ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6)2020 , THE SURGEON CONTACTED THE COMPANY FIELD SERVICE ENGINEER (FSE) VIA EMAIL TO RAISE THE COMPLAINT THAT IT IS IMPOSSIBLE TO SUCCESSFUL IMPORT A PLAN FROM THE ROBOT TO THE PLANNING STATION. THE SURGEON ATTEMPTED TO USE DIFFERENT USBS IN EXPORTING THE PLAN FROM THE ROBOT, HOWEVER STILL RECEIVED THE "IMPOSSIBLE TO LOAD PATIENT FOLDER" WHEN TRYING TO OPEN THE PLAN IN THE PLANNING STATION. THE SURGEON DID REPORT HOWEVER, THAT THERE WAS NO ISSUE IN EXPORTING A PATIENT FOLDER FROM THE PLANNING STATION AND IMPORTING TO THE ROBOT. A FSE WENT ONSITE ON (B)(6)2020 AND COMPARED THE LICENSES ON THE PLANNING STATION AND THE ROBOT. IT WAS FOUND THAT THE PLANNING STATION'S LICENSE WAS MISSING ACCESS TO "FRAME REGISTATION" AND THUS THE LICENSES ON THE ROBOT AND THE PLANNING STATION DID NOT MATCH. THE LICENSE GENERATOR WAS UTILIZED ON THE PLANNING STATION TO CREATE A NEW LICENSE (TO MATCH THE LICENSE ON THE ROBOT). THE PATIENT FOLDER FROM THE ROBOT WAS THEN ABLE TO BE SUCESSFULLY IMPORTED ON THE PLANNING STATION. IT WAS ALSO TESTED THAT PATIENT FOLDERS CREATED ON THE PLANNING STATION COULD BE IMPORTED TO THE ROBOT. THE ISSUE WAS THEREFORE RESOLVED.

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 SURGICAL PROCEDURE, THE CUSTOMER WAS USING TWO SP NEEDLE DRIVERS FOR SUTURING. THE CUSTOMER FOUND DAMAGE ON THE INSTRUMENT SHEATHS AND CAMERA SHEATH. FRAGMENTS FROM AN UNKNOWN SOURCE WERE IDENTIFIED AND RETRIEVED FROM THE PATIENT DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE OR NURSE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE FRAGMENTS WERE RETRIEVED DURING THE SAME PROCEDURE. THERE WERE NO POST-OPERATIVE TESTS PERFORMED TO CHECK FOR REMAINING FRAGMENTS. BOTH THE CAMERA SHEATH AND INSTRUMENT SHEATH WERE IN USE FOR 30-40 MINUTES PRIOR TO THE ISSUE AND WERE INSPECTED PRIOR TO USE. THE CUSTOMER CONFIRMED THAT THE INSTRUMENT SHEATH WAS FOUND TO BE SCRATCHED AFTER THE SURGERY. THE SURGEON DID NOT NOTICE ANY ISSUES WITH FUNCTIONALITY DURING THE SURGICAL PROCEDURE. THE CUSTOMER DID NOT HEAR ANY SOUND OF INSTRUMENTS COLLIDING WITH ANOTHER DEVICE OR OTHER HARD MATERIAL, BUT HEARD A "RELATED ERROR NOTIFICATION." THE FRAGMENTS DID NOT FALL INSIDE THE PATIENT DURING AN INSTRUMENT TIP/ACCESSORY COLLISION. THE INSTRUMENT WAS NOT REMOVED INTR

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 SURGICAL PROCEDURE, THE CUSTOMER FOUND DAMAGE ON THE INSTRUMENT SHEATH AND CAMERA SHEATH. FRAGMENTS FROM AN UNKNOWN SOURCE WERE IDENTIFIED AND RETRIEVED FROM THE PATIENT DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE OR NURSE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE FRAGMENTS WERE RETRIEVED DURING THE SAME PROCEDURE. THERE WERE NO POST-OPERATIVE TESTS PERFORMED TO CHECK FOR REMAINING FRAGMENTS. BOTH THE CAMERA SHEATH AND INSTRUMENT SHEATH WERE IN USE FOR 30-40 MINUTES PRIOR TO THE ISSUE AND WERE INSPECTED PRIOR TO USE. THE CUSTOMER CONFIRMED THAT BOTH SHEATHS WERE FOUND TO BE SCRATCHED AFTER THE SURGERY. THE SURGEON DID NOT NOTICE ANY ISSUES WITH FUNCTIONALITY DURING THE SURGICAL PROCEDURE. THE CUSTOMER DID NOT HEAR ANY SOUND OF INSTRUMENTS COLLIDING WITH ANOTHER DEVICE OR OTHER HARD MATERIAL, BUT HEARD A "RELATED ERROR NOTIFICATION." THE FRAGMENTS DID NOT FALL INSIDE THE PATIENT DURING AN INSTRUMENT TIP/ACCESSORY COLLISION. THE INSTRUMENT WAS NOT REMOVED INTRAOPERATIVELY. THE WRIST WAS STRAIGHTENED UPON THE FINAL REMOVAL OF T

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 — Death 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.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE SITE WAS DOING A BIOPSY CASE WITHOUT THE PRESENCE OF A FIELD SERVICE ENGINEER (FSE). AN FSE WAS SUPPORTING THE CASE THROUGH FACETIME VIA CELLPHONE. AS THE SURGEON WAS PULLING OUT THE BIOPSY NEEDLE FOR THE FINAL CORE TO BE TAKEN, AN INTER-OP. BLEED OCCURRED. THE SURGEON EXPLAINED THE TYPE OF TUMOR THAT THIS PATIENT HAD WAS NORMALLY SURROUND BY A LOT OF VASCULAR STRUCTURES SURROUNDING THE TUMOR. HE SAID THE ROSA WAS ACCURATE AND THERE WERE NO ISSUES WITH ROSA. THE BLEED WAS CAUSED BY THE TUMOR. THE PATIENT WAS CLEARED AND DISCHARGED FROM THE HOSPITAL WITHIN 48 HOURS OF THE SURGERY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(4) 2020, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A WORLD JOURNAL OF SURGERY ARTICLE TITLED, ¿MINIMALLY INVASIVE VERSUS OPEN PANCREATIC SURGERY IN PATIENTS WITH MULTIPLE ENDOCRINE NEOPLASIA TYPE 1¿ ( C. LOPEZ, ET AL. 2016). PER THE CLINICAL ARTICLE, EIGHT HOURS AFTER UNDERGOING A DA VINCI-ASSISTED SPLEEN-PRESERVING DISTAL PANCREATIC RESECTION PROCEDURE, THE PATIENT EXPERIENCED "LIFE-THREATENING" POST-OPERATIVE BLOOD LOSS. THE PATIENT UNDERWENT RESUSCITATION AND AN EMERGENCY LAPAROTOMY TO CONTROL BLEEDING FROM THE SPLENIC ARTERY. THE BLEEDING WAS "MOST LIKELY CAUSED BY A NECROSIS OF THE VESSEL WALL RESULTING FROM THE ULTRACISION DEVICE."

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.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE PATIENT WAS ATTACHED TO THE ROSA SUPPORT ARM AND POSITIONED SUPINE, WITH ABOUT A 15 DEGREE LATERAL TURN OF THE HEAD TO THE PATIENT¿S LEFT. SURGEONS USED THE O-ARM 2 TO GET A SCAN OF THE PATIENT WITH THE LEKSELL AND RADIOLUCENT BOX, THEN LOADED THE SCAN INTO THE ROSA SOFTWARE. HOWEVER, WHEN SURGEON CHOSE "FRAME REGISTRATION" IN THE EXAM MANAGER AND MARKED THE POINTS, THE SOFTWARE GAVE THE ERROR THAT IT COULD NOT PROPAGATE THE MARKERS THROUGH THE SLICES WHEN "PROPAGATION" WAS SELECTED (9:00AM). A SECOND SCAN WITH THE O-ARM 2 WAS TAKEN, THIS TIME WITH SLIGHTLY DIFFERENT PARAMETERS, BUT THE SAME ERROR APPEARED. SURGEONS WERE FORCED TO SWITCH TO MARKER REGISTRATION OFF THE LEKSELL POSTS BECAUSE THEY DID NOT WANT TO EXPOSE THE PATIENT TO ANOTHER CT SCAN. AFTER REGISTRATION WAS COMPLETE, THE SURGERY PROCEEDED WITHOUT ANY FURTHER INCIDENTS AND THE SURGEONS WERE HAPPY WITH PLACEMENT OF THE LASER FIBERS. PATIENT WAS ALREADY UNDER ANESTHESIA, BEFORE FIRST INCISION, NO IMPACT TO PATIENT, DELAY TO CASE 30 MINS.

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.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AROUND 9:00 EST, THE BONE FIDUCIAL CT SCAN WAS ATTEMPTED TO BE MERGED TO THE MRI SCAN ALREADY LOADED INTO THE PLAN WITH TRAJECTORIES PLACED. THE CT SCAN WAS TAKEN BY THE AIRO SCANNER, AND THE PATIENT WAS PRONE AND CONNECTED TO ROSA WITH A RADIOLUCENT MAYFIELD HEAD HOLDER. WHEN TRYING TO MERGE THE CT SCAN TO THE MRI SCAN, THE MERGE FAILED, AND THE SURGEON ATTEMPTED TO MANUALLY MERGE THE IMAGING, BUT WAS UNSUCCESSFUL. THE SEMI-AUTOMATIC MERGE FUNCTION WAS ATTEMPTED AS WELL, BUT THAT MADE THE MERGE EVEN WORSE. THE SURGEON COMPLAINED THAT MANUALLY MERGING THE SCAN WOULD TAKE TOO LONG AND THE ACCURACY WOULDN'T BE TRUST-ABLE FOR SURGERY. THE FIELD SERVICE ENGINEER (FSE) ATTEMPTED TO MERGE THE MRI TO THE CT SCAN (OPPOSITELY MERGING THE SCANS), AND THIS APPEARED TO HAVE WORKED CORRECTLY. THE SURGEON WAS OKAY WITH THE MERGE, BUT THAT MEANT THE TRAJECTORIES THEY PLANNED WERE LOST, SO THEY WERE UPSET THEY LOST EVERYTHING THEY PLANNED, AND WASTED THEIR TIME. THE SURGEON RE-PLANNED THE TRAJECTORIES BASED ON THE NEW MERGE, BUT IT TOOK ABOUT AN HOUR TO FINALIZE. THE PATIENT WAS UNDER ANESTHESIA AND NO INCISIONS WERE MADE. THE DELAY WAS OVER AN HOUR DUE TO MERGING ISSUES AND RE-PLANNING TRAJECTORI

