS NO REPORTED MALFUNCTION OF A DA VINCI DEVICE DURING THE PROCEDURE. THE STUDY INVESTIGATOR REPORTED THE EVENT AS NOT A SERIOUS ADVERSE EVENT (SAE), DEFINITELY RELATED TO THE NSM PROCEDURE, POSSIBLY RELATED TO THE RECONSTRUCTION PROCEDURE, NOT RELATED TO THE DA VINCI STUDY DEVICE AND NOT RELATED TO THE PATIENT'S PRE-EXISTING CONDITIONS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A REVIEW OF THE ARTICLE WAS CONDUCTED WHICH AIMED TO INVESTIGATE THE SAFETY, EFFICACY, AND SHORT-TERM OUTCOMES OF TRANSORAL ROBOTIC SURGERY (TORS) FOR SUPRAGLOTTIC LARYNGEAL CANCER. THE STUDY, A MULTICENTER RETROSPECTIVE ANALYSIS, ANALYZED 27 PATIENTS UNDERGOING TRANSORAL ROBOTIC SURGERY (TORS) BETWEEN JANUARY 2018 AND APRIL 2024. A TOTAL OF 27 PATIENTS WITH SUPRAGLOTTIC LARYNGEAL CANCER WERE ENROLLED IN 4 CENTERS, INCLUDING 24 MALES AND 3 FEMALES. A TOTAL OF SEVERAL PATIENTS EXPERIENCED PERIOPERATIVE COMPLICATIONS, INCLUDING PALATAL ARCH MUCOSAL INJURY IN 23 CASES (85.19%), DYSPHAGIA IN 4 CASES (14.81%), INCISOR INJURY IN 1 CASE (3.70%), AND LARYNGEAL BLEEDING IN 1 CASE (3.70%) OCCURRING ONE WEEK AFTER SURGERY, WHICH CEASED AFTER APPROXIMATELY 30 ML BLOOD LOSS AND WAS ATTRIBUTED TO DETACHMENT OF THE HIBICOBINA ALBA IN THE OPERATIVE CAVITY. NO DEVICE MALFUNCTIONS WERE REPORTED, AND THE AUTHORS DID NOT REPORT ANY EVENTS CAUSED BY THE DA VINCI SURGICAL SYSTEM. INTUITIVE SURGICAL INC. (ISI) HAS MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, AS OF THE DATE OF THIS REPORT, NO NEW INFORMATION HAS BEEN OBTAINED.

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 DURING THE SURGEON'S EGPS 1L L5/S1 PLIF ON A GRADE 1 SPONDYLOLISTHESIS PATIENT. THEY PLANNED PEDICLE SCREWS RELATIVELY STRAIGHT ON, AS HE INTENDED A MIDLINE INCISION. THE SURGEON APPROVED THE PLAN. THEY PLACED THE LONG QUATTRO SPIKE AND LONG SURVEILLANCE MARKER DUE TO PATIENT HYPERLORDOSIS, AND PERFORMED THE MERGE, WHICH WAS APPROVED. THEY BROUGHT IN THE ROBOT AND MARKED THE SKIN, BUT THE SURGEON SWITCHED TO MINI WILES INCISIONS. BETWEEN THE MERGE AND SCREW INSERTION, THE SURGEON BUMPED EITHER THE SM OR DRB TWICE, SHIFTING THE RED MARKER. HE VERIFIED NAVIGATION ACCURACY USING THE CHICKEN FOOT ALONG THE QUATTRO BASE, SM, AND SPINOUS PROCESS BEFORE RE-REGISTERING THE SM. THE RIGHT L5 SCREW FAILED TO PENETRATE THE POSTERIOR VB WALL, SO THEY PLACED RIGHT S1 FIRST TO CHECK DRILL SHARPNESS, THEN CHANGED TO A NEW DRILL. THE LEFT L5 AND S1 SCREWS WERE PLACED NEXT. THE POST-OP X-RAYS SHOWED LEFT L5 COMPLETELY OUT OF THE PEDICLE IN AP BUT PERFECT LATERALLY. THEY PERFORMED ANOTHER MERGE, APPROVED BY THE SURGEON, AND REPLACED LEFT L5.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: NAVARRO-GARCIA DE LLANO, J. P., RIOS-ZERMENO, J., ROBERTS, A. P., IYER, H. G., SANCHEZ-GARAVITO, J. E., SAFA, A., MARTIN DEL CAMPO, I., GRAEPEL, S., PATTERSON, J. S., WHITE, K. E., BOJAXHI, E., NAVARRO-RAMIREZ, R., QUIÑONES-HINOJOSA, A., AKINDURO, O. O., BUCHANAN, I. A., CHEN, S. G., <(>&<)> ABODE-IYAMAH, K. (2025). SPINAL VERSUS GENERAL ANESTHESIA IN ROBOTIC MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION: A COMPARATIVE STUDY ON SURGICAL OUTCOMES. JOURNAL OF NEUROSURGERY: SPINE, 1¿9. HTTPS://DOI.ORG/10.3171/2025.6.SPINE25442 SUMMARY OBJECTIVE: THE IMPLEMENTATION OF ROBOTICS AND SPINAL ANESTHESIA (SA) IN SPINE SURGERY IS RAPIDLY EXPANDING, OFFERING SIGNIFICANT BENEFITS FOR AN INCREASINGLY COMPLEX AND AGING PATIENT POPULATION WITH DEGENERATIVE SPINAL DISEASE. HERE, THE AUTHORS PRESENT THE LARGEST COHORT TO DATE EVALUATING THE COMBINED USE OF THESE TWO TECHNIQUES IN MINIMALLY INVASIVE (MIS) TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF). METHODS: THE AUTHORS RETROSPECTIVELY ANALYZED SURGICAL OUTCOMES OF A SERIES OF PATIENTS WHO UNDERWENT ROBOT-ASSISTED (RA)¿MIS TLIF UNDER SA AND GENERAL ANESTHESIA (GA) AT THEIR INSTITUTION FROM 2018 TO 2024. PRIMARY OUTCOMES INCLUDED OPERATI

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 CASE WAS A T11-L3 PERC SPINE FUSION WITH A SPINE TUMOR AT L1. WE PLACED THE DRB IN THE RIGHT PSIS AND THE SURVEILLANCE IN THE LEFT ILIAC CREST. AFTER THE FIRST SPIN WHEN DR. (B)(6) CLICKED ON HIS FIRST SCREW HE NOTED THAT THE NAV WAS WAY OFF (TOWARDS THE PATIENTS MIDLINE). IT WAS DISCOVERED AT THIS TIME THAT THE SURVEILLANCE WAS NOT SET PRIOR TO SPINNING SO WE WANTED TO PLAY IT SAFE AND RE SPIN. AFTER RESPINNING WE PLACED THE T12, L2 AND ONE L3 SCREW ON THE LEFT AND WHEN WE WENT TO PLACE THE L3 SCREW ON THE RIGHT HE NOTED THAT THE NAV WAS WAY OFF AGAIN. THIS TIME THE SURVEILLANCE HAD BEEN PROPERLY SET AND WAS STILL GREEN. THEN WE MOVED THE DRAPE NORTH (THE PATIENTS T11 ENTRY POINT WAS PREVIOUSLY NOT DRAPED OUT ENOUGH TO ACCESS) AND RE SPUN AGAIN. IMMEDIATELY AFTER THE 3RD SPIN WHEN HE WENT TO CHECK ACCURACY, HE NOTED THAT IT WAS AGAIN OFF AND THAT HE DIDN'T TRUST THE NAV MOVING FORWARD. THE SURVEILLANCE WAS ALSO STILL GREEN AT THIS TIME AS WELL.

