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Property damage only2026-03NHTSAWaymoLos Angeles30270-14496Passenger Car · struck on the rear right · proceeding straight
- Crash With
- Passenger Car
- Highest Injury Severity Alleged
- Property Damage. No Injured Reported
- SV Pre-Crash Movement
- Proceeding Straight
- SV Contact Area
- Rear Right
- SV Precrash Speed (MPH)
- 3
- CP Pre-Crash Movement
- Proceeding Straight
- CP Contact Area
- Front Right
- Within ODD?
- Yes
- Automation System Engaged?
- ADS
- Roadway Type
- Street
- Weather
- Cloudy
- 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 March [XXX], 2026 at 5:19 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 stopped facing east in the left lane on [XXX] in a queue of traffic for a red light at the intersection with [XXX], with its left turn signal activated in preparation for an unprotected left turn onto [XXX]. After the traffic light turned green, the Waymo AV proceeded forward a short distance, then began slowing before entering the intersection to yield to oncoming traffic traveling westbound through the intersection. As the Waymo AV was slowing, a passenger car 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. Both vehicles sustained damage. 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 established30270-14496WaymoSource file ↗Property damage only2026-03NHTSAWaymoTempe30270-14271Pickup Truck · struck on the rear left · stopped
- Crash With
- Pickup Truck
- Highest Injury Severity Alleged
- Property Damage. No Injured Reported
- SV Pre-Crash Movement
- Stopped
- SV Contact Area
- Rear Left
- SV Precrash Speed (MPH)
- 0
- CP Pre-Crash Movement
- Other, see Narrative
- CP Contact Area
- Front Left
- Within ODD?
- Yes
- Automation System Engaged?
- ADS
- Roadway Type
- Street
- Weather
- Cloudy
- Investigating Agency
- Tempe 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 March [XXX], 2026 at 6:23 AM MT a Waymo Autonomous Vehicle ("Waymo AV") operating in Tempe, Arizona was in a collision involving a pickup truck on [XXX] near [XXX]. The Waymo AV was traveling southbound in the designated left turn lane on [XXX] when it began to slow for a queue of traffic stopped for a red light at the intersection with [XXX]. While the Waymo AV was slowing, an SUV traveling westbound on [XXX] proceeded to enter the intersection at [XXX], at the same time as a pickup truck traveling northbound on [XXX] proceeded straight through the intersection against a red light, and the front of the pickup truck made contact with the left side of the SUV. As a result of this contact, the SUV was pushed northbound onto [XXX], and the pickup truck proceeded straight northbound, crossing into southbound [XXX] and entering the Waymo AV's lane of travel. The Waymo came to a stop to yield to the pickup truck, and the front right side of the pickup truck made contact with the rear right side of the stationary Waymo AV. At the time of the impact, the Waymo AV's Level 4 ADS was engaged in autonomous mode. All three vehicles sustained damage. 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 established30270-14271WaymoSource file ↗Property damage only2026-03NHTSAWaymoDallas30270-14333SUV · struck on the left, rear · stopped
- Crash With
- SUV
- Highest Injury Severity Alleged
- Property Damage. No Injured Reported
- SV Pre-Crash Movement
- Stopped
- SV Contact Area
- Left, Rear
- SV Precrash Speed (MPH)
- 0
- CP Pre-Crash Movement
- Passing
- CP Contact Area
- Front
- 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 March [XXX], 2026 at 4:18 AM CT a Waymo Autonomous Vehicle ("Waymo AV") operating in Dallas, Texas was in a collision involving an SUV on [XXX] near [XXX]. The Waymo AV was traveling southwestbound on a narrow portion of [XXX], with vehicles parked at the curb in both directions, when it slowed to a stop in-lane to yield to two pedestrians standing in the roadway between two parked vehicles on the east side of [XXX]. While the Waymo AV was stopped, an SUV traveling northeastbound on [XXX] slowed to a stop in close proximity to the Waymo AV, then proceeded forward to pass the Waymo AV to the left, and the front left side of the SUV made contact with the left side of the stationary Waymo AV. The SUV then reversed briefly and proceeded forward to pass the Waymo AV to the left again, and the left side 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 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 established30270-14333WaymoSource file ↗Property damage only2026-03NHTSAWaymoAustin30270-14450Pickup Truck · struck on the rear · stopped
- Crash With
- Pickup Truck
- Highest Injury Severity Alleged
- Property Damage. No Injured Reported
- SV Pre-Crash Movement
- Stopped
- SV Contact Area
- Rear
- SV Precrash Speed (MPH)
- 0
- CP Pre-Crash Movement
- Passing
- CP Contact Area
- Left
- Within ODD?
- Yes
- Automation System Engaged?
- ADS
- Roadway Type
- Street
- Weather
- Cloudy
- 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 March [XXX], 2026 at 8:51 AM CT a Waymo Autonomous Vehicle ("Waymo AV") operating in Austin, Texas was in a collision involving a pickup truck 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, made more narrow by the presence of a curb extension on the south curb of [XXX], when the Waymo AV maneuvered to the right and slowed to a stop in-lane prior to the curb extension to yield to a pickup truck traveling westbound on [XXX]. While the Waymo AV was stopped, the pickup truck proceeded to pass the Waymo AV to the left, and the left side of the pickup truck 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 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 established30270-14450WaymoSource file ↗Property damage only2026-03NHTSAWaymoLos Angeles30270-14227SUV · struck on the rear · proceeding straight
- Crash With
- SUV
- Highest Injury Severity Alleged
- Property Damage. No Injured Reported
- SV Pre-Crash Movement
- Proceeding Straight
- SV Contact Area
- Rear
- SV Precrash Speed (MPH)
- 12
- CP Pre-Crash Movement
- Backing
- CP Contact Area
- Rear Left
- Within ODD?
- Yes
- Automation System Engaged?
- ADS
- Roadway Type
- Street
- Weather
- Partly Cloudy
- 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 March [XXX], 2026 at 1:13 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 traveling northbound on [XXX] when an SUV that was traveling northbound on [XXX] in front of the Waymo began to slow and turn left towards a driveway on the west side of [XXX]. The Waymo AV slowed for the SUV and then began to pass the SUV on the right as the SUV came to a stop in-lane on [XXX], facing northwest. As the Waymo AV began to proceed straight behind the stopped SUV, the SUV began to reverse, and the rear right side of the SUV made contact with the rear left side 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. 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 established30270-14227WaymoSource file ↗No injury reported2026-03NHTSAAvrideDallas31101-14647struck on the front right · proceeding straight
- Crash With
- Other, see Narrative
- Highest Injury Severity Alleged
- No Injured Reported
- SV Pre-Crash Movement
- Proceeding Straight
- SV Contact Area
- Front Right
- SV Precrash Speed (MPH)
- 29
- CP Pre-Crash Movement
- Other, see Narrative
- CP Contact Area
- Unknown
- Within ODD?
- Yes
- Automation System Engaged?
- ADS
- Roadway Type
- Street
- Weather
- Clear
- Make
- HYUNDAI
- Model
- Ioniq 5
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 March [XXX], 2026 at 3:54 PM, an AVRIDE autonomous vehicle (the "AVRIDE AV") was in a collision in Dallas, Texas on [XXX] near [XXX]. The AVRIDE AV was driving northeastbound in the right lane on [XXX] in autonomous mode when it approached a traffic sign laying down in the right lane. Upon noticing the sign, the AVRIDE AV moved into the left lane. While moving into the left lane, the right front of the AVRIDE AV made contact with the road sign. The AVRIDE AV sustained minor damage. No injuries were reported.
cause not established31101-14647AvrideSource file ↗Property damage only2026-03NHTSAZooxSan Francisco30610-14419Passenger Car · struck on the rear · stopped
- Crash With
- Passenger Car
- Highest Injury Severity Alleged
- Property Damage. No Injured Reported
- SV Pre-Crash Movement
- Stopped
- SV Contact Area
- Rear
- SV Precrash Speed (MPH)
- 0
- CP Pre-Crash Movement
- Passing
- CP Contact Area
- Front
- Within ODD?
- Yes
- Automation System Engaged?
- ADS
- Roadway Type
- Street
- Weather
- Clear
- Investigating Agency
- None
- Make
- ZOOX
- Model
- Zoox
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 autonomous vehicle, traveling west on [XXX] toward [XXX] in San Francisco, stopped next to parked vehicles with active hazard lights to pick up a passenger. Just after the passenger entered the Zoox vehicle, a passenger car (Vehicle 2) traveling behind attempted to pass on the left and swiped the Zoox vehicle's left rear fender. The Zoox vehicle was towed from the scene and was found to have sustained minor damage. No injuries were reported, and police were not notified.
cause not established30610-14419ZooxSource file ↗Property damage only2026-03NHTSAWaymoSan Francisco30270-14332Pickup Truck · struck on the front left · stopped
- Crash With
- Pickup Truck
- Highest Injury Severity Alleged
- Property Damage. No Injured Reported
- SV Pre-Crash Movement
- Stopped
- SV Contact Area
- Front Left
- SV Precrash Speed (MPH)
- 0
- CP Pre-Crash Movement
- Parking Maneuver
- CP Contact Area
- Rear
- Within ODD?
- Yes
- Automation System Engaged?
- ADS
- Roadway Type
- Street
- Weather
- Partly Cloudy
- 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 March [XXX], 2026 at 6:45 PM PT a Waymo Autonomous Vehicle ("Waymo AV") operating in San Francisco, California was in a collision involving a pickup truck on [XXX] near [XXX]. The Waymo AV was stopped in-lane facing east on [XXX] to yield to a pickup truck that began to reverse in-lane directly in front of the Waymo AV in an attempt to parallel park at the curb on the right side. While the Waymo AV was stopped, the pickup truck proceeded forward into the roadway before coming to a stop in-lane. The Waymo AV proceeded forward momentarily to begin passing the pickup truck on the left, then slowed to a stop behind the pickup truck as the pickup truck began reversing again. The pickup truck continued to reverse towards the right curb, and the rear left side of the pickup truck made contact with the front right side 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. 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 established30270-14332WaymoSource file ↗No injury reported2026-03NHTSAAvrideDallas31101-14652making left turn
- Crash With
- Other, see Narrative
- Highest Injury Severity Alleged
- No Injured Reported
- SV Pre-Crash Movement
- Making Left Turn
- SV Contact Area
- Unknown
- SV Precrash Speed (MPH)
- 13
- CP Pre-Crash Movement
- Stopped
- CP Contact Area
- Unknown
- Within ODD?
- Yes
- Automation System Engaged?
- ADS
- Roadway Type
- Intersection
- Weather
- Clear
- Make
- HYUNDAI
- Model
- Ioniq 5
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 March [XXX], 2026, at 10:23 AM, an AVRIDE autonomous vehicle (the "AVRIDE AV") was in a collision in Dallas, Texas at the intersection of [XXX] and [XXX]. The AVRIDE AV was traveling northwestbound on [XXX] in autonomous mode approaching the intersection with [XXX] with a safety driver behind the wheel. As the AVRIDE AV approached the green light at the intersection, the AVRIDE AV planned to continue driving straightforward through the intersection. While entering the intersection, the safety driver took over the vehicle in manual mode and took a left turn onto the left lane on [XXX]. The right lane on [XXX] was blocked off by a temporary traffic control sign. As the safety driver made the left hand turn, the right front of the AVRIDE AV made contact with the traffic sign. The AVRIDE AV sustained minor damage. The traffic sign sustained zero damage. No injuries were reported.
cause not established31101-14652AvrideSource file ↗No injury reported2026-03NHTSAWeRideSan Jose30792-14655Pickup Truck · struck on the rear right · stopped
- Crash With
- Pickup Truck
- Highest Injury Severity Alleged
- No Injured Reported
- 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
- Street
- Weather
- Clear
- Make
- NISSAN
- Model
- Ariya Hatchback
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 the morning of March [XXX], 2026, at approximately 11:46 a.m., a WeRide autonomous vehicle (Vehicle 1) was traveling along [XXX] in San Jose, California, proceeding straight in the second lane from the left as it approached the intersection with [XXX]. Operating in autonomous mode, the vehicle came to a complete stop at a red traffic signal. While stopped, Vehicle 1 was struck from behind by a white 2012 Chevrolet Colorado pickup truck (Vehicle 2), whose driver failed to stop in time. Immediately following the collision, the In-vehicle safety operator of Vehicle 1 disengaged autonomous mode and assessed the situation. Both drivers then relocated their vehicles to a safe area nearby, where they exchanged information and performed a visual inspection of the damage. The damage to both vehicles was minor in nature. Vehicle 1 sustained a small scratch to its rear bumper, while Vehicle 2 sustained a corresponding minor scratch to its front bumper. No injuries were reported by either party, and emergency services were not requested.
cause not established30792-14655WeRideSource file ↗Property damage only2026-03NHTSAZooxSan Francisco30610-14665Passenger Car · struck on the front left, front, front right · stopped
- Crash With
- Passenger Car
- Highest Injury Severity Alleged
- Property Damage. No Injured Reported
- SV Pre-Crash Movement
- Stopped
- SV Contact Area
- Front Left, Front, Front Right
- SV Precrash Speed (MPH)
- 0
- CP Pre-Crash Movement
- Traveling Wrong Way
- CP Contact Area
- Rear Right
- 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) operating in autonomous mode was stopped behind traffic in the through lane on westbound [XXX] at a red traffic light at [XXX] in San Francisco with a passenger car (Vehicle 2), stopped directly ahead. After both vehicles were fully stopped, Vehicle 2 began moving backward toward the still-stopped Zoox vehicle, and even though the Zoox vehicle honked its horn, Vehicle 2 continued to move backward and made contact with the Zoox vehicle's front bumper. The Zoox vehicle operator then disengaged from autonomy. The Zoox vehicle sustained minor damage. No injuries were reported, and police were not notified.
cause not established30610-14665ZooxSource file ↗Property damage only2026-03NHTSAAvrideDallas31101-14509SUV · struck on the front left · proceeding straight
- Crash With
- SUV
- Highest Injury Severity Alleged
- Property Damage. No Injured Reported
- SV Pre-Crash Movement
- Proceeding Straight
- SV Contact Area
- Front Left
- SV Precrash Speed (MPH)
- 19
- CP Pre-Crash Movement
- Entering Traffic
- CP Contact Area
- Front Right
- Within ODD?
- Yes
- Automation System Engaged?
- ADS
- Roadway Type
- Street
- Weather
- Clear
- Investigating Agency
- Dallas Police Department
- Make
- HYUNDAI
- Model
- Ioniq 5
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 March [XXX], 2026, at 12:52 PM, an AVRIDE autonomous vehicle (the "AVRIDE AV") was in a collision in Dallas, Texas on [XXX] near [XXX]. The AVRIDE AV was traveling southeastbound on [XXX] in autonomous mode. As the AVRIDE AV drove straight ahead, an SUV on the right side of [XXX] from [XXX] began to turn right onto [XXX]. There was a stop sign on [XXX] that the SUV ignored before turning right onto [XXX].. This resulted in the left front of the SUV making contact with the right front of the AVRIDE AV. Both vehicles sustained damage. Both vehicles required a tow. No injuries were reported.
cause not established31101-14509AvrideSource file ↗Not graded by the source2026-02-26FDA MAUDEGlobus MedicalExcelsiusGPS3004142400-2026-00051ExcelsiusGPS
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 EXCELSUS GPS SYSTEM, THE SCREW MISSED TARGET AND APPEARED TOO HIGH IN PEDICLE.THEY BELIEVE THE TRAJECTORY WAS SLICED BUT NEED AN ACCURACY CHECK REGARDLESS. THEY REPLACED SCREW WITH NEW PLAN.
cause not established3004142400-2026-00051Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2026-02-26FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2026-16776da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H11 FOR FOLLOW-UP INFORMATION.
cause not established2955842-2026-16776Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2026-02-25FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2026-16865da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H11 FOR FOLLOW-UP INFORMATION.
cause not established2955842-2026-16865Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2026-02-24FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2026-16445da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY THAT WAS INSTALLED ON AN MCS INSTRUMENT FELL OFF INSIDE THE PATIENT. INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS EVENT: THE MCS TIP COVER ACCESSORY FELL INSIDE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE WHICH WAS COMPLETED ROBOTICALLY. THE ISSUE DID NOT CAUSE A PROCEDURE DELAY AND THERE WAS NO INJURY TO THE PATIENT. THE MCS TIP COVER ACCESSORY IS NOT AVAILABLE FOR RETURN TO ISI FOR FAILURE ANALYSIS EVALUATION.
cause not established2955842-2026-16445Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2026-02-24FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2026-21101da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H11 FOR FOLLOW-UP INFORMATION.
cause not established2955842-2026-21101Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2026-02-24FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2026-16442da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE TIP COVER ACCESSORY OF THE MONOPOLAR CURVED SCISSORS INSTRUMENT FELL OFF. INTUITIVE SURGICAL (IS) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS EVENT: THE TIP COVER ACCESSORY FELL INTO THE PATIENT AND WAS RETRIEVED FROM THE PATIENT DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED ROBOTICALLY. THE ISSUE DID NOT CAUSE A PROCEDURE DELAY AND THERE WAS NO INJURY TO THE PATIENT. THE TIP COVER ACCESSORY IS NOT AVAILABLE FOR RETURN TO INTUITIVE FOR FURTHER EVALUATION.
cause not established2955842-2026-16442Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2026-02-24FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2026-16443da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY THAT WAS INSTALLED ON AN MCS INSTRUMENT FELL OFF INSIDE THE PATIENT. INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS EVENT: THE MCS TIP COVER ACCESSORY FELL INSIDE THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE WHICH WAS COMPLETED ROBOTICALLY. THE ISSUE DID NOT CAUSE PROCEDURE DELAY AND THERE WAS NO INJURY TO THE PATIENT. THE MCS TIP COVER ACCESSORY IS NOT AVAILABLE FOR RETURN TO INTUITIVE FOR FURTHER EVALUATION.
cause not established2955842-2026-16443Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2026-02-24FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2026-17159da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H11 FOR FOLLOW-UP INFORMATION.
cause not established2955842-2026-17159Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2026-02-23FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2026-22615da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY THAT WAS INSTALLED ON AN MCS INSTRUMENT CAME OFF AND FELL INSIDE THE PATIENT¿S ABDOMINAL CAVITY. THE MCS TIP COVER ACCESSORY WAS RETRIEVED DURING THE SAME PROCEDURE WHICH WAS COMPLETED ROBOTICALLY.
cause not established2955842-2026-22615Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2026-02-23FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2026-16602da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTRIC BYPASS SURGICAL PROCEDURE, A SMALL PIECE OF BLACK MATERIAL FROM THE INSIDE OF A CANNULA SEAL CAP FELL INTO THE PATIENT. THE SURGICAL TEAM NOTICED THE ISSUE IMMEDIATELY AND REMOVED THE INSTRUMENT. THE PIECE REPORTEDLY CAME FROM A UNIVERSAL SEAL. THE SURGEON PICKED UP THE PIECE WITH A GRASPER, AND THE ASSISTANT REACHED IN THROUGH THE SAME PORT TO REMOVE IT. THEY THEN REPLACED THE CAP WITH ANOTHER ONE, AND NO FURTHER ISSUES WERE ENCOUNTERED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER DID NOT RECALL THE CASE. THE SEAL BROKE OFF WHILE AN INSTRUMENT WAS BEING INSERTED OR REMOVED. THE CUSTOMER NOTICED SOME LEAKING OF CO2 AND THEN LUCKILY SAW THE RUBBER SEAL IN THE SURGICAL FIELD AND REMOVED IT.
cause not established2955842-2026-16602Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2026-02-23FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2026-20847da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A PATIENT IN A STUDY UNDERWENT A DA VINCI-ASSISTED PULMONARY SEGMENTECTOMY SURGICAL PROCEDURE. THREE DAYS AFTER SURGERY, THE PATIENT EXPERIENCED FATIGUE FEVER/PYREXIA AND WAS TREATED WITH AN UNSPECIFIED ANTIBIOTIC. THE EVENT WAS REPORTED AS RESOLVED AND DISCHARGE OCCURRED THREE DAYS LATER. THE INDEX PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS AND NO MALFUNCTION OF THE DA VINCI DEVICE, INSTRUMENTS OR ACCESSORIES. THE STUDY INVESTIGATOR REPORTED THE EVENT AS NOT A SERIOUS ADVERSE EVENT, A CLAVIEN-DINDO GRADE II, AND NOT RELATED TO THE DA VINCI STUDY DEVICE.
cause not established2955842-2026-20847Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2026-02-23FDA MAUDEMedtronic plc — Surgical RoboticsMazor X3005075696-2026-00061Mazor X
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 AT S2-T3, SEVEN SCREWS WERE MISPLACED TOWARDS THE SPINAL CANAL. SIX SCREWS WERE ON THE RIGHT AND ONE WAS ON THE LEFT. THERE WERE FIVE REGISTRATIONS IN THE CT TO FLUORO WORKFLOW, AS THERE WERE FIVE SEGMENTS. AFTER S2 THERE WAS AN ANATOMY SHIFT, SO RE-REGISTRATION WAS NEEDED. OTHERWISE, ALL LEVELS WERE GREEN WITH THE EXCEPTION OF ONE, WHICH WAS BELIEVED TO BE T6. THE NAVIGATION WAS ACCURATE. THE MISPLACED SCREWS WERE REMOVED AND REPLACED USING A NAVIGATION SYSTEM. THE PATIENT HAS EXPERIENCED TRANSIENT WEAKNESS IN THE HIP, WHICH AS RESOLVED. THE DELAY WAS AROUND AN HOUR. THE DEVIATION WAS 3MM.
cause not established3005075696-2026-00061Medtronic plc — Surgical RoboticsMazor XRead the record ↗Not graded by the source2026-02-20FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2026-16456da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED THORACIC PROCEDURE, A FRAGMENT FROM A UNIVERSAL SEAL BROKE OFF AND FELL INSIDE THE PATIENT. ALL FRAGMENTS WERE SUCCESSFULLY 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.
cause not established2955842-2026-16456Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Death reported2026-02-20Press recordsTesla
A judge has denied Tesla's request to overturn a $243 million jury verdict that held the automaker partially responsible for a fatal crash involving its Autopilot driver assistance system.
cause not establishedTeslaRead the record ↗Not graded by the source2026-02-20FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2026-16033da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED EXTENDED TOTALLY EXTRAPERITONEAL (ETEP) UNILATERAL INGUINAL HERNIA REPAIR PROCEDURE, A PIECE OF THE RUBBER INSIDE OF THE A UNIVERSAL SEAL BROKE OFF AND FELL INTO THE PATIENT. THE PIECE WAS RECOVERED DURING THE SAME SURGICAL PROCEDURE AND NO INJURY WAS REPORTED. THE UNIVERSAL SEAL WAS REPLACED WITH A SPARE TO CONTINUE THE PROCEDURE AS PLANNED. THE PROCEDURE WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.
cause not established2955842-2026-16033Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2026-02-19FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2026-16179da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SINGLE-PORT (SP) RIGHT UPPER LOBE WEDGE RESECTION PROCEDURE, THE PATIENT SUSTAINED A RIB INJURY ADJACENT TO THE ACCESS PORT. THIS WAS NOTED AT THE COMPLETION OF THE PROCEDURE WHEN THE ROBOT WAS UNDOCKED AND WHEN IT WAS TIME TO CLOSE. THE PATIENT WAS POSITIONED ON THE TRUMPF BED AND SLID DURING THE PROCEDURE, CONTRIBUTING TO THE RIB FRACTURE ADJACENT TO THE ACCESS PORT. THE INTUITIVE SURGICAL, INC. (ISI) REPRESENTATIVE WHO WAS PRESENT ATTRIBUTED THIS TO THE PATIENT'S HIGHER BODY MASS INDEX (BMI) AND FEET NOT BEING SECURED. THE PROCEDURE WAS COMPLETED ROBOTICALLY, AND DUE TO THE INJURY, THE PATIENT WAS HOSPITALIZED OVERNIGHT FOR OBSERVATION. NO SCANS WERE PERFORMED INTRAOPERATIVELY. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF AN SP SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED.
