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.

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

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 EXCELSIUS GPS SURGERY THERE WAS A L4 ACCURACY ISSUE WITH PLACEMENT OF THE SCREW. THE SCREW WAS REMOVED AND REPLACED.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE FOLLOWING ARTICLE HAS BEEN REVIEWED: MCNIERNEY D, CHEN J, ZEIN JG, VASZAR L, SWANSON K, AZADEH N, SAKATA KK. COMPARING MONARCH VERSUS ION ROBOTIC-ASSISTED BRONCHOSCOPY PLATFORMS: A PROPENSITY SCORE-MATCHED ANALYSIS. J BRONCHOLOGY INTERV PULMONOL. 2025 JUL 15;32(4):E01019. DOI: 10.1097/LBR.0000000000001019. PMID: 40662912, AND CITED FOUR (4) INSTANCES OF PNEUMOTHORAX WITH CHEST TUBE PLACEMENT. THIS REPORT IS BEING SUBMITTED FOR THESE EVENTS.

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 CART BOOT UP ISSUE AND ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

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 SURGERY WAS PERFORMED AT THE L3-4 SITE, INSTEAD OF THE L3-5 SITE. THIS WAS NOT DISCOVERED DURING THE SURGERY OR DURING THE PATIENT'S STAY IN THE HOSPITAL. UPON THE PATIENT'S RETURN VISIT, HE WAS ADVISED BY THE SURGEON THAT THE SURGERY WAS PERFORMED AT THE WRONG LEVEL. AN ADDITIONAL SURGERY AT THE CORRECT SITE WAS SCHEDULED FOR ON (B)(6) 2025. THE PATIENT CLAIMS TO HAVE SEVERE PAIN, DIFFICULTY IN AMBULATING AND FOOT DROP.

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 EXCELSIUS GPS WERE GUIDED IN INACCURATE TRAJECTORIES IN A T10-PELVIS.

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 >1.5MM AT ENTRY FOR I' J'AND K'. DEFLECTION VERBALIZED BY CSR DURING DRILLING. J' DRILL BIT WAS RE-DRILL AND REPOSITIONED ONE TIME.

Crash With

Other, see Narrative

SV Pre-Crash Movement

Proceeding Straight

SV Contact Area

Front Right

SV Precrash Speed (MPH)

4

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 July [XXX], 2025 at 6:20 PM MT a Waymo Autonomous Vehicle ("Waymo AV") operating in Mesa, Arizona was in a collision involving a detached object from a pickup truck on [XXX] at [XXX]. The Waymo AV was traveling northbound in the left turn lane on [XXX] and slowing for a queue of traffic at the intersection with [XXX]. A pickup truck was traveling southbound in the leftmost lane on the west side of [XXX] without its rear driver side tire. As the SUV continued to proceed straight, an object detached from the pickup truck's rear axle and rolled into the Waymo AV's lane of travel, making contact with the front of the Waymo AV. At the time of the impact, the Waymo AV's Level 4 ADS was engaged in autonomous mode. The Waymo AV sustained damage. The passenger in the Waymo AV later alleged an injury of unspecified nature and severity. 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

Animal

SV Pre-Crash Movement

Proceeding Straight

SV Contact Area

Front Right, Bottom

SV Precrash Speed (MPH)

13

CP Pre-Crash Movement

Other, see Narrative

Within ODD?

Yes

Automation System Engaged?

ADS

Roadway Type

Street

Weather

Clear

Investigating Agency

None

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 vehicle (Vehicle 1) in autonomous mode was traveling in the left lane on southwest-bound [XXX] toward [XXX] in San Francisco when a ball, immediately followed by a dog, entered the roadway from between parked cars on the left side of [XXX] directly into the path of the Zoox vehicle. The Zoox vehicle braked in response, but its underbody made contact with the dog. The Zoox vehicle operator then disengaged autonomous mode and brought the vehicle to a stop. The Zoox vehicle operator then reversed the vehicle to free the dog. The dog owner did not indicate injuries to the dog at the scene. The dog and its owner then returned to the sidewalk and the Zoox vehicle operator drove the vehicle from the scene. The police were not called. Zoox subsequently received an email alleging injuries to the dog, "abrasions behind its left front leg and a possible cracked rib."

CyberKnife — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: RECTAL TOXICITY DUE TO PROSTATE TREATMENT.

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, THE CASE WAS ABORTED DUE TO ROBOTIC ERROR, AND SCREWS WERE THEN PLACED WITHOUT ROBOT.

