da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED THYROIDECTOMY SURGICAL PROCEDURE, THE HARMONIC ACE WAS NOTED TO BE BROKEN UPON FIRING. THE CUSTOMER RETRIEVED THE TIP FROM THE BODY, AND THE NURSE CHANGED THE NEW INSTRUMENT TO FINISH THE PROCEDURE. AFTER THE PROCEDURE THE NURSE DISCARDED THE BROKEN TIP. THERE WAS NO REPORT OF FRAGMENT(S) FALLING INSIDE THE PATIENT. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE REPORTED PRODUCT WAS INSPECTED PRIOR TO USE. THE INSTRUMENT WAS USED FOR 30 MINUTES AND BROKE UPON FIRING THE INSTRUMENT. SITE CONFIRMED A FRAGMENT OF THE HARMONIC INSERT BROKE IN THE PATIENT AND THE ASSISTANT RETRIEVED THE FRAGMENT FROM THE PATIENT'S BODY. IT IS UNKNOWN IF THE INSTRUMENT COLLIDED WITH OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE PROCEDURE. NO POST-OPERATIVE TESTS WERE PERFORMED TO CHECK FOR ANY REMAINING FRAGMENTS. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT. NO INFORMATION WERE PROVIDED PERTAINING TO THE PATIENT'S PRE-EXISTING MEDICAL CONDITIONS AND RELEVANT TESTS/

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 HARMONIC ACE BROKE APART. PIECES FELL INSIDE THE PATIENT BUT THE SURGEON WAS ABLE TO RETRIEVE ALL OF THE PIECES. THE SITE STATED THAT THEY HAD THREE DIFFERENT OPERