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 A SINGLE POSITION LATERAL USING EGPS AND AIRO. L3-S1 FIXATION WITH L3-4 L4-5 LATERAL FUSION. THERE WERE HIGH SKIVE WARNINGS ON R L4 SCREW INSERTION. THE SCREW PLACED SLIGHTLY SUPERIOR AND LATERAL TO PLAN. THE SURGEON ATTEMPTED TO PLACE SCREW MULTIPLE TIMES AND EACH ATTEMPT GAVE HIGH SKIVE WARNINGS DESPITE HS DRILL AND SIDE CUTTING DRILL FOLLOWING TRAJECTORY. IT WAS NOT TAPPED. THERE WERE NO SURVEILLANCE WARNINGS. IT WAS THEIR FIRST CASE WITH EGPS 6.1 SOFTWARE USING RELINE SCREWS. THE R L5 SCREW HAD SIMILAR ISSUE AND WAS FINALLY PLACED OVER K-WIRE. (AWL - K-WIRE - NON-NAVIGATED DRIVER) ON AIRO SCAN REVIEW THE R L4 SCREW WAS PLACED SLIGHTLY SUPERIOR AND LATERAL TO PLAN. SCREW WAS REMOVED AND NOT REPLACED. THE PATIENT SHOWED NO ADVERSE EFFECTS FROM MISPLACED SCREW.

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 PROCEDURE, IT WAS OBSERVED THAT THE RUBBER COATING AT THE TIP OF THE SYNCHROSEAL INSTRUMENT HAD PEELED OFF AFTER THE TISSUE WAS CLAMPED. CONSEQUENTLY, A FRAGMENT FELL INSIDE THE PATIENT BUT WAS IMMEDIATELY RETRIEVED DURING THE SAME PROCEDURE. THE SYNCHROSEAL INSTRUMENT WAS REPLACED WITH A BACKUP, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED ROBOTICALLY, WITHOUT FURTHER 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 HIATAL HERNIA-PARAESOPHAGEAL PROCEDURE, THE TIP OF THE HARMONIC ACE INSTRUMENT BROKE OFF, RESULTING IN A FRAGMENT FALLING INSIDE THE PATIENT. THE INSTRUMENT WAS INSPECTED BEFORE USE AND NO UNUSUAL OBSERVATIONS WERE NOTED. THE INSTRUMENT WAS USED FOR HIATAL DISSECTION WHEN THE ISSUE OCCURRED; THERE WAS NO INSTRUMENT COLLISION. THE FRAGMENT WAS SUCCESSFULLY RETRIEVED WITHIN THE SAME PROCEDURE UNDER DIRECT VISUALIZATION, AND CONFIRMATION OF REMOVAL WAS MADE. THE PROCEDURE WAS COMPLETED AS PLANNED WITHOUT ANY ADDITIONAL ADVERSE IMPACT ON THE PATIENT. NO X-RAY WAS PERFORMED. THE CAUSE OF THE BREAKAGE REMAINS UNKNOWN.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED DISTAL GASTRECTOMY SURGICAL PROCEDURE, WHEN CHANGING FORCEPS ON ARM, THE BLACK VALVE PART OF THE UNIVERSAL SEAL BROKE AND FELL INTO THE BODY. THE FALLEN PART 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 ACCESSORY WAS INSPECTED PRIOR TO USE, AND NO DAMAGE WAS NOTED. WHILE PERFORMING TISSUE MOBILIZATION, BLACK FRAGMENTS WERE FOUND. THE BLACK FRAGMENTS OBSERVED WERE FRAGMENTS THAT FELL OF THE VALVE FROM UNIVERSAL SEAL. IT IS UNKNOWN WHAT THE SURGEON BELIEVED WAS THE CAUSE OF THE FRAGMENTS FALLING INTO THE PATIENT. THE ACCESSORY WAS USED FOR ABOUT TWO HOURS. IT IS UNKNOWN IF THE FRAGMENTS FELL INSIDE THE PATIENT DURING AN INSTRUMENT TIP, OR ACCESSORY COLLISION. THE FRAGMENTS WERE RETRIEVED WITH RAPALO FORCEPS. IT WAS CONFIRMED THAT ALL FRAGMENTS WERE RETRIEVED AND MATCHED WITH THE DAMAGED AREA. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENTS. NO POST OPERATIVE TESTS LIKE AN X-RAY ULTRASOUND WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. PROCEDURE WAS COMPLETED ROBOTICA

