Crash With

Passenger Car

SV Pre-Crash Movement

Changing Lanes

SV Contact Area

Left

SV Precrash Speed (MPH)

56

CP Pre-Crash Movement

Other, see Narrative

CP Contact Area

Front

Within ODD?

Yes

Automation System Engaged?

ADS

Roadway Type

Highway / Freeway

Weather

Clear

Investigating Agency

Arizona Department of Public Safety

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 February [XXX], 2026 at 7:09 AM MT a Waymo Autonomous Vehicle ("Waymo AV") operating in Scottsdale, Arizona was in a collision involving a passenger car on [XXX] near [XXX]. The Waymo AV was traveling northbound on [XXX] in the rightmost lane. A passenger car traveling northbound in the second to the left lane, in front of and to the left of the Waymo AV, began to slow and change lanes to the right when a second passenger car made contact with the rear right side of the first passenger car. The second passenger car continued forward and made contact with an SUV stopped in the queue of traffic in the second from the left lane. As a result of the initial contact with the second passenger car, the first passenger car was pushed east across two lanes of travel, and entered the Waymo AV's lane of travel. The Waymo AV slowed and maneuvered to the right to avoid the oncoming passenger car and the front left side of the passenger car made contact with the left side of the Waymo AV. The Waymo AV rotated to the left and came to rest facing southwest in the second and third from the left lanes. During two subsequent maneuvers in which the Waymo AV pulled forward and to the right in an attempt to navigate off the freeway, the front left corner of the Waymo AV made contact with an "Oversized Load" sign attached to a heavy truck stopped in the second from the left lane. At the time of all impacts, the Waymo AV's Level 4 ADS was engaged in autonomous mode. All involved vehicles sustained damage. The driver of the first passenger car was transported to a hospital by an ambulance with unknown injuries, and the passenger of the Waymo AV alleged minor 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.

Crash With

Other, see Narrative

Highest Injury Severity Alleged

Property Damage. No Injured Reported

SV Pre-Crash Movement

Proceeding Straight

SV Contact Area

Rear Left, Front Left

SV Precrash Speed (MPH)

20

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 February [XXX], 2026 at 2:19 AM CT a Waymo Autonomous Vehicle ("Waymo AV") operating in Austin, Texas was in a collision involving a flat wooden object on [XXX] near [XXX]. The Waymo AV was traveling southeastbound on [XXX] when the front right and rear right tires of the Waymo AV made contact with a flat wooden object that was laying in the roadway. At the time of the impact, the Waymo AV's Level 4 ADS was engaged in autonomous mode. The Waymo AV 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.

Crash With

Passenger Car

Highest Injury Severity Alleged

Property Damage. 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

Intersection

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 February [XXX], 2026 at 8:41 AM CT a Waymo Autonomous Vehicle ("Waymo AV") operating in Austin, Texas was in a collision involving a passenger car on [XXX] at [XXX]. The Waymo AV was stopped facing northwest in the left lane on [XXX] at a green light at the intersection with [XXX]. While the light remained green, the Waymo AV proceeded forward into the intersection then slowed to a stop, and 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 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.

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: DURING MAKO TKA, WHEN MEASURING THE VIRTUAL GAP, THE INSERTION OF THE MEDIAL COLLATERAL LIGAMENT (MCL) TORE SLIGHTLY WHEN VALGUS STRESS WAS APPLIED. THE TORE PART WAS SUTURED.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: KERAUDY, A., DE BUCK, P., HAETTEL, P., GHANNAM, B., ASSAKER, R., LEROY, H.-A. (2026). 2-STAGED ROBOT-ASSISTED VERTEBRECTOMY FOR METASTATIC LUMBAR SPINE LESION: A PROOF-OF-CONCEPT CASE. EUROPEAN SPINE JOURNAL. HTTPS://DOI.ORG/10.1007/S00586-025-09713-Z SUMMARY: PURPOSE: SPINAL METASTASES FROM TESTICULAR NON-SEMINOMATOUS GERM CELL TUMORS (NSGCTS) ARE EXTREMELY RARE AND MAY REQUIRE COMPLEX SURGICAL STRATEGIES. THIS CASE AIMS TO ILLUSTRATE THE ROLE OF ROBOT-ASSISTED SPINE SURGERY (RASS) IN ACHIEVING ONCOLOGICAL RESECTION AND SPINAL STABILIZATION IN THE CONTEXT OF VERTEBRAL INVASION. METHODS: A 33-YEAR-OLD MALE WITH METASTATIC NSGCT PRESENTED WITH LOCALIZED L3 VERTEBRAL INVOLVEMENT. A TWO-STAGE SURGICAL APPROACH WAS PERFORMED. THE FIRST STAGE INVOLVED POSTERIOR DECOMPRESSION AND VERTEBRAL RESECTION. PEDICLE SCREW PLACEMENTS AND OSTEOTOMIES WERE PERFORMED UNDER ROBOT-ASSISTED GUIDANCE. THE SECOND STAGE CONSISTED OF ANTERIOR TUMOR AND VERTEBRAL BODY RESECTION VIA LAPAROTOMY, FOLLOWED BY EXPANDABLE TITANIUM CAGE PLACEMENT. RESULTS: COMPLETE VERTEBRECTOMY AND TUMOR RESECTION WERE ACHIEVED WITH NO POSTOPERATIVE NEUROLOGICAL DEFICITS. THE ROBOT-ASSISTED TECHNIQUE ALLOWED PRECISE EXECUTION OF