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE FIELD SERVICE ENGINEER WAS PRESENT FOR AN ABLATION CASE AT (B)(6) WITH DR. (B)(6). SURGEON WANTED TO USE FRAME REGISTRATION, SO PLACED THE FRAME ON THE PATIENT AND TOOK AN O-ARM SPIN WITH THE PATIENT ALREADY HOOKED TO THE ROSA. WHEN THE FSE AND SURGEON TRIED TO MARK THE POINTS FOR FRAME IDENTIFICATION, THE ERROR MESSAGE THAT THE MARKERS WERE MARKED INCORRECTLY CAME UP AFTER HITTING PROPAGATION. A SMALL AMOUNT OF THE ZS ON THE RADIOLUCENT BOX WAS MISSING FROM THE SCAN (PREOP O-ARM), SO CR AND SURGEON DECIDED TO TAKE ANOTHER SCAN AND MAKE SURE THAT THOSE ZS WERE ALL PRESENT. HOWEVER, THE SAME ISSUE OCCURRED WITH THE SECOND SCAN (PREOP 2). SURGEON AND CR NOTED THAT THERE WAS A LOT OF NOISE AND DROPOUT IN THE SCAN THAT SEEMED TO AFFECT THE SHAPE/QUALITY OF THE MARKERS IN THE O-ARM SCAN. HOWEVER, NOTHING UNUSUAL WAS IN THE SCAN AND A SIMILAR SETUP HAD BEEN USED PREVIOUSLY WITHOUT ANY PROBLEMS. SURGEON ENDED UP USING FIDUCIAL REGISTRATION FROM THE PINS OF THE LEKSELL FRAME TO MOVE FORWARD WITH THE CASE. DELAY TO CASE 2 HOURS, PATIENT WAS ALREADY UNDER ANESTHESIA, NO PATIENT IMPACT.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE EVENT OCCURRED ON (B)(6)2020. WE WERE NOTIFIED OF THE EVENT ON THAT DATE. THE PATIENT HAD AN INTRACRANIAL HEMORRHAGE. THE SURGEON PLACED ALL THE BOLTS, AND ALL DISTANCE NUMBERS WERE OBTAINED. SURGEON THEN STARTED TO PLACE THE ELECTRODES, IT WAS NOTICED THAT THE INTRACRANIAL PRESSURE MONITOR WAS HIGH. SURGEON MADE THE DECISION TO ABORT THE CASE AND GO TO CT. THE BLEED WAS OBSERVED, AND THEY WENT BACK TO THE OR FOR A CRANIOTOMY. THE PATIENT SURVIVED THE SURGERY, AND IS RECOVERING. THE PATIENT HAD PREVIOUS BRAIN SURGERIES THAT IS BELIEVED TO CONTRIBUTE TO THE OUTCOME.

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 PROCEDURE, WHILE USING THE HARMONIC ACE INSTRUMENT THE JAW BROKE OFF AND FELL INTO THE PATIENT. THE FRAGMENT WAS RETRIEVED AND REMOVED FROM THE PATIENT DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE FRAGMENT WAS RETRIEVED USING A LAPAORSCOPIC GRASPER. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT. ACCORDING TO THE CUSTOMER, IT WAS NOT NECESSARY TO PERFORM POST-OPERATIVE TESTS. THE FRAGMENT FELL WHILE DISSECTING FAT TISSUE (PERIHEPATIC). THE SURGEON DID NOT NOTICE ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT UNTIL THE SMALL PART FELL. THE CUSTOMER BELIEVED THAT SOMETHING RELATED WITH ULTRASONIC MOVEMENTS CAUSED THE INSTRUMENT TO BREAK. THE INSTRUMENT WAS USED FOR 20 MINUTES PRIOR TO THE ISSUE. THE INSTRUMENT WAS INSPECTED PRIOR TO USE. THERE WAS NO DAMAGE OR COLLISION BETWEEN INSTRUMENTS OR HARD MATERIAL.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A DBS PROCEDURE WAS BEING PERFORMED. MARKER REGISTRATION OCCURRED WITH 5 FIDUCIALS AND THE RMS OF THE REGISTRATION WAS 0.86MM. AFTER, REGISTRATION AND VERIFICATION, THE FIDUCIALS WERE REMOVED BECAUSE THEY WERE IN THE WAY OF THE OPERATING AREA. AT THE FIRST TRAJECTORY TARGETING THE VIM, THERE WERE GOOD RESULTS WITH THE MICROELECTRODE RECORDINGS. THE SURGICAL TEAM THEN DECIDED TO TARGET A SLIGHTLY ADJACENT AREA OF THE VIM FOR A 'SECOND RUN'. DURING THIS RUN, THE PHYSICAL RESPONSE THAT THE PATIENT HAD TO THE STIMULUS MADE THE PATIENT UNCOMFORTABLE. THIS DISCOMFORT LED TO THE PATIENT TRYING TO SHIFT THEIR WEIGHT IN THE SURGICAL BED (THE PATIENT WAS AWAKE DURING THIS TESTING) AND THUS LEADING TO THE SHIFT IN THE HEAD FRAME. THIS CAUSED FUTURE INACCURACIES TO AROUND 3-4MM, HOWEVER THERE WAS NO PERMANENT LEAD PLACED. THESE INACCURACIES WERE FOUND DURING AN INTEROPERATIVE CT SCAN. UPON DISCOVERY, MULTIPLE FACTORS WERE CHECKED (IE: MERGING, REGISTRATION, TOOLS/INSTRUMENTS USED) AND THE SURGEON DISCOVERED THAT THE LEKSELL FRAME ON THE PATIENT HAD ACTUALLY LOOSENED WHEN SHE WAS MOVING AND THUS CAUSED THE INACCURACY. ONCE THIS DISCOVERY WAS MADE, THE SURGEON AND THE STAFF ABORTED THE 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 INSTRUMENT TIP BROKE AND FELL INTO THE PATIENT. THE FRAGMENT WAS RETRIEVED IN THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS IN USE FOR APPROXIMATELY 5 MINUTES WHEN THE TIP BROKE WHILE DISSECTING. ACCORDING TO THE SURGEON, HE WAS FREEING THE THYROID GLAND ATTACHMENTS AND AS HE APPLIED ENERGY THERE WAS NO DESIRED EFFECT WHICH HE USUALLY GETS AND WHEN HE OPENED THE JAW THE INSTRUMENT TIP BROKE. THE FRAGMENT THAT FELL INTO THE PATIENT WAS RETRIEVED BY AN UNSPECIFIED HAND INSTRUMENT DURING THE SAME PROCEDURE. THE SURGEON VISUALLY CONFIRMED ALL FRAGMENTS WERE RETRIEVED. NO POST-OPERATIVE TESTS OR ADDITIONAL SURGICAL PROCEDURES WERE PERFORMED. IT WAS REPORTED THAT THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. THE INSTRUMENT HAD NOT BEEN REMOVED PRIOR TO BREAKAGE. FURTHERMORE, IT WAS CONFIRMED THAT THERE WAS NO INJURY TO THE PATIENT AND THE PATIENT WAS DISCHARGED NORMALLY AND HAD NOT RETURNE