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 PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT, INADVERTENTLY ARCED TO UNSPECIFIED TISSUE. TO ADDRESS THE ISSUE, A BACKUP MCS INSTRUMENT WAS UTILIZED WITH THE SAME MCS TIP COVER ACCESSORY. HOWEVER, THE SAME ISSUE RECURRED. AN INTUITIVE SURGICAL INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WAS CONSULTED AND ADVISED THE CUSTOMER TO REPLACE THE MCS TIP COVER ACCESSORY IF PHYSICAL DAMAGE WAS OBSERVED AND FURTHER RECOMMENDED DISCONNECTING THE BIPOLAR CABLE IF THE ISSUE OCCURRED NEAR A BIPOLAR INSTRUMENT, GRIPPING TISSUE. AT THIS TIME, IT IS UNKNOWN HOW THE ISSUE WAS ULTIMATELY RESOLVED, WHETHER THE PATIENT SUSTAINED ANY INJURY, OR IF ADDITIONAL MEDICAL INTERVENTIONS WERE REQUIRED. THE PROCEDURE WAS COMPLETED ROBOTICALLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, 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: IT WAS REPORTED THAT DURING AN UNSPECIFIED DA VINCI-ASSISTED PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT, INADVERTENTLY ARCED TO UNSPECIFIED TISSUE. TO ADDRESS THE ISSUE, A BACKUP MCS INSTRUMENT WAS UTILIZED WITH THE SAME MCS TIP COVER ACCESSORY. HOWEVER, THE SAME ISSUE RECURRED. AN INTUITIVE SURGICAL ,INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WAS CONSULTED AND ADVISED THE CUSTOMER TO REPLACE THE MCS TIP COVER ACCESSORY IF PHYSICAL DAMAGE WAS OBSERVED AND FURTHER RECOMMENDED DISCONNECTING THE BIPOLAR CABLE IF THE PROBLEM OCCURRED NEAR A BIPOLAR INSTRUMENT GRIPPING TISSUE. IT IS UNKNOWN HOW THE ISSUE WAS RESOLVED, IF THERE WAS INJURY TO THE PATIENT, OR IF THE PATIENT REQUIRED ANY ADDITIONAL MEDICAL INTERVENTIONS. THE PROCEDURE WAS COMPLETED ROBOTICALLY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING AN UNSPECIFIED DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY FELL FROM THE SHAFT OF A MCS INSTRUMENT SEVERAL TIMES. THE ISSUE OCCURRED WHILE THE SURGEON WAS PERFORMING DISSECTION. THE MCS TIP COVER ACCESSORY WAS RETRIEVED BY AN ASSISTANT. THE MCS INSTRUMENT HAD BEEN IN USE FOR 2 HOURS PRIOR TO THIS EVENT. THE MCS TIP COVER ACCESSORY WAS PROPERLY INSTALLED WITH THE INSTALLATION TOOL AND NO PART OF THE ORANGE INSULATION WAS VISIBLE. NO LUBRICANTS OR A REDUCER WERE USED. THERE HAD BEEN NO DIFFICULTY REMOVING THE INSTRUMENT AND THE INSTRUMENT'S WRIST WAS STRAIGHTENED UPON REMOVAL. NO ADDITIONAL PROCEDURE WAS PERFORMED TO RETRIEVE THE MCS TIP COVER ACCESSORY. ADDITIONALLY, NO POST-OPERATIVE IMAGING WAS PERFORMED DUE TO THE FALLEN INSTRUMENT ACCESSORY. THE PROCEDURE WAS COMPLETED ROBOTICALLY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE INNER RUBBER OF THE UNIVERSAL SEAL PART TORE OFF AND FELL INSIDE THE PATIENT'S BODY. IT IS UNKNOWN IF A FRAGMENT WAS RETRIEVED. 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 PARTIAL RIGHT NEPHRECTOMY SURGICAL PROCEDURE FOR 3CM LOWER POLE TUMOR, EXCESSIVE BLEEDING OCCURRED REQUIRING THE PROCEDURE TO BE CONVERTED TO AN OPEN APPROACH. THE SURGEON HAD CLAMPED THE RENAL VEIN RATHER THAN THE INTENDED RENAL ARTERY. DURING DISSECTION OF THE TUMOR, THE EXCESSIVE BLEEDING OCCURRED DUE TO CLAMPING THE RENAL VEIN, NOT THE RENAL ARTERY. THE BLEEDING WAS NOT ABLE TO BE CONTROLLED ROBOTICALLY, SO THE PROCEDURE WAS CONVERTED TO AN OPEN APPROACH. THE PATIENT IS REPORTED TO BE RECOVERING WELL.

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 THE SURGEON HAS HAD ISSUES WITH ACCURACY WHEN PLACING THE DRILL IN END EFFECTOR. OUR PLANS LOOK REALLY GOOD AND THEN THIS CHANGES WHEN A DRILL IS PLACED IN END EFFECTOR. THE TRAJECTORY IS WAY OFF AND MEDIAL FROM CHOSEN PLAN. WE DID EVERYTHING THAT CSR RECOMMENDED TO TROUBLE SHOOT, BUT THE PROBLEM PERSISTED. AFTER ATTEMPTING TO TROUBLESHOOT IS WHEN WE ABORTED SCREW INSERTION.

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 A SCREW WAS MISPLACED DURING A PROCEDURE WITH EGPS. THE SURGEON FOUND OUT VIA POST-OPERATIVE CT, BEFORE THIS THERE WAS NO AWARENESS THAT THERE HAD BEEN A MISPLACED SCREW. CASE WAS AN MIS TRAUMA STABILIZATION FOR T12 FRACTURE, T10, 11, L1 AND L2 INSTRUMENTS. THE SCREWS IN QUESTION WERE AN L2 RIGHT PEDICLE SCREW, BREACHING MEDIALLY AND AN L2 LEFT PEDICLE SCREW BREACHING LATERALLY. SURGEON STATED THAT PATIENT DIDN'T EXHIBIT ANY NEUROLOGICAL DEFICIT HOWEVER THE SCREWS NEEDED TO BE REVISED. WE JUST COMPLETED REVISION SURGERY AND CONFIRMED CORRECT PLACEMENT OF L2 SCREWS AND EXTENDING DOWN TO L3. SCREW PLACEMENT CONFIRMED WITH INTRA-OPERATIVE CONE BEAM CT. SURGEON WAS UNSURE AND WASN'T ABLE TO POINT SPECIFICALLY TO ANY SIGNIFICANT EVENT E.G. FRAME SHIFT THAT WOULD HAVE CONTRIBUTED TO THE DEVIATION, SHE STATED THAT THE PATIENT HAD VERY SCLEROTIC BONE AND TISSUE AND THIS MAY HAVE MECHANICALLY PULLED THE SCREWS OFF COURSE, SHE STATED THAT INSERTING THE SCREWS WAS "TOUGH" AND WAS CONSTANTLY FIGHTING FORCES. THE PATIENT ALSO HAD VERY NARROW PEDICLES, AND INSTRUMENTATION WAS GOING TO BE CHALLENGING IN ANY SCENARIO. I WASN'T PRESENT IN T

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITHOUT LYMPHADENECTOMY SURGICAL PROCEDURE, THE "SHEATH" OF THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT REMAINED IN THE PATIENT WHEN THE CUSTOMER REMOVED THE SCISSORS. THE MCS TIP COVER ACCESSORY FELL INTO THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED. AN UNSPECIFIED POST-OPERATIVE TEST WAS PERFORMED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: NO CLINICAL CONSEQUENCES FOR THE PATIENT; THE SHEATH WAS REMOVED BEFORE THE PATIENT WAS SUTURED. ACTIONS TAKEN AT THE HEALTHCARE FACILITY FOR PATIENT MANAGEMENT: THE TEAM NOTICED THAT THE SHEATH HAD REMAINED INSIDE THE PATIENT AND REMOVED IT BEFORE SUTURING. THIS INCIDENT OCCURRED AT LEAST TWICE, WITHOUT CONSEQUENCE FOR THE PATIENT BECAUSE THE SHEATH WAS SEEN AND REMOVED EACH TIME. HOWEVER, IT WAS NOTED THAT THIS PRESENTS A RISK TO THE PATIENT IF THE TEAM DID NOT NOTICE IT BEFORE SUTURING.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE SCREEN FREEZES AFTER THE BONE REGISTRATION WAS COMPLETED AND BEFORE THE OSTEOTOMY. MPS TRIED EVERYTHING HE COULD DO TO FIX THE PROBLEM, BUT TO NO AVAIL, SO HE CONTACTED (B)(4). REBOOTING AND BYPASSING EACH CABLE DID NOT RESTORE THE SCREEN. THE DOCTOR IN CHARGE CONSULTED WITH THE PATIENT'S FAMILY AND REOPERATED AT A LATER DATE, CLOSING THE WOUND AND CLOSING IT.