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 WHEN DOING AN SI JOINT FUSION WITH OUR SURGEON, OUR MERGE SEEMED TO BE GOOD. HOWEVER, UPON STARTING THE FIRST SCREW, THE HIGHSPEED DRILL WAS NOTICEABLY DEEPER THAN ITS ACTUAL DEPTH. WE TRIED TO FIX IT AND WHEN STANDARD TROUBLE SHOOTING WAS DONE NOTHING CHANGED BUT THE SURGEON WANTED TO PROCEED. THE SCREW PLACED WAS POSTERIOR AND INFERIOR TO THE PLAN. WE DECIDED TO COMPLETELY REMERGE. SIMILAR SHOTS WERE TAKEN AND THE SCREWS WERE PLACED TO PLAN WITH NO DEPTH ISSUES.

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

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: OROSZ, L. D., POULTER, G. T., HAINES, C. M., LEE, N. J., RAFIQZAD, Y., LEREBO, W. T., ROY, R. T., JAZINI, E., GUM, J. L., LEHMAN, R. A., GOOD, C. R. (2026). COMPREHENSIVE OUTCOMES FOLLOWING NAVIGATED ROBOTICS IN THORACOLUMBAR SPINE SURGERY: THE PROGRSS FINAL ANALYSIS. GLOBAL SPINE JOURNAL. HTTPS://DOI.ORG/10.1177/21925682261421190 SUMMARY STUDY DESIGN: PROSPECTIVE MULTICENTER COHORT STUDY. OBJECTIVES: INTEGRATION OF ROBOTIC GUIDANCE WITH NAVIGATION REPRESENTS A NATURAL EVOLUTION IN SPINE SURGERY TECHNOLOGIES. BOTH MODALITIES HAVE INDEPENDENTLY DEMONSTRATED IMPROVED IMPLANT ACCURACY, REDUCED RADIATION EXPOSURE, AND EXPANDED MINIMALLY INVASIVE CAPABILITIES, YET DATA ON INTEGRATED PLATFORMS REMAIN LIMITED. THE PROSPECTIVE ROBOTIC-GUIDED REGISTRY OF SPINE SURGERY (PROGRSS) EVALUATES SURGICAL, CLINICAL, AND PATIENT-REPORTED OUTCOMES ACROSS A BROAD RANGE OF PROCEDURES PERFORMED WITH AN INTEGRATED ROBOTIC-ASSISTED NAVIGATION SYSTEM. METHODS: ADULTS UNDERGOING NAVIGATED ROBOTIC THORACOLUMBAR SURGERY BETWEEN 2020 AND 2024 WERE ENROLLED BY SIX SURGEONS ACROSS FOUR CENTERS. DEMOGRAPHIC, SURGICAL, AND ROBOT-RELATED METRICS WERE COLLECTED. PATIENT-REPORTED OUTCOMES INCLUDED ODI AND PROMIS GLOBA

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A FRAGMENT FELL INTO THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. NO ABNORMALITIES WERE OBSERVED DURING THE PRE-OPERATIVE INSPECTION OF THE INSTRUMENT. THE PROBLEM WAS IDENTIFIED DURING GRASPING, WHICH IS WHEN THE BREAKAGE OCCURRED, AND THERE WERE NO COLLISIONS WITH OTHER INSTRUMENTS AT ANY POINT DURING USE. THE AFFECTED AREAS INCLUDED THE OPENING AND CLOSING OF THE GRIP, ITS LATERAL MOVEMENT, AND THE UP AND DOWN MOVEMENT OF THE WRIST. FRAGMENTS FELL INTO THE PATIENT AND WERE SUBSEQUENTLY RETRIEVED USING LAPAROSCOPIC TOOLS. NO X-RAY WAS PERFORMED. THE INSTRUMENT HAD BEEN IN USE FOR 60 MINUTES PRIOR TO THE ONSET OF THE ISSUE, WHICH WAS DISCOVERED INTRAOPERATIVELY. INCREASED PRESSURE ON THE BLADE WAS SUSPECTED TO BE THE CAUSE OF THE PROBLEM, LEADING TO TIP BREAKAGE WHILE REMOVING THE INSTRUMENT; THE TIP WAS THEN IMMEDIATELY REMOVED. AT THE TIME OF REMOVAL, THE WRIST WAS EXTENDED, NO RESISTANCE WAS FELT THROUGH THE CANNULA, AND THERE WERE NO VISIBLE SIGNS OF DAMAGE TO THE CANNULA OR OTHER INSTRUMENT PARTS. THE PROCEDURE WAS COMPLETED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: INITIAL SURGERY PERFORMED: (B)(6)2026- ROBOTIC HYSTERECTOMY WITH SALPINGO-OOPHORECTOMY, TOT SLING, CYSTOSCOPY. PATIENT HAD COMPLICATIONS FOLLOWING SURGERY AND WAS TAKEN BACK TO THE OPERATING ROOM ON (B)(6) 2023. DURING THAT SURGERY A SMALL THIN METALLIC FOREIGN BODY WAS FOUND IN THE PATIENT'S ABDOMEN. THE PATIENT HAD A PERFORATED COLON. IT IS UNKNOWN IF THE WIRE WAS THE DIRECT CAUSE OF THE PERFORATION. IT IS BELIEVED TO HAVE COME FROM THE CABLE THAT IS USED WITH ONE OF THE ROBOTIC ARMS. ADD'L DEVICES: REF: 470-179, LOT: K14250913 0700, VERSION 23 MONOPOLAR CURVED SCISSOR; REF: 470-194, LOT: K10250501 0265, VERSION 9 MEGA NEEDLE DRIVER; REF: 471-309, LOT: K13251028 0471, VERSION 17 MEGA SUTURE CUT NEEDLE DRIVER; REF: 471-296, LOT: K10250925 0121, VERSION 10 LARGE SUTURE CUT NEEDLE DRIVER; REF: 471-093, LOT: K10241205 0112, VERSION 14 PRO-GRASP FORCEPS; REF: 470-318, LOT: K10250424 0184, VERSION 15 SMALL GRASPING RETRACTOR.

