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 MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY ALLEGEDLY TORE AND FELL INSIDE THE PATIENT¿S STOMACH. IT IS UNCLEAR IF THE WHOLE OR A FRAGMENT OF THE MCS TIP COVER ACCESSORY FELL INSIDE THE PATIENT. IT IS ALSO UNKNOWN IF THE MCS TIP COVER ACCESSORY OR FRAGMENT WAS FOUND AND RETRIEVED FROM THE PATIENT.

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 AT THE END OF THE PROCEDURE, THE PHYSICIAN NOTICED A TEAR ON THE RIGHT SIDE OF THE TRACHEA AT THE DISTAL END. THE PATIENT WAS SENT TO ANOTHER DEPARTMENT TO HAVE A STENT PLACED TO TREAT THE TEAR. NO DEVICE MALFUNCTION WAS REPORTED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AT APPROXIMATELY 12:30PM, POST OPERATIVE CT SCAN NAMED CT POSTOP WAS ACQUIRED BY O-ARM AND LOADED INTO ROSA. SURGEON NOTED 19 ACCURATE ELECTRODES AND 1 INACCURATE ELECTRODE AT TRAJECTORY J ALTHOUGH ANCHOR BOLT WAS ACCURATELY PLACED. ELECTRODE WAS APPROXIMATELY 7MM ABOVE PLANNED TARGET. SURGEON PLANNED ALTERNATIVE TRAJECTORY JJ BUT POSTOPERATIVE CT SCAN NAMED CT POSTOP2 SHOWED NEW ELECTRODE WAS APPROXIMATELY 14MM ABOVE PLANNED TARGET. SURGEON BELIEVES UNKNOWN CEREBRAL ELEMENT DEFLECTING ELECTRODES AND THAT INACCURACY IS NOT DUE TO ROSA ERROR, LEFT ELECTRODE JJ IN THE BRAIN FOR RECORDING PURPOSES AND DID NOT INSERT AN ALTERNATIVE.

ROSA Robotic Surgery — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: SURGEON REPORTED ON (B)(6) THAT A PATIENT THAT HAD A SURGERY ON (B)(6) 2019 WITH ROSA DEVICE THE WEEK BEFORE PASSED AWAY FROM A BLEED. THE SURGEON SAID THAT THE ROSA ACCURACY WAS GOOD, AND DIDN'T BELIEVE IT CONTRIBUTED TO THE DEATH. THE PATIENT DID EAT THE MORNING OF THE CASE, CAUSING THE CASE TO BE DELAYED. THE TWO CT MACHINES AT THE HOSPITAL WERE OUT THE MORNING OF THE CASE, SO THE PATIENT WENT TO ANOTHER SITE TO HAVE A CT MORNING OF THE CASE. THE PATIENT WAS AWAKE DURING THE CT. ANESTHETIST REPORTED THERE MAY HAVE BEEN A BIG DIFFERENCE IN CO2 CAUSING SWELLING, AFTER ANESTHESIA. THE SURGEON ALSO ADD THAT THE PATIENT HAD LOTS OF BRAIN SWELLING AFTER THE CASE.

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 FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A GUIDANCE DEVICE BEING USED IN A SPINAL PROCEDURE. IT WAS REPORTED THAT 3DEFINE FAILED DURING THE PROCEDURE. A SECOND 3DEFINE WAS SUCCESSFUL. REGISTRATION WAS PERFORMED QUICKLY. UPON INSTRUMENTING FIRST TRAJECTORY (LEFT L4), THE WORKSTATION BEEPED AND GAVE AN INSTRUCTION TO LOCK THE ARM IN THE SOFTWARE. THE SURGEON DID NOT HAVE TOOLS IN THE ARM GUIDE WHEN THIS NOTIFICATION OCCURRED. THE ARM WAS RELOCKED IN THE SOFTWARE AND ANOTHER 3DEFINE WAS PERFORMED. THE 3DEFINE FAILED AGAIN ON THE FIRST ATTEMPT. THE SECOND ATTEMPT FOR 3DEFINE WAS SUCCESSFUL. REGISTRATION WAS PERFORMED QUICKLY, AND SURGEON INSTRUMENTED ALL 4 TRAJECTORIES. AP AND LATERAL X-RAY IMAGES VERIFIED WIRES WERE ACCURATELY PLACED. TWO DAYS FOLLOWING THE CASE, THE REP RECEIVED NOTIFICATION THAT THE RIGHT L4 SCREW HAD BEEN MISPLACED LATERAL AND SUPERIOR. REVISION PROCEDURE WAS SCHEDULED FOR SATURDAY (B)(6) 2019 TO REMOVE SCREW AND PLACE NEW ONE. IT WAS ALSO NOTED THAT THE WORKSTATION WOULD NOT ALLOW IMPORT OR EXPORT OF ANY DATA. THE PATIENT COMPLAINED OF RIGHT LEG PAIN POST OPERATIVELY. ADDITIONAL INFORMATI

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE INDIAN DISTRIBUTOR INFORMED A ZIMMER BIOMET TEAM MEMBER ON (B)(6) 2019 THAT THE FORCE SENSOR CABLE AND CONNECTOR GOT DAMAGED DURING A SURGERY. NO CASUALTIES AND THE CASE WAS COMPLETED AFTER FIXING THE CABLE.

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 WHEN THE FIELD SERVICE ENGINEER ARRIVED THE SCREEN DEVICE WAS BLACK AND THE POWER LIGHTS WERE NOT ON. ONE OF THE NURSES PLUGGED IN AND TURNED ON THE ROBOT THE SAME MORNING BEFORE THE FSE ARRIVED. THE NURSE SAID THE ROBOT NEVER BOOTED WHEN HE TURNED IT ON AND THAT THE SCREEN WAS ALWAYS BLANK THAT DAY. THE SURGERY WAS DELAYED TO THE AFTERNOON. THE FSE WAS ABLE TO DETERMINE THAT THE ISSUE WAS COMING FROM THE A FUSE THAT WAS BLOWN, AND WAS ABLE TO REPLACE IT SUCCESSFULLY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A "PARTIAL NEPHROTIC ROBOTIC LAPAROSCOPIC PROCEDURE" ON (B)(6)2019 WHO WAS READMITTED TO THE HOSPITAL "FOUR DAYS AFTER HER SURGERY" ON (B)(6) 2021 EXHIBITING POST-OPERATIVE SYMPTOMS OF ¿REGURGITATED APPROXIMATE 30 TIMES DURING THE PREVIOUS NINE HOURS"; VOMITING "BLACK COFFEE GROUND MATERIAL THAT SMELLED OF FECES." A RE-OPERATION WAS PERFORMED TO REPAIR AN "8MM HOLE" THAT HAD BEEN ¿LEFT BY THE ARM OF THE TROCHAR" CAUSING THE PATIENT¿S BOWEL TO BECOME "HERNIATED AND STRANGULATED." THE PATIENT WAS REPORTED AS STABLE AND THE PATIENT WAS DISCHARGED. IT WAS ALSO ALLEGED THAT A "BROKEN MACHINE" WAS NOT "ADEQUATELY REPAIRED" PRIOR TO THE INITIAL PROCEDURE ON (B)(6) 2019. IT WAS ALSO ALLEGED THAT DURING THE INITIAL PROCEDURE ON (B)(6) 2019, THERE WAS A "NEED TO CONVERT TO AN OPEN PROCEDURE," THERE WERE "ADDITIONAL OR LARGER INCISIONS," THAT THERE WAS ¿EQUIPMENT FAILURE," AND THERE WERE "UNCONTROLLED ELECTRICAL CURRENTS" WITH "PARTS OF THE ROBOT BEING LEFT BEHIND," AND THERE WERE "TISSUE BURNS" DUE TO "THE SURGEON NOT BEING IN TOTAL CONTROL OF THE ROBOT." THE FOLLOWING ADDITIONAL