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ABSTRACT: COMPUTERIZED NAVIGATION IS CURRENTLY WIDE SPREADING AROUND THE WORLD IN SPINE SURGERY, AIMING TO ALLOW MORE ACCURATE AND SAFE PROCEDURES. SINCE THE END OF THE 20TH CENTURY, NAVIGATION APPEARED TO BE SUPERIOR TO TRADITIONAL FREE-HAND TECHNIQUE TO INSERT PEDICLE SCREWS. THUS ITS USE IS BECOMING A GOLD STANDARD IN MANY FACILITIES. ROBOTIC GUIDANCE AIMS TO STABILIZE A ROBOTIC ARM AFTER SURGICAL PLANNING OF SCREW TRAJECTORY. THE MAZOR X STEALTH IS A RECENT DEVICE WHICH COMBINES ROBOTIC GUIDANCE AND NAVIGATION. THE AIM OF THE STUDY WAS TO COMPARE OPERATIVE AND RADIOLOGIC RESULTS AND ALSO RADIATION EXPOSURE BETWEEN THE MAZOR X STEALTH AND THE O-ARM NAVIGATION FOR PEDICLE SCREW INSERTION. MATERIAL AND METHODS: ALL PATIENTS WHO REQUIRED PEDICLE SCREW INSERTION FOR POSTERIOR LUMBAR FUSION WERE PROSPECTIVELY INCLUDED AND DIVIDED INTO TWO GROUPS: RG WHEN OPERATED WITH THE MAZOR X STEALTH, AND NV WHEN OPERATED WITH THE O-ARM AND NAVIGATION AS A CONTROL GROUP. AGE, OPERATIVE DATA SUCH AS NUMBER OF LEVELS OPERATED, NUMBER OF SCREWS INSERTED, OPERATIVE TIME IN MINUTES (MIN), ESTIMATED BLOOD LOSS (EBL IN MILLILITERS, ML), TIME TO INSERT SCREWS (IN MIN). SATISFACTION OF SCREW POSITIONING W

Senhance — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE COMPLAINANT, VAIDA NAUSEDIENE, REPORTED THAT ON DAY 4, THE PATIENT DEVELOPED FEVER, SIGNS OF PERITONITIS. THE ADVERSE EVENT WAS AN ANASTOMOTIC LEAKAGE. ON (B)(6) 2020, PATIENT WAS RE-OPERATED VIA LAPAROTOMY, DISRUPTION OF ANASTOMOSIS, LAVAGE AND DRAINAGE OF THE ABDOMEN, END COLOSTOMY. PATIENT WAS THEN TREATED IN ICU, THUS POSTOPERATIVE COURSE AND RECOVERY WAS LONGER DUE TO INFECTION OF THE LAPAROTOMY WOUND, WITH OBESITY AND CO-MORBIDITIES PRESENT. PATIENT RECOVERED AND WAS DISCHARGED FOR A 20-MARCH-2020 DATE OF RESOLUTION. THIS EVENT DID NOT OCCUR WITHIN THE U.S. THE EVENT OCCURRED IN (B)(6) HOSPITAL IN LITHUANIA. ADDITIONALLY, THIS EVENT OCCURRED ON 29-FEBRUARY-2020, AND ASENSUS SURGICAL WAS INTERNALLY MADE AWARE ON 16-AUGUST-2023.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE PATIENT FOLDER WAS LOADED IN FROM A USB, AND THE COMPANY FIELD SERVICE ENGINEER (FSE) RECEIVED THE ERROR 'IMPOSSIBLE TO LOAD PATIENT FOLDER'. IT WAS CONCLUDED THAT THE CONTRAST/3D THRESHOLD ON THE FIRST IMAGE SET WAS THE PROBLEM. THE VALUES IN THE [3D_THRESHOLD] SECTION WERE DELETED AND REPLACED. ROSANNA WAS LAUNCHED AND THE PATIENT FOLDER DID NOT SHOW UP UNDER THE USB OR UNDER THE SAVED EXAMS. IT WAS ALSO ATTEMPTED TO LOAD THE FOLDER ONTO THE PLANNING LAPTOP AND WITH A DIFFERENT USB, WITH THE SAME RESULT. ULTIMATELY A NEW PATIENT FOLDER WAS CREATED, WITHOUT THE CORRUPTED CT.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A FEW DAYS AFTER A SUCCESSFUL BIOPSY PROCEDURE, A PNEUMOTHORAX IN THE RIGHT LOWER LOBE WAS DISCOVERED AND REPORTED BY THE PHYSICIAN ON (B)(6) 2020. A CHEST TUBE WAS PLACED TO RESOLVE THE PNEUMOTHORAX. THE PATIENT RECOVERED AND WAS RELEASED ON (B)(6) 2020.

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.

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 THE CASE, THE PATIENT EXPERIENCE A PNEUMOTHORAX. THE PNEUMOTHORAX WAS LOCATED IN THE RIGHT UPPER LOBE. A CHEST TUBE WAS PLACED AND THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE PATIENT WAS IN STABLE CONDITION AND WAS DISCHARGED FROM THE HOSPITAL AFTER THREE DAYS.

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.