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 BECAME LOOSE AND FELL INTO THE PATIENT'S BODY. THE ACCESSORY 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: PRIOR TO USE, BOTH THE INSTRUMENT AND THE MCS TIP COVER ACCESSORY WERE INSPECTED AND FOUND TO BE IN NORMAL CONDITION WITH NO DAMAGE OBSERVED. DURING THE PROCEDURE, THE MCS TIP COVER ACCESSORY FELL INSIDE THE PATIENT WHILE THE SURGICAL TASK OF INSTRUMENT EXCHANGE¿SPECIFICALLY SWITCHING TO A LARGE NEEDLE DRIVER¿WAS BEING PERFORMED. THE ACCESSORY WAS SUBSEQUENTLY RETRIEVED USING THE ASSISTANT PORT (12MM). THE SURGEON BELIEVES THAT THE ACCESSORY SLIPPED OFF OR BROKE DUE TO A DEFECTIVE PRODUCT. THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT HAD BEEN IN USE FOR OVER 60 MINUTES AT THE TIME OF THE EVENT. NO ISSUES WITH THE FUNCTIONALITY OF THE MCS INSTRUMENT WERE NOTICED DURING THE PROCEDURE, NOR WAS THERE ANY COLLISION WITH OTHER INSTRUMENTS. THE MCS TIP COVER ACCESSORY APPEARED TO BE PROPERLY INSTALLED DURING SURGERY, W

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CITATION: SEIF, HASSAN, ET AL. ¿A RETROSPECTIVE COHORT STUDY COMPARING ROBOT-ASSISTED AND CONVENTIONAL FLUOROSCOPY-GUIDED PEDICLE SCREW PLACEMENT.¿ JOURNAL OF CLINICAL MEDICINE, VOL. 14, NO. 19, 26 SEPT. 2025, PP. 1¿14, HTTPS://DOI.ORG/10.3390/JCM14196831. BACKGROUND/OBJECTIVES: PEDICLE SCREW PLACEMENT IS CRUCIAL FOR RESTORING STABILITY. EMERGING ROBOT-ASSISTED TECHNOLOGIES MAY OFFER ENHANCED PRECISION AND REDUCED RADIATION EXPOSURE. THIS STUDY AIMED TO COMPARE THE ACCURACY AND CLINICAL OUTCOMES OF ROBOT-ASSISTED VERSUS CONVENTIONAL FLUOROSCOPY-GUIDED PEDICLE SCREW PLACEMENTS. METHODS: THIS RETROSPECTIVE COHORT STUDY INCLUDED 218 PATIENTS UNDERGOING PEDICLE SCREW PLACEMENT AT A SINGLE SPINE CENTER BETWEEN 2019 AND 2023. OF THESE, 105 PATIENTS UNDERWENT ROBOT-ASSISTED SURGERY USING THE MAZOR X¿ STEALTH EDITION (MEDTRONIC, MINNEAPOLIS, MN, USA), AND 113 UNDERWENT CONVENTIONAL FLUOROSCOPY-GUIDED SURGERY. THE PRIMARY OUTCOME WAS SCREW PLACEMENT ACCURACY (GRADE 0 = OPTIMAL, GRADES 1¿3 = SUBOPTIMAL, ACCORDING TO THE GERTZBEIN¿ROBBINS CLASSIFICATION). SECONDARY OUTCOMES INCLUDED ESTIMATED BLOOD LOSS (EBL), RADIATION EXPOSURE, LENGTH OF HOSPITAL STAY (LOS), CLINICAL OUTCOME ACCORDING TO 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: 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 A 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: 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 DR. (B)(6) USED THE EXCELSIUS ROBOT (INTRA-OP WORKFLOW) FOR A T11-L1 POSTERIOR LATERAL FUSION. IT IS TO BE NOTED HE ONLY PLACED PEDICLE SCREWS AT T11AND L1 SKIPPING T12 DUE TO A TUMOR SURROUNDING THE T12 VERTEBRAL BODY. DR. (B)(6) DECIDED TO PERFORM HIS DECOMPRESSION THROUGH A POSTERIOR MIDLINE INCISION PRIOR TO PLACING PEDICLE SCREWS BECAUSE HE WANTED TO KNOW HOW FAR THE TUMOR HAD SPREAD. DR. (B)(6) WANTED TO USE THE DRB AND SURVEILLANCE MARKER AND PLACED THEM IN THE PSIS AFTER DECOMPRESSION. AFTER SCREWS WERE PLACED AND ANOTHER CT SCAN WAS PERFORMED VIA E3D THE PEDICLE SCREWS ON THE PATIENT'S RIGHT SIDE WERE MEDIAL OF THE PLANNED TRAJECTORY. LEFT PEDICLE SCREWS WERE IN THE PROPER TRAJECTORY. SURVEILLANCE SHOWED THAT THE DRB HAD NOT MOVED DURING THE CASE. DR. HAMILTON REMOVED THE RIGHT SCREWS AND IMPLANTED THEM FREEHAND. HE ADVISED HE DID NOT SEE ANY DURAL LEAKS AND LATER TOLD US THE PATIENT WAS DOING 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 DURING THE REGISTRATION PROCESS, HD INTRAOPERATIVE 3D SPIN WAS USED FOR REGISTRATION. AFTER THE SPIN WAS COMPLETED, AN XRAY GENERATOR FAILURE POP UP WAS OBSERVED. THE SCAN ACQUIRED WAS UNUSABLE, WHITED OUT AND GRAINY. THE SURGEON ABANDONED E3D AND ROBOT FOR THE DURATION OF THE CASE. ADDITIONALLY, AUTO REGISTRATION FAILED AND SCAN DID NOT PUSH OVER TO ROBOT AUTOMATICALLY.