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, RUBBER PARTS WERE DAMAGED AND FELL OFF THE CANNULA UNIVERSAL SEAL ACCESSORY. A FRAGMENT FELL INTO THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ACCESSORY WAS INSPECTED PRIOR TO USE AND NO DAMAGE OR ABNORMALITIES WERE FOUND. DURING THE PROCEDURE, A FRAGMENT FROM THE DEVICE FELL INSIDE THE PATIENT WHILE THE INSTRUMENT WAS BEING INSERTED OR REMOVED. THE SURGEON DID NOT PROVIDE A SPECIFIC CAUSE FOR THE BREAKAGE; IT WAS ONLY NOTICED WHEN THE INCIDENT OCCURRED, WITH NO PRIOR SIGNS. THE ACCESSORY HAD BEEN USED FOR APPROXIMATELY 120 MINUTES BEFORE THE ISSUE AROSE, AND NO FUNCTIONAL ISSUES WERE OBSERVED DURING THE PROCEDURE. THERE WAS NO COLLISION WITH OTHER INSTRUMENTS OR HARD MATERIALS. THE FRAGMENT FELL DURING AN INSTRUMENT TIP/ACCESSORY COLLISION DURING INSTRUMENT MANIPULATION. AN INSTRUMENT WAS REMOVED PRIOR TO BREAKAGE WITH THE WRIST STRAIGHTENED, AND NO RESISTANCE WAS FELT DURING REMOVAL THROUGH THE CANNULA. THE FRAGMENT WAS RETRIEVED USING LAPAROSCOPIC FORCEPS, A

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PANCREATODUODENECTOMY SURGICAL PROCEDURE, THE PATIENT EXPERIENCED POSTOPERATIVE BLEEDING AND REQUIRED AN ANGIOGRAM. THE INITIAL ROBOTIC PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATIONS. THERE WAS NO EXCESSIVE INTRAOPERATIVE BLEEDING NOTED. THE VESSEL SEALER CURVED INSTRUMENT WAS USED ON THE DORSAL PANCREATIC ARTERY, WHERE THE BLEEDING WAS IDENTIFIED POSTOPERATIVELY. THE VESSEL WAS APPROXIMATELY 2MM IN DIAMETER. THE BLEEDING WAS CONTROLLED BY THE ANGIOGRAM; NO FURTHER INTERVENTION WAS REQUIRED, AND THE PATIENT DID NOT HAVE TO BE TAKEN BACK TO THE OPERATING ROOM.

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 SHEATH OF THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY FELL INTO A PATIENT. THE MCS TIP COVER ACCESSORY WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED. AN UNSPECIFIED POST-OPERATIVE TEST WAS PERFORMED. THERE WERE NO CLINICAL CONSEQUENCES FOR THE PATIENT; THE SHEATH WAS REMOVED BEFORE THE PATIENT WAS SUTURED. THE TEAM NOTICED THAT THE SHEATH HAD REMAINED INSIDE THE PATIENT AND REMOVED IT BEFORE SUTURING. THIS INCIDENT OCCURRED AT LEAST TWICE, WITHOUT CONSEQUENCE FOR THE PATIENT BECAUSE THE SHEATH WAS SEEN AND REMOVED EACH TIME. HOWEVER, IT WAS NOTED THAT THIS WOULD PRESENT A RISK TO THE PATIENT IF THE TEAM DID NOT NOTICE IT BEFORE SUTURING.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE TIP OF THE HARMONIC ACE INSTRUMENTS BROKE. A FRAGMENT FELL INTO THE PATIENT. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS. THE FRAGMENT WAS RETRIEVED AND THE CUSTOMER CONFIRMED RETRIEVAL BY ENSURING THAT THE SHAPE OF THE BLADE WAS COMPLETE. NO ADDITIONAL SURGICAL PROCEDURE REQUIRED TO REMOVE THE FRAGMENT. NO POST-OPERATIVE TESTS, SUCH AS AN X-RAY OR ULTRASOUND, WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH A BACK-UP HARMONIC ACE INSTRUMENT. THERE WAS NO INJURY TO THE PATIENT, AND THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SHEATH OF THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY FELL INTO A PATIENT AND THE ACCESSORY WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED. AN UNSPECIFIED POST-OPERATIVE TEST WAS PERFORMED. THERE WERE NO CLINICAL CONSEQUENCES FOR THE PATIENT; THE SHEATH WAS REMOVED BEFORE THE PATIENT WAS SUTURED. THE TEAM NOTICED THAT THE SHEATH HAD REMAINED INSIDE THE PATIENT AND REMOVED IT BEFORE SUTURING. IT WAS NOTED THAT THIS INCIDENT OCCURRED AT LEAST TWICE, WITHOUT CONSEQUENCE FOR THE PATIENT BECAUSE THE SHEATH WAS SEEN AND REMOVED EACH TIME. HOWEVER, IT WAS NOTED THAT THIS WOULD PRESENT A RISK TO THE PATIENT IF THE TEAM DID NOT NOTICE IT BEFORE SUTURING.

