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. IT WAS REPORTED THAT THERE WAS A DEVIATION. DURING THE CASE, TWO DIFFERENT REGISTRATIONS WERE TAKEN FOR C7-L1 TO T3-T6. THE SURGEON FINISHED INSERTING ALL THE SCREW ON THE LEFT SIDE OF THE PATIENT, WHEN MOVING TO THE RIGHT AT T4, WHEN USING THE MIDAS DRILL, THE PATIENT SPINAL CORD WAS KNICKED, RESULTING IN LOSS OF MOTOR ON THE RIGHT SIDE OF THE PATIENT. THE MANUFACTURER REPRESENTATIVE NOTED THAT DURING PLANNING, THE SCREW WAS PLANNED A BIT LATERAL TO THE PEDICLE, WHICH COULD CONTRIBUTE TO THE SITUATION. THE SURGEON ENDED UP REMOVING ALL SCREWS AND CLOSE THE PATIENT UP FOR MRI. THE PATIENT WAS AFFECTED. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE TRAJECTORIES WERE DEVIATED ABOUT 3.5MM MEDIALLY. THE SURGERY HAS NOT BEEN RESCHEDULED AS OF YET. THE SITE IS CURRENTLY MONITORING THE PATIENT¿S MOTOR FUNCTION AND WILL RESCHEDULE ONCE EVERYTHING IS BACK TO BASELINE.

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 SIGMOID COLECTOMY SURGICAL PROCEDURE, A PIECE OF THE CANNULA SEAL FELL INTO THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING LAST SCREW PLACEMENT (L5R) THE HIGH SPEED DRILL, PILOT DRILL AND THE TAP WERE NAVIGATED ACCURATELY, BUT SCREW WAS NOT. THE SCREW WAS PUT SLIGHTLY IN FORAMEN, IT WAS FOUND IN THE X-RAY VERIFICATION SHOT. SCREW WAS IMMEDIATELY REMOVED AND RE-PLANNED AND AGAIN - HIGH SPEED DRILL, PILOT DRILL AND TAP WERE NAVIGATED ACCURATELY, BUT DURING SCREW PLACEMENT THE DOCTOR SAW AND FELT THAT THE SCREW JUMPED INTO OLD CANAL. ONCE MORE SCREW WAS IMMEDIATELY REMOVED AND RE-PLANNED AND AGAIN HIGH SPEED DRILL, PILOT DRILL AND TAP WERE NAVIGATED ACCURATELY, BUT SCREW WAS PUT WITHOUT ROBOT/NAVIGATION WITH STANDARD SCREWDRIVER AND UNDER X-RAY CONTROL. AFTER DISCUSSION WITH THE REP HE COULDN'T CONFIRM THAT THE OFFSET TURNED TO RED WHEN SCREWDRIVER WAS IN EE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED VENTRAL HERNIA SURGICAL PROCEDURE, THE CUSTOMER STATED THAT THE CAUTERY WAS NOT WORKING, AND A QUESTION MARK WAS DISPLAYED ON THE INTEGRATED ELECTROSURGICAL UNIT (IESU/ERBE) FRONT PANEL, INDICATING THAT THE ERBE COULD NOT DETERMINE WHICH UNIVERSAL SURGICAL MANIPULATOR (USM) THE INSTRUMENT WAS ENGAGED ON. THE CUSTOMER HAD REPLACED THE CORDS AND EXHAUSTED THEIR SUPPLY. THE CUSTOMER TRIED DIFFERENT CAUTERY INSTRUMENTS, STILL THE ISSUE PERSISTED. THE CUSTOMER POWER CYCLED THE SYSTEM AND REMOVED AC POWER FROM THE ERBE AND THE ISSUE PERSISTED. THE SYMPTOMS INDICATED BAD ENERGY CORD(S) OR BAD ENERGY CONNECTORS ON THE ERBE. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY WITH NO REPORTS OF PATIENT INJURY. AN 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.

CyberKnife — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: SIDE EFFECT - ANESTHESIA DELAROSA (AD).

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE ROBOT SEEMED TO BE MORE SENSITIVE THEN USUAL AND A SCREW ACTUALLY SEEMED TO MISS LATERALLY. TO HELP WITH EXAMINING WHAT WENT WRONG, THE DIFFICULTIES WE HAD PERSISTED ON THE PATIENTS RIGHT SIDE. THE PA SEEMED TO THINK THE TRAJECTORY LOOKED PERFECT UNTIL IT CAME TIME FOR THE DRIVER ARRAY TO PASS DOWN THE END EFFECTOR, THEN SHOWING A SUDDEN CHANGE IN TRAJECTORY. I AM UNSURE IF AN ISSUE COULD BE RELATED TO TECHNIQUE OR NOT. WE HAVE SINCE USED THE ROBOT THIS WEEK AND DID NOT SEEM TO HAVE ISSUES.

Senhance — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE EVENT OCCURRED OUTSIDE THE UNITED STATES. THE EVENT OCCURRED ON (B)(6) 2022, INTERNALLY MADE AWARE ON (B)(6) 2023. THE PATIENT EXPERIENCED SUTURE FAILURE WHICH REQUIRED INTERVENTION FOR TREATMENT (RESOLVED ON (B)(6) 2022). INTERVENTION INCLUDED, RELAPAROSCOPY, COLONOSCOPY, AND ENDOVAC THERAPY. IT WAS REPORTED THAT THE CAUSALITY TO THE SENHANCE SURGICAL SYSTEM WAS POSSIBLE.