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, A SMALL PIECE OF BLACK RUBBER WAS INCIDENTALLY FOUND INSIDE THE PATIENT. THE CUSTOMER REMOVED THE PIECE DURING THE SAME SURGICAL PROCEDURE AND DETERMINED THAT THE FRAGMENT WAS PART OF A UNIVERSAL SEAL. THE PATIENT'S ABDOMINAL CAVITY WAS SEARCHED PRIOR TO CLOSURE. THE PROCEDURE WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO GATHER ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT; 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 SURGICAL PROCEDURE, THE SINGLE PORT (SP) MONOPOLAR SCISSORS TIP ACCESSORY FELL OFF INTO THE PATIENT AND HAD TO BE REMOVED. IT IS UNKNOWN IF THE FRAGMENT WAS FULLY RECOVERED OR WHAT INTERVENTION, RESOLUTION, AND EFFECT THIS HAD ON THE PATIENT.

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 FOLLOWING DEEP ELECTRODE IMPLANTATION, POSTOPERATIVE CT DEMONSTRATED A SUBARACHNOID HEMORRHAGE. THE SURGERY WAS COMPLETED USING THE UNIT. PREOPERATIVE PLANNING REPORTEDLY SHOWED NO OBVIOUS VASCULAR INTERFERENCE, AND THE CAUSE WAS UNKNOWN. THE SURGEON COMMENTED THAT THE HEMORRHAGE MAY HAVE BEEN RELATED TO PLACEMENT OF AN ELECTRODE TOWARD THE LEFT AMYGDALA AND POSSIBLE TRACTION ON THE SYLVIAN FISSURE DURING TRACT CREATION. THE PATIENT HAD NO DECREASE IN CONSCIOUSNESS AND WAS MANAGED WITH BLOOD PRESSURE CONTROL AND OBSERVATION WITHOUT DRUG ADMINISTRATION. A REPEAT CT PERFORMED APPROXIMATELY 4 HOURS POSTOPERATIVELY DEMONSTRATED NO HEMORRHAGE EXPANSION, AND A SUBSEQUENT PROGRESS CHECK APPROXIMATELY 2 DAYS LATER AGAIN NOTED NO EXPANSION WITH THE PATIENT IN GOOD HEALTH. AN ANGIOGRAM WAS PERFORMED APPROXIMATELY 3 DAYS POSTOPERATIVELY, AND THE PLAN WAS TO REMOVE THE ELECTRODE IF NO ANEURYSM WAS IDENTIFIED. THE PATIENT REMAINED IN GOOD HEALTH WITH NO DECREASE IN CONSCIOUSNESS, AND NO HEMORRHAGE EXPANSION WAS OBSERVED ON SERIAL CT EVALUATIONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