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 DURING THE VERIFICATION STEP OF THE REGISTRATION, IT WAS NOTED THAT THE TEMPLES ON THE SCAN LOOKED TOO DEEP IN THE SKIN. UPON EXAMINATION OF THE CT, IT APPEARED THAT THE PATIENT WAS WEARING GLASSES WHILE THE SCAN WAS TAKEN DUE TO AN INDENT ON THE SKIN. A COUPLE OF THE TRAJECTORIES WERE ALONG THIS LINE; HOWEVER, THE SURGEON DEBATED IF THE REGISTRATION COULD STILL BE USED. UPON CHECKING THE ENTRY POINT OF OTHER TRAJECTORIES, IT WAS SEEN THAT THE CROSSHAIR OF THE LASER LOOKED PERFECTLY ON THE SKIN FOR SOME, BUT WAS OFF FOR OTHERS. THE REGISTRATION WAS CANCELLED AND RE-PERFORMED. THIS CAUSED A DELAY OF ABOUT 30 MINUTES TO THE SURGERY. DURING THE TEMPLE SCAN OF THE SECOND REGISTRATION THE AREA WHERE THE PATIENT WAS WEARING GLASSES WAS AVOIDED. THE VERIFICATION OF THE SECOND REGISTRATION WAS ACCEPTABLE AND BETTER THAN THE FIRST.

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 VIA SOCIAL MEDIA (I.E. (B)(6) POST) THAT A PATIENT UNDERWENT AN UNSPECIFIED DA VINCI-ASSISTED ¿BIOPSY¿ PROCEDURE AND ALLEGEDLY EXPERIENCED OPERATIVE COMPLICATIONS. PER THE INITIAL (B)(6) POSTING, THE FOLLOWING WAS NOTED: ¿MY FATHER DIED TWO YEARS AGO WHEN A DAVINCI-AIDED BIOPSY CAUSED MASSIVE BLEEDING. HE MADE ME PROMISE I WOULD NOT SUE. HE DID NOT MAKE ME PROMISE I WOULD NOT TALK ABOUT IT.¿ ON (B)(6) 2019, THE INITIAL REPORTER POSTED THE FOLLOWING SUBSEQUENT (B)(6) POSTING: ¿(B)(6). YOU CAN TAKE IT FROM THERE.¿ REFER TO THE FOLLOWING LINK FOR THE (B)(6) POSTINGS: "(B)(6)".

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 VIA SOCIAL MEDIA THAT AFTER UNDERGOING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY PROCEDURE, THE PATIENT CLAIMED THAT HE EXPERIENCED A POST-OPERATIVE COMPLICATION AS A RESULT OF ALLEGED DAMAGE TO HIS URINARY SPHINCTER. WITHIN THE WEB ARTICLE, "FDA SOUNDS AN ALARM ON USING ROBOTIC DEVICES IN CANCER SURGERIES, CITING CONCERNS ABOUT SAFETY AND RESULTS" (DATED 02/28/2019), THE PATIENT POSTED THE FOLLOWING COMMENT: (B)(6).

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 NOTED BY THE FIELD SERVICE ENGINEER (FSE) THAT THE PRE-OP EXAM THAT WAS GOING TO BE USED WAS CUT OFF JUST BELOW THE PATIENT'S EYE LIDS, CUTTING OFF MOST OF THE NOSE. THE FSE NOTIFIED THE SURGEON AND EXPLAINED THAT THIS MAY CAUSE AN ISSUE WITH THE REGISTRATION AND VERIFICATION, SINCE THE ACQUISITION PROTOCOL STATES THAT THE NOSE NEEDS TO BE INCLUDED FOR LASER REGISTRATION. THE SURGEON DID NOT HAVE ANOTHER SCAN TO USE, AND WANTED TO GIVE THE REGISTRATION A TRY WITH THE CUT OFF SCAN. DURING REGISTRATION, THE SURGEON MADE SURE TO STAY ABOVE THE PORTION WHERE THE SCAN WAS CUT OFF, AND THE FSE DID NOT NOTICE ANY ERRORS. THE LASER REGISTRATION VERIFICATION SEEMED TO HAVE PASSED AFTER CHECKING THE INITIAL 7 POINTS ON THE FRONT OF THE PATIENT'S FACE. THE LASER WAS THEN BROUGHT TOWARDS THE BACK OF THE PATIENT'S SKULL TO VERIFY THE REGISTRATION WHERE THE TRAJECTORIES WERE BEING PLACED. THE FSE NOTICED THAT THE LASER MARKER FOR VERIFICATION WAS AROUND 4MM OFF THE SKIN OF THE SKULL ON THE SOFTWARE. THE AREA THAT WAS CHECKED HAD BEEN SHAVEN, AND THERE WAS NO HAIR THAT APPEARED TO BE INTERFERING WITH THE LASER. OTHER POINTS ON THE SKULL WERE CHECKED AND GAVE SIMILAR RESULTS, SHOWING THAT T