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 PROSTATECTOMY WITH LYMPHADENECTOMY PROCEDURE, THE MONOPOLAR CURVED SCISSOR (MCS) TIP COVER ACCESSORY CAME LOOSE WHEN REMOVING THE MCS INSTRUMENT AND FELL INSIDE THE PATIENT'S ABDOMEN. AT THE TIME THE EVENT OCCURRED, THE SURGICAL STAFF WAS IN THE PROCESS OF EXCHANGING THE MCS INSTRUMENT WITH A LARGE NEEDLE DRIVER INSTRUMENT. THERE WAS NO DIFFICULTY FELT WHILE REMOVING THE MCS INSTRUMENT. AFTER THE EVENT OCCURRED, THE MCS INSTRUMENT REMAINED OUTSIDE THE PATIENT FOR THE REMAINDER OF THE PROCEDURE AND WAS NO LONGER USED DURING THE PROCEDURE. PER THE SURGEON, THE MCS TIP COVER ACCESSORY LIKELY CAME LOOSE DURING THE INSTRUMENT CHANGE. THE MSC TIP COVER ACCESSORY APPEARED TO HAVE BEEN PROPERLY INSTALLED DURING THE SURGICAL PROCEDURE WITH NO PART OF THE ORANGE SURFACE VISIBLE AFTER INSTALLATION NOR WAS IT INSTALLED BEYOND THE ORANGE SURFACE. THE INSTALLATION TOOL HAD BEEN USED; ELECTROLUBE OR ANY OTHER LUBRICANT HAD NOT BEEN APPLIED PRIOR TO INSTALLATION OF THE MCS TIP COVER ACCESSORY. THE MCS INSTRUMENT AND MCS TIP COVER ACCESSORY HAD BEEN INSPECTED PRIOR TO USE. THE SURGEON DID NOT NOTICE ISSUES WITH THE FUNCTIONALITY OF THE MCS INS

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THIS EVENT OCCURRED IN AN INTRA-OP T10-PELVIS REVISION CASE. EXISTING HARDWARE WAS PRESENT FROM L3-S1. AFTER ALL STEPS OF THE INTRA-OP WORKFLOW HAD BEEN COMPLETED, A THOROUGH AND DETAILED ANATOMY CHECK WAS DONE. THE SURGEON AND HIS FELLOW ADJUSTED ALL SCREWS THAT HAD BEEN PRELIMINARILY PLANED. AFTER THE SURGEONS MODIFIED, REVIEWED, AND APPROVED ALL SCREWS; THE ROBOT WAS PUSHED INTO THE CORRECT POSITION. SCREWS WERE PLACED T10-L2 ON THE LEFT PRIOR TO PLACING SCREWS T10-L2 ON THE RIGHT (SURGEON PREFERENCE). S2AI SCREWS WERE PLACED LAST. ACCURACY CHECKS WERE CONDUCTED THROUGHOUT THE SCREW PLACEMENT PROCESS A SPIN WAS CONDUCTED AFTER ALL SCREWS WERE PLACED. THE LEFT T10 SCREW APPEARED TO BREACH THE MEDIAL WALL OF THE PEDICLE AND THE SCREW APPEARED SLIGHTLY MEDIAL TO THE PLAN. THE EXTENT OF THE BREACH COULD NOT BE DETERMINED DUE TO THE SCAN QUALITY (VERY POOR DUE TO THE PATIENT SIZE AND METAL SCATTER). THE SURGEON CAREFULLY REVIEWED THE SCREW AND NEURO MONITORING DATA BEFORE DECIDING TO LEAVE IT IN PLACE. THE LEFT T10 PEDICLE WAS SMALL, AND THE SURGEON SELECTED A SCREW DIAMETER THAT WAS CLINICALLY APPROPRIATE AND HIM EFFECTIVE FIXATION. THE SURGEON FELT IT WAS POSSIBLE THAT THE 4.5 HIGH

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 THERE WAS A VIBRATING ROBOTIC ARM WITH HIGHLY INACCURATE TRAJECTORIES (2CM FROM TARGET). MULTIPLE ISSUES NOTED BY SURGEON, SURGERY WAS CANCELLED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

Robot Lifestyle — Lime green robotic lawn mower, without specific markings. Product sold online, in particular via AliExpress. Hazard (Cuts): The product's lift and tilt sensors may not activate, and the mower may thus tilt and expose the blades or continue to operate, exposing any bystander to a risk of cuts. Furthermore, the mower can drive onto the foot of a child without stopping the blades, and cause injuries. The product does not comply with the requirements of the Machinery directive nor with the Europe...

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 MONARCH BRONCHOSCOPY PROCEDURE THE PATIENT SUSTAINED A PNEUMOTHORAX. RIGHT UPPER-LOBE, GROUND-GLASS OPACIFICATION WITH SOME SOLID AREA. AN ARCPOINT NEEDLE AND AN AURIS CYTOLOGY BRUSH WERE USED DURING THIS PROCEDURE BUT WERE DISPOSED OF AFTERWARDS, THE LOT NUMBER WAS NOT RECORDED. PATIENT RECEIVED A SMALL-BORE TUBE, A POST-PLACEMENT X-RAY, WITH NO PLEURAL VACUUM NEEDED. THE PATIENT WAS DISCHARGED THE NEXT DAY.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING L3-L4 SPL CASE, C-ARM IMAGES WERE MIRRORED AFTER THE MERGE. BEFORE THE MERGE, EVERYTHING WENT NORMALLY: IMAGES WERE TRANSFERRED NORMALLY, CENTROIDS WERE PLACED BUT AFTER MERGING C-ARM SHOTS WERE REVERSED. RE-IMAGING THE PATIENT, RESETTING SOFTWARE, RESTARTING C-ARM, RESTARTING EGPS, CREATING NEW CASE DID NOT SOLVE THE PROBLEM. ALSO DURING PANNING PHASE, THE ANTERIOR PART OF THE CAGE NEEDED TO BE PLANNED POSTERIORLY TO GET LEFT SIDE ACCESS. PROCEDURE WAS PERFORMED THE OLD FASHION WAY.