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 FOUR PEDIC/E SCREWS WERE NOT PLACED ACCORDING TO THE SCREW PLAN. INTRA-OPERATIVE IMAGING SHOWED THE SCREWS WERE PLACED MEDIALLY AND WERE OFF BY TWO VERTEBRAL LEVELS. THE SCREWS WERE REMOVED AND NEW ANTERIOR, POSTERIOR, AND LATERAL C­ ARM IMAGES WERE REGISTERED AND MERGED. USING THE EXCELSIUS GPS, THE SCREWS WERE CORRECTLY PLACED AT LS AND S1 ACCORDING TO THE INITIAL PLAN.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE CUSTOMER REPORTED A PNEUMOTHORAX ON (B)(6) 2020, AFTER THE THIRD CASE. IT WAS A SMALL RIGHT APICAL PNEUMOTHORAX. OLYMPUS NEEDLE AND AURIS FORCEPS WERE USED ALONG WITH FLUOROSCOPY. THE LOCATION OF THE TARGET WAS THE RIGHT UPPER LOBE. A SMALL PLEURAL CATHETER WAS USED AND LUNG WAS EXPANDED. NO FAULTS OCCURRED DURING THE TREATMENT AND PATIENT¿S CONDITION WAS STABLE. THE CASE WAS COMPLETED AND A MALIGNANT DIAGNOSIS CONFIRMED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: SURGEON PERFORMED CONTACT-LESS REGISTRATION USING CT. FIRST INSTANCE ERROR REPORTED INSUFFICIENT ACCURACY. SECOND INSTANCE WAS ALSO INACCURATE. THIRD WAS SUCCESSFUL AND SHOWED ADEQUATE ACCURACY DURING VERIFICATION. DELAY OF 30 MINUTES DUE TO REPEATED REGISTRATION ATTEMPTS. SEEG SURGERY, NO INCISION MADE.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE FOLLOWING EVENTS OCCURRED DURING AN ABLATION CASE WITH COMPANY FIELD SERVICE ENGINEER (FSE) ASSISTING. (1) AT APPROXIMATELY 7:52 AM AFTER THE MANUAL SCANS DURING REGISTRATION, THE SOFTWARE DETECTED SIGNIFICANT ERRORS RESULTING IN A RE-START OF THE REGISTRATION. WHEN ADJUSTING THE 3D RECONSTRUCTION OF THE CT SCAN, THE FSE, PROCEEDED TO HIT COMPUTE AND VALIDATE. THE REGISTRATION TAB WAS THEN PRESSED, AND AT THIS TIME, THE ERROR 'ROSANNA BRAIN.EXE HAS STOPPED RESPONDING' POPULATED THE SCREEN AND THE ROSA ROBOT PROCEEDED TO SHUT DOWN. THE FSE THEN TURNED ON THE ROBOT. AFTER CLICKING THE LOAD THE PATIENT FOLDER TAB, IT WAS DISCOVERED THAT THE NEEDED PATIENT FOLDER (THAT HAD JUST BEEN USED) WAS MISSING AND OR DELETED FROM THE ROSA ROBOT. IT SHOULD BE NOTED THAT IT WAS THE ONLY PATIENT FOLDER MISSING FROM THE ROSA AND PAST PLANS (FOR PREVIOUS PATIENTS) WERE STILL ACCESSIBLE. THE FSE TRIED RESTARTING THE ROSA ROBOT AND THE ISSUE PERSISTED. THE FSE THEN LOGGED INTO THE MAINTENANCE SIDE OF THE ROBOT, AND FOUND THE PATIENT FOLDER IN D:/MEDTECH/DATA/PATIENT FOLDER AND COPIED IT TO A USB. THE FSE THEN LOGGED BACK INTO ROSA BRAIN, HOWEVER AGAIN THE PATIENT FOLDER WOULD NOT POPULATE AND WAS S

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A COMPLAINT WAS PRESENTED TO A FIELD SERVICE ENGINEER (FSE) ON 12 FEB 2020 BY A RESIDENT. THE MESSAGE SAID "WE RECENTLY HAD TWO ROSA BIOPSIES THAT WERE NON-DIAGNOSTIC. BASED ON POSTOP IMAGING, IT LOOKS LIKE THE TRAJECTORIES WERE TOO SHORT ¿ THE NEEDLE TRAJECTORY DIDN¿T GO DEEP ENOUGH". AFTER RECEIVING THIS MESSAGE THE FSE REACHED OUT TO ANOTHER FSE TO PERFORM A FULL PREVENTATIVE MAINTENANCE (PM) ON THE (B)(4) ROBOT. THE PM WAS COMPLETED ON 13 FEB 2020. ROBOT (B)(4) PASSED ALL PM TESTING. AFTER PERFORMING A PM, THE FSE HAD A BIOPSY CASE. AN OARM SPIN WAS PERFORMED WITH THE BIOPSY NEEDLE IN THE HEAD ON THIS PATIENT AND THE TRAJECTORY ON EXTREMELY ACCURATE AND THE SURGEON WAS VERY SATISFIED. ON THIS DAY WE ALSO FOUND ON ONE OF THE TWO PATIENTS HE HAD PREVIOUSLY MENTIONED WAS DIAGNOSED DESPITE HIS INITIAL THOUGHTS AND COMMENTS. THEREFORE, ONLY ONE PATIENT WAS LESS THAN A CM SHALLOW.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A COMPLAINT WAS PRESENTED TO A FIELD SERVICE ENGINEER (FSE) ON 12 FEB 2020 BY A RESIDENT. THE MESSAGE SAID "WE RECENTLY HAD TWO ROSA BIOPSIES THAT WERE NON-DIAGNOSTIC. BASED ON POSTOP IMAGING, IT LOOKS LIKE THE TRAJECTORIES WERE TOO SHORT ¿ THE NEEDLE TRAJECTORY DIDN¿T GO DEEP ENOUGH". AFTER RECEIVING THIS MESSAGE THE FSE REACHED OUT TO ANOTHER FSE TO PERFORM A FULL PREVENTATIVE MAINTENANCE (PM) ON THE (B)(4) ROBOT. THE PM WAS COMPLETED ON 13 FEB 2020. ROBOT (B)(4) PASSED ALL PM TESTING. AFTER PERFORMING A PM, THE FSE HAD A BIOPSY CASE. AN OARM SPIN WAS PERFORMED WITH THE BIOPSY NEEDLE IN THE HEAD ON THIS PATIENT AND THE TRAJECTORY ON EXTREMELY ACCURATE AND THE SURGEON WAS VERY SATISFIED. ON THIS DAY WE ALSO FOUND ON ONE OF THE TWO PATIENTS HE HAD PREVIOUSLY MENTIONED WAS DIAGNOSED DESPITE HIS INITIAL THOUGHTS AND COMMENTS. THEREFORE, ONLY ONE PATIENT WAS LESS THAN A CM SHALLOW.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DE BIASE, G., GRUENBAUM, B. F., BOJAXHI, E., PATTERSON, J. S., SABETTA, K., QUINONES-HINOJOSA, A., ABODE-IYAMAH, K. (2025). AWAKE MINIMALLY INVASIVE SURGERY TRANSFORAMINAL LUMBAR INTERBODY FUSION UNDER SPINAL ANESTHESIA: SCREW PLACEMENT ACCURACY AND 1 YEAR FOLLOW-UP. WORLD NEUROSURGERY, 194(123478), 1¿7. HTTPS://DOI.ORG/10.1016/J.WNEU.2024.11.061 OBJECTIVE: WE ASSESSED THE ACCURACY OF PEDICLE SCREWS PLACED DURING AWAKE MINIMALLY INVASIVE SURGERY (MIS) TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) UNDER SPINAL ANESTHESIA AND ANALYZED OUTCOMES AT THE 1-YEAR FOLLOW-UP. METHODS: WE INCLUDED PATIENTS WHO UNDERWENT AWAKE MIS-TLIF UNDER SPINAL ANESTHESIA AT AN ACADEMIC CENTER FROM FEBRUARY 2020 TO FEBRUARY 2022. THE GERTZBEIN-ROBBINS CLASSIFICATION WAS USED FOR SCREW ACCURACY RATING. RESULTS: A TOTAL OF 100 PEDICLE SCREWS WERE INSERTED IN 24 PATIENTS, WITH THE MOST COMMON LEVEL BEING L4-5. MEDIAN AGE WAS 63.5 ±16.5 (INTERQUARTILE RANGE) YEARS, 42% MALE, MEDIAN BODY MASS INDEX 28 ± 6 KG/M2, AND MEDIAN AMERICAN SOCIETY OF ANESTHESIOLOGISTS CLASS WAS 2 ± 1. TWO PATIENTS UNDERWENT A 2-LEVEL FUSION, AND 22 PATIENTS UNDERWENT A 1-LEVEL FUSION. MEDIAN ESTIMATED BLOOD LOSS WAS 35 ± 25 ML, MEDIAN

