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Not graded by the source2025-12-24FDA MAUDEGlobus MedicalExcelsiusGPS3004142400-2026-00008ExcelsiusGPS
ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM THERE WAS AN ISSUE WHILE CONNECTED TO A DESIGNATED RED (EMERGENCY POWER) OUTLET, THE ROBOT UNEXPECTEDLY SHUT DOWN WITHOUT WARNING. AFTER ATTEMPTING TO POWER THE SYSTEM USING MULTIPLE OUTLETS THROUGHOUT THE HOSPITAL, WE WERE STILL UNABLE TO MAINTAIN POWER. THE PLUG INDICATOR LIGHT DOES NOT ILLUMINATE WHEN CONNECTED, AND THE BATTERY INDICATOR ONLY FLASHES. AS A RESULT, THE ROBOT CANNOT BE KEPT POWERED ON. WE WERE FORCED TO ABORT THE PROCEDURE AND CANCEL MULTIPLE SCHEDULED CASES OVER THE NEXT SEVERAL DAYS.
cause not established3004142400-2026-00008Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2025-12-05FDA MAUDEGlobus MedicalExcelsiusGPS3004142400-2025-00303ExcelsiusGPS
ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING AN EXCELSIUSGPS SURGERY A S2AI SCREW WAS PLACED MEDIAL AND INFERIOR. THE NAVIGATION IMAGES SHOWED THAT THE SCREW WAS ON PLAN AND IN THE PROPER PLACE HOWEVER THAT WAS NOT THE CASE. UPON X-RAY IMAGES TO CONFIRM, THE SURGEON NOTICED THAT THE SCREW WAS MEDIAL AND INFERIOR. THE SURGEON REMOVED THE SCREW AND REPLACED THE SCREW IN THE CORRECT SPOT WITHOUT TO USE OF THE ROBOT OR NAVIGATION.
cause not established3004142400-2025-00303Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2025-12-03FDA MAUDEGlobus MedicalExcelsiusGPS3004142400-2025-00302ExcelsiusGPS
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 EGPS SURGERY THAT THE SCREW WAS FIGHTING US AS IT ADVANCED. WE DECIDED TO BACK OUT SCREW. THE SCREW WAS FIGHTING US. THERE WAS A STABILIZER FAILURE. THE SURGEON REMOVED POWER BLOCK AND USED T. WE STILL COULDN'T BACK OUT. WE NOTICED STAR TIP OF CUP DRIVER LODGED INTO THE FEMALE STAR OF SCREW. WE REMOVED ROBOT FROM FIELD. WE TOOK AN X-RAY AND THE L4 WAS LOW AND MEDIAL AND NOT IN THE PLANNED TRAJECTORY. THE SURGEON TESTED DRB RIGIDITY WITH FINGERS AND IT WAS COMPLETELY OUT OF BONE. THE SURGEON PROCEEDED TO REMOVE SCREW VIA DRILLING AROUND IT. THE SCREW WAS REMOVED. WE PROCEEDED WITH LAMI/DECOMPRESSION. WE PLACED SCREWS NON ROBOTICALLY POST DECOMPRESSION.
cause not established3004142400-2025-00302Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2025-12-02FDA MAUDEDePuy SynthesVELYS™ Robotic-Assisted Solution1818910-2025-21991VELYS
VELYS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT A PATIENT WITH A LIGHT OSTEOPOROSIS SUFFERED A FEMORAL FRACTURE 2.5 WEEKS AFTER A TOTAL KNEE ARTHROPLASTY PROCEDURE PERFORMED WITH THE VELYS ROBOTIC ASSISTED SURGERY SYSTEM; THE FRACTURE OCCURRED WHEN SHE STOOD UP FROM A SEATED POSITION, AND THE SURGEON SUSPECTED IT WAS CAUSED BY THE HOLES MADE BY THE VELYS ARRAY PINS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
cause not established1818910-2025-21991DePuy SynthesVELYS™ Robotic-Assisted SolutionRead the record ↗Not graded by the source2025-12-02FDA MAUDEDePuy SynthesVELYS™ Robotic-Assisted Solution1818910-2025-21990VELYS
VELYS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT A PATIENT WITH A LIGHT OSTEOPOROSIS SUFFERED A FEMORAL FRACTURE 2.5 WEEKS AFTER A TOTAL KNEE ARTHROPLASTY PROCEDURE PERFORMED WITH THE VELYS ROBOTIC ASSISTED SURGERY SYSTEM; THE FRACTURE OCCURRED WHEN SHE STOOD UP FROM A SEATED POSITION, AND THE SURGEON SUSPECTED IT WAS CAUSED BY THE HOLES MADE BY THE VELYS ARRAY PINS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
cause not established1818910-2025-21990DePuy SynthesVELYS™ Robotic-Assisted SolutionRead the record ↗Not graded by the source2025-11-21FDA MAUDEGlobus MedicalExcelsiusGPS3004142400-2025-00295ExcelsiusGPS
ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM, T10-L2 OPEN FUSION INSTRAOP MERGE WITH E3D, T10/T11/T12 WERE ALL MEDIAL/LATERAL MISSED SCREWS, T12 RIGHT AND LUMBAR SCREWS WERE PERFECT. T10 BILATERAL AND T11 RIGHT WERE REMOVED AND REPLACED AFTER THE SECOND E3D SPIN.
cause not established3004142400-2025-00295Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2025-11-18FDA MAUDEGlobus MedicalExcelsiusGPS3004142400-2025-00293ExcelsiusGPS
ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM, THERE WAS AN ISSUE WITH THE END EFFECTOR AND ACCURACY, AND THERE WAS ALSO AN ISSUE WITH REHOMING AFTER INITIAL ACCURACY CONCERNS. WE PLANNED LEVELS L4, L5, AND S1 BUT ONLY COMPLETED THE LEVELS L4, L5 DURING THE PROCEDURE. ALL 4 SCREWS WERE NOT PLACED AS PLANNED; THEY WERE ALL CONSIDERED LOWER THAN THE INITIAL PLAN THE SURGEON CREATED. THEN WE DID X-RAYS AND CONFIRMED THE SCREWS WERE OUT OF PLACEMENT. ROBOT WAS REMOVED FROM THE PROCEDURE ARE BUT STILL IN THE OR UNTIL THE CASE WAS COMPLETED.
cause not established3004142400-2025-00293Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2025-11-17FDA MAUDEGlobus MedicalExcelsiusGPS3004142400-2025-00289ExcelsiusGPS
ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT THERE WAS A RADIAL ERROR OF GREATER THAN 1.5MM AT MULTIPLE TRAJECTORIES. THE RIGHT OF ELECTRODE WAS REMOVED AND NO OTHER ELECTRODE WAS PLACED ALONG THIS PLANNED TRAJECTORY. NO FURTHER REVISION IS NEEDED.
cause not established3004142400-2025-00289Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2025-11-06FDA MAUDEGlobus MedicalExcelsiusGPS3004142400-2025-00294ExcelsiusGPS
ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE PLACING CRANIAL LEADS WITH THE EXCELSIUS GPS THE LEFT SIDE LEAD SHIFTED SUPERIOR AT THE VENTRICLE. THE SURGEON STATED THAT THE LEAD RAN ALONG THE SUPERIOR EDGE OF THE HIPPOCAMPUS BUT DECIDED TO PLACE THE LEAD AGAIN. THE EGPS WAS PUSHED BACK IN AFTER LMCS VERIFIED CONTINUED ACCURACY. THE EGPS ARM WAS ALIGNED TO THE LEFT TRAJECTORY AND THE PROCESS REPEATED. THE O-ARM WAS BROUGHT BACK IN AND THE SPIN WAS PERFORMED AND TRANSFERRED. THE LEAD WAS FOUND TO HAVE HIT THE VENTRICLE AND SHIFTED SUPERIOR AGAIN BUT WAS INFERIOR TO THE PREVIOUS LEAD PLACEMENT AND WAS THUS MORE ON TRAJECTORY. THE SURGEON WAS SATISFIED WITH THE PLACEMENT AND CLOSING BEGAN.