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 PROCEDURE USING THE EXCELSIUS GPS SYSTEM, A PEDICLE PROBE WAS PLACED AND A MEDIAL BREACH WITH CEREBROSPINAL FLUID LEAK WAS OBSERVED AND FIXED INTRAOPERATIVELY.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER A MONARCH BRONCHOSCOPY PROCEDURE ON (B)(6) 2022, THE PATIENT RETURNED TO THE EMERGENCY ROOM (ER) ON (B)(6) 2022, EXPERIENCING SHORTNESS OF BREATH. A CHEST TUBE WAS PLACED AND THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE PHYSICIAN WHO PERFORMED THE BRONCHOSCOPY DOES NOT ATTRIBUTE THIS EVENT TO THE MONARCH SYSTEM, STATING IT WAS A RESULT OF THE NEEDLE BEING DEPLOYED INTO THE EDGE OF THE PLEURA. THE PATIENT DID NOT EXPERIENCE ANY OTHER ISSUES OTHER THAN SHORTNESS OF BREATH. THE CHEST TUBE WAS REMOVED ON (B)(6) 2022, A X-RAY WAS PERFORMED, AND THE PATIENT WAS DISCHARGED. THERE WAS NO EVIDENCE THAT THE MONARCH SYSTEM DID NOT PERFORM AS INTENDED.

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 EXPERIENCED ADVERSE EFFECTS FOLLOWING SURGERY WHERE A SCREW USING THE EXCELSIUS GPS SYSTEM WAS MISPLACED INTRA-OPERATIVELY CAUSING A LEFT MEDIAL BREACH.

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 H10/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 ANTERIOR RESECTION SURGICAL PROCEDURE, THE CUSTOMER REPORTED THAT THE VISION WAS LOST. THEY ATTEMPTED TO RECONNECT THE CAMERA TO THE ENDOSCOPE CONTROLLER (EC), BUT THE CAMERA HAD A SELF-TEST FAILURE, AND THE COLOR BAR WAS DISPLAYED. THEY REPLACED THE CAMERA WITH A BACKUP ONE, BUT ALL THE AVAILABLE CAMERAS HAD THE SAME SYMPTOM. LASTLY, THEY REBOOTED THE SYSTEM AND CLEANED THE CAMERA CONNECTOR; HOWEVER, THE ISSUE PERSISTED. THE CUSTOMER ELECTED TO CONVERT TO LAPAROSCOPIC PROCEDURE. NO KNOWN IMPACT OR PATIENT CONSEQUENCE REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP ON 19-OCT-2022 AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CAMERAS WERE INSPECTED PRIOR TO USE WITH NO ABNORMALITY. DURING THE PROCEDURE, THE VISION LOSS OCCURRED ON BOTH OF THE SURGEON SIDE CONSOLE (SSC) AND VISION SIDE CART (VSC). INFORMATION REGARDING PATIENT DEMOGRAPHICS, RELEVANT TESTING, AND MEDICAL HISTORY WERE REQUESTED; HOWEVER, THE REPORTER WAS NOT ABLE TO PROVIDE THAT 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 DURING A DA VINCI-ASSISTED PROCEDURE THAT ARM 3 OF THE SINGLE PORT (SP) SYSTEM ENCOUNTERED INSTRUMENT ENGAGEMENT ISSUES. THE OR STAFF STATED THEY UNDOCKED THE ARM AND RE-DRAPED BEFORE CALLING. THEY HAD ALSO POWER CYCLED AND TRIED MORE THAN ONE INSTRUMENT ON ARM 3, BUT ISSUES PERSISTED. THE PATIENT WAS ON THE TABLE, UNDER ANESTHESIA, AND PORTS HAD BEEN PLACED AT THE TIME. THE TSE REVIEWED THE LIVE LOGS AND FOUND ERRORS 23300 AND 31009. THE TSE INFORMED THE OR STAFF THAT ALL TROUBLESHOOTING STEPS HAD BEEN PERFORMED AND ARM 3 NEEDS SERVICE. IT WAS CONFIRMED FOLLOWING A FOLLOW-UP CALL THAT THE SURGEON CONVERTED TO AN XI MULTIPORT SYSTEM. THERE WAS NO REPORT OF PATIENT INJURY. AN ATTEMPT HAS BEEN MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER CONCERNING THE REPORTED EVENT WITH NO SUCCESS.

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 AFTER A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE SCRUB COUNT WAS OFF, AND THE CUSTOMER WAS MISSING A MONOPOLAR CURVED SCISSORS (MCS) TIP COVER. THE CUSTOMER LOCATED THE MCS TIP COVER INSIDE OF THE PATIENT AND REMOVED IT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE ON (B)(6) 2022 AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER STATED THAT THE ISSUE WAS IDENTIFIED WHILE CLOSING THE PATIENT. THE MCS INSTRUMENT AND TIP COVER WERE INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE MCS TIP COVER WAS RETRIEVED BY GOING BACK IN THE ABDOMEN. ALL FRAGMENTS WERE RETRIEVED, AND THIS WAS CONFIRMED THROUGH INSPECTION OF THE MCS TIP COVER. THE CASE WAS EXTENDED FOR A FEW MINUTES DUE TO THE ISSUE. IT WAS UNKNOWN WHAT TASK WAS PERFORMED WHEN THE MCS TIP COVER FELL INTO THE PATIENT. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE MCS INSTRUMENT DURING THE PROCEDURE. THE MCS INSTRUMENT DID NOT COLLIDE WITH ANOTHER INSTRUMENT. A REDUCER WAS NOT USED. THERE WAS NO DIFFICULTY REMOVING THE MCS INSTRUMENT. THE MCS INSTRUMENT WRIST WAS STRAIGHTENED UPON REMOVAL. NO D

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING NAVIGATION, WHILE MOVING TO TRAJECTORY FOR OUR L5 R AND S1 R SCREWS THE AXIAL SLICE WAS UNRECOGNIZABLE (COULD NOT MAKE OUT ANY PEDICLE, VERTEBRAL BODY, S.P). WE CHECK OUR LEFT SIDED SCREWS TRAJECTORY, AND EVERYTHING LOOKED PERFECT. I WENT BACK TO THE PLANNING PAGE TO CHECK OUR RIGHT SIDED SCREWS AXIAL IMAGES AND AGAIN, EVERYTHING LOOKED PERFECT. THOUGH, WHILE BRINGING INSTRUMENTS IN THE EE ALL INSTRUMENT TRACKED CORRECTLY DOWN PLANNED SCREW TRAJECTORY EVEN THOUGH IT DID NOT VISIBLY LOOK LIKE A CORRECT AXIAL SLICE (ANATOMY UNRECOGNIZABLE). AFTER A FEW SOFTWARE RESETS AND A HARD SHUT DOWN, AND SWITCHING EES I INFORMED DR. GENTRY IT WAS JUST THE SLICE OF THE SCAN WE WERE IN, AND I BELIEVED EVERYTHING WAS SAFE. WHEN ADDING LAYERS TO OUR AXIAL CUT THE IMAGE WAS IMPROVING (COULD MAKE OUT DISTINCT ANATOMY) BUT DOC STILL DID NOT TRUST IT. ADJUSTING THE PLAN HAD LITTLE TO NO EFFECT AS WELL. HE WOULD NOT MAKE AN INCISION TO CHECK TRAJECTORY OF INSTRUMENTS UNDER FLOURO AND BAILED ON THE ROBOT.

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 LITERATURE ARTICLE DESCRIBED A CASE STUDY OF A 73-YEAR-OLD FEMALE PATIENT WHO UNDERWENT A DA VINCI-ASSISTED ROBOTIC POSTERIOR MEDIASTINAL MASS RESECTION ON THE LEFT CHEST. A CHEST DRAINAGE TUBE WAS PLACED. MAGNETIC RESONANCE IMAGING (MRI) OF THE THORACIC SPINE SHOWED A POST-OPERATIVE ABNORMAL SIGNAL AND A LEFT PARAMASS OF THE 10TH THORAX VERTEBRAE. CEREBROSPINAL FLUID LEAKAGE OCCURRED AFTER SURGERY DUE TO THE CLOSE RELATIONSHIP BETWEEN THE MEDIASTINAL MASS AND THE INTERVERTEBRAL FORAMINA, RESULTING IN A DURAL TEAR. BEDREST WAS ORDERED. MRIS WERE REPEATED AT ONE AND TWO WEEKS AFTER THE SURGERY. THE ABNORMAL SIGNAL WAS SMALLER THAN BEFORE. THE CHEST DRAIN WAS REMOVED, AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL 15 DAYS AFTER SURGERY. THE PATIENT REMAINED ON BEDREST FOR TWO WEEKS AFTER DISCHARGE. THE EVENT WAS REPORTED AS CURED AFTER THREE WEEKS OF BEDRIDDEN TREATMENT. THERE WERE NO DA VINCI DEVICE MALFUNCTIONS REPORTED.

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 AFTER AN L2/L3 INTERBODY INSERTION, DURING A L2/-L4 SCREW REVISION AND TLIF SPINAL FUSION, THE SURGEON USED THE GUIDANCE SYSTEM TO INSERT THE FIRST SCREW AT L2 ON THE LEFT. THE PROCEDURE WENT FINE. THE SURGEON THEN USED THE GUIDANCE SYSTEM AGAIN TO PLACE ANOTHER SCREW ON THE RIGHT L2 (SURGEON WAS ON THE PATIENT'S LEFT, DEVIATING FROM STANDARD SITE'S PROCESS), THE PATIENT BUCKED DURING INSERTION. THE SURGEON WAS INFORMED THAT THE PATIENT BUCKED AND DECIDED TO CONTINUE WITH THE CASE. POST-OPERATIVELY THE PATIENT'S RIGHT FOOT HAD SOME SENSATION AND WAS UNABLE TO MOVE. THE SURGEON THEN WENT INTO THE OPERATING ROOM TO REMOVE THE RIGHT L2 SCREW, BUT THE PATIENT'S RIGHT FOOT WAS STILL UNABLE TO MOVE. A POST-OP CT WAS COMPLETED AND REVEALED THAT L2 SCREW WAS MEDIAL.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CHECKED THE SYSTEM AFTER REPLACING THE FUSES AND FOUND THAT THE POWER IS BACK ON THE SYSTEM WITH POWER AND BATTERY LED INDICATOR ON THE CONTROL PANEL. SYSTEM'S FANS WERE ALSO RUNNING BUT THERE WAS NO DISPLAY ON THE MONITOR. LED ON THE MONITOR IS RED. I.E. NO VIDEO SIGNALS FROM COMPUTER. 2. CONNECTED AN EXTERNAL HDMI CABLE FROM PC TO MONITOR DIRECTLY BUT STILL NO VIDEO SIGNAL ON MONITOR. 3. CONNECTED EXTERNAL MONITOR ON THE PC DIRECTLY AND NO DISPLAY ON THE EXTERNAL MONITOR TOO. 4. CHECKED THE VOLTAGE ON PC POWER SUPPLY AND IT WAS 54 VOLT DC. 5. PC FAN WAS ALSO RUNNING. 6. IT HAS BEEN OBSERVED THAT THE PC IS NOT BOOTING UP SO THERE IS NO DISPLAY ON THE MONITOR. KINDLY SUGGEST FURTHER.

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 THE SYSTEM APPEARED TO REGISTER BUT ACCURACY SEEMED TO BE OFF SIGNIFICANTLY RESULTING IN MISPLACED SCREWS. AT THE TIME OF THE COMPLAINT COMING IN, THE CONFIRMATION SPIN HAD NOT YET BEEN TAKEN, SO EXACT DETAILS OF PLACEMENT WERE NOT YET KNOWN, LIKELY MEDIAL ON THE LEFT AND LATERAL ON THE RIGHT. THE PROCEDURE WAS ON L4-L5, PLACED RIGHT FIRST THEN LEFT, USING CT TO FLUORO WORKFLOW. THERE WAS NO DELAY AND NO IMPACT ON THE PATIENT OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT IT WAS ASSUMED THAT THE TRAJECTORIES WERE OFF GREATER THAN10MM BECAUSE TWO WERE NOT IN BONE. THE SCREWS WERE REMOVED PRIOR TO THE CONFIRMATION SPIN. TWO OF THESE SCREWS PATHWAYS WERE NOT ABLE TO BE LOCATED. NO SCREWS WERE REPLACED AT THE TIME OF THE CASE. THE CASE WAS NOT COMPLETED. THE SCREWS WERE TAKEN OUT AND THE CASE WAS ABORTED. THERE HAS BEEN NO NOTIFICATION ON RESCHEDULING THE CASE.

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 A PATIENT UNDERWENT A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE ON AN UNSPECIFIED DATE AND DIED FROM CANCER IN 2016. ACCORDING TO THE INITIAL REPORTER, THE PATIENT'S TREATMENT WAS NEGATIVELY AFFECTED BY THE DA VINCI-ASSISTED SURGERY. THE INITIAL REPORTER INDICATED THAT THE PATIENT UNDERWENT THE HYSTERECTOMY FOR CANCER THAT REOCCURRED FOR A SECOND TIME. PER THE INITIAL REPORTER, IT IS BELIEVED THAT THE ROBOTIC PROCEDURE "STIRRED UP THE CANCER" AND EXPEDITED HER DEATH BY SPREADING. THE PATIENT REPORTEDLY DIED WITHIN SIX MONTHS OF THE SURGERY. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. 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: A REVIEW OF AN ARTICLE WAS PERFORMED THAT EVALUATED THE CASE OF A PATIENT THAT SUSTAINED AN AORTIC INJURY DURING A DA VINCI-ASSISTED RETROPERITONEAL LYMPHADENECTOMY PROCEDURE. THE CAUSE OF THE AORTIC INJURY IS UNKNOWN. REPAIR OF THE COMPLICATION COULD NOT BE PERFORMED LAPAROSCOPICALLY; HOWEVER, GRASPER INSTRUMENTS WERE USED TO MAINTAIN HEMOSTASIS WHILE A CONVERSION TO OPEN SURGERY WAS INITIATED. SAFETY MECHANISMS LOCKED THE GRASPERS IN PLACE, PREVENTING TISSUE RELEASE, BUT RESULTING IN ADDITIONAL AORTIC INJURY. FORCEFUL REMOVAL OF THE GRASPERS WAS EVENTUALLY SUCCESSFUL, AND DEFINITIVE AORTIC REPAIR WAS THEN PERFORMED. THE PATIENT REPORTEDLY DID WELL POST-OPERATIVELY AND WAS DISCHARGED HOME. THE ARTICLE NOTES: "PATHOLOGIC EXAMINATION REVEALED A MALIGNANT MIXED MÜLLERIAN TUMOR OF THE ENDOMETRIUM WITH LYMPH NODE METASTASIS. ONE YEAR LATER, SHE HAD COMPLETED CHEMOTHERAPY, WAS LIVING INDEPENDENTLY, AND WAS IN REMISSION. SHE HAD NO ABDOMINAL COMPLAINTS OR CLAUDICATION. SURVEILLANCE AXIAL IMAGING DID DEMONSTRATE A 35% REDUCTION IN VESSEL DIAMETER AT THE SITE OF REPAIR." MULTIPLE ATTEMPTS TO CONTACT AUTHOR AND REPORTER WERE MADE, NO RESPONSE WITH ADDITIONAL INFORMATION.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A PROCEDURE. IT WAS REPORTED THAT THE ARM SEEMED TO SHIFT AFTER THE SITE DRILLED, TAPPED, AND TOOK THE CANNULA OUT. THE ARM LOOKED LIKE IT SHIFTED BY ABOUT 5 MM. WHEN THE SCREW WAS BEING PLACED, IT LOOKED LIKE IT WAS NOT FOLLOWING THE SAME TRACK AND WAS NOT FOLLOWING THE SAME HOLE. THE FIRST SCREW LOOKED MEDIAL ON CONFIRMATION SHOTS. THE SHIFT WAS DURING THE LEFT S1 SCREW PLACEMENT. THE MANUFACTURER REPRESENTATIVE AND HEALTHCARE PROFESSIONALS CAME TO A CONCLUSION THAT THE CANNULA WAS RESTING ON THE L5 SCREW HEAD CAUSING THE ARM TO BE DEVIATED WHEN PLACING THE CANNULA. WHEN THE CANNULA WAS REMOVED THE ARM SHIFTED, AND THE SCREW WAS NOT FALLING INTO THE DRILLED HOLE. THE SURGERY WAS ABORTED AND RESCHEDULED. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS DELAYED LESS THAN ONE HOUR.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE CLINICAL SALES REPRESENTATIVE (CSR) CALLED AN INTUITIVE SURGICAL INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT THAT THE CANNULA KEPT SLIPPING OUT AND THE SURGEON HAD TO CONVERT TO OPEN SURGERY. THE PATIENT STAYED IN THE HOSPITAL AN EXTRA COUPLE OF DAYS BECAUSE OF THE OPEN SURGERY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. 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.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: FAILED MERGE OF L4 DURING AN L4-L5 SINGLE POSITION LATERAL. PATIENT WAS POSITIONED LEFT SIDE UP AND THE BED WAS BROKEN SLIGHTLY PRIOR TO DRAPING THE PATIENT. IMAGES WERE ACQUIRED FOR THE MERGE. WE WERE ABLE TO GET A GOOD/APPROVABLE MERGE FOR L5 ON THE FIRST ATTEMPT. DESPITE MULTIPLE ATTEMPTS AND EXTENSIVE TROUBLESHOOTING, WE WERE NOT ABLE TO GET A GOOD/APPROVABLE MERGE FOR L4. THE AP VIEW CONSISTENTLY HAD MORE SHIFT THEN IN THE LATERAL AT L4.