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 THE SURGEON DECIDED TO USE BONE FIDUCIALS FOR PATIENT REGISTRATION. SIX BONE FIDUCIALS WERE INSERTED TO THE PATIENT'S SKULL, AND THEN THE PATIENT WAS TAKEN AWAY FROM THE OR TO GET A CT SCAN DONE WITH THE FIDUCIALS INSERTED. AFTER UPLOADING THE IMAGES, THE FIELD SERVICE ENGINEER NOTICED THERE WERE MORE THAN THE 255 MAXIMUM NUMBER OF SLICES IN THE IMAGE SET. THE FSE REMOVED ENOUGH SLICES FROM THE IMAGE SET (REMOVED SLICES BELOW THE NOSE) AND ATTEMPTED TO MERGE THAT SCAN TO THE CUT-OFF PRE-OP CTA SCAN. THE MERGE WAS UNSUCCESSFUL. THE FSE NOTIFIED THE SURGEON THAT THE MOST LIKELY REASON FOR THE FAILURE IS THAT THE SCAN BEING MERGED TO IS CUT OFF AT THE NOSE. THE FSE ATTEMPTED TO MERGE THE BONE FIDUCIAL CT TO ONE OF THE PRE-OP MR SCANS THAT WERE ALREADY UPLOADED, AND THE MERGE APPEARED TO BE SUCCESSFUL TO THE MR SCAN (MR SCAN WAS NOT CUT AT THE NOSE). AFTER ACCEPTING THIS MERGE, THE PRE-OP CTA AND NEWLY MERGED BONE FIDUCIAL CT WERE COMPARED TO SEE IF THEY OVERLAYED CORRECTLY. THERE WAS A NOTICEABLE DIFFERENCE BETWEEN THE TWO SCANS, WHERE ONE WAS SHIFTED A MM OR SO FROM THE OTHER. THE FSE AND SURGEON BOTH DECIDED THIS MERGE WAS NOT CORRECT. THE FSE ATTEMPTED TO PERFO

At 7:00 p.m. on March 21, 2019, an employee was realigning robot arm and ring on Press #30. The employee's hand was in the machinery when the ejector plate/ring retracted into the press which caught the employee's left hand between the mold and the ring. The employee suffered fingertip amputations to the index and middle fingers on his left-hand. Hospitalization was not required.

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 INITIALLY REPORTED THAT AFTER UNDERGOING A DA VINCI-ASSISTED NISSEN FUNDOPLICATION PROCEDURE, A PUNCTURE WOUND WAS FOUND ON THE PATIENT'S SIGMOID COLON. THE PATIENT WAS REPORTEDLY STILL IN THE HOSPITAL. ON (B)(4) 2019, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT WAS OBTAINED: THE CSR WAS PRESENT DURING THE DA VINCI-ASSISTED NISSEN FUNDOPLICATION PROCEDURE WHICH WAS NOT RECORDED ON VIDEO. NO INTRA-OPERATIVE COMPLICATIONS WERE IDENTIFIED. THERE WERE ALSO NO REPORTS OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. THE SURGICAL PROCEDURE WAS COMPLETED ROBOTICALLY. ON POST-OPERATIVE DAY #1, THE PATIENT HAD COMPLAINTS OF ABDOMINAL PAIN. THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM (OR) AND A PUNCTURE WOUND ON THE SIGMOID COLON WAS IDENTIFIED. A BOWEL RESECTION WAS PERFORMED BY A COLORECTAL SURGEON TO ADDRESS THE BOWEL INJURY. ON AN UNSPECIFIED DATE POST-OPERATIVELY, THE CSR WAS INFORMED THAT THE PATIENT ULTIMATELY EXPIRED. THE CSR SPOKE TO THE SURGEON ABOUT THE POST-OPERATIVE COMPLICATION (I.E. BOWEL INJURY). ACCORDING TO THE CSR, THE SURGEON DID NOT K

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: SURGEON WANTED TO PERFORM LASER REGISTRATION. HOWEVER, AFTER TAKING THE INITIAL POINTS AND SCANS, THE FIELD SERVICE ENGINEER (FSE) RECEIVED THE ERROR MESSAGE THAT THE "REGISTRATION COULD NOT BE COMPUTED". EVEN AFTER ADJUSTING THE INITIAL POINTS, FSE RECEIVED THE SAME MESSAGE. FSE AND SURGEON ATTEMPTED LASER REGISTRATION A 2ND TIME AFTER ADJUSTING THE 3D RECONSTRUCTION. UNFORTUNATELY, THE SAME ERROR MESSAGE WAS RECEIVED AFTER TAKING THE INITIAL POINTS AND SCANS AGAIN. FSE MOVED THE ROBOT CLOSER TO THE PATIENT, AND AFTER THE 3RD REGISTRATION ATTEMPT, REGISTRATION WAS COMPLETED SUCCESSFULLY. PATIENT WAS UNDER ANESTHESIA, NO INCISION HAD BEEN MADE. DELAY TO CASE WAS SUPERIOR TO 30 MINUTES. NO PATIENT IMPACT. ADDITIONALLY, 2 ROBOT SHUT DOWNS OCCURRED DURING THE CASE. THE FIRST SHUTDOWN OCCURRED DURING THE 1ST REGISTRATION ATTEMPT. THE SECOND SHUTDOWN OCCURRED DURING THE 3RD REGISTRATION ATTEMPT.

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 APPROXIMATELY TWO (2) HOURS AFTER A SUCCESSFUL MONARCH-ASSISTED BIOPSY PROCEDURE, A PNEUMOTHORAX WAS IDENTIFIED WHILE THE PATIENT WAS STILL IN THE HOSPITAL, AND A CHEST TUBE WAS PLACED. THE PATIENT WAS DISCHARGED THE NEXT DAY. THERE WERE NO REPORTED ISSUES WITH THE MONARCH SYSTEM. THE PHYSICIAN STATED THAT THE CAUSE OF PNEUMOTHORAX WAS THE ANATOMY OF THE PATIENT'S NODULE AND THE SEVERITY OF THEIR LUNG DISEASE. THE PHYSICIAN ALSO STATED THAT THE PNEUMOTHORAX WAS NOT CAUSED BY THE MONARCH PLATFORM. PNEUMOTHORAX IS A KNOWN POTENTIAL RISK OF PERIPHERAL LUNG BIOPSY.

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 THE DISTANCE SENSOR CABLE BECAME PINCHED IN THE FINAL ROBOT ARM JOINT DURING THE REGISTRATION. THE SYSTEM FROZE AND IT WAS NOT POSSIBLE TO RESTART OR SEND THE ROBOT ARM TO THE HOME POSITION. THE FIELD SERVICE ENGINEER EXITED THE CASE APPLICATION AND ENTERED THE MAINTENANCE MODE TO LOAD THE KINEVERIF PROGRAM, AFTER WHICH HE WAS ABLE TO DRIVE THE ROBOT TO THE HOME POSITION AND TO RELEASE THE CABLE. IT WAS THE HARD CASE PART OF THE CABLE THAT BECAME TRAPPED. THERE WERE SOME PRESSURE MARKS VISIBLE ON THE INSULATION, BUT NO SIGNS OF DAMAGE TO THE ACTUAL CABLE. THE DEVICE WAS RESTARTED BUT THE SYSTEM WOULDN¿T PROGRESS PAST ASKING TO CONFIRM CALIBRATION OF DISTANCE SENSOR LASER TOOL. AFTER MULTIPLE ATTEMPTS THE DEVICE WAS TURNED OFF ENTIRELY AND REBOOTED. AFTER THIS THE DEVICE WORKED AS INTENDED.