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: DEEP LATERAL ANTERIOR CUT RELATIVE THE IMPLANT, OTHER CUTS FLUSH. GRAFTING REQUIRED UNDER THE CUT. ADDITIONAL INFORMATION RECEIVED ON 14/10/25: THERE WAS A GAP BETWEEN THE IMPLANT AND THE CUT THAT THE SURGEON SAID WAS 5MM. HOWEVER, IN THE PICTURE IT LOOKS SLIGHTLY LESS. THERE HAS NOT BEEN ANY IMPACT OR ADVERSE CONSEQUENCES REPORTED SINCE AS A RESULT OF THIS EVENT EXCEPT FOR THE REQUIRED GRAFTS AS MENTIONED.

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.

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. IT WAS REPORTED THAT A CT REVEALED FORAMINAL STENOSIS DUE TO A FRACTURE OF THE PATIENT'S SUPERIOR ARTICULAR PROCESS POST-OPERATIVELY. ADDITIONALLY, THE PATIENT HAS INCREASED LEFT LEG PAIN. IT WAS NOTED THE GUIDANCE ROBOT WAS USED FOR THE DECORTICATION OF THE BONE. THE PROCEDURE PERFORMED WAS A INTERBODY FUSION FROM LEVELS L5-S1. ADDITIONAL SURGERY WAS PERFORMED THE DAY AFTER TO ADDRESS THE ADVERSE EVENT. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THE GUIDANCE SYSTEM WAS INVOLVED IN AN ABNORMAL DECORTICATION. THE SYSTEM WAS USED TO DECORTICATE AND CANNULATE THE PEDICLE. AN APPROPRIATE SIZED SCREW WAS PLACED. POST-OP, THE PATIENT INDICATED THAT THEY HAD EXTREME PAIN. THE FRACTURED PROCESS HAD BEEN CANNULATED BY THE GUIDANCE 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A PIECE OF A UNIVERSAL SEAL POPPED OFF MID-PROCEDURE AND FELL INTO THE PATIENT. IT WAS CAUGHT AND REMOVED FROM THE ABDOMEN. THE CUSTOMER NOTED THAT THE LOT NUMBER WAS UNKNOWN DUE TO THE SEAL HAVING BEEN DISCARDED.

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 DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT WAS FOUND TO HAVE AN ISSUE WITH THE BLADE. A BACKUP INSTRUMENT WAS USED AND THE PROCEDURE WAS COMPLETED. AN UNSPECIFIED POST-OPERATIVE TEST WAS REPORTEDLY PERFORMED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE NURSE STATED THAT DURING A PROCEDURE USING THE HARMONIC ACE, THE BLADE BROKE AT THE TIP AND WAS COMPLETELY DETACHED FROM THE INSTRUMENT. THE BROKEN FRAGMENTS DROPPED INTO THE PATIENT¿S BODY BUT WERE ALL RETRIEVED WITHOUT RESIDUAL FOREIGN BODIES.

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 INACCURACY. IT WAS STATED THAT DURING NAVIGATION, THE TRAJECTORIES APPEARED TO BE ACCURATE, BUT AFTER PLACING T4 SCREW ON THE RIGHT SIDE, THE SURGEON WAS NOTIFIED BY NEURO-MONITORING TEAM THAT THEY HAD LOST READINGS OF THE PATIENT'S RIGHT LEG. AFTER TAKING AN IMAGE TO CONFIRM SCREW PLACEMENT, THE SCREW APPEARED TO BE PLACED MEDIALLY BY AN UNKNOWN AMOUNT OF UNITS. THEY TOOK OUT THIS SCREW AND ABANDONED USE OF THE ROBOT AND CLOSED THE PATIENT. THEY RE-PLACED THIS SCREW USING THE MEDTRONIC NAVIGATION SYSTEM DURING A FOLLOW UP SURGERY ON (B)(6) 2025. THE PATIENT WAS BEING MONITORED FOR PARALYSIS ON THE RIGHT LEG. SURGICAL DELAY WAS NOTED AS 5-10 MINUTES. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE SITE REGISTERED ONCE, BUT THE C-ARM BUMPED THE ROBOT ON THE WAY OUT, SO THEY HAD TO REGISTER A SECOND TIME. IT WAS ALSO NOTED THAT THE PLANNED TRAJECTORY AT T4 ON THE RIGHT, WAS ORIGINALLY WITHIN THE PREFERRED PARAMETERS FOR AN OPEN CASE, HOWEVER, UPON DRILLING AT THE ORIGINAL TRAJECTORY THE DOCTOR FELT THEY WERE TO