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 REVISION SURGERY WAS NEEDED TO REMOVE AND REPLACE MISPLACED SCREWS THAT WERE PLACED USING THE EXCELSIUS GPS SYSTEM. THIS EVENT OCCURED IN BELGIUM.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CENTROIDS WERE PLACED IN THE CENTER OF THE BODIES WITH THE SURGEON'S GUIDANCE. THE MERGE AT ALL LEVELS SHOWED A LARGE SHIFT OF THE VERTEBRAL BODIES IN THE AP VIEW. THE DRR FILE WAS NOTICEABLY A FEW CM TO THE RIGHT OF THE X-RAY ALL LEVELS. SOME TROUBLESHOOTING WAS PERFORMED, BUT THE ISSUE WAS NOT RESOLVED. THE SURGEON DECIDED TO PLACE CAGES WITHOUT NAVIGATION.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CASE L5-S2AI. THERE WAS BIG SHIFT AT S1, WE CONTINUED TO TAKE NEW PICTURES AND THERE CONTINUED TO BE A LARGE SHIFT AT S1, S2. WE HAD TO DO ANOTHER HARD SHUTDOWN. WE TOOK NEW PICTURES AND THERE IS STILL A BIG SHIFT AT S1, S2.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF AN UROLOGY JOURNAL ARTICLE TITLED, ¿SINGLE PORT VS MULTIPORT ROBOTIC PYELOPLASTY: PROPENSITY-SCORE MATCHED ANALYSIS OF PERIOPERATIVE AND FOLLOW-UP OUTCOMES¿ (HARRISON, R., AHMED, M., ET AL., 2022). WITHIN THE JOURNAL ARTICLE, OPERATIVE COMPLICATIONS INVOLVING SINGLE-PORT (SP) ROBOTIC-ASSISTED PYELOPLASTY (RAP) PROCEDURES WERE NOTED. IN THE ARTICLE, THE FOLLOWING IS NOTED: ¿AN INTRAOPERATIVE COMPLICATION OCCURRED DURING ONE SP-RAP CASE. WHILE INCISING THE PERITONEUM TO ACCESS THE ABDOMINAL CAVITY, A SMALL ENTEROTOMY WAS NOTED IN A PORTION OF THE SMALL BOWEL THAT WAS ADHERENT TO THE PERITONEUM IN A PATIENT WITH PRIOR ABDOMINAL SURGERY. THE INJURED AREA WAS REPAIRED IN TWO LAYERS, USING 3-0 VICRYL FOR THE MUCOSA, AND 3-0 SILK FOR THE SEROSA IN A LEMBERT FASHION.¿ ADDITIONALLY, IT IS DOCUMENTED: ¿ONE SP-RAP PATIENT UNDERWENT SURGICAL DEBRIDEMENT FOR A POORLY HEALING, LEFT LOWER ABDOMINAL QUADRANT WOUND (CLAVIEN CLASS IIIB)." INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE AUTHOR. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING THE CASE, A MERGE COULD NOT BE OBTAINED. TRIED TO GET IT AFTER THE CASE BUT IT DID NOT WORK.

Mazor X — Death 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 MULTIPLE CONTROLLER ERROR MESSAGES WERE OBSERVED. "ERROR 3489 NO CONNECTION DUE TO CONTROLLER ERROR" APPEARED RIGHT AFTER THE SYSTEM WAS MOUNTED TO THE BED. A SOFT REBOOT DID NOT CLEAR THE ISSUE, AND A SEPARATE ERROR POPPED UP STATING "CONTROL ISSUE ENCOUNTERS SHUT DOWN WORKSTATION AND TURN ON AGAIN". THE MANUFACTURER REPRESENTATIVE HAD TO THEN REDO THE SET-UP STEPS TO CONTINUE WITH CASE. HALFWAY THROUGH THE CASE THE ERROR ISSUE HAPPENED AGAIN WHILE MOUNTED TO THE PATIENT, SO THE MANUFACTURER REPRESENTATIVE HAD TO REDO THE 3 DEFINE. THE ERROR ISSUE HAPPENED A 3RD TIME AFTER UN-MOUNTING FROM THE BED. THE OUTLET WAS SWAPPED AFTER THE FIRST OCCURRENCE, HOWEVER THE ISSUE CONTINUED TO PERSIST. L4 TO L2 WERE FREEHANDED. IT WAS DURING THE FREEHAND PORTION THAT THE CONTROLLER ERROR/REBOOT REQUEST INITIALLY OCCURRED. AFTER RESETTING THE SYSTEM A CONFIRMATION SPIN WAS TAKEN. THE GUIDANCE SYSTEM THEN PRESENTED THE SAME CONTROLLER ERROR MESSAGES AND HAD TO BE SHUT DOWN/RESET BEFORE DOING THE FIRST REGISTRATION. THE FIRST SEGMENT OF SCREWS WERE PLACED ROBOTICALLY FROM L1 TO T8,

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: UNSUCCESSFUL MERGE AT T1. MULTIPLE MERGES WERE ATTEMPTED WITH DIFFERENT FLUORO IMAGES AND CENTROID PLACEMENTS. AFTER FAILING T1-T3 MERGE MULTIPLE TIMES, WE TRIED MERGING C7-T2 WHICH WAS ALSO UNSUCCESSFUL.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IN THESE CASES, NO MATTER WHAT, THE MERGE BOUNCED SIMILAR TO E3D.