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 THE SURGEON STATED THAT THE AUTOMATIC FUSION OF THE MRI AND CT WAS NOT WORKING PROPERLY. FINALLY FUSION WAS PERFORMED MANUALLY AND THE SURGERY WAS CONTINUED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE FORCE SENSOR CONNECTION OF DEVICE RO16084 AT SHENZHEN SECOND PEOPLE'S HOSPITAL WAS FOUND BROKEN DURING PRE-OPERATIVE INSPECTION. SURGERY WAS CONVERTED INTO TRADITIONAL SURGERY.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PATIENT UNDERWENT MONARCH BRONCHOSCOPY PROCEDURE WITH BIOPSY UNDER CLINICAL PROTOCOL AND AURIS BECAME AWARE OF AN EVENT FROM CLINICAL CASE REPORT FORM THAT ON (B)(6) 2019 A PNEUMOTHORAX WAS IDENTIFIED IN A PATIENT FOLLOWING A BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2019 USING THE MONARCH ENDOSCOPY PLATFORM (MONARCH PLATFORM). ACCORDING TO THE REPORT, A SIX-MILLIMETER PNEUMOTHORAX WAS OBSERVED IN A POST PROCEDURE X-RAY APPROXIMATELY 2 HOURS POST BRONCHOSCOPY PROCEDURE. THE X-RAY WAS REPEATED APPROXIMATELY 3 HOURS POST PROCEDURE AND THE PATIENT WAS DEEMED STABLE AND DISCHARGED FROM THE HOSPITAL. THE PATIENT REPORTED A MILD SORE THROAT AND CHEST PAIN BUT OTHERWISE FELT FINE IN A 24-HOUR FOLLOW-UP PHONE CALL. TWO (2) DAYS AFTER THE PROCEDURE ((B)(6) 2019), AN URGENT CARE PHYSICIAN CONTACTED THE HOSPITAL WHERE THE PROCEDURE WAS PERFORMED TO REPORT THAT AN X-RAY INDICATED A 25% COLLAPSE OF THE PATIENT'S RIGHT LUNG. A FELLOW ADVISED SENDING THE PATIENT TO HOSPITAL TO BE MONITORED WITH REPEAT X-RAY IN MORNING. ON (B)(6) 2019 A FELLOW RECEIVED A CALL FROM PHYSICIAN AT THE HOSPITAL INDICATING THAT THE PATIENT'S PNEUMOTHORAX MEASURED 13 MM AND CHEST CT DEMONSTRATED HYDROPNEUMOTHORAX AT TIM

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AT APPROXIMATELY 2:00 PM, POST-OPERATIVE CT SCAN OF SEEG PATIENT SHOWED SMALL HEMORRHAGE NEAR THE SURFACE OF TRAJECTORY 7. SURGEON DOES NOT BELIEVE THIS ISSUE WAS DUE TO ROSA MALFUNCTION. THEN, FUSION OF POST-OPERATIVE CT SCAN OF SEEG PATIENT SHOWED 3 ELECTRODES PLACED MORE THAN 10 MM DEEPER THAN PLANNED TRAJECTORIES: TRAJECTORY 1, TRAJECTORY 3, AND TRAJECTORY 4. OTHER ELECTRODES WERE PLACED WITH SUFFICIENT ACCURACY, AND SURGEON DOES NOT BELIEVE THIS ISSUE WAS DUE TO ROSA MALFUNCTION. PATIENT WAS IN THE ROOM AND ANESTHETIZED, INCISIONS WERE MADE, NO DELAY TO SURGERY, NO CLINICAL CONSEQUENCES.

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 INITIALLY REPORTED THAT DURING AN UNSPECIFIED DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGICAL STAFF ENCOUNTERED BLEEDING. THE SURGICAL STAFF ATTEMPTED UNSUCCESSFULLY TO CONTROL THE BLEEDING USING A "TACHOSIL TISSUE SEALING SHEET." ANOTHER PHYSICIAN WAS CALLED IN TO ASSESS THE EVENT. THE PATIENT¿S BLOOD PRESSURE HAD REPORTEDLY ¿DROPPED TO LESS THAN 60¿ DURING THE EVENT. THE CAUSE OF THE BLEEDING IS UNKNOWN AND IT IS UNCLEAR WHAT ADDITIONAL MEDICAL INTERVENTION, IF ANY, WAS ADMINISTERED DUE TO THE INTRA-OPERATIVE COMPLICATION. ON (B)(6) 2019, A PHYSICIAN FROM THE SITE PROVIDED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE PATIENT EXPERIENCED HEMORRHAGING FROM THE PULMONARY VEINS AND THE CASE WAS CONVERTED TO A THORACOTOMY.

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 WEDGE RESECTION PROCEDURE, THE JAWS OF A CURVED-TIP STAPLER 30 INSTRUMENT ALLEGEDLY GOT STUCK ON TISSUE. THE SURGICAL STAFF ATTEMPTED UNSUCCESSFULLY TO OPEN THE JAWS OF THE CURVED-TIP STAPLER 30 INSTRUMENT USING A STAPLER RELEASE KIT (SRK). THE SURGICAL STAFF ENDED UP USING A TRADITIONAL LAPAROSCOPIC STAPLER INSTRUMENT TO REMOVE THE ROBOTIC STAPLER INSTRUMENT. THERE WAS NO REPORT OF A PATIENT INJURY BY THE INITIAL REPORTER. ON (B)(6) 2019, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE'S ROBOTICS COORDINATOR AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: A 3RD-PARTY INSTRUMENT WAS USED LAPAROSCOPICALLY TO REMOVE THE CURVED-TIP STAPLER 30 INSTRUMENT AND THE SURGERY WAS COMPLETED WITH NO REPORTED INJURY TO THE PATIENT. "EXTRA TISSUE" WAS REPORTEDLY REMOVED DURING THE PROCESS OF RETRIEVING THE ROBOTIC STAPLER INSTRUMENT. THE ROBOTICS COORDINATOR EXPLAINED THAT TISSUE WITHIN THE CLAMPED JAWS OF THE CURVED-TIP STAPLER 3 WAS REMOVED. THERE WAS NO REPORTED EXTRA BLEEDING AS A RESULT. THERE HAVE BEEN NO REPORTS OF INJURY/HARM TO PATIENT POST-OPERATIVELY. IT WAS REPORTED THAT THERE WAS AN ISSUE WIT

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING SEEG SURGERY A CORTEX BLEEDING WAS REPORTED TO THE CST WHO WAS NOT ON SITE. THE SURGEON STATED THAT SCAN LOOKS GOOD.

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 DURING A SURGERY THE FIRST REGISTRATION FAILED. SITE WAS GIVEN INSTRUCTIONS TO ADJUST THE CONTRAST OF THE CT AND SMOOTH OUT THE 3D RECONSTRUCTION. LATER IT WAS REPORTED 2 MORE REGISTRATIONS HAD FAILED DUE TO 'INSUFFICIENT ACCURACY' AND ON A THIRD, THE SCREEN WENT BLACK AND THE ARM WAS LOCKED WHILE ATTEMPTING TO FIX AN INITIAL POINT. SITE WAS GIVEN INSTRUCTIONS TO PERFORM THE PROCESS OF CONFIRMING WHICH CT SCAN WAS USED FOR THE 3D RECONSTRUCTION AND REGISTRATION WAS COMPLETED ALL THE WAY THROUGH VERIFICATION. WHEN THE DISTANCE SENSOR WAS DRIVEN TO THE TRAJECTORY, THE SURGEON WAS NOT HAPPY WITH WHERE THE ENTRY POINT LOOKED ON THE PATIENT'S HEAD. HE SAID THAT THE PATIENT WAS OVERWEIGHT AND HAD A LOT OF MOVABLE SKIN. THE SURGEON MENTIONED TRYING TO SWITCH TO BONE FIDUCIAL REGISTRATION, HOWEVER DUE TO SUPPLY ISSUES WITH THE BONE FIDUCIALS, THE CASE WAS ABORTED AND WILL BE RESCHEDULED.

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) WAS PRESENT FOR AN SEEG CASE AT RILEY CHILDREN¿S. THE SURGEON HAD PLANNED 11 TRAJECTORIES. THE SURGEON INSERTS LARGER BOLTS (3.2MM OUTER DIAMETER) FOR HIS SEEG CASES SO THAT HE CAN POTENTIALLY USE THE SAME BOLTS TO TREAT THE PATIENT WITH ABLATION IF NECESSARY. THEREFORE, HE WAS DRILLING WITH THE 3.2MM DRILL ADAPTOR (SERIAL NUMBER (B)(6) ON THE FIRST TRAJECTORY (LISTED AS #4 IN THE PATIENT PLAN) WHEN THE DRILL BIT BECAME LODGED IN THE DRILL ADAPTOR. SINCE THE SITE DOES NOT HAVE A BACKUP 3.2MM ROSA DRILL ADAPTOR, THE SURGEON AND THE OR STAFF REMOVED THE DRILL BIT FROM THE ADAPTOR. THIS REQUIRED SOME EFFORT, AND WATER IRRIGATION AND MINERAL OIL WERE USED TO HELP LUBRICATE THE INSIDE OF THE ADAPTOR. AFTER SUCCESSFULLY REMOVING THE DRILL BIT AND REPLACING IT WITH A NEW ONE, THE SURGEON TESTED WHETHER THE NEW DRILL BIT WAS ABLE TO EASILY SLIDE INTO THE ADAPTOR WITHOUT ANY CATCHING OR PROBLEMS. HE DIDN¿T NOTICE ANY PROBLEMS, AND WANTED TO TRY FINISHING TO DRILL THE HOLE. FSE AND OR TEAM DECIDED IT WOULD BE BEST TO CONTINUALLY IRRIGATE WITH WATER DURING THE DRILL PROCESS TO REMOVE HEAT AND KEEP THE DRILL BIT AND ADAPTOR LUBRICATED. THE SURGEON WAS THEN ABLE

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ROSA SOFTWARE INDICATED LASER REGISTRATION WAS INSUFFICIENTLY ACCURATE. SURGEON PROCEEDED TO VERIFICATION STAGE BUT WAS NOT SATISFIED WITH ACCURACY AT SEVERAL POINTS. SURGEON RE-STARTED REGISTRATION BUT RESULTS WERE AGAIN INSUFFICIENTLY ACCURATE. SURGEONS RE-POSITIONED PATIENT TO BE LOWER TOWARD THE FLOOR AND RE-STARTED REGISTRATION, BUT RESULTS WERE AGAIN INSUFFICIENTLY ACCURATE. SURGEONS DETERMINED ACCURACY WAS SUFFICIENTLY ACCURATE IN VERIFICATION STAGE FOR THE PURPOSE OF LASER ABLATION, AND PROCEEDED WITH SURGERY. POST-OPERATIVE MRI INDICATES LASER CATHETER PLACEMENT WAS SUFFICIENTLY ACCURATE. SURGEON BELIEVES REGISTRATION PROBLEMS MAY HAVE BEEN DUE TO SWELLING FROM PRIOR PLACEMENT OF HEAD HOLDER PIN NEAR THE CENTER OF THE FOREHEAD. PATIENT WAS ANESTHETIZED, FIRST INCISION WAS MADE, ESTIMATED TIME LOST WAS 45 MINUTES.