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 CANNULA WAS INSERTED INTO THE CENTER TRAJECTORY, MER TESTING WAS PERFORMED. THE CANNULA WAS THEN MOVED TO THE MEDIAL TRAJECTORY. HOWEVER, RESULTS WERE NOT AS DESIRED AND THE TARGET WAS MOVED 3MM MEDIAL FROM THE ORIGINAL CENTER TRAJECTORY. THE LEAD WAS PLACED. DURING TESTING, IT WAS DECIDED TO MOVE THE CANNULA/LEAD TO THE POSTERIOR TRAJECTORY. AT THIS POINT, THE PATIENT APPEARED TO HAVE A STROKE AND THE PATIENT WAS CLOSED AND TAKEN TO THE ER. FOLLOW UP WITH THE SURGEON REVEALED THAT THERE WERE TWO BLEEDS UNILATERALLY ON THE RIGHT AT THE INTERNAL CAPSULE. THE SURGEON STATED THAT EVERY TRACK PLACED IS A 1% RISK OF THIS OCCURRING (4 TOTAL TRACKS ON RIGHT SIDE). THE LAST INFORMATION RECEIVED WAS THAT THEY WERE WAKING THE PATIENT UP, BUT IT IS UNKNOWN IF ANY DEFICITS ARE TEMPORARY AT THIS TIME.

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.

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 AND REVISED INTRA-OPERATIVELY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE BLADE WAS FOUND BROKEN ON THE HARMONIC ACE INSTRUMENT. A FRAGMENT FELL INTO THE PATIENT AND WAS RETRIEVED IN A DIFFERENT 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 HYSTERECTOMY SURGERY, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY DEVELOPED A HOLE, WHICH LED TO THERMAL INJURY OF THE SMALL INTESTINE. THE INCIDENT OCCURRED WHILE THE SURGEON WAS DISSECTING THE UTERUS ON THE LEFT SIDE. AS THE TIP OF THE MCS INSTRUMENT WAS POSITIONED AGAINST THE UTERUS, A PORTION OF THE SMALL INTESTINE CAME INTO CONTACT WITH THE INSTRUMENT'S SHAFT, WHICH IS NORMALLY INSULATED BY THE MCS TIP COVER ACCESSORY. DUE TO THE HOLE NEAR THE ORANGE MARKER ON THE MCS TIP COVER ACCESSORY, A BURN APPROXIMATELY 1 CM IN DIAMETER OCCURRED ON THE INTESTINE. THE SURGEON PROMPTLY SUTURED THE AFFECTED AREA TO PREVENT RUPTURE, AND A GASTROINTESTINAL SURGEON WAS CONSULTED TO EVALUATE THE INJURY. THE ASSESSMENT CONFIRMED THAT THE INTERVENTION WAS SUFFICIENT. THE AFFECTED MCS INSTRUMENT WAS REMOVED AND THE MCS TIP COVER ACCESSORY WAS REPLACED. NO ELECTRICAL ARCING WAS OBSERVED AT THE TIME OF THE EVENT, AND THE PROCEDURE WAS COMPLETED ROBOTICALLY. THE SURGEON ASSESSED THE IMPACT ON THE PATIENT'S OUTCOME AS MINIMAL, AND NO POST-OPERATIVE 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: 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 PANCREATODUODENECTOMY SURGICAL PROCEDURE, THE METAL TIP ON HARMONIC ACE INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE 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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED AND REVISED INTRA-OPERATIVELY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY SLIPPED OFF THE MCS INSTRUMENT INSIDE THE PATIENT, AND WAS SUBSEQUENTLY DISCOVERED IN THE PELVIC AREA. THE MCS TIP COVER ACCESSORY WAS RETRIEVED DURING THE SAME PROCEDURE, USING A THIRD-PARTY LAPAROSCOPIC GRASPER INSTRUMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED ROBOTICALLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, NO RESPONSE HAS BEEN RECEIVED.