Senhance — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE COMPLAINANT, DR. (B)(6) REPORTED THAT ON (B)(6) 2022, A GASTROSCOPY WAS PERFORMED FOR DYSPHAGIA. THIS EVENT REVEALED A BOLUS OCCLUSION IN THE LOWER ESOPHAGUS WITH NECROSIS OF THE WALL TO INDICATE AN ESOPHAGEAL PERFORATION. THE PATIENT WAS TREATED VIA RE-LAPAROSCOPY, ESOPHAGEAL SUTURE, ESOSPONGE, AND SEVERAL VAC CHANGES. VAC THERAPY WAS COMPLETED ON (B)(6) 2022 ON (B)(6) 2022, AN X-RAY SWALLOW SHOWED TIGHTNESS AND AFTER A SLOW BUILD-UP OF FOOD, THE PATIENT WAS DISCHARGED ON (B)(6) 2022. AT HOME THE PATIENT WAS LISTLESS AND WAS RE-ADMITTED AS INPATIENT FROM (B)(6) 2022 THRU (B)(6) 2022 WHEN SHE WAS DISCHARGED. AFTER THIS PERIOD, PATIENT DID WELL WITH NO WEIGHT LOSS AND NO DYSPHAGIA. IT WAS REPORTED THAT CAUSALITY TO THE SENHANCE SURGICAL SYSTEM WAS CERTAIN. THIS EVENT DID NOT OCCUR WITHIN THE UNITED STATES. THE EVENT OCCURRED IN (B)(6). ADDITIONALLY, THIS EVENT OCCURRED ON (B)(6) 2022, AND ASENSUS SURGICAL WAS INTERNALLY MADE AWARE ON 02-DECEMBER- 2022.

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 PROSTATECTOMY WITH LYMPHADENECTOMY PROCEDURE, THERE WAS AN ORIENTATION ISSUE WITH THE 30-DEGREE ENDOSCOPE 2 HOURS INTO THE PROCEDURE. THE ENDOSCOPE WAS NOT ABLE TO SWITCH BETWEEN UP AND DOWN VIEW AND ONLY ONE ENDOSCOPE WAS AVAILABLE FOR THIS SURGERY. THERE WAS A BEEP EVERY TIME THE SURGEON WANTED TO CHANGE THE SCOPE ORIENTATION. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) DID NOT FIND ANY RELATED ERRORS IN THE LIVE LOGS. PRIOR TO CALLING ISI TECHNICAL SUPPORT, THE CUSTOMER HAD ALREADY DISCONNECTED FROM THE VISION SIDE CART (VSC) AND PATIENT SIDE CART (PSC) AND RESEATED THE ENDOSCOPE. THE TSE ASKED THE CUSTOMER IF THEY HAD ALREADY RESEATED THE STERILE ADAPTER, BUT THE CUSTOMER HAD NOT, AND THEY DID NOT WANT TO DO SO AS THE SURGERY WAS IN PROGRESS. NO MECHANICAL SOUND WAS PRESENT FROM THE ENDOSCOPE WHEN THE 30 DEGREE UP/DOWN BUTTON WAS PRESSED. THE CUSTOMER DECIDED TO CONTINUE THE PROCEDURE AS IS. ISI FOLLOWED UP WITH THE INITIAL REPORTER (SURGEON) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGEON INDICATED THAT THE PROBLEM AROSE AT THE TIME OF PERFORMING A RETRO-BLADDER ANASTOMOSIS ON A PROST

At 9:15 p.m. on September 1, 2022, an employee was placing welding tips into a welding tip cartridge for a spot welding robot. The spot welding robot was not locked out and activated as the employee placed the tips into the cartridge. The employee's upper torso was crushed, killing him.

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 A MONARCH BRONCHOSCOPY CASE, AT APPROXIMATELY 3:20 PM, THERE WAS A NAVIGATION FUSION ERROR (FAULT 1224) THAT REQUIRED THE USER TO RE-REGISTER. THE NAVIGATION ERROR (FAULT 1224) OCCURRED 58MM AWAY FROM THE ENDOBRONCHIAL TUMOR AND DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S PROCEDURE-RELATED INJURY. THE FAULT MESSAGE ON THE CART: FAULT ID 711-50-0-0: SCOPE DISCONNECTED WAS REPORTED DUE TO THE BRONCHOSCOPE BEING REMOVED FROM THE PATIENT. THE USE OF THE MONARCH SYSTEM WAS ENDED TO CONTROL BLEEDING. THE CUSTOMER USED COLD SALINE AND TAMPONADE TO CONTROL THE BLEEDING. THE PHYSICIAN STATED THE BLEEDING WAS NOT CAUSED FROM THE MONARCH DEVICE, IT WAS CAUSED FROM A UNIQUE TYPE OF ENDOBRONCHIAL TUMOR THE PATIENT HAD AND WAS BLEEDING FROM THIS TUMOR. AFTER THE BLEEDING WAS CONTROLLED, THE PHYSICIAN SAMPLED THE LYMPH NODES VIA EBUS (ENDOBRONCHIAL ULTRASOUND BRONCHOSCOPY). IT REQUIRED TWO REBOOTS TO RESOLVE ERROR AND ENABLE USER TO MOVE FORWARD WITH MONARCH PROCEDURE AND COMPLETE CASE SUCCESSFULLY.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: T10 -PELVIS WITH S2AI SCREW CASE. ROBOT WAS FINICKY THROUGHOUT CASE, HAD TROUBLES WHEN DROPPING THE DRIVER ARRAY IN. WHEN PUTTING THE DRIVER DOWN THE END EFFECTOR THE SCREW ALIGNMENT WAS OFF, AND THE OFFSET WAS RED. TRIED FIXING THE BALLS AND SWITCHING DRIVER ARRAY. WHEN WE GOT DOWN TO S2AI SCREWS, THE SCREW WAS NOT ALIGNED WITH THE PLAN AND SURGEON HAD TO ABORT THE S2AI SCREWS. SUBMITTED CASE LOGS TODAY.

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 THE PATIENT UNDERWENT DA VINCI-ASSISTED THYMECTOMY FOR A MALIGNANT THYMOMA ON (B)(6) 2022 AS PART OF THE SP THORACIC CLINICAL STUDY. THE PATIENT EXPERIENCED DELAYED MILD PHRENIC NERVE INJURY WITH ELEVATED LEFT HEMIDIAPHRAGM ON (B)(6) 2022. NO MEDICAL ACTION OR INTERVENTION WAS REQUIRED FOR THE REPORTED EVENT, AND WAS ASSESSED AS CLAVIEN-DINDO GRADE I. THERE WERE NO INTRA-OPERATIVE COMPLICATIONS NOR ANY MALFUNCTIONS OF DV SYSTEMS, INSTRUMENTS OR ACCESSORIES OCCURRED DURING THE PROCEDURE. THE PATIENT WAS DESCRIBED AS HAVING A LARGE THYMOMA IN THE AORTOPULMONARY WINDOW. ACCORDING TO THE SURGEON, THE THYMOMA DID NOT INVADE THE PHRENIC NERVE, BUT THE NERVE WAS UNDER SOME TRACTION DURING DISSECTION. THE STUDY INVESTIGATOR ASSESSED THE EVENT AS RELATED TO THE DA-VINCI ASSISTED PROCEDURE BUT NOT RELATED TO THE DV SYSTEMS, INSTRUMENTS OR ACCESSORIES.