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

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION SURGICAL PROCEDURE, A PIECE OF THE BLADE DETACHED FROM THE SYNCHROSEAL INSTRUMENT. THE USER WAS ABLE TO COMPLETE THE PROCEDURE WITH NO FURTHER ISSUE REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO DAMAGE OBSERVED. THERE WERE NO INSTRUMENT COLLISIONS. THE FRAGMENT THAT FELL INSIDE THE PATIENT WAS RETRIEVED DURING THE SAME PROCEDURE. THERE WAS NO FURTHER INJURY TO THE PATIENT.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM, PEDICLE SCREWS WERE NOT PLACED AS PLANNED WITH THE E3D INTRAOP EXCELSIUS CASE.

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, THAT WAS INSTALLED ON AN MCS INSTRUMENT, FELL OFF INSIDE THE PATIENT. THE MCS TIP WAS RECOVERED DURING THE SAME PROCEDURE WHICH 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.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SINGLE-PORT UNSPECIFIED ¿HEAD AND NECK¿ SURGICAL PROCEDURE, THE PATIENT DEVELOPED A POSTOPERATIVE HEMORRHAGE AND ULTIMATELY EXPIRED. THE SURGEON INFORMED THE INTUITIVE CLINICAL SALES REPRESENTATIVE THAT THE ROBOTIC PROCEDURE WAS COMPLETED WITHOUT ANY INTRAOPERATIVE COMPLICATIONS; HOWEVER, THE PATIENT DEVELOPED POST-OPERATIVE COMPLICATIONS DUE TO UNSPECIFIED BLEEDING FROM THE NON-SPECIFIC PROCEDURE. NO ADDITIONAL EVENT INFORMATION WAS PROVIDED. THE SURGEON STATED THAT THE ADVERSE EVENT ¿HAD NOTHING TO DO WITH THE DA VINCI SP SYSTEM¿. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE SURGEON WERE MADE; HOWEVER, NO RESPONSE WAS RECEIVED.

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 WAS REPORTED: SURGEON COMPLAINED POST-OP ABOUT CUP PLACEMENT AND IT NOT BEING IN HIS 45/20 ANGLE. REVISION SURGERY PERFORMED SAME DAY TO ONLY RE-POSITION THE CUP. CASE TYPE / APPLICATION: THA 4.1.

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

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT THE SURVEILLANCE HAS BEEN UNABLE TO HOLD GREEN STATUS AND DRIFTS TO YELLOW AND RED CONSTANTLY FOR THE LAST SEVERAL WEEKS. TODAY ANOTHER SCREW WAS PLACED LATERAL TO THE PEDAL SIMILAR TO WHAT HAPPENED TWO WEEKS AGO ON THE SAME UNIT EXHIBITING THE SAME PROBLEMS. THIS HAPPENED ONE OTHER TIME A FEW WEEKS EARLIER. THE SURGEON REMOVED THE BREACHED SCREW AND REPLACED USING TRADITIONAL NON-ROBOTIC/NAVIGATED MANNER. THE SURGEON HAS PUT OVER A THOUSAND SCREWS IN WITH THE ROBOT AND THIS IS THE SECOND TIME THIS HAS HAPPENED IN THE LAST TWO WEEKS WITH THE SAME UNIT EXHIBITING THE SAME ISSUE.

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.