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 AN L2-L3 FUSION PROCEDURE USING COMPUTED TOMOGRAPHY-FLUORO REGISTRATION, NAVIGATION WITH THE GUIDANCE SYSTEM APPEARED TO BE INACCURATE BY 2 MILLIMETERS (MM), DEEP ON THE RIGHT SIDE OF L2 WHEN USING THE DILATOR OR THE PASSIVE PLANAR PROBE. THIS RESULTED IN A NERVE INJURY TO THE PATIENT. ANOTHER SNAPSHOT WAS PERFORMED AS A TROUBLESHOOTING STEP, WHICH DID NOT RESOLVE THE ISSUE. THE SYSTEM WAS THEN RE-REGISTERED, WHICH RESOLVED THE NAVIGATION INACCURACY. SURGICAL DELAY WAS LESS THAN ONE-HOUR. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PATIENT HAD SOME NUMBNESS/TINGLING. THEY HAD NOT MOBILIZED MUCH AS THEY WERE STILL RECOVERING, SO IT WAS UNKNOWN WHETHER IT WOULD MATERIALIZE TO ANY SORT OF DEFICIT.

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.

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, A T1-T12 SPINAL FUSION. IT WAS REPORTED THAT AN ALLEGED INACCURACY OCCURRED. INITIALLY, THE FIRST SURFACE SCAN WAS DELETED WITHOUT USER ACTION, AND THE SECOND SURFACE SCAN WAS UNUSABLE DUE TO A SHOULDER SHIFT. A THIRD SURFACE SCAN WAS SUCCESSFULLY PERFORMED. MEDTRONIC IMAGING WAS CONDUCTED FOR SCREW PLACEMENT PLANNING AND VERIFICATION. THE FIRST SCREW WAS PLACED, BUT WHEN THE ROBOT ARM WAS MOVED TO THE SECOND SCREW LOCATION, THE SURGEON OBSERVED THAT THE LOCATION APPEARED INACCURATE. THE ROBOT ARM USE WAS HALTED, AND CHICKENFOOT WAS USED TO CONFIRM THE LOCATION OF THE FIRST SCREW PLAN, REVEALING THAT THE PLAN WAS APPROXIMATELY 1 CENTIMETER (CM) LATERAL TO THE ACTUAL FIRST SCREW PLACEMENT. THE GUIDANCE SYSTEM USE WAS ABORTED. THE SURGICAL TEAM SWITCHED TO MEDTRONIC IMAGING AND NAVIGATION SYSTEM FOR PLACEMENT OF THE REMAINING SCREWS. MEDTRONIC IMAGING SHOWED THAT THE FIRST SCREW APPEARED TO BE 1 CM MEDIAL OF THE ORIGINALLY PLANNED LOCATION, AND IT WAS REPORTED THAT THE SCREW PENETRATED THE CANAL AT P1. A CEREBROSPINAL FLUID (CSF) LEAK WAS IDENTIFIED AND WAS REPORTEDLY BEING ADDRESSED DURI

VELYS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: POPLITEAL ARTERIA INJURY WHILE USING VELYS DURING A KNEE ARTHROPLASTY. THE SURGEON EXPLAINED THAT THEY DID NOT USE RETRACTORS AS USUAL FOR A RECUT AND FACED A POPLITEAL ARTERIA INJURY. THEY MADE A SUTURE DIRECTLY ON THE ARTERIA TO STOP THE BLEEDING AND THE PATIENT HAD NO MAJOR HEMORAGIA, AND NO OTHER VASCULAR SURGERY NEEDED. ARTHERIOGRAPHY WAS DONE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A FIFTEEN MINUTE DELAY. PATIENT RECEIVED SURVEILLANCE IN THE ICU FOR A NIGHT AND A PLATELET-INHIBITING AGENT.