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 PARASTOMAL HERNIA REPAIR, THE SURGEON WAS USING A MONOPOLAR CURVED SCISSOR (MCS) INSTRUMENT AND POTENTIAL ARCING OCCURRED AGAINST A PROGRASP FORCEPS INSTRUMENT. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE SURGEON STATED HE WAS TAKING DOWN ADHESIONS WITH THE MCS AND THE PROGRASP FORCEPS INSTRUMENTS. THE SURGEON INDICATED THAT HE DID NOT WITNESS ARCING FROM THE MCS INSTRUMENT; HOWEVER, HE SAW SMOKE. THERE WAS CHARRED TISSUE ON THE BASE OF THE ABDOMEN ON VISCERAL TISSUE NEAR THE PROGRASP FORCEPS INSTRUMENT. UPON EXAMINATION, HE DID NOT NOTICE ANY HOLES IN THE TISSUE AND HENCE DID NOT WARRANT ANY REPAIR. THE SURGEON ASKED FOR THE PROGRASP FORCEPS INSTRUMENT TO BE SWAPPED, AND NO ISSUE WAS REPORTED AFTERWARDS. THE SURGEON CONFIRMED NO FRAGMENTS FELL INSIDE THE PATIENT FROM THE PROGRASP FORCEPS INSTRUMENT. ON POST-OPERATIVE DAY (POD) #6, THE PATIENT UNDERWENT A SECOND OPEN PROCEDURE FOR UNSPECIFIED SYMPTOMS. THE PATIENT WAS IDENTIFIED WITH A BOWEL INJURY ON THE LARGE INTESTINE, RIGHT BELOW THE CANNULA INSTALLATION (INFERIOR LEFT) WHERE THE PROGRASP FORCEPS INSTRU

Brinker International has paused a robotics test with Bear Robotics, which deployed server robots at 61 Chili's restaurants, CEO Kevin Hochman said Wednesday during Brinker's earnings call.

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 DURING A MONARCH BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE TARGET WAS A LOWER LOBE. PATIENT HAD SEVERE EMPHYSEMA, WHICH THE DOCTOR STATED AT THE BEGINNING OF THE CASE CAN LEAD TO AN INCREASED RISK FOR A PNEUMOTHORAX. THE PNEUMOTHORAX WAS DISCOVERED POST OP AND DID NOT REQUIRE A CHEST TUBE. NO MALFUNCTION, FAULT OR ERRORS WERE REPORTED. A MEDTRONIC ARCPOINT NEEDLE WAS ALSO USED DURING THE PROCEDURE. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY.

CyberKnife — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PATIENT EXPERIENCED URINARY AND FECAL RETENTION AND INCONTINENCE AFTER CYBERKNIFE TREATMENTS.

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 PULMONARY LOBECTOMY THE USER EXPERIENCED AN INCOMPLETE SEAL USING THE SYNCHROSEAL INSTRUMENT (LOT #L10220711-0413) AND ENCOUNTERED AN ¿INSPECT JAWS FOR DAMAGE¿ ERROR MESSAGE. A SECOND SYNCHROSEAL INSTRUMENT (LOT #L10220711-0396) WAS INSTALLED BUT ALSO DISPLAYED THE SAME ERROR MESSAGE. ACCORDING TO THE INITIAL REPORTER, AT THE TIME THE EVENT OCCURRED, THE SURGEON WAS ATTEMPTING TO DISSECT TISSUE WHICH HAD EXCESS MOISTURE AND BLEEDING OCCURRED. AS A RESULT, THE PROCEDURE WAS CONVERTED TO OPEN SURGERY IN ORDER TO CONTROL THE BLEEDING. THE BLEEDING WAS DESCRIBED AS BEING MILD TO MODERATE AND THE ESTIMATED BLOOD LOSS WAS 50 CC. ACCORDING TO THE SURGEON, THE INSTRUMENT FUNCTIONED PROPERLY FOR ONE HOUR AT WHICH POINT THE CUSTOMER EXPERIENCED IMPROPER/INCOMPLETE SEALING AND TISSUE STICKING TO THE INSTRUMENT JAWS. THERE WAS MINIMAL TO NO TENSION ON THE LUNG VESSEL BEING SEALED. NO EVIDENCE OF VESSEL CALCIFICATION WAS NOTED. THE VESSEL WAS NOT GREATER THAN 5MM IN DIAMETER. TISSUE EFFECT WAS OBSERVED DURING THE SEALING CYCLE(S). THE INSTRUMENT JAWS DID NOT COME INTO CONTACT WITH A CLIP, SUTURE, STAPLE, OR OTHER METAL OBJECTS WHEN THE REPORTED IS

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 PATIENT EXPERIENCED BLEEDING IN THE LEFT LOWER LOBE DURING THE MONARCH BRONCHOSCOPY PROCEDURE. THE BLEEDING WAS CONTROLLED BY EXOCRINE PANCREATIC INSUFFICIENCY (EPI) ADMINISTRATION. THE PATIENT WAS HOSPITALIZED FOR HYPOXIA AND PLACED ON OXYGEN. PRIOR TO THE PROCEDURE THE PATIENT WAS ON OXYGEN AND CURRENTLY ON OXYGEN AT HOME. THE PATIENT WAS RELEASED THE FOLLOWING DAY.