cause not established3004142400-2025-00294Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2025-11-05FDA MAUDEGlobus MedicalExcelsiusGPS3004142400-2026-00009ExcelsiusGPS
ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING AN EXCELSIUSGPS SURGERY THE FIRST SCREW LOOKED TO PLAN. THE SECOND SCREW, L4R, LOOKED LIKE IT WAS TO PLAN, BUT THE OFFSET WAS RED, AND DOC WAS WORRIED. THERE WERE NO NAV SHIFTS AFTER LANDMARK CHECK. HE DIDN'T LIKE, CAME BACK IN WITH DURA PRO, PUT IN SCREW AGAIN, BUT THIS TIME WAS LATERAL. HE DID A LANDMARK CHECK, EVERYTHING ACCURATE. HE DID THE SCREW FREEHAND NAV, WHICH WAS TO PLAN. THE L4L SCREW OFFSET WAS RED, AND SCREW LOOKED LATERAL, BUT DOC SAID THAT IT FELT GOOD TO HIM AND DURA PRO WAS GREEN AND RIGHT ON TRAJECTORY. THE SCREW WAS LATERAL. IT WAS POSSIBLY LATERAL DUE TO RETRACTOR, OR PATIENT MOVEMENT. THE DR. TOOK OUT SCREW, AND REPLACED SCREW FREEHAND WITHOUT NAVIGATION USING FLOUROSCOPY. ALL SCREWS TO PLAN AT END.
cause not established3004142400-2026-00009Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2025-11NHTSAWaymoLos Angeles30270-13167Passenger Car · struck on the rear right · proceeding straight
- Crash With
- Passenger Car
- SV Pre-Crash Movement
- Proceeding Straight
- SV Contact Area
- Rear Right
- SV Precrash Speed (MPH)
- 2
- CP Pre-Crash Movement
- Proceeding Straight
- CP Contact Area
- Front Right
- Within ODD?
- Yes
- Automation System Engaged?
- ADS
- Roadway Type
- Street
- Weather
- Cloudy, Rain
- Investigating Agency
- Los Angeles Police Department
- Make
- JAGUAR
- Model
- I-PACE
SV is the subject vehicle — the one whose operator filed the report. CP is the crash partner, the other party. Contact area is where each was struck. NHTSA requires a report for any crash involving the driving system regardless of fault.
On November [XXX], 2025 at 4:52 PM PT a Waymo Autonomous Vehicle ("Waymo AV") operating in Los Angeles, California was in a collision involving a passenger car on [XXX] at [XXX]. The Waymo AV was traveling northeastbound on [XXX], with its right turn signal activated, when it slowed to a stop for a stop sign at the intersection with [XXX]. The Waymo AV proceeded forward slowly as it was yielding to vehicles traveling southeastbound on [XXX] and preparing to turn right onto [XXX]. While the Waymo was proceeding forward, a passenger car traveling northeastbound on [XXX] approached the Waymo AV from behind and the front of the passenger car made contact with the rear of the Waymo AV. At the time of the impact, the Waymo AV's Level 4 ADS was engaged in autonomous mode. Both vehicles sustained damage. The passenger in the Waymo AV was not belted at the time of the collision. The passenger in the Waymo AV was transported to a hospital by an ambulance with unknown injuries. Waymo is reporting this crash under Request No. 1 of Standing General Order 2021-01 because an individual involved was transported from the scene to a hospital for medical treatment. Waymo may supplement or correct its reporting with additional information as it may become available.
cause not established30270-13167WaymoSource file ↗Not graded by the source2025-11NHTSAWaymoSan Francisco30270-13198Passenger Car · struck on the rear right · stopped
- Crash With
- Passenger Car
- SV Pre-Crash Movement
- Stopped
- SV Contact Area
- Rear Right
- SV Precrash Speed (MPH)
- 0
- CP Pre-Crash Movement
- Proceeding Straight
- CP Contact Area
- Front Right
- Within ODD?
- Yes
- Automation System Engaged?
- ADS
- Roadway Type
- Intersection
- Weather
- Clear
- Investigating Agency
- San Francisco Police Department
- Make
- JAGUAR
- Model
- I-PACE
SV is the subject vehicle — the one whose operator filed the report. CP is the crash partner, the other party. Contact area is where each was struck. NHTSA requires a report for any crash involving the driving system regardless of fault.