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 SYNCHROSEAL INSTRUMENT'S BLADE BROKE AND DETACHED FROM THE INSTRUMENT. A FRAGMENT FELL INSIDE THE PATIENT BUT WAS RETRIEVED DURING THIS PROCEDURE. THE PROCEDURE WAS COMPLETED AS PLANNED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE BLADE WAS FOUND TO BE BROKEN ON THE HARMONIC ACE INSTRUMENT. A FRAGMENT FELL INSIDE A PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE WHICH WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO GATHER ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT; 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: ON (B)(6) 2025, INTUITIVE SURGICAL, INC. (ISI) RECEIVED AN FDA MEDWATCH REPORT (MDR) WITH MDR REPORT #MW5176084 STATING: "WHILE USING HARMONIC ACE DURING ROBOTIC TLH, TIP OF HARMONIC BROKE OFF IN PATIENT. SURGEON CHOSE TO LEAVE THE TIP; THOUGHT IT WOULD CAUSE MORE HARM IF RETRIEVAL OCCURRED." ISI MADE MULTIPLE FOLLOW-UP ATTEMPTS 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 DISTAL PANCREATECTOMY SURGICAL PROCEDURE, THE BLADE HEAD BROKE ON THE HARMONIC ACE INSTRUMENT. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUTTER HEAD GASKET FELL OFF COMPLETELY INSIDE THE PATIENT, AND THE DROPPED FRAGMENTS WERE REMOVED FROM THE PATIENT'S BODY. THE INSTRUMENT WAS INTACT BEFORE USE. THE BREAKAGE OCCURRED DURING TISSUE DISSECTION, AND NO CONTACT WITH HARD OBJECTS WAS MADE. THE INSTRUMENT HAD BEEN IN USE FOR APPROXIMATELY 15 MINUTES WHEN THE BREAKAGE HAPPENED.

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 AFTER A SUCCESSFUL ROBOTIC BRONCHOSCOPY PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX. PATIENT WAS HOSPITALIZED AND CHEST TUBE WAS PLACED. NO DEVICE ISSUES WERE REPORTED.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IAO, C., GUO, X., QIU, W., QI, Q., GUO, Z., SUN, C., ZHONG, W., & LI, W. (2025). RETROSPECTIVE ANALYSIS OF CLINICAL MANAGEMENT STRATEGIES FOR CAGE RETROPULSION FOLLOWING POSTERIOR LUMBAR INTERBODY FUSION. ORTHOPAEDIC SURGERY, 17(11), 3133¿3141. HTTPS://DOI.ORG/10.1111/OS.70174 SUMMARY OBJECTIVES: CAGE RETROPULSION (CR) IS A COMMON COMPLICATION FOLLOWING POSTERIOR LUMBAR INTERBODY FUSION (PLIF). SYMPTOMATIC PATIENTS WITH CR OFTEN REQUIRE REVISION SURGERY. HOWEVER, THERE IS A LACK OF LITERATURE SUPPORTING THE EFFECTIVENESS OF CONSERVATIVE TREATMENT FOR CR. THIS STUDY COMPARES CLINICAL AND RADIOGRAPHIC OUTCOMES BETWEEN CONSERVATIVE TREATMENT AND REVISION SURGERY IN PATIENTS WITH CR AFTER PLIF. METHODS: A TOTAL OF 55 PATIENTS WITH CR AFTER PLIF TREATED AT OUR INSTITUTION BETWEEN 2016 AND 2023 WERE RETROSPECTIVELY REVIEWED; P OSTOPERATIVE RADIOGRAPHIC DATA OF FOLLOW-UP WERE USED TO DIAGNOSE CR. CLINICAL OUTCOMES WERE ASSESSED BEFORE THERAPY AND AT THE FINAL FOLLOW-UP USING THE VISUAL ANALOG SCALE (VAS) FOR LOWER BACK PAIN AND LEG PAIN, OSWESTRY DISABILITY INDEX (ODI) SCORES, AND JAPANESE ORTHOPEDIC ASSOCIATION 29 (JOA-29) SCORES. THE TREATMENT EFFECTIVENESS WAS EVALUATED BASED ON WHETHE