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 INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED ABDOMINOPERINEAL RESECTION (APR) PROCEDURE, THE SURGICAL STAFF IDENTIFIED A BURN ON THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY THAT WAS INSTALLED ON A MCS INSTRUMENT. AFTER EXAMINING THE BOWEL, A ¿SMALL BURN¿ WAS DISCOVERED. THE MCS TIP COVER ACCESSORY WAS REMOVED AND REPLACED. THE SURGICAL PROCEDURE WAS COMPLETED ROBOTICALLY. ON (B)(6) 2019, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE CSR WAS NOT PRESENT DURING THE SURGICAL PROCEDURE. THE SITE¿S ROBOTICS COORDINATOR CONTACTED THE CSR AND INFORMED HIM THAT THE SURGEON HAD PLACED A STITCH OVER THE BURN INJURY. NO OTHER CLINICAL INFORMATION WAS PROVIDED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING A SURGERY, WHILE MOVING TO ONE OF THE TRAJECTORIES, THE ROBOT ARM HIT THE MAYFIELD HEAD HOLDER. THE ROBOT SHUT DOWN AND WAS RESTARTED. GUIDANCE MODE WAS SELECTED TO CONNECT TO THE ARM; HOWEVER, THE ARM CLICKED ONCE FOR THE CONNECTION AND AGAIN TWICE AND AN ERROR MESSAGE APPEARED FOR THE COMMUNICATION ERROR. WHILE THE ERROR MESSAGE ASKING TO SAVE THE PATIENT FOLDER AND SHUT DOWN THE ROBOT WAS VISIBLE, ANOTHER MESSAGE APPEARED ASKING WHAT DEVICE WAS ON THE ARM. INSTRUMENT HOLDER WAS SELECTED AND CALIBRATED AND IT WAS ATTEMPTED TO MOVE THE ARM OUT OF THE WAY; HOWEVER, ANOTHER ERROR MESSAGE STATED THAT THE COOPERATIVE MOVEMENT COULD NOT BE PERFORMED. FOLLOWING THIS MESSAGE, THE ROBOT WAS SHUT DOWN. THE ROBOT WAS RESTARTED AGAIN AND A CONNECTION WAS ATTEMPTED; HOWEVER, THE SAME ERROR MESSAGES APPEARED. THE SIDE PANEL WAS REMOVED FROM THE ROBOT TO TRY TO RELEASE THE ARM IN MANUAL MODE. SEVERAL ATTEMPTS WERE MADE TO MOVE EACH JOINT; HOWEVER, ALL OF THE JOINTS WERE FIRMLY LOCKED IN PLACE AND WOULD NOT MOVE. IT WAS THEN ATTEMPTED TO ROTATE THE MAYFIELD HEAD HOLDER AWAY FROM THE ARM TO GIVE CLEARANCE FOR THE ARM TO CONNECT. THE SURGEON DREW TWO BLACK MARKS ON THE MAYFIELD HEAD HOLDER

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 CANNULAS WERE BLOCKED INSIDE THEIR INSTRUMENT HOLDERS. THIS OCCURRED WITH SEVERAL SETS OF INSTRUMENTS THAT DAY. REPORTEDLY, THE SURGERY WAS DELAYED BY 3H (TOTAL SURGERY TIME : 6H INSTEAD OF 3H), WHICH IS CONSIDERED AS A SERIOUS INJURY. NO CLINICAL CONSEQUENCES FOR THE PATIENT WERE REPORTED OTHER THAN THE 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: IT WAS REPORTED THROUGH A SOCIAL MEDIA BLOG THAT AFTER UNDERGOING A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE IN 2013, THE PATIENT WAS FOUND TO HAVE SUSTAINED VAGINAL CUFF DEHISCENCE WITH VAGINAL CUFF CELLULITIS AND A PELVIC ABSCESS. AS A RESULT, THE PATIENT UNDERWENT SUBSEQUENT SURGERY. THE PATIENT HAS ALSO REPORTEDLY EXPERIENCED CHRONIC PAIN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED.

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 PATIENT SUFFERED A PNEUMOTHORAX DURING OR AFTER THE PROCEDURE. THE PATIENT WAS ADMITTED AND A CHEST TUBE WAS PLACED. THE PNEUMOTHORAX RESOLVED AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY WITH NO RESIDUAL EFFECTS. NO DEVICE MALFUNCTION WAS REPORTED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PATIENT WAS BROUGHT IN ROOM AND HEAD WAS FIXATED ONTO THE BED AS WELL AS BEING ATTACHED TO THE ROSA BRAIN. ONCE THE ROBOT WAS ATTACHED, IT WAS NOTICED THAT THE MONTERIS HEAD FIXATION WAS GOING TO BE IMPEDING WITH THE TRAJECTORY, THEREFORE THE SURGEON AND THE OR STAFF DECIDED TO UTILIZE THE DORO THREEPIN HEAD FIXATION DEVICE. THE SINGLE PIN WAS PLACED ON THE LEFT FOREHEAD NEAR THE HAIRLINE AND THE TWO-PIN SIDE WAS POSITIONED ON THE BACK RIGHT OF THE HEAD. THE PATIENTS WAS SUPINE WITH ABOUT A 60 DEGREE HEAD TILT TO THE LEFT. THE PATIENT THEN WAS CONNECTED DIRECTLY TO ROSA BRAIN. THE LASER REGISTRATION WAS PERFORMED. AFTER COMPLETING REGISTRATION, IT WAS THAT THE ROSA BRAIN STABILIZATION SYSTEM WAW NOT LOCKED DOWN. THE SURGEON WAS INFORMED AND INSTEAD OF RE-DOING REGISTRATION, HE DECIDED TO PERFORM THE VERIFICATION ONCE MORE WITH THE STABILIZATION SYSTEM LOCKED. RE-VERIFICATION SUCCESSFULLY PASSED. A CT SCAN WAS PERFORMED AND WAS MERGED TO ROSA. PATIENT WAS DRAPED AND THE PROCEDURE WAS READY TO BEGIN. THE PATIENT PREVIOUSLY HAD A CRANIOTOMY IN THIS AREA AND HAD A MESH PLATE IMPLANTED. THEREFORE, THE SURGEON COULD NOT PLACE A BOLT IN THIS AREA DUE TO THERE BEING NO BONE. THE SURGEON IN

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 UNDERGOING AN UNSPECIFIED DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT EXPERIENCED POST-OPERATIVE ILEUS. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. ON (B)(4) 2019, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE DA VINCI-ASSISTED SURGICAL PROCEDURE WAS COMPLETED AS PLANNED. THE CYSTECTOMY WAS COMPLETED ROBOTICALLY AND THE ILEAL CONDUIT WAS PERFORMED OUTSIDE OF THE PATIENT'S BODY CAVITY. ON (B)(6) 2019, THE PATIENT WAS REPORTEDLY STILL IN THE HOSPITAL. HOWEVER, THE REASON FOR THE PROLONGED HOSPITALIZATION IS UNKNOWN. ON (B)(4) 2019, ISI CONTACTED THE SITE AND WAS INFORMED THAT THE PATIENT WAS DISCHARGED ON AN UNSPECIFIED DATE. A NURSE AT THE SITE INDICATED THAT THE "DECREASE IN INTESTINAL MOVEMENT" WAS "TEMPORARY" AND WAS POSSIBLY ATTRIBUTED TO ANESTHESIA.