On November [XXX], 2025 at 10:09 AM PT a Waymo Autonomous Vehicle ("Waymo AV") operating in San Francisco, California was in a collision involving a passenger car on [XXX] at [XXX]. The Waymo AV was stopped in the right lane on [XXX], southwestbound for a red light at the intersection with [XXX]. While the Waymo AV remained stopped, a passenger car that was initially stopped directly behind the Waymo AV proceeded forward, and the front of the passenger car made contact with the rear of the Waymo AV. At the time of the impact, the Waymo AV's Level 4 ADS was engaged in autonomous mode. Neither vehicle sustained damage. The driver of the passenger car was transported from the scene to a hospital with unknown injuries. Waymo is reporting this crash under Request No. 1 of Standing General Order 2021-01 because an individual involved was transported from the scene to a hospital for medical treatment. Waymo may supplement or correct its reporting with additional information as it may become available.
cause not established30270-13198WaymoSource file ↗Not graded by the source2025-11NHTSAZooxMiami30610-13377Motorcycle · struck on the left · proceeding straight
- 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.
cause not established30610-13377ZooxSource file ↗Not graded by the source2025-10-17FDA MAUDEGlobus MedicalExcelsiusGPS3004142400-2025-00259ExcelsiusGPS
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.
cause not established3004142400-2025-00259Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2025-10-16FDA MAUDEGlobus MedicalExcelsiusGPS3004142400-2025-00267ExcelsiusGPS
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.
cause not established3004142400-2025-00267Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2025-10-15FDA MAUDEGlobus MedicalExcelsiusGPS3004142400-2025-00275ExcelsiusGPS
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.
cause not established3004142400-2025-00275Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2025-10-15FDA MAUDEGlobus MedicalExcelsiusGPS3004142400-2025-00256ExcelsiusGPS
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
cause not established3004142400-2025-00256Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2025-10-02FDA MAUDEGlobus MedicalExcelsiusGPS3004142400-2025-00252ExcelsiusGPS
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.
cause not established3004142400-2025-00252Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2025-10NHTSAWaymoLos Angeles30270-11849SUV · struck on the rear · parked
- 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.
cause not established30270-11849WaymoSource file ↗Not graded by the source2025-10NHTSAWaymoSan Francisco30270-13056stopped
- 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.
cause not established30270-13056WaymoSource file ↗Not graded by the source2025-10NHTSAWaymoSan Francisco30270-11997stopped
- 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.
cause not established30270-11997WaymoSource file ↗Not graded by the source2025-09-30FDA MAUDEGlobus MedicalExcelsiusGPS3004142400-2025-00249ExcelsiusGPS
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.
cause not established3004142400-2025-00249Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2025-09-24FDA MAUDEGlobus MedicalExcelsiusGPS3004142400-2025-00240ExcelsiusGPS
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.
cause not established3004142400-2025-00240Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2025-09-23FDA MAUDEGlobus MedicalExcelsiusGPS3004142400-2025-00244ExcelsiusGPS
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.
cause not established3004142400-2025-00244Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2025-09-22FDA MAUDEGlobus MedicalExcelsiusGPS3004142400-2025-00229ExcelsiusGPS
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.
cause not established3004142400-2025-00229Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2025-09-18FDA MAUDEGlobus MedicalExcelsiusGPS3004142400-2025-00233ExcelsiusGPS
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.
cause not established3004142400-2025-00233Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2025-09-16FDA MAUDEGlobus MedicalExcelsiusGPS3004142400-2025-00235ExcelsiusGPS
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.
cause not established3004142400-2025-00235Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2025-09-12FDA MAUDEDePuy SynthesVELYS™ Robotic-Assisted Solution1818910-2025-20272VELYS
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.
cause not established1818910-2025-20272DePuy SynthesVELYS™ Robotic-Assisted SolutionRead the record ↗Not graded by the source2025-09NHTSAWaymoAustin30270-11840Animal · struck on the front right · proceeding straight
- 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.
cause not established30270-11840WaymoSource file ↗Not graded by the source2025-08-21FDA MAUDEGlobus MedicalExcelsiusGPS3004142400-2026-00050ExcelsiusGPS
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.
cause not established3004142400-2026-00050Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2025-08-14FDA MAUDEAuris HealthMonarch Platform3014447948-2025-00024Monarch Platform
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.
cause not established3014447948-2025-00024Auris HealthMonarch PlatformRead the record ↗Not graded by the source2025-07-17FDA MAUDEAuris HealthMonarch Platform3014447948-2025-00023Monarch Platform
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.
cause not established3014447948-2025-00023Auris HealthMonarch PlatformRead the record ↗Not graded by the source2025-07-10FDA MAUDEGlobus MedicalExcelsiusGPS3004142400-2025-00283ExcelsiusGPS
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.
cause not established3004142400-2025-00283Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2025-07-10FDA MAUDEGlobus MedicalExcelsiusGPS3004142400-2025-00153ExcelsiusGPS
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.
cause not established3004142400-2025-00153Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2025-07-03FDA MAUDEGlobus MedicalExcelsiusGPS3004142400-2025-00268ExcelsiusGPS
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.
cause not established3004142400-2025-00268Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2025-07NHTSAWaymoMesa30270-11361struck on the front right · proceeding straight
- 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.
cause not established30270-11361WaymoSource file ↗Not graded by the source2025-07NHTSAZooxSan Francisco30610-11514Animal · struck on the front right, bottom · proceeding straight
- 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."
cause not established30610-11514ZooxSource file ↗Not graded by the source2025-06-25FDA MAUDEAccuray3003873069-2025-00001CyberKnife
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.
cause not established3003873069-2025-00001AccurayRead the record ↗Not graded by the source2025-06-25FDA MAUDEGlobus MedicalExcelsiusGPS3004142400-2025-00218ExcelsiusGPS
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.
cause not established3004142400-2025-00218Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2025-06-25FDA MAUDEAccuray3003873069-2025-00002CyberKnife
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.
cause not established3003873069-2025-00002AccurayRead the record ↗Not graded by the source2025-06-03FDA MAUDEGlobus MedicalExcelsiusGPS3004142400-2025-00257ExcelsiusGPS
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.
cause not established3004142400-2025-00257Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2025-05-29FDA MAUDEGlobus MedicalExcelsiusGPS3004142400-2025-00127ExcelsiusGPS
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.
cause not established3004142400-2025-00127Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2025-05-21FDA MAUDEAuris HealthMonarch Platform3014447948-2025-00021Monarch Platform
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.
cause not established3014447948-2025-00021Auris HealthMonarch PlatformRead the record ↗Not graded by the source2025-05-20FDA MAUDEAuris HealthMonarch Platform3014447948-2025-00020Monarch Platform
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.
cause not established3014447948-2025-00020Auris HealthMonarch PlatformRead the record ↗Not graded by the source2025-05-20FDA MAUDEAuris HealthMonarch Platform3014447948-2025-00019Monarch Platform
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.
cause not established3014447948-2025-00019Auris HealthMonarch PlatformRead the record ↗Not graded by the source2025-05-12FDA MAUDEGlobus MedicalExcelsiusGPS3004142400-2025-00143ExcelsiusGPS
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.
cause not established3004142400-2025-00143Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2025-05-06FDA MAUDEAuris HealthMonarch Platform3014447948-2025-00018Monarch Platform
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..
cause not established3014447948-2025-00018Auris HealthMonarch PlatformRead the record ↗Not graded by the source2025-05-06FDA MAUDEAuris HealthMonarch PlatformMW5170510Monarch Platform
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.
cause not establishedMW5170510Auris HealthMonarch PlatformRead the record ↗Not graded by the source2025-05-06FDA MAUDEAuris HealthMonarch Platform3014447948-2025-00017Monarch Platform
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.
cause not established3014447948-2025-00017Auris HealthMonarch PlatformRead the record ↗Not graded by the source2025-05-02FDA MAUDEGlobus MedicalExcelsiusGPS3004142400-2025-00125ExcelsiusGPS
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.
cause not established3004142400-2025-00125Globus MedicalExcelsiusGPSRead the record ↗