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 CUSTOMER REPORTED REPEATED NON-RECOVERABLE ERRORS. THE REPEATED ERRORS POINTED TO THE MASTER TOOL MANIPULATORS (MTM) RIGHT AND WERE FOUND IN THE ERROR LOG. THE PROCEDURE WAS CONVERTED TO OPEN. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE NEPHROURETERECTOMY PROCEDURE HAD BEEN IN PROGRESS FOR 2 HOURS AND 30 MINUTES WHEN THE ISSUE OCCURRED. IT IS UNCLEAR WHETHER THERE WAS ANY ADDITIONAL DELAY TO THE SURGERY, AS THE CUSTOMER COULD NOT SPECIFY THE DURATION OF ANY POSSIBLE DELAYS. IN RESPONSE TO THE TECHNICAL PROBLEM, EITHER A FIELD SERVICE ENGINEER (FSE) OR TECHNICAL SUPPORT ENGINEER (TSE) WAS CONTACTED FOR TROUBLESHOOTING. THE TROUBLESHOOTING INVOLVED RESTARTING THE SYSTEM; HOWEVER, THE NON-RECOVERABLE ERROR REOCCURRED, AND THE PROBLEM WAS NOT RESOLVED BY THE RESTART. THE SYSTEM HAD BEEN INSPECTED PRIOR TO USE, AND NO ISSUES WERE NOTED DURING ITS SETUP. ULTIMATELY, THE SURGERY WAS CONVERTED TO AN OPEN PROCEDURE DUE TO REPEATED NON-RECOVERABLE ERRORS WITH THE SYSTEM. THE PATIENT TOLERATED THIS CHANGE, WITH NO REPORTED ADVERSE EFFECTS RESU

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

da Vinci Surgical System — Death 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 PULMONARY LOBECTOMY PROCEDURE, AN INADVERTENT PERFORATION OF THE PULMONARY ARTERY OCCURRED WHILE USING A THIRD-PARTY LAPAROSCOPIC STAPLER INSTRUMENT, RESULTING IN SIGNIFICANT HEMORRHAGE AND THE PATIENT ULTIMATELY EXPIRED. THE EXACT VOLUME OF BLOOD LOSS IS UNKNOWN. THE SURGEON DOES NOT BELIEVE THAT THE DA VINCI SYSTEM, INSTRUMENTS, OR ACCESSORIES CAUSED OR CONTRIBUTED TO THE EVENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT THE CUSTOMER HAS INDICATED THAT THEY WILL NOT GRANT PERMISSION FOR FURTHER ACCESS TO THE EVENT INFORMATION.

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

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE USING THE E3D TO PRE OP MERGE, NAVIGATION LOOKED CORRECT BUT UPON TAKING X-RAYS, NAVIGATION WAS OFF A SIGNIFICANTLY ANTERIORLY. THE DISC PREP THAT WAS DONE BASED OFF THE GPS NAVIGATION ON THE ROBOT RESULTED IN VIOLATING THE INFERIOR ENDPLATE OF THE SUPERIOR VERTEBRAL BODY, WHICH CAUSE THE SABLE CAGE TO SUBSIDE. ON THE NAVIGATION, THE CAGE LOOKED LIKE IT WAS WELL WITHIN THE DISC SPACE, BUT UNDER X-RAY IT WAS CLEARLY NOT. WE TRIED TO RE-PLACE THE CAGE BUT HAD THE SAME RESULT.

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 DURING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY FELL INSIDE THE PATIENT. THE INCIDENT OCCURRED WHEN THE ORANGE SURFACE OF THE MCS INSTRUMENT WAS OBSERVED TO HAVE BECOME EXPOSED DURING USE. THE ACCESSORY CONTINUED TO SHIFT UNTIL THE CLEAR PORTION NEARLY COVERED THE ENTIRE TIP OF THE MCS INSTRUMENT BLADES. WHILE ATTEMPTING TO REMOVE THE INSTRUMENT, THE MCS TIP COVER ACCESSORY ULTIMATELY FELL INSIDE THE PATIENT. THE ACCESSORY WAS SUCCESSFULLY RETRIEVED DURING THE SAME PROCEDURE, AND THE SURGERY WAS COMPLETED ROBOTICALLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, NO RESPONSE HAS BEEN RECEIVED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SINGLE PORT EXCISION OF SEMINAL VESICLES PROCEDURE, THE PATIENT SIDE MANIPULATOR (PSM) #4 WAS EXPERIENCING A DRAPING FAULT AND CAMERA ENGAGEMENT ISSUES AFTER THE SINGLE PORT ACCESS PORT WAS PLACED. THE CUSTOMER ATTEMPTED TO USE A NEW DRAPE, BUT THE ISSUE REMAINED. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) RECOMMENDED CHECKING THE PINS ON PSM #4. THE CUSTOMER CHECKED THE POGO PINS AND NOTICED ONE OF THE BLACK POGO PINS WAS PUSHED UP INTO THE ARM AND WAS NOT SPRINGING DOWN. AS A RESULT, THE CUSTOMER ELECTED TO CONVERT THE CASE USING A DA VINCI MULTI-PORT SYSTEM, REQUIRING PLACEMENT OF ADDITIONAL PORT INCISIONS. THE CUSTOMER STATED THE PATIENT TOLERATED THE CONVERSION AND THERE WAS NO HARM OR INJURY REPORTED. THE CUSTOMER STATED THERE WERE NO POST-OPERATIVE COMPLICATION, AND THE PATIENT IS HOME RECOVERING. THE PROCEDURE WAS COMPLETED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NEPHRECTOMY SURGICAL PROCEDURE, THE CUSTOMER REPORTED TO TECHNICAL SUPPORT ENGINEER (TSE) WHILE USING A SINGLE PORT (SP) SYSTEM, THAT THERE WAS A REPORTED ERROR ON PATIENT SIDE MANIPULATOR (PSM) 3. THE CUSTOMER REBOOTED THE SYSTEM TO RESOLVE THE ISSUE; HOWEVER, THE SURGEON PREFERRED TO CONVERT THE PROCEDURE WITH A DA VINCI MULTIPORT SYSTEM TO CONTINUE THE PROCEDURE. THE PROCEDURE WAS CONVERTED TO ANOTHER DV SYSTEM. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS EVENT: THE REPORTER CONFIRMED THAT THE PROBLEM OCCURRED DURING THE FIRST AND ONLY PROCEDURE PERFORMED WITH THE SP0459 SYSTEM. THE PROCEDURE WAS CONVERTED FROM SINGLE PORT TO A MULTI-PORT XI SYSTEM DUE TO THE SYSTEM ISSUE DURING THE PARTIAL NEPHRECTOMY.