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, MONOPOLAR CURVED SCISSORS (MCS) TIP COVER FELL INTO PATIENT INTRA-ABDOMINALLY ON (B)(6) 2025. LAPAROSCOPY AND EXPLORATION LAPAROTOMY DID NOT FIND THE FOREIGN BODY. THE COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED THE NEXT DAY CONFIRMED AN INTRA-ABDOMINAL FOREIGN BODY. REPEAT SURGERY WAS SCHEDULED FOR (B)(6) 2025 FOR REMOVAL OF THE FOREIGN BODY BUT WAS PERFORMED ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS CHECKED BY THE NURSE PRIOR TO USE, BUT NOT BY THE SURGEON. DURING INSTRUMENT REMOVAL, THE NURSE OBSERVED THE MCS TIP COVER ACCESSORY SLIPPING. IT WAS REMOVED AND INSPECTED FOR PROPER PLACEMENT, THEN REATTACHED. HOWEVER, ONCE INSIDE THE ABDOMEN, THE COVER BEGAN TO SLIP AGAIN, DEVELOPED A VISIBLE CRACK, AND ULTIMATELY FELL INTO THE ABDOMEN DURING WITHDRAWAL. THE SURGEON SUSPECTS THE CAUSE WAS ¿SNAGGING¿ OF THE PROTECTIVE SHEATH AT THE INTERNAL ORIFICE OF THE TROCAR. THE EXACT DURATION OF MCS USE WAS DIFFICULT TO ESTIMATE, BUT THREE TIP COVERS WERE REQUIRED, AS TWO CRACKED¿ONLY ONE

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

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: 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 A PATIENT IS SUFFERING PARAPLEGIA POST EGPS SURGERY. THE SURGEON IMPLIED HE FELT EGPS INSTRUMENTATION MAY HAVE CONTRIBUTED TO THE OUTCOME. SEPARATE CASE SUMMARY SUBMITTED DETAILING OBSERVED SURGICAL EVENTS. FROM INITIAL INFORMATION GATHERING WE HAVE BEEN INFORMED THAT THERE APPEARS TO BE HEMATOMA AND BONE FRAGMENTS IN THE CANAL SPACE AT AROUND THE T9 ANATOMICAL AREA. FROM CONVERSATIONS WITH THE CLINICIAN'S SURGICAL IMPLANTATION FROM THE PROCEDURE APPEARS TO BE CORRECTLY POSITIONED AND IMPLANT ACCURACY APPEARS TO NOT BE IN QUESTION. INITIAL REPORTING FROM THE SURGEON USER APPEARED TO INDICATE HE FELT THAT THE HIGH-SPEED DRILL OR THE PILOT DRILL COULD HAVE MOVED BONE FRAGMENTS INTO THE CANAL AT THIS AREA. IT IS UNCLEAR WHETHER THERE IS ANY EVIDENCE OF INSTRUMENTATION BREACH E.G. CLEARLY DEFINED INSTRUMENT TRACKS, INTO THE CANAL, HOWEVER THE SUGGESTION APPEARED TO BE THE SURGEON FELT THAT THESE INSTRUMENTS MAY HAVE MECHANICALLY DISLODGED THE BONY ANATOMY AND HAD A CAUSATIVE EFFECT.

Crash With

SUV

SV Pre-Crash Movement

Parked

SV Contact Area

Rear

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

Street

Weather

Clear

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.

Other than an update to the highest severity injury alleged field to reflect an unknown injury level, the content of this report is unchanged from the initial report submitted on October [XXX], 2025 [Report ID # 30270-11849-1]. On October [XXX], 2025 at 10:16 PM PT a Waymo Autonomous Vehicle ("Waymo AV") operating in Los Angeles, California was in a collision involving an SUV on [XXX] near [XXX]. The Waymo AV was parked at the curb facing north on [XXX] for a passenger drop-off with hazard lights activated. An SUV traveling northbound on [XXX] maneuvered towards the parked Waymo AV. As the SUV approached the Waymo AV from behind, the front of the SUV made contact with the rear left side of the stationary Waymo AV. At the time of the impact, the Waymo AV's Level 4 ADS was engaged in autonomous mode. Both vehicles sustained damage. Waymo later received notice of alleged unknown injuries from the passengers in the Waymo AV. Waymo is reporting this crash under Request No. 1 of Standing General Order 2021-01 because a vehicle involved was towed away. Waymo may supplement or correct its reporting with additional information as it may become available.