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PRIOR TO CONTACTLESS REGISTRATION, WHILE TRYING TO CALIBRATE THE LASER THE SITE RECEIVED THE ERROR 'ERROR WHILE INITIALIZING THE DISTANCE SENSOR. SWITCH OFF AND BACK ON THE DISTANCE SENSOR BEFORE TYING AGAIN'. IT WAS ALSO REPORTED THAT THEIR APPEARED TO BE TWO BEAMS ON THE CALIBRATION PLATE. THE SENSOR WAS SWITCHED OFF AND BACK ON AND THE USER STILL RECEIVED THE ERROR. THE ROBOT WAS THEN TURNED OFF AND REBOOTED AND THE LASER LENS WAS CLEANED. THE ERROR WAS STILL BEING RECEIVED SO THEY USED A DIFFERENT LASER. RESULTED IN ABOUT 45 MINUTE DELAY AS A SECOND LASER HAD TO BE RETRIEVED FROM ANOTHER ROBOT TO CONTINUE. THE CASE RESUMED AS NORMAL.

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 8MM BLADELESS OBTURATOR INSTRUMENT TIP WAS BROKEN OFF AND FELL INSIDE THE PATIENT. THE TIP WAS NOT RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO OTHER REPORTED ISSUES. INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE OPERATING ROOM (OR) MANAGER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE TIP OF THE 8MM BLADELESS OBTURATOR INSTRUMENT WAS NOT RETRIEVED. THE INSTRUMENT DID NOT MAKE CONTACT WITH ANY OTHER INSTRUMENT OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. THE OR MANAGER WAS NOT SURE IF THE INSTRUMENT WAS INSPECTED PRIOR TO USE OR IF THE INSTRUMENT WAS REMOVED DURING THE PROCEDURE. THE OR MANAGER WAS UNSURE IF ANY POST-OPERATIVE TESTS (X-RAY, ULTRA SOUND) WERE PERFORMED TO CHECK FOR THE TIP. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT. THE PROCEDURE WAS COMPLETED ROBOTICALLY. THE OPERATION ROOM MANAGER NOTED THAT THE INSTRUMENT WOULD BE RETURNED TO ISI FOR FAILURE INVESTIGATION.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE FIELD SERVICE ENGINEER (FSE) ASSISTED THE SURGEON WHILE IMPORTING THE CT INTO THE SETUP PATIENT FOLDER (RO1506620200127B). IMPORT OF THE CT WENT WELL. THEN SURGEON WANTED TO RECOGNIZE THE FRAME IN THE CT. HE RECORDED THE 9 INITIAL POINTS AND CLICKED PROPAGATION. WHEN GOING THROUGH THE SLICES, THE SURGEON AND THE FSE FOUND THAT THE MARKER JUMPS ON A PART OF THE X-RAY PROTECTION GLASSES, WHICH THE PATIENT WORE DURING THE CT ACQUISITION. SURGEON CLICKED ON PROPAGATION AND GOT AN RMS > 2 MM (RED FLAGGED). HE RESETED THE POINTS AND CHANGED THE SLICE, WHERE HE RECORDED THE INITIAL POINTS AND CLICKED PROPAGATION AGAIN. WHEN GOING THROUGH THE SLICES HE FOUND THE INITIAL POINTS CHANGED TO A BAD POINT. THE FSE AND SURGEON AGREED ON IMPORTING AGAIN ONLY A PARTIAL CT. WHEN DETECTING THE FRAME ON THE PARTIAL CT, THEY COULD ACHIEVE AN RMS OF 0,8 MM. BY CHANGING THE INITIAL SLICE THEY ACHIEVED A RMS OF 0,78 MM. THE FIRST SURGEON CLICKED ON ACCEPT. ANOTHER ASSISTED SURGEON DID NOT WANT TO ACCEPT. THEN HE TRIED TO LOAD THE SAME CT A 3. TIME, TO TRY LOADING A DIFFERENT PART OF THE CT. (B)(6) DID NOT LOAD THE SERIES ANY. MORE. THEY SET UP THE PATIENT FOLDER (RO1506620200127A) WITH ONLY A T1 AND T