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

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

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A PORTION OF THE CANNULA SEAL WAS IDENTIFIED INSIDE THE PATIENT. THE FOLLOWING INFORMATION IS UNKNOWN: THE EVENT DATE, IF THE FRAGMENT WAS RETRIEVED, AND THE PROCEDURE/PATIENT OUTCOME. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO GATHER ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT; HOWEVER, NO RESPONSE HAS BEEN RECEIVED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING AN UNSPECIFIED DA VINCI-ASSISTED SURGICAL PROCEDURE, A PORTION OF A UNIVERSAL SEAL FELL INSIDE THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED. THE FOLLOWING INFORMATION IS UNKNOWN: THE EVENT DATE, THE CAUSE OF THE CANNULA SEAL FRAGMENT FALLING INSIDE THE PATIENT, IF THE FRAGMENT WAS RETRIEVED, AND THE PROCEDURE OUTCOME. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO GATHER ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT; HOWEVER, NO RESPONSE HAS BEEN RECEIVED.

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 IN AN EXCELSIUS GPS SURGERY, IT WAS NOTICED THAT AFTER TAKING X-RAYS IN THE OR FOR THE PRE OP CT WORKFLOW AND DOING THE MERGE, THE PLANNED SCREWS WERE TOTALLY WRONG IN THE X-RAY. WE TOOK THEM OUT TO BE NOT HASSITATED. WHEN WE PLACED THE FIDUCIALS INTO THE LATERAL VIEW VERTEBRA, THE AP ONES WERE COMPLETELY OFF AND NEEDED TO BE PLACED IN THE CENTRE. THEN WE HAD AN ANATOMICAL SHIFT IN LATERAL VIEW. WE COULD NOT CHOOSE ALL THE DIFFERENT VIEWS LIKE STANDARD OR STANDARD OPTIMIZED OR L2 SEED AUTOMATICALLY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING AN UNSPECIFIED DA VINCI-ASSISTED PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY FELL INSIDE THE PATIENT UPON REMOVAL OF THE MCS INSTRUMENT FROM THE UNIVERSAL SURGICAL MANIPULATOR (USM). THE TIP COVER ACCESSORY WAS RETRIEVED USING A UNSPECIFIED GRASPER INSTRUMENT, DURING THE SAME PROCEDURE. A BACKUP MCS TIP COVER ACCESSORY WAS UTILIZED TO COMPLETE THE PROCEDURE. THE SURGERY WAS COMPLETED ROBOTICALLY AND A POST-OPERATIVE TEST LIKE AN X-RAY OR ULTRASOUND WAS NOT PERFORMED AS THE TIP COVER ACCESSORY IS NOT RADIOPAQUE.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CITATION: HTTP://DX.DOI.ORG/10.1590/S1808-185120262501303235. SUMMARY: OBJECTIVE: TO ANALYZE THE LIMITATIONS AND COMPLICATIONS OF USING A ROBOTIC SYSTEM IN SPINAL SURGERIES DURING THE LEARNING CURVE. METHODS: TO EVALUATE THE RESULTS OF THE APPLICATION OF 415 PEDICLE SCREWS IN 67 PATIENTS UNDERGOING SPINAL SURGERY IN WHICH THE ROBOTIC SYSTEM WAS USED. RECORDING TIME, FLUOROSCOPY TIME, INTRAOPERATIVE RADIATION DOSE, IMPLANT ACCURACY, ABANDONMENT OF THE ROBOTIC SYSTEM, PROBLEMS WITH THE SYSTEM PROGRAM, AND CLINICAL COMPLICATIONS WERE EVALUATED. RESULTS: DISCREPANT VALUES WERE OBSERVED IN RECORDING TIME IN 9 (13.43%) PATIENTS, IN FLUOROSCOPY TIME IN 3 (4.47%), AND IN INTRAOPERATIVE RADIATION DOSE IN 8 (11.94%). MALPOSITIONING (VERTEBRAL PEDICLE WALL RUPTURE > 2 MM) OCCURRED IN 3.5% OF THE IMPLANTS EVALUATED IN THE AXIAL PLANE AND 0.48% IN THE SAGITTAL PLANE. NO ABANDONMENT OF THE ROBOTIC SYSTEM WAS OBSERVED. NEUROLOGICAL DEFICIT WAS OBSERVED IN ONE PATIENT. CONCLUSIONS: THE ROBOTIC SYSTEM DEMONSTRATED EFFECTIVENESS AND PRECISION IN IMPLANT PLACEMENT, BUT SYSTEM LIMITATIONS WERE OBSERVED, MAINLY RELATED TO THE ACQUISITION OF GOOD-QUALITY IMAGES FOR SYSTEM REGISTRATION. LEVEL OF EVIDENCE