Crash With

Other, see Narrative

SV Pre-Crash Movement

Stopped

SV Contact Area

Unknown

SV Precrash Speed (MPH)

0

CP Pre-Crash Movement

Other, see Narrative

CP Contact Area

Unknown

Within ODD?

Yes

Automation System Engaged?

ADS

Roadway Type

Street

Weather

Clear

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 October [XXX], 2025 at 8:17 PM PT a Waymo Autonomous Vehicle ("Waymo AV") operating in San Francisco, California was alleged to have contributed to a collision between two SUVs on California State [XXX] near [XXX]. The Waymo AV was traveling northbound in the second from the right lane on California State [XXX] when it slowed to a stop in-lane with its left turn signal activated to stage a lane change into the designated left turn lane for the intersection with [XXX]. While the Waymo AV was stopped, a passenger car traveling northbound in the second from the right lane on California State [XXX] slowed to a stop behind the Waymo AV and an SUV slowed to a stop behind the passenger car. A second SUV traveling northbound in the second from the right lane on California State [XXX] then approached the first stopped SUV from behind, and the front left side of the second SUV made contact with the rear right side of the first SUV. At the time of the impact, the Waymo AV's Level 4 ADS was engaged in autonomous mode. Both of the SUVs sustained damage. Waymo received notice of the alleged contribution on November 3, 2025. Waymo is reporting this crash under Request No. 2 of Standing General Order 2021-01. Waymo may supplement or correct its reporting with additional information as it may become available.

Crash With

Other, see Narrative

SV Pre-Crash Movement

Stopped

SV Contact Area

Unknown

SV Precrash Speed (MPH)

0

CP Pre-Crash Movement

Other, see Narrative

CP Contact Area

Unknown

Within ODD?

Yes

Automation System Engaged?

ADS

Roadway Type

Highway / Freeway

Weather

Rain

Investigating Agency

California Highway Patrol

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 October [XXX], 2025 at 9:11 AM PT a Waymo Autonomous Vehicle ("Waymo AV") operating in San Francisco, California was stopped in-lane when a collision occurred between an SUV and a pickup truck on [XXX] South near the [XXX] on-ramp. The Waymo AV was traveling north on [XXX] near the intersection with [XXX]. The Waymo AV slowed and continued past the intersection with [XXX] and continued onto the [XXX] South on-ramp at [XXX]. The Waymo AV came to a stop at the stop sign at the entrance to [XXX] South and then proceeded approximately 30 meters in the right-most lane of [XXX] South and came to a stop in a location with no right-hand shoulder. The Waymo AV remained stopped and four vehicles (two buses, two passenger vehicles) entered [XXX] South from the [XXX] on-ramp and passed the Waymo AV on the left. After the Waymo AV had been stopped for a period of two minutes and 18 seconds, a white SUV entered [XXX] South from the [XXX] on-ramp. After the SUV proceeded past the stop sign onto [XXX] South, it merged into the lane to the left of the Waymo AV. As the SUV entered the lane to the left of the Waymo AV, the front left corner of the SUV made contact with the right side of a pickup truck traveling in the lane to the left of the Waymo AV. The pickup truck then lost control, traveling into the right lane and through the barrier on the rightmost side of the bridge carrying [XXX] over [XXX], then fell to the roadway below. The SUV came to a stop and remained stopped in the lane to the left of the Waymo AV. The passenger of the Waymo AV exited the vehicle after the collision. The Waymo AV proceeded on [XXX] South in autonomous mode. At the time of the impact between the SUV and pickup truck, the Waymo AV's Level 4 ADS was engaged in autonomous mode. The SUV and pickup truck sustained damage. Shortly after the collision, Waymo received notice that minor injuries were reported by passengers of the pickup truck. Waymo is reporting this crash under Request No. 1 of Standing General Order 2021-01 because a vehicle involved was towed away. Waymo may supplement or correct its reporting with additional information as it may become available.