CyberKnife — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: RECTAL TOXICITY DUE TO PROSTATE TREATMENT.

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 RELINE MAS REDUCTION SCREWS WERE UTILIZED WITH THE ROBOT FOR THIS CASE. BLACK EXCELSIUS ARRAY WITH AN ADAPTER WAS UTILIZED. TWO EXCELSIUS ARRAYS WERE SET UP WITH MAS REDUCTION DRIVERS AND VERIFICATION OF THESE ARRAYS WAS CHALLENGING. THE CAMERA WAS HAVING A HARD TIME SEEING THESE ARRAYS. SPHERES WERE MANIPULATED MULTIPLE TIMES AND BOTH DRIVER ARRAYS WERE TRIED. ONCE THE CAMERA WAS ABLE TO SEE THE ARRAYS, IT TOOK MULTIPLE VERIFICATION ATTEMPTS AND MANIPULATION.

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 EXCELSIUSHUB SYSTEM, AN INTRA-OPERATIVE CORRECTION WAS REQUIRED FOR A MISPLACED IMPLANT.

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

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 NAVIGATION ISSUES AND ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

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.

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 IMPLANTS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.

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 NAVIGATION ACCURACY ISSUES AND ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT..

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING MULTIPLE PROCEDURES, THE MONARCH ROBOT NAVIGATION SYSTEM WAS UNSURE WHICH AREA OF THE LUNG IT WAS IN WITH DISTANCE MEASUREMENTS VARYING UP TO 30MM. BIOMED WAS ABLE TO RECREATE PRODUCT ISSUE IN DEMO ENVIRONMENT. PROBLEMS INTERMITTENTLY BEGAN AFTER SOFTWARE UPDATE 5 WEEKS AGO BUT BECAME MORE CONSISTENT LAST WEEK.

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.

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, THE CASE WAS ABORTED DUE TO PATIENT INJURY.

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.

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

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED AFTER BLEEDING WAS NOTICED. SHORTLY AFTER, THE PATIENT DISPLAYED SUSPECTED PRESENCE OF STROKE AND/OR HEMATOMA.

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

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

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. A VALVE WAS PLACED AND PATIENT WAS HOSPITALIZED. NO DEVICE ISSUES WERE REPORTED.

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. A CHEST TUBE WAS PLACED. NO SYSTEM ISSUES WERE REPORTED.

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 ROBOTIC BRONCHOSCOPY PROCEDURE THE PHYSICIAN HAD DIFFICULTY WITH THE PATIENT SENSORS AND ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO 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 THE PATIENT PRESENTED 3 WEEKS OR 3 MONTHS POST-OP WITH A FRACTURED FEMUR AT THE LOCATION WHERE THE FEMORAL REFERENCE PINS WERE INSTALLED. ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED TO CORRECT THE FRACTURE. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

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 THE MONARCH BRONCHOSCOPY PROCEDURE, THE PHYSICIAN WAS PERFORMING THE BRONCHOALVEOLAR LAVAGE (BAL) WHEN THE PATIENT HAD A CARDIAC ARREST. THE PHYSICIAN WAS ABLE TO CONFIRM A PULSE BACK ON THE PATIENT. THE PATIENT IS IN STABLE CONDITION.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS BEEN REPORTED THROUGH A MEDWATCH RECEIVED FROM THE FDA ALLEDGING OCCURANCES OF INACCURATE CUTS AND INCORRECT PLACEMENT OF IMPLANTS RESULTING IN PATIENT INJURIES. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT THE PHYSICIAN USED EBUS TO TARGET THE RIGHT UPPER LOBE (RUL). THE PHYSICIAN NOTICED THROUGH HIS MANUAL SCOPE THAT THERE WAS A SMALL LACERATION ON THE MUCOSA OF THE POST INTERIOR WALL OF THE RIGHT MAIN STEM. THE PHYSICIAN WAS NOT SURE HOW THIS OCCURRED. THE PHYSICIAN DECIDED TO ABORT THE CASE BECAUSE THEY DID NOT WANT TO CAUSE ANY FURTHER INJURY. THE PATIENT DID NOT EXPERIENCE ANY BLEEDING UPON WAKING UP. NOTABLY, THE ANESTHESIOLOGIST SUGGESTED THAT THE PATIENT MAY HAVE HAD FRAIL TISSUE, AND THE PHYSICIAN RECALLED A SIMILAR INCIDENT FROM TWO YEARS PRIOR IN THE SAME LOCATION, WHICH HAD RESOLVED WITHOUT COMPLICATIONS.