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 HYSTERECTOMY PROCEDURE. SIX DAYS AFTER SURGERY, A POSTOPERATIVE ILEUS, SECONDARY TO A TROCAR HERNIA, WAS IDENTIFIED WHICH REQUIRED SURGICAL INTERVENTION; IT WAS REPORTED AS RESOLVED THE NEXT DAY. THERE WAS NO ICU ADMISSION AND NO PROLONGED HOSPITALIZATION ATTRIBUTED TO THE EVENT. THE STUDY INVESTIGATOR REPORTED THE EVENT AS SEVERE, A SERIOUS ADVERSE EVENT (REQUIRING MEDICAL OR SURGICAL INTERVENTION), A CLAVIEN-DINDO GRADE III, NOT RELATED TO THE STUDY PROCEDURE, NOT RELATE TO A THIRD-PARTY DEVICE, BUT PROBABLY RELATED TO THE PATIENT'S UNDERLYING DISEASE STATUS, AND POSSIBLY RELATE TO THE DA VINCI INVESTIGATIONAL DEVICE.

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 ROBOT WOULD NOT START. IT TURNED ON, BUT THE SCREEN WAS BLACK. THIS HAPPENED TWICE. THE THIRD TIME IT STARTED WITHOUT ANY PROBLEMS. IT UNDOCKED ITSELF DURING THE OPERATION. WE DOCKED IT MANUALLY AND CONTINUED THE OPERATION. EVERYTHING WENT WELL. HOWEVER, AFTER THE INTRAOPERATIVE CT SCAN, 3 OUT OF 8 SCREWS WERE INCORRECTLY INSERTED. WE CLOSED THE CASE IN THE ROBOT AND STARTED A NEW ONE AS IF IT WERE A NEW OPERATION. WE DID A 3D SCAN AGAIN, PLANNED THE SCREWS AND INSERTED THEM. EVERYTHING WENT WELL AND AFTER THE CONTROL SCAN THE SCREWS WERE ALREADY INSERTED CORRECTLY. THE PATIENT DID NOT SUFFER ANY HARM.

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

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A L1-L5 OPEN TLIF, USING INTEROP WORKFLOW WITH E3D. WE PLACED L1 LEFT SCREW FIRST. THEN CHECKED ALL SCREWS WITH FLUORO AFTER THEY WERE ALL PLACED AND BOTH L1 SCREWS WERE SHIFTED TO THE LEFT. WE THEN WENT IN TO FIX THEM AND DID ANOTHER SPIN, AND IT WAS STILL OFF. WE ENDED UP PLACING BOTH TOP SCREWS FREEHAND WITHOUT NAVIGATION.

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 OBSERVED BLEEDING. THE CASE WAS COMPLETED; THE BLEEDING OCCURRED IN ASSOCIATION WITH A CRYOBIOPSY, AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). THE PATIENT WAS SUBSEQUENTLY DISCHARGED FROM THE HOSPITAL AND A DIAGNOSIS WAS ESTABLISHED. THE PHYSICIAN DID NOT ATTRIBUTE THIS EVENT TO THE MONARCH 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) PROTECTIVE SHEATH DOES NOT STAY ON THE SCISSORS. THE SHEATH ENDS UP INSIDE THE PATIENT'S ABDOMEN DURING THE PROCEDURE. THE DOCTOR TRIED A SECOND PROTECTIVE SHEATH FROM THE SAME BATCH AND THE SAME THING HAPPENED. 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.

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) PROTECTIVE SHEATH DOES NOT STAY ON THE SCISSORS. THE SHEATH ENDS UP INSIDE THE PATIENT'S ABDOMEN DURING THE PROCEDURE. THE DOCTOR TRIED A SECOND PROTECTIVE SHEATH FROM THE SAME BATCH AND THE SAME THING HAPPENED. 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.

the robot "experienced a rare hardware failure while crossing railroad tracks"

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 ASSISTED RADICAL EXTRAPERITONEAL WITH LYMPHADENECTOMY PROSTATECTOMY SURGICAL PROCEDURE, THE CUSTOMER TRIED 4-5 TIPS AND SHEATHS BUT THE CORD LIGHT ON THE EMBEDDED SERIALIZER FOR MASTER (ESM) WAS AMBER, AND THEY WERE RECEIVING A MESSAGE TO REMOVE THE TIP AND INSTALL A NEW SHEATH. PRIOR TO CALLING, THE CUSTOMER HAD REPLACED THE TIP AND INSTRUMENT ON THE MONOPOLAR CURVED SCISSORS (MCS) MULTIPLE TIMES AND TRIED FIVE DIFFERENT INSTRUMENTS, WITH NO CHANGE. THE CUSTOMER NOTED THAT THEY HAD USED THE INSTRUMENT IN DIFFERENT DRIVES, ALSO WITH NO CHANGE, BUT HAD NOT REPLACED THE CORD. THE TECHNICAL SUPPORT ENGINEER (TSE) SUGGESTED THEY REPLACE THE MONOPOLAR ENERGY CORD WHICH THE USER PERFORMED WITH NO CHANGE. THE USER THEN POWERED OFF THE ERBE GENERATOR AND ENERGY SHIELD MONITOR (ESM) AND THE SYSTEM FAULTED AND THE CALLER POWER CYCLED THE SYSTEM TO RESTORE ESM FUNCTIONALITY. THE TSE WALKED THE CALLER THROUGH RESEATING THE GROUND CONNECTOR AND GREEN MONOPOLAR CABLE CONNECTOR TO ANOTHER MONOPOLAR RECEPTACLE ON THE FRONT OF THE ERBE WITH NO CHANGE. THE CALLER THEN USED A 3RD MONOPOLAR GREEN/GRAY ENERGY CABLE FROM THE ESM TO THE INSTRUMENT WITH NO C

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 THYROIDECTOMY PROCEDURE, THE TIP OF THE HARMONIC ACE INSTRUMENT BROKE AND FELL INSIDE THE PATIENT. THE FRAGMENT TIP WAS RETRIEVED AND CONFIRMED WITH VISUAL INSPECTION DURING THE SAME SURGICAL PROCEDURE. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO RETRIEVE THE FRAGMENT. NO IMAGING WAS PERFORMED. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH A BACK-UP INSTRUMENT WITH LESS THAN 15 MINUTES OF DELAY. THERE WAS NO INJURY TO THE PATIENT. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO ANY POST-SURGICAL COMPLICATIONS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CYSTODUODENOSTOMY SURGICAL PROCEDURE, THE FRONT END OF THE HARMONIC ACE INSTRUMENT FRACTURED AND A FRAGMENT FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME SURGICAL 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.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT FOLLOWING A SEEG PROCEDURE, THE PATIENT DEVELOPED A HEMATOMA DUE TO INACCURATE ELECTRODE PLACEMENT. THE TEAM COMPLETED LASER REGISTRATION AND REPORTED GOOD ACCURACY DURING THE VERIFICATION STEP. THEY COMPLETED A POST-OP CT SCAN AND NOTICED THAT SEVERAL OF THE ENTRIES WERE 5+MM OFF FROM THE PLAN. THE SURGEON REPORTS THAT SEVERAL OF THE ELECTRODES ARE DEFLECTED IN THE BRAIN, BUT THIS IS DUE TO THE PATIENT¿S TUBEROUS SCLEROSIS. THE SURGEON¿S PRIMARY CONCERN IS THE INACCURACIES AT THE ENTRY POINTS. THE PATIENT IS STABLE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE BLADE ON THE HARMONIC ACE WAS BROKEN WHEN TESTED. A FRAGMENT FELL INTO THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED BEFORE USE, WITH NO DAMAGE DETECTED, AND WAS USED FOR LESS THAN HALF AN HOUR BEFORE A FRAGMENT FELL INSIDE THE PATIENT DURING TESTING. THE SURGEON BELIEVES THE BREAKAGE MAY BE RELATED TO QUALITY. FUNCTIONALITY ISSUES WERE NOTED, BUT NO COLLISION WITH OTHER INSTRUMENTS OR HARD MATERIALS OCCURRED. THE FRAGMENT FELL DURING AN INSTRUMENT TIP ACCESSORY COLLISION AND WAS RETRIEVED VISUALLY BY THE ASSISTANT USING FORCEPS; ALL FRAGMENTS WERE CONFIRMED RETRIEVED WITH NO NEED FOR ADDITIONAL SURGICAL INTERVENTION OR POSTOPERATIVE TESTS. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITHOUT PATIENT INJURY OR POST-SURGICAL COMPLICATIONS RELATED TO RETAINED FOREIGN OBJECTS. THE INSTRUMENT IS AVAILABLE FOR RETURN, BUT THE FRAGMENT WILL REMAIN AT THE HOSPITAL, AND NO PHOTOS OR VIDEOS WERE AVAILABLE FOR REVIEW.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL EXTRAPERITONEAL PROSTATECTOMY WITH LYMPHADENECTOMY PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY FELL INSIDE THE PATIENT. DURING THE CASE, WHILE THE SURGEON WAS DISSECTING AND CUTTING TISSUE, IT WAS OBSERVED THAT THE MCS TIP COVER ACCESSORY BEGAN TO SLIDE DOWN OVER THE TIP OF THE MCS INSTRUMENT. THE SURGEON ATTRIBUTED THE DETACHMENT OF THE MCS TIP COVER ACCESSORY TO POSSIBLY USING TOO MUCH LUBRICANT. UPON NOTICING THE ISSUE, THE SURGICAL TEAM ATTEMPTED TO REMOVE THE INSTRUMENT; HOWEVER, THE MCS TIP COVER ACCESSORY BECAME STUCK IN THE TROCAR. THE MCS TIP COVER ACCESSORY WAS THEN SUCCESSFULLY RETRIEVED WITH A GRASPER FROM THE TROCAR WITHOUT THE NEED FOR ANY ADDITIONAL SURGICAL PROCEDURE, SUCH AS LAPAROSCOPY OR AN OPEN SURGERY. THERE WAS NO INJURY TO THE PATIENT CAUSED BY THIS INTRAOPERATIVE EVENT, NOR WAS THERE A NEED FOR ANY POST-OPERATIVE DIAGNOSTIC IMAGING SUCH AS X-RAYS OR ULTRASOUNDS. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH THE USE OF A BACKUP MCS TIP COVER ACCESSORY AFTER THE INITIAL ONE WAS REMOVED. FOLLOWING THE SURGERY, THE PATIENT DID NOT RETURN TO THE HOSPITAL FOR ANY POST-SURGICAL COMPLICATI