cause not established2955842-2026-16179Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2026-02-19FDA MAUDEAuris HealthMonarch Platform3014447948-2026-00012Monarch 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 PATIENT DEVELOPED A PNEUMOTHORAX. PATIENT WAS HOSPITALIZED AND CHEST TUBE WAS PLACED. THE PNEUMOTHORAX RESOLVED AND THE PATIENT WAS RELEASED ON (B)(6) 2026. NO DEVICE ISSUES WERE REPORTED.
cause not established3014447948-2026-00012Auris HealthMonarch PlatformRead the record ↗Not graded by the source2026-02-19FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2026-21103da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H11 FOR FOLLOW-UP INFORMATION.
cause not established2955842-2026-21103Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2026-02-18FDA MAUDEZimmer Biomet3009185973-2026-00002ROSA Robotic Surgery
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 IMAGING OBTAINED IMMEDIATELY AFTER DEEP ELECTRODE PLACEMENT SUGGESTED A MILD EPIDURAL HEMATOMA, AND THE PATIENT WAS MANAGED WITH OBSERVATION. DURING THE PROCEDURE, THE ELECTRODE INSERTED INTO THE INSULA ON THE SECOND TRAJECTORY WAS REPLACED AFTER A BREAK IN THE ELECTRODE WIRE WAS CONFIRMED, AND THE PHYSICIAN INDICATED THAT THE REPLACEMENT MAY HAVE CONTRIBUTED TO THE HEMATOMA. A FOLLOW-UP CT SCAN OBTAINED APPROXIMATELY SEVERAL HOURS LATER SHOWED NO ENLARGEMENT OF THE HEMATOMA, AND THE PATIENT REMAINED CONSCIOUS. THE PATIENT WAS MONITORED WITHOUT THERAPEUTIC INTERVENTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
cause not established3009185973-2026-00002Zimmer BiometRead the record ↗Not graded by the source2026-02-18FDA MAUDEGlobus MedicalExcelsiusGPS3004142400-2026-00047ExcelsiusGPS
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, THE SURGEON DECIDED TO ABORT A EXCELSIUS GPS SI LOK SURGERY ON (B)(6) 2026. HE WAS NOT CONFIDENT WITH THE ACCURACY AND SAFETY CHECKS. THE ENTIRE SURGERY WAS ABORTED AND THE PATIENT WAS ALREADY UNDER ANESTHESIA.
cause not established3004142400-2026-00047Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2026-02-18FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2026-25853da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A PATIENT IN A STUDY UNDERWENT A DA VINCI ASSISTED SACROCOLPOPEXY AND COLPORRHAPHY SURGICAL PROCEDURE. ON POST-OPERATIVE DAY TWO, PRIOR TO DISCHARGE, THE PATIENT EXPERIENCED A HYPERTENSIVE CRISIS. THERE WAS A CARDIOLOGY CONSULT AND THE PATIENT'S HYPERTENSION MEDICATION WAS ADJUSTED TO HIGHER DOSES OF ENALAPRIL. THE INDEX PROCEDURE WAS COMPLETED WITHOUT ANY INTRA-OPERATIVE COMPLICATIONS; IT WAS REPORTED THERE WERE NO DA VINCI DEVICE MALFUNCTIONS. THE EVENT WAS REPORTED AS RESOLVED THREE DAYS LATER; DISCHARGE TO HOME OCCURRED THE SAME DAY. THE STUDY INVESTIGATOR REPORTED THE EVENT AS MODERATE SEVERITY, NOT A SERIOUS ADVERSE EVENT, A CLAVIEN-DINDO GRADE II, NOT RELATED TO THE STUDY PROCEDURE, NOT RELATED TO THE PATIENT'S UNDERLYING DISEASE STATUS, NOT RELATED TO THE DA VINCI INVESTIGATIONAL DEVICE AND NOT RELATED TO A THIRD-PARTY DEVICE. THE PATIENT'S PRIOR HEALTH CONDITION OF KNOWN HYPERTONIA MAY BE RELEVANT TO THIS INCIDENT.