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 TRANSABDOMINAL PREPERITONEAL UMBILICAL HERNIA REPAIR PROCEDURE, A FRAGMENT FROM THE BLACK PART OF THE UNIVERSAL SEAL BROKE OFF INSIDE THE PATIENT. THE SURGEON SUCCESSFULLY RETRIEVED THE PIECE, AND THE PROCEDURE CONTINUED AS PLANNED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: 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 BILATERAL NIPPLE SPARING MASTECTOMY (NSM) PROCEDURE. DURING THE PROCEDURE, THE PATIENT EXPERIENCED A SKIN BURN/BLISTERING ON THE RIGHT BREAST. THE COMPLICATION WAS TREATED WITH BACITRACIN ON THE WOUND AND NITRO PASTE AROUND THE WOUND. AS A RESULT, NO TISSUE EXPANDER WAS PLACED INTRA-OPERATIVELY, ONLY ACELLULAR DERMAL MATRIX. AS A RESULT, NO TISSUE EXPANDER WAS PLACED INTRA-OPERATIVELY, ONLY ACELLULAR DERMAL MATRIX. POST-OPERATIVELY, THE BILATERAL SKIN FLAPS WERE VIABLE AT THE END OF THE PROCEDURE AND A BILATERAL TWO-STAGE RECONSTRUCTION WAS PERFORMED. TISSUE EXPANDER WAS PLACED TO THE LEFT BREAST ONLY. THE STUDY INVESTIGATOR REPORTED THE EVENT AS NOT A SERIOUS ADVERSE EVENT (SAE), POSSIBLY RELATED TO DA VINCI DEVICE, POSSIBLY RELATED TO THE NSM PROCEDURE, BUT NOT RELATED TO THE RECONSTRUCTION PROCEDURE, NOT RELATED TO OTHER PROCEDURES OR EVENTS, AND NOT RELATED TO THE PATIENT'S PRE-EXISTING CONDITION. A DEVICE MALFUNCTION DID NOT RESULT IN THE ADVERSE 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE HARMONIC ACE CURVED SHEERS JAWS BROKE IN 2 PIECES. THE FRAGMENT 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 SURGICAL PROCEDURE, A BLACK FOREIGN OBJECT THAT HAD FALLEN INTO THE PATIENT APPEARED ON THE MONITOR DURING THE PROCEDURE, AND IT 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: 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 clinical literature study evaluated the oncological and functional outcomes after salvage robotic-assisted laparoscopic radical prostatectomy (sRALP). The study consisted of 60 patients who were consecutively treated with sRALP for radiorecurrent prostate cancer (PCa). The data was collected from a hospital registry and electronic patient journals (EPJ) between 2013 and 2021 from one hospital site. Post surgical complications included, 15 patients with urinary stricture required surgical intervention. During the follow-up period, 11 patients received an artificial urinary sphincter, and 10 patients underwent urinary diversion. In total, 19 patients were treated with either an artificial urinary sphincter and/or urinary diversion. In addition, 2 patients developed pelvic osteomyelitis, requiring multiple surgical and medical interventions, ultimately leading to urinary diversion. Two patients suffered urinary sepsis, one of them due to iatrogenic small bowel perforation, one had a lung embolus, one experienced a stroke, and nine patients required antibiotics due to infections.It was concluded that sRALP for radiorecurrent PCa has limited effect on oncological outcomes. It was reco

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.

Crash With

Animal

SV Pre-Crash Movement

Proceeding Straight

SV Contact Area

Front Right

SV Precrash Speed (MPH)

26

CP Pre-Crash Movement

Other, see Narrative

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 September [XXX], 2025 at 11:34 PM CT a Waymo Autonomous Vehicle ("Waymo AV") operating in Austin, Texas was in a collision involving a domestic animal on [XXX] near [XXX]. The Waymo AV was traveling eastbound on a narrow portion of [XXX] with vehicles parked at the curb in both directions. A domestic animal emerged from behind a vehicle that was parked on the north side of [XXX] and entered the Waymo AV's lane of travel, and the front of the Waymo AV made contact with the domestic animal, which appears to be a cat. At the time of the impact, the Waymo AV's Level 4 ADS was engaged in autonomous mode. The domestic animal sustained injuries. 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.