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE FIELD SERVICE ENGINEER RECEIVED A CALL FROM THE SURGEON BECAUSE THE CONTROLLER OF THE ROBOT (B)(6) HAS NOT ACHIEVED TO ESTABLISHED A CONNECTION WITH ROSA SOFTWARE 3.1.0. AFTER SOME TROUBLESHOOTING'S BY PHONE, THOMAS CONCLUDED THAT THE ISSUE CANNOT BE SOLVED WITHOUT ANY TECHNICAL ASSISTANCE ON SITE. THE SURGERY WAS CANCELED, WITH NO PATIENT IMPACT. THE NEXT DAY, ANOTHER FSE AN WAS ON SITE. HE NOTICED THAT THE STARC CARD WAS LOOSING. HE SOLVED THE ISSUE BY RECONNECTING THE STARC CARD TO THE CONTROLLER.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2020, A FIELD SERVICE ENGINEER (FSE) WAS PRESENT TO ASSIST A SURGERY AFTER THE UPGRADE OF DEVICE (B)(6) FROM 3.0 TO 3.1 BY A TECHNICAL TEAM MEMBER THE DAY BEFORE. AT THE BEGINNING, TWO PROBLEMS WERE IDENTIFIED, THE SOFTWARE LANGUAGE WAS NOT FRENCH AND THE DIRECT TRANSFER CONNECTION BETWEEN THE DEVICE AND THE O-ARM WAS NOT ESTABLISHED. THE FSE CALLED TWO OTHER FSES IN ORDER TO FIX THE ISSUE. AFTER MODIFICATION, THE DEVICE STAYED BLOCKED 1 HOUR WITHOUT BEING ABLE TO BE STARTED FOLLOWING THE MODIFICATION OF THE IP ADDRESS OF THE PACS. THE FSE CALLED A SERVICE TRANSFER ENGINEER IN ORDER TO OBTAIN THE CORRECT IP ADDRESS AND FIX THE ISSUE. SURGERY WAS PERFORMED NORMALLY WITH ONE HOUR DELAY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: INSTRUMENT NOT GRABBING SUTURE. FDA SAFETY REPORT ID# (B)(4).

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON 10-FEBRUARY-2020, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA VOLUNTARY REPORT # MW5092558 WITH THE FOLLOWING EVENT DESCRIPTION, "THE PATIENT SUFFERED VAGINAL DEHISCENCE 12 WEEKS AFTER RECEIVING A DA VINCI ROBOTIC HYSTERECTOMY. REQUIRED EMERGENCY SURGERY TO PREVENT BOWEL EVISCERATION AND DEATH." HOWEVER, THERE IS NO ADDITIONAL INFORMATION PROVIDED REGARDING THE DA VINCI SURGICAL SYSTEM, HOSPITAL SITE NAME, OR PATIENT. AS A RESULT, ISI COULD NOT PERFORM FOLLOW-UP INVESTIGATION TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT.

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 FOR FOLLOW-UP INFORMATION.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MAKO ROBOTIC EQUIPMENT MADE INCORRECT POSTERIOR CHAMBER CUT DURING SURGERY. FDA SAFETY REPORT ID# (B)(4).

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: EVENT REPORTED BY THE FIELD SERVICE ENGINEER : THE ROBOT BS18962, WOULDN¿T CONNECT. THE PATIENT WAS ATTACHED TO THE ROBOT, AS WE WANTED TO START THE REGISTRATION PROCESS THE ROBOT DISPLAYED 'UNRECOVERABLE ERROR OCCURRED' WHICH RESULTED IN A SHUTDOWN. WHEN THE ISSUE OCCURRED WE DISCONNECTED THE PATIENT WITHIN 15-20 MINUTES AND THE SURGERY WAS PERFORMED USING A DIFFERENT METHOD.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THE LEFT LS SCREW WAS PLACED LOW TO PLAN. THE SCREW WAS REPOSITIONED INTRA-OPERATIVELY TO A NEW TRAJECTORY USING FLUOROSCOPIC IMAGING. IMMEDIATELY POST-OPERATIVE THE PATIENT HAD LIMITED MOVEMENT TO THE LOWER LEG AND FOOT. 28 DAYS LATER, THE SURGEON REPORTED THAT THE PATIENT HAD STARTED TO RECOVER MOVEMENT AND BELIEVED THIS IMPROVEMENT WOULD CONTINUE.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: SURGEON PERFORMING MARKER REGISTRATION, NOTED THAT MOVEMENT IS MARKEDLY DIFFERENT POST-UPGRADE. SURGEONS BOTH NOTED THE INCREASED DIFFICULTY WITH MOVEMENT USING POINTER TO PERFORM REGISTRATION. SURGEON FINDS IT "ALMOST UNUSABLE". SURGEONS EXPRESSED CONCERN FOR FUTURE SCHEDULED CASES; ADDITIONALLY NOTED THAT MAYBE WILL NOT PURCHASE SECOND SYSTEM IF CONTINUES TO BE DIFFICULT TO USE. DELAY OF 30 MINUTES. PATIENT UNDER ANESTHESIA, PINNED, BUT AWAKE; DBS PROCEDURE.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MARKERS REGISTRATION FLIPPED ANTERIOR AND POSTERIOR UPON VERIFICATION. MARKERS WERE RECORDED IN CORRECT ORDER. REGISTRATION WAS PERFORMED AGAIN, AND AN ADDITIONAL MARKER WAS DEFINED ON THE LEKSELL FRAME TO ORIENT AN ADDITIONAL MARKER IN NON-SYMMETRICAL PLACEMENT. RMS WAS ACCEPTABLE. DELAY OF 25 MINUTES. PATIENT UNDER ANESTHESIA, BUT AWAKE, DBS PROCEDURE, PATIENT PINNED. NO INCISION.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2020, PATIENT EXPERIENCED A PNEUMOTHORAX DURING THE POST PROCEDURE CHEST FLUOROSCOPY USING THE MONARCH SYSTEM. PATIENT WAS REQUIRED TO BE HOSPITALIZED. CHEST TUBE WAS PLACED ON (B)(6) 2020. PNEUMOTHORAX WAS RESOLVED AND PATIENT WAS RELEASED. ELEVEN SUCCESSFUL BIOPSIES WERE COMPLETED USING FIVE NON-AURIS NEEDLES, THREE NON-AURIS BRUSHES, AND THREE AURIS FORCEPS.