cause not established2955842-2026-25853Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2026-02-17FDA MAUDEIntuitive Surgical, Inc.2955842-2026-16404Ion Endoluminal System
Ion Endoluminal 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 ION TRANSBRONCHIAL LUNG BIOPSY PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX REQUIRING PLACEMENT OF A CHEST TUBE AND HOSPITALIZATION. THE TARGETED LESION WAS A LEFT UPPER LOBE INFERIOR NODULE ABUTTING THE MOST INFERIOR PART OF THE LINGULA BEHIND THE HEART. PER THE PHYSICIAN, THERE WERE SUBOPTIMAL ANGLES AND THE DEPTH PERCEPTION WAS NOT GOOD. FINE NEEDLE ASPIRATIONS (FNA) PASSES AND FORCEPS WERE USED. THE PHYSICIAN REPORTED THAT THEY INSERTED THE FORCEPS FURTHER THAN INTENDED AND LIKELY CAUSED THE PNEUMOTHORAX. A LARGE PNEUMOTHORAX WAS IDENTIFIED DURING THE ION PROCEDURE; THEREFORE, A 14 FRENCH CHEST TUBE WAS PLACED AND THE PROCEDURE WAS ABORTED. THE PATIENT WAS HOSPITALIZED 4 DAYS THEN DISCHARGED HOME IN STABLE CONDITION. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. THE DIAGNOSIS WAS MAC-NTM (MYCOBACTERIUM AVIUM COMPLEX NONTUBERCULOUS MYCOBACTERIA).
cause not established2955842-2026-16404Intuitive Surgical, Inc.Read the record ↗Not graded by the source2026-02-17FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2026-16034da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ROBOTIC HYSTERECTOMY PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY DETACHED FROM AN MCS INSTRUMENT AND FELL INSIDE THE PATIENT. THE CUSTOMER CONFIRMED THAT THE MCS TIP COVER ACCESSORY WAS NOT LOOSE AT THE TIME OF INSTALLATION. THE DETACHED MCS TIP COVER ACCESSORY WAS RETRIEVED USING A GRASPER, AND IT WAS CONFIRMED THAT NO RESIDUAL MATERIAL REMAINED IN THE PATIENT. THE CUSTOMER FURTHER REPORTED THAT THE MCS TIP COVER ACCESSORY HAD BEEN PROPERLY INSTALLED, WITH NO ORANGE SURFACE VISIBLE, AND THAT NO UNUSUAL COLLISIONS OR RESISTANCE WERE ENCOUNTERED DURING USE. FOLLOWING THE EVENT, NO DAMAGE WAS OBSERVED ON THE INSTRUMENT, ACCESSORY, OR CANNULA.
cause not established2955842-2026-16034Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2026-02-16FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2026-15973da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H11 FOR FOLLOW-UP INFORMATION.
cause not established2955842-2026-15973Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2026-02-13FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2026-15535da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LEFT HEMICOLECTOMY PROCEDURE, TISSUE ADHERED TO THE JAWS OF THE SYNCHROSEAL INSTRUMENT FOLLOWING ENERGY ACTIVATION. MANUAL REMOVAL OF THE TISSUE BY PULLING RESULTED IN BLEEDING. TO ADDRESS THE COMPLICATION AND CONTINUE THE PROCEDURE, A VESSEL SEALER EXTEND (VSE) INSTRUMENT WAS USED. THIS INCIDENT CAUSED A 15-MINUTE DELAY; HOWEVER, THE PROCEDURE WAS SUCCESSFULLY COMPLETED ROBOTICALLY. AN INTUITIVE SURGICAL INC. (ISI) FIELD SERVICE ENGINEER (FSE) HAS BEEN REQUESTED TO FURTHER INVESTIGATE AND RULE OUT THE E-100 GENERATOR AS A POTENTIAL CAUSE. ADDITIONALLY, AN ISI TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE SYSTEM LOGS AND CONFIRMED THAT NO ERRORS WERE PRESENT. ISI HAS ATTEMPTED TO GATHER ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT; HOWEVER, NO RESPONSE HAS BEEN RECEIVED.
cause not established2955842-2026-15535Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2026-02-13FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2026-15752da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ABDOMINOPERINEAL RESECTION PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT BURNED BOWEL TISSUE. IT WAS STATED THAT THE MCS TIP COVER ACCESSORY WAS INSTALLED CORRECTLY, HOWEVER, ENERGY "BURNED THROUGH THE TIP COVER". THE PART WAS REPLACED AND THE PROCEDURE WAS COMPLETED.
cause not established2955842-2026-15752Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2026-02-13FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2026-15404da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H11 FOR FOLLOW-UP INFORMATION.
cause not established2955842-2026-15404Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2026-02-13FDA MAUDEGlobus MedicalExcelsiusGPS3004142400-2026-00043ExcelsiusGPS
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 REVISION CASE WITH THE SURGEON WE HAD A SCREW PLACED LATERALLY OF THE INTENDED PLANNED SCREW, THE SCREW THAT WAS PLACED LATERALLY WAS THE LEFT L3 SCREW. WE ALSO HAD SOME DIFFICULTY WITH MOTION ON THE MERGE, WHICH WAS SURPRISING BECAUSE THE PATIENT HAD PREVIOUSLY IMPLANTED HARDWARE WHICH USUALLY MAKES THE PROCESS EASIER. THE LATERALLY PLACED SCREW WAS BACKED OUT AND RE-DIRECTED MANUALLY WITHOUT THE ROBOT. NONE OF THIS CAUSED ANY ISSUES WITH THE PATIENT OR PROCEDURE. THE SURGEON HAS REQUESTED THAT THE CALIBRATION OF THE ROBOT BE CHECKED.
cause not established3004142400-2026-00043Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2026-02-13FDA MAUDEMedtronic plc — Surgical RoboticsMazor X3005075696-2026-00050Mazor X
Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PROCEDURE WAS A SPINE PROCEDURE. IT WAS NOTED THAT THERE WAS ONE CASE WITH A SCREW PLACEMENT DEVIATION, AND ANOTHER CASE FROM ANOTHER DAY, WHERE REGISTRATION OF THE SECOND SEGMENT WAS NOT SUCCESSFUL AND SURGERY WAS COMPLETED WITHOUT THE USE OF THE GUIDANCE SYSTEM.
cause not established3005075696-2026-00050Medtronic plc — Surgical RoboticsMazor XRead the record ↗Not graded by the source2026-02-13FDA MAUDEGlobus MedicalExcelsiusGPS3004142400-2026-00042ExcelsiusGPS
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, A SCREW WAS MISPLACED DURING A T11-L3 PERCFUSION CASE TODAY. THE SCREW WAS REMOVED, AND WE DID THE REST UNDER FLUORO WITHOUT THE ROBOT. EVERY INSTRUMENT HE PUT DOWN THE END EFFECTOR WAS SUPER OFF EVEN THE ANATOMY CHECKS WERE ACCURATE. IT COULD'VE BEEN A SCAN ISSUE WE DON'T KNOW.
cause not established3004142400-2026-00042Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2026-02-11FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2026-15542da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H11 FOR FOLLOW-UP INFORMATION.
cause not established2955842-2026-15542Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2026-02-10FDA MAUDEAuris HealthMonarch Platform3014447948-2026-00010Monarch 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 PATIENT DEVELOPED A PNEUMOTHORAX THAT REQUIRED CHEST TUBE. NO DEVICE ISSUES WERE REPORTED.
cause not established3014447948-2026-00010Auris HealthMonarch PlatformRead the record ↗Not graded by the source2026-02-09FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2026-16031da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H11 FOR FOLLOW-UP INFORMATION.
cause not established2955842-2026-16031Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2026-02-09FDA MAUDEAuris HealthMonarch Platform3014447948-2026-00011Monarch 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 PATIENT DEVELOPED A PNEUMOTHORAX. PATIENT WAS HOSPITALIZED AND PIGTAIL CATHETER WAS PLACED. THE PNEUMOTHORAX RESOLVED AND THE PATIENT WAS RELEASED ON (B)(6) 2026. NO DEVICE ISSUES WERE REPORTED.
cause not established3014447948-2026-00011Auris HealthMonarch PlatformRead the record ↗Not graded by the source2026-02-09FDA MAUDEStryker3005985723-2026-00121Mako Robotic-Arm
Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT DURING A RIGHT MAKO TKA 2.0 PROCEDURE, THE PATIENT'S POPLITEAL ARTERY WAS NICKED. THE SURGEON DID EXTEND THE BOUNDARIES ON CUTS, BUT IT IS NOT KNOWN AT WHAT POINT DURING THE PROCEDURE THE ARTERY WAS NICKED. ISSUE WAS NOTICED WHEN THE SURGEON WAS CLEANING OUT POSTERIOR OSTEOPHYTES. A FEMORAL POPLITEAL BYPASS WAS PERFORMED TO ADDRESS THE ISSUE. SURGERY WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF 1.5 TO 2 HOURS. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
cause not established3005985723-2026-00121StrykerRead the record ↗Not graded by the source2026-02-09FDA MAUDEAuris HealthMonarch Platform3014447948-2026-00009Monarch 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 PATIENT DEVELOPED A PNEUMOTHORAX THAT REQUIRED CHEST TUBE. NO DEVICE ISSUES WERE REPORTED.
cause not established3014447948-2026-00009Auris HealthMonarch PlatformRead the record ↗Not graded by the source2026-02-09FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2026-14962da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H11 FOR FOLLOW-UP INFORMATION.
cause not established2955842-2026-14962Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2026-02-06FDA MAUDEAuris HealthMonarch Platform3014447948-2026-00008Monarch 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 PATIENT DEVELOPED A PNEUMOTHORAX. PATIENT WAS HOSPITALIZED AND CHEST TUBE WAS PLACED. THE PNEUMOTHORAX RESOLVED AND THE PATIENT WAS RELEASED ON (B)(6) 2026. NO DEVICE ISSUES WERE REPORTED.
cause not established3014447948-2026-00008Auris HealthMonarch PlatformRead the record ↗