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 VENTRAL HERNIA REPAIR PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY THAT WAS INSTALLED ON AN MCS INSTRUMENT FELL OFF INSIDE THE PATIENT. THE MCS TIP COVER ACCESSORY WAS INSPECTED PRIOR TO USE AND NO ABNORMALITIES WERE REPORTED. THE TIP COVER FELL INSIDE THE PATIENT DURING A DISSECTION, AND THE CAUSE OF ITS DETACHMENT IS UNKNOWN. IT HAD BEEN IN USE FOR 20 TO 30 MINUTES BEFORE THE INCIDENT, WITH NO ISSUES NOTICED IN THE SCISSORS' FUNCTIONALITY. THE TIP COVER APPEARED TO BE PROPERLY INSTALLED DURING THE PROCEDURE, WITH NO PART OF THE ORANGE SURFACE VISIBLE AFTER INSTALLATION, AND THE INSTALLATION TOOL WAS USED. NO ELECTROLUBE OR OTHER LUBRICANT WAS APPLIED TO THE MCS INSTRUMENT BEFORE INSTALLING THE TIP COVER, AND NO REDUCER WAS USED. THERE WAS NO COLLISION WITH OTHER INSTRUMENTS OR HARD MATERIALS DURING THE PROCEDURE. DURING REMOVAL OF THE MCS INSTRUMENT THROUGH THE CANNULA, NO RESISTANCE WAS FELT. THE SURGICAL STAFF DID NOT NOTICE ANY DAMAGE TO THE CANNULA OR ANY OTHER DAMAGE TO THE MCS INSTRUMENT AFTER THE INCIDENT. THE MCS TIP COVER ACCESSORY WAS RETRIEVED FOLLOWING A CONVERSION OF THE CASE TO A LAPAROTOMY. THE P

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, AN ENDOSCOPE PLUS STOPPED WORKING AND A FRAGMENT FELL INSIDE THE PATIENT. IT IS UNKNOWN IF THE FRAGMENT 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGEON SIDE CONSOLE (SSC) WENT BLACK ON BOTH THE VIEWER AND THE TOUCHPAD. THE CUSTOMER CONTACTED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOR ASSISTANCE. TROUBLESHOOTING FIRST CONSISTED OF CHECKING THE SYSTEM LOGS, WHICH SHOWED THE SSC WAS NOT CONNECTED TO THE VISION SIDE CART (VSC). THE TSE INSTRUCTED THE CUSTOMER TO SHUT DOWN THE SYSTEM, CLEAN THE BLUE FIBER CABLE AT BOTH THE SSC AND VSC, AND RESTART. DESPITE THESE EFFORTS, THE SSC REMAINED DISCONNECTED ACCORDING TO THE VSC, WITH THE POWER BUTTON BLINKING BLUE AND NO DISPLAY ON THE SCREENS, THOUGH FAN NOISE REMAINED PRESENT. ATTEMPTS TO START IN STAND-ALONE MODE DID NOT RESTORE FUNCTION. THE SURGEON THEN ELECTED TO ABORT THE PROCEDURE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: During dissection along the superior border of the left renal vein, a minor arterial bleed was encountered. Initial maneuvers with monopolar and bipolar energy were attempted but unsuccessful. Direct pressure was easily able to achieve hemostasis while a suture was prepared. Post procedure, the patient recovered uneventfully. The robotic-assisted procedure led to complete resection with an uncomplicated hospital course, and discharge home on postoperative day one.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: This clinical study article reviewed a total of 44 adult patients who underwent robotic completion cholecystectomy (CC) between August 2020 and March 2025. The article noted the following: One patient with a retained common bile duct stone requiring a postoperative ERCP, one patient with a perihepatic collection treated with antibiotics, and one patient with a wound infection.It was concluded that robotic CC is a safe and technically feasible approach with high success and low complication rates.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.