At 4:30 a.m. on January 9, 2020, an employee and Coworker #1 were performing maintenance work drilling out and replacing bolts for an access panel on the pusher table of an auto depalletizing robot (Robot #2) within a robot cell. At the same time, coworker #2 was preparing to test the operational functions of the dunnage robot (Robot #1). Coworker #2 completed maintenance work on Robot #1 while the employee and Coworker #1 remained inside the robot cell. Coworker #2 exited the robot cell to reset the light curtains. The employee and Coworker #1 had entered the robot cell through the light curtains and that neither had isolated the electrical and pneumatic energy sources at the controls on Robot #2 or affixed lockout devices before performing maintenance work. Coworker #2 reset the robot cell perimeter light curtains for Robot #1 and Robot # 2 in preparation for a test run on Robot #1. The Robot #2 pusher table and robot arm turned on after the perimeter light curtains were reset and the run cycle was initiated in automatic mode on the operator control panel. The employee and Coworker #1 were both sitting on the Robot #2 pusher table while repairing damaged bolts on the table, so the pusher arm sensor for the Robot #2 pusher arm detected something on the table that needed to be pushed off. Coworker #1 managed to get off the pusher table without injury, but the employee was unable to move in time. The employee's feet had dropped down into the recessed area where they had removed an access plate from the table. His feet were repeatedly struck by the pusher arm as the robot tried to complete the normal programmed action of clearing materials from the table outgoing conveyors. His coworkers hit the emergency stop buttons on the outside of the robot cell and helped the employ

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING GUIDANCE OF THIRD TRAJECTORY, THE ROBOT ARM COLLIDED WITH AN ANCHOR BOLT, AND THE RESULTING IMPACT KNOCKED IT OUT OF THE PATIENT¿S HEAD. THE CASE WAS THEN ABORTED. BECAUSE A FIELD SERVICE ENGINEER (FSE) WAS NOT PRESENT AT THE TIME OF THE EVENT, WE ARE STILL MISSING A LOT OF THE DETAILS. A FSE PERFORMED ACCURACY CHECKS ON FRIDAY, 10-JAN-2020, AND VERIFIED THAT THE SYSTEM PASSED THOSE CHECKS SUCCESSFULLY.

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 2 ELECTRODES IMPLANTED, ABORTED PROCEDURE AFTER THIRD TRAJECTORY. POST-OP SCAN INDICATED BOTH ELECTRODES WERE DEEP ROUGHLY 3-5MM.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AT THE BEGINNING OF REGISTRATION SURGEON ASKED FOR HIS SPEED TO BE SWITCHED FROM SLOW TO FAST. WHEN USING THE TOUCH SCREEN TO DO THIS TASK, THE SCREEN FROZE AND THE ROBOT SHUTDOWN. WE THEN CONTINUED TO COMPLETE REGISTRATION. AFTER REGISTRATION, THE SURGEON REQUESTED THAT WE USE THE DISTANCE SENSOR TO MARK THE ENTRY POINTS ON THE HEAD. WHILE DRIVING TO TRAJECTORY 13, JOINT NUMBER 6 COLLIDED WITH THE TELESCOPIC ARM. THIS RESULTED IN A SHUTDOWN. AFTER REBOOTING, IT WAS NOT POSSIBLE TO MOVE THE ARM AWAY FROM THE TELESCOPIC ARM BECAUSE THE ROBOT WOULD SHUTDOWN JUST BEFORE SHOWING THE 'CLEARING THE PATIENT' SCREEN. THERE WERE MULTIPLE SHUTDOWNS BEFORE THE FIELD SERVICE ENGINEER (FSE) DECIDED TO MANUALLY RELEASE THE ARM. THE FSE REMOVED THE SIDE PANEL AND MANUALLY RELEASED THE ARM BY MOVING JOINT NUMBER 3. THE FSE REBOOTED THE ROBOT AND CONTINUED ON WITH THE SURGERY. THERE WAS NO HARM TO THE PATIENT. THIS PROCESS DELAYED THE CASE ABOUT 30 MINUTES.

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 DURING A ROSA BRAIN PROCEDURE, AN RNS NEUROSTIMULATOR KIT (COMPETITOR PRODUCT) WAS PLACED INTO THE WRONG SPOT IN THE OPTICAL NERVE. THE PATIENT HAS EXPERIENCED PAIN SINCE THE PROCEDURE. DURING FOLLOW-UP EVALUATION, THE FREQUENCY WAS INCREASED ON THE RNS DEVICE WHICH CAUSED A SEIZURE. IT WAS CONFIRMED AT THAT TIME THAT THE RNS WAS PLACED IN THE WRONG LOCATION. THE DEVICE WAS REMOVED AND REPLACED APPROXIMATELY 4 (FOUR) YEARS LATER. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

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 ON (B)(6) 2019, A PATIENT HAD A PNEUMOTHORAX THAT WAS DISCOVERED AFTER A PROCEDURE. THE LOCATION OF THE LESION IS IN THE LEFT UPPER LOBE, AND A NEEDLE BIOPSY WAS PERFORMED USING A SUPER D ARCPOINT NEEDLE. THE LOCATION OF THE PNEUMOTHORAX IS IN THE LINGULAR OF THE LEFT LUNG. THERE WERE TWO PATHWAYS TAKEN TO ACCESS THE LESION, ONE FROM THE LEFT LOWER LOBE, AND ANOTHER FROM THE LEFT UPPER LOBE. A CHEST TUBE WAS PLACED IN THE PATIENT AND WAS ADMITTED TO THE HOSPITAL OVERNIGHT. THERE WAS NO REPORT OF DEVICE FAILURE.