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 AFTER A SUCCESSFUL FACIAL LASER REGISTRATION, DISCREPANCY WAS NOTICED DURING THE VERIFICATION STEPS BETWEEN THE LASER POINTS MEASURED ON THE FACE AND THOSE MEASURED ON THE BACK/TOP OF THE HEAD (POINTS WERE FLOATING ABOUT 5MM ABOVE THE SKIN ON THE SCAN). THIS OCCURRED UPON EACH OF THE 3 SUBSEQUENT ATTEMPTS. THE SURGEON FINALLY SWITCHED TO MARKER REGISTRATION (BONE FIDUCIALS) AND COULD COMPLETE THE SURGERY. THIS EVENT CAUSED A 2 HOURS 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: IT WAS REPORTED THROUGH A SOCIAL MEDIA BLOG THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY, THE PATIENT CLAIMED THAT THE SURGEON AND THE ROBOT "HURT" HER URETER. AS A RESULT OF THE ALLEGED OPERATIVE COMPLICATION, THE PATIENT INDICATED THAT SHE NEEDED A NEPHROSTOMY TUBE PLACED FOR 2 YEARS FOLLOWED BY THE NEED FOR URETERAL STENT REPLACEMENT EVERY 3 MONTHS. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AT 10:04AM, CT SCAN TAKEN FROM INTRAOPERATIVE O-ARM (MEDTRONIC) DID NOT MERGE ACCURATELY WITH PRE-OPERATIVE MRI. SURGEON ATTEMPTED AUTOMATIC AND SEMI-AUTOMATIC MERGE, BOTH TO PRE-OP MRI AND TO PRE-OP CT, AND EXCLUDED UNNECESSARY SLICES, BUT PROBLEM PERSISTED. NEXT, O-ARM TECHNICIAN RE-DEFINED ORIENTATION OF AXES USING O-ARM SOFTWARE PRIOR TO EXPORT, BUT PROBLEM PERSISTED. NEXT, SURGEON ATTEMPTED TO MANUALLY CORRECT ORIENTATION OF AXES BY RE-POSITIONING THE PATIENT¿S HEAD TO BE CLOSER TO SUPINE NEUTRAL AND RE-SCANNING, BUT PROBLEM PERSISTED. SURGEON DID NOT WANT TO USE MANUAL MERGING BECAUSE OF TIME CONCERNS AND PROCEEDED TO CONTACTLESS REGISTRATION INSTEAD OF MARKERS. PATIENT WAS ANESTHETIZED, INCISIONS WERE MADE AND BONE FIDUCIALS INSERTED, ESTIMATED DELAY TO CASE IS 45 MINUTES.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AT 11:35AM, SURGEON INSERTED DRILL BIT INTO ROSA 2.45MM DRILL ADAPTOR AND NOTED THAT "BLACK ASH-LIKE MATERIAL" WAS PUSHED OUT FROM INSIDE THE FIRST ADAPTOR INDICATING INSUFFICIENT STERILIZATION/CLEANING. UNCLEAN ROSA ADAPTOR AND ADTECH DRILL BIT WERE SET ASIDE, AND BACKUPS PREPARED. AT APPROXIMATELY 11:40AM, WHILE SURGICAL FELLOW DRILLED THROUGH SKULL AT TRAJECTORY "LEFT FRONTAL" FOR APPROXIMATELY ONE MINUTE, DRILL BIT FUSED IN THE 2.45MM ADAPTOR (MT-02-161 S18411). SURGEON DECIDED TO POSTPONE SURGERY UNTIL THE FOLLOWING MORNING DUE TO CONCERNS REGARDING DURATION OF ANESTHETIZATION. FIELD SERVICE ENGINEER REQUESTED FUSED ADAPTOR FOR FURTHER ANALYSIS, BUT NURSE MANAGER REFUSED. (B)(6) SURGERY WAS COMPLETED SUCCESSFULLY ON (B)(6) 2019.

At 3:15 p.m. on January 30, 2019, an employee was working at a full-service restaurant. She was operating a Robot Coupe food processor. She was feeding a piece of cabbage into the chute of the food processor. As she was aligning the piece, her finger was caught and sucked into the chute. Her finger came into contact with the blade. The tip of the middle finger on her right hand was amputated. She was hospitalized.

mBot — Kit for building a blue metal robot, supplied in a cardboard box with markings. Only model mBot V1.1 is affected and subject to this measure. Hazard (Burns, Chemical): Due to a short-circuit, the batteries can overheat and the plastic of the battery compartment can melt. Moreover, the battery compartment of the remote-control can easily be opened without use of any tools, giving access to the button cell batteries. A child may sustain burns from the overheating parts or put the batteries in t...

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 CANNULAS WERE BLOCKED INSIDE THEIR INSTRUMENT HOLDERS. THIS OCCURRED WITH SEVERAL SETS OF INSTRUMENTS THAT DAY. REPORTEDLY, THE SURGERY WAS DELAYED BY 3H (TOTAL SURGERY TIME: 6H INSTEAD OF 3H), WHICH IS CONSIDERED AS A SERIOUS INJURY. NO CLINICAL CONSEQUENCES FOR THE PATIENT WERE REPORTED OTHER THAN THE 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: IT WAS REPORTED THAT AFTER UNDERGOING A DA VINCI-ASSISTED INGUINAL HERNIA REPAIR PROCEDURE, THE PATIENT WAS RELEASED AFTER RECOVERY. ON AN UNSPECIFIED DATE POST-OPERATIVELY, THE PATIENT RETURNED TO THE HOSPITAL DUE TO INTERNAL BLEEDING AND UNDERWENT A SMALL BOWEL RESECTION. IT WAS ALLEGED THAT THE OPERATIVE COMPLICATIONS WERE CAUSED BY ¿STRAY ENERGY¿ FROM A MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT. ON (B)(6) 2019, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE¿S OR MANAGER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THERE WERE NO REPORTED ISSUES WITH THE DA VINCI SURGICAL SYSTEM AND NO INTRA-OPERATIVE COMPLICATIONS DURING THE CASE. ON (B)(6) 2019, THE PATIENT RETURNED TO THE HOSPITAL AND WAS FOUND TO HAVE A HOLE IN THE SMALL BOWEL. THE PATIENT UNDERWENT A SMALL BOWEL RESECTION VIA OPEN SURGERY TO ADDRESS THE SMALL BOWEL COMPLICATION. THE'S SITES PATHOLOGY DEPARTMENT ANALYZED THE SPECIMEN AND COULD NOT DETERMINE A CAUSE FOR THE BOWEL COMPLICATION. ACCORDING TO THE ISI CLINICAL SALES REPRESENTATIVE (CSR), THE SURGEON SPECULATED THAT THE BOWEL INJURY WAS A RESULT OF "CAPACITIVE COUPLING" FROM THE MCS INSTRUMENT. THE CSR INDICATED THAT THE SITE

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: SURGEON HAD LOADED THIS PATIENT'S MRI AND CTA INTO PLANNING STATION AND EXPORTED TO ROBOT WITHOUT ISSUE. PATIENT WAS ANESTHETIZED, BUT NO INCISION HAD BEEN MADE. FIELD SERVICE ENGINEER (FSE) ATTEMPTED TO LOAD SERIES FROM O-ARM INTO ROSANNA SOFTWARE. THE SURGEON DETECTED NOISE ON RE-CONSTRUCTION, AND WANTED TO RE-LOAD SERIES WITHOUT INCLUDING ALL SLICES. MULTIPLE WINDOWS SHUTDOWNS OCCURRED. ATTEMPTING TO IMPORT THE SCAN CAUSED ISSUES. THE FSE DELETED SERIES IN ROSANNA EXAM MANAGER, BUT WAS STILL UNABLE TO LOAD. TO TROUBLESHOOT, FSE ATTEMPTED TO MANUALLY DELETE SERIES FROM PATIENT FOLDER USING MAINTENANCE LOG-IN. FSE CONTINUED TO RECEIVE "IMPOSSIBLE TO LOAD" ERROR. PATIENT FOLDER WAS THEN RE-IMPORTED FROM SURGEON'S FLASH DRIVE AND OVERWRITTEN TO THE ORIGINAL PATIENT FOLDER. DURING SURGERY, THE SURGEON WANTED TO VIEW MRI AND CTA ON SCREEN DURING GUIDANCE MODE. A WINDOWS ERROR OCCURRED, AND THE USER NEEDED TO RESTART ROSANNA/ MARIO. SHUTDOWN RESULTED IN A 10MIN DELAY (APPROX.), FROM SHUTDOWN AND RESTART TO RESUME GUIDANCE. THE SURGEON REQUESTED TO VIEW MRI FOR ADDITIONAL PLANNING, AND A SHUTDOWN OCCURRED (7MIN DELAY APPROX.). OVERALL DELAY FROM SHUTDOWNS: 1 HOUR 8 MINUTES. AT END OF CA

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 A SURGERY IT WAS NOTICED THAT THE CONNECTOR BETWEEN THE FORCE SENSOR AND THE ROBOT ARM WAS DAMAGED, THUS PREVENTING THE CONNECTION TO THE DEVICE. IT WAS NOT POSSIBLE TO REPAIR, THEREFORE THE SURGERY ASSISTED WITH ROSA WAS ABORTED, AND THE SURGERY WAS CONVERTED TO TRADITIONAL SURGERY.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IN PREPARATION OF THE SURGERY THE ROBOT WAS TURNED ON, AND IT WAS NOT POSSIBLE TO CONNECT TO THE ROBOT ARM DESPITE SEVERAL ATTEMPTS. THE PATIENT WAS ALREADY IN THE OR AND PREPARED FOR SURGERY. MULTIPLE RESOLUTIONS WERE ATTEMPTED UNSUCCESSFULLY. THE SURGERY WAS ABORTED AND POSTPONED TO ANOTHER DAY.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING A SURGERY THE ROBOT FAILED TO CONNECT. MULTIPLE ATTEMPTS WERE MADE BUT DID NOT RESOLVE THE ISSUE. THE SURGEON DID NOT FEEL THAT THE ROBOT WAS RELIABLE AND DECIDED TO POSTPONE THE CASE. THE PATIENT WAS WOKEN FROM ANESTHESIA. NO CUTS WERE MADE.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: FOLLOWING A SURGERY USING MAZOR X SYSTEM, AT (B)(6) INTERNATIONAL HOSPITAL (B)(6), ON (B)(6) 2019, IT WAS REPORTED THAT WHILE USING THE SYSTEM TO DIRECT DRILLING INTO A VERTEBRA FROM A POSTERIOR DIRECTION, THE VERTEBRAL BODY WAS BREACHED ANTERIORLY AND PERFORATED THE INFERIOR VENA CAVA (IVC). L3-L5 SCREW PLACEMENT WAS PLANNED INTRA-OPERATIVELY USING O-ARM IMAGING. DURING THE PROCEDURE, L3L AND L4L WERE DRILLED USING THE SHORT DRILL GUIDE AND SHORT DRILL BIT. AS SURGEON FELT K-WIRE WAS DEVIATED, INDICATED BY BLOODSTAIN AND BONE ON THE DRILL, FURTHER X-RAY AND 3D IMAGING CONFIRMED THE DRILLS PERFORATED THE FRONT VERTEBRAL BODY. MAZOR X PROCEDURE WAS ABORTED. PATIENT UNDERWENT CT SCAN AND FOUND TEAR VEIN AND BLOOD CONGESTION NEARBY INFERIOR VENA CAVA. THE CLINICAL INVESTIGATION HAD SHOWN THE TRAJECTORIES EXECUTED WERE ACCURATE WITHIN THE PEDICLE AND PER PLAN, IN BOTH AXIAL & SAGITTAL PLANES. AS THERE ARE NO ISSUES OF ABNORMAL ANATOMY OR PLATFORM MOUNTING OR EVIDENCE FOR MALFUNCTION, IT WAS CONCLUDED THAT THE ROOT CAUSE FOR THE ANTERIOR BREACHING DURING THE MAZOR X PROCEDURE IS INCORRECT HARDWARE USE. IT IS PROBABLE THAT THERE WAS DEVIATION FROM SURGICAL TECHNIQUE, MANIFESTED AS USING

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 HYSTERECTOMY PROCEDURE, ELECTRICAL ENERGY BURNED THROUGH A MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY THAT WAS INSTALLED ON A MCS INSTRUMENT. AS A RESULT, THE PATIENT SUSTAINED AN INJURY THROUGH THE ILIAC ARTERY. THE CASE WAS REPORTEDLY CONVERTED TO OPEN SURGERY. ON (B)(4) 2019, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES ASSOCIATE (CSA) AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE CSA WAS NOT PRESENT DURING THE SURGICAL PROCEDURE. THE SITE¿S ROBOTICS COORDINATOR CLAIMED THAT ELECTRICAL ENERGY ¿ESCAPED¿ THROUGH THE MCS TIP COVER ACCESSORY. THE SURGICAL STAFF INITIALLY ATTEMPTED TO REPAIR THE VESSEL INJURY USING THE DA VINCI SURGICAL SYSTEM. HOWEVER, THE CASE WAS REPORTEDLY CONVERTED TO OPEN SURGERY TO REPAIR THE VESSEL. AFTER THE VESSEL WAS REPAIRED, THE HYSTERECTOMY WAS COMPLETED VIA OPEN SURGERY. NO POST-OPERATIVE COMPLICATIONS HAVE BEEN REPORTED. THE CSA INDICATED THAT THE LAST TIME HE HAD SPOKEN TO THE CUSTOMER, THE SITE¿S RISK MANAGEMENT DEPARTMENT HAD THE MCS INSTRUMENT AND/OR MCS TIP COVER ACCESSORY.

an electrical fault at one of the first generation battery charging units at the edge of the ambient storage grid at the Andover plant caused the plastic lid on the top of a grocery-carrying robot to catch light.