Mazor system (model not stated) — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CITATION: HTTPS://DOI.ORG/10.1016/J.JOR.2026.01.009 SUMMARY: OBJECTIVES: TO EVALUATE THE CLINICAL, IMAGING, AND PERI-OPERATIVE RESULTS OF ROBOTIC-GUIDED CONVENTIONAL VERSUS ROBOT ASSISTED MINIMALLY INVASIVE TECHNIQUES FOR S2 ALAR-ILIAC (S2AI) SCREW PLACEMENTDURING SPINOPELVIC FIXATION. METHODS: A PROSPECTIVE COMPARATIVE STUDY COMPARING THE CLINICORADIOLOGICAL PARAMETERS OF PATIENTS UNDERGOING CONVENTIONAL ROBOTIC ASSISTED S2AI SCREW INSERTION AND THOSE WHO UNDERWENT ROBOTIC MINIMALLY INVASIVE PERCUTANEOUS SCREW INSERTION BETWEEN NOVEMBER 2023 AN D JUNE 2025 WAS DONE. DATA COLLECTED INCLUDED DEMOGRAPHICS, OPERATIVE TIME, INTRAOPERATIVE BLOOD LOSS, POSTOPERATIVE PAIN, HOSPITAL STAY, RADIOGRAPHIC ANGLES, RADIATION DOSE, SCREW ACCURACY, AND COMPLICATIONS. RESULTS: A TOTAL OF 102 PATIENTS UNDERWENT SPINOPELVIC FIXATION DURING THE STUDY PERIOD - 56 PATIENTS (116 SCREWS) UNDERWENT CONVENTIONAL ROBOTIC ASSISTED S2AI SCREW INSERTION AND 46 PATIENTS (92 SCREWS) UNDERWENT ROBOT ASSISTED PERCUTANEOUS S2AI SCREW INSERTION. BOTH GROUPS SHOWED ACCURATE SCREW PLACEMENT WITHOUT ANY INTRAOPERATIVE ADVERSE EVENTS. THE ROBOT ASSISTED PERCUTANEOUS GROUP HAD MARKEDLY REDUCED POSTOPERATIVE VAS SCORES (3.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AURON, M., BARKAY, G., EINAV, O., LANIADO, D., WEIL, Y., SCHROEDER, J. E. (2026). ROBOTIC-ASSISTED VERSUS FLUOROSCOPY-GUIDED SACROILIAC SCREW FIXATION: A RETROSPECTIVE COMPARATIVE STUDY. INJURY, 57(3), 113019. HTTPS://DOI.ORG/10.1016/J.INJURY.2026.113019 BACKGROUND: PERCUTANEOUS SACROILIAC (SI) SCREW FIXATION IS A WIDELY USED TECHNIQUE FOR STABILIZING SACRAL FRACTURES BUT IS CONSIDERED TECHNICALLY DEMANDING DUE TO COMPLEX PELVIC ANATOMY AND PROXIMITY TO NEUROVASCULAR STRUCTURES. CONVENTIONAL FLUOROSCOPY-GUIDED METHODS ARE ASSOCIATED WITH A RELATIVELY HIGH RISK OF SCREW MISPLACEMENT AND CONSIDERABLE RADIATION EXPOSURE TO PATIENTS AND STAFF. ROBOTIC-ASSISTED NAVIGATION SYSTEMS HAVE BEEN INTRODUCED TO ENHANCE SCREW ACCURACY AND REDUCE RADIATION EXPOSURE. THE AIM OF THIS STUDY WAS TO ASSESS THE EFFICIENCY, SAFETY, AND ACCURACY OF SACROILIAC SCREW FIXATION USING A ROBOT-ASSISTED METHOD COMPARED WITH A CONVENTIONAL FREEHAND TECHNIQUE. METHODS: MEDICAL RECORDS OF PATIENTS TREATED WITH SACROILIAC SCREW FIXATION FOR SACRAL FRACTURES AT A SINGLE LEVEL 1 TRAUMA CENTER BETWEEN DECEMBER 2014 AND AUGUST 2025 WERE RETROSPECTIVELY ANALYZED. PATIENTS WERE DIVIDED INTO ROBOTIC-ASSISTED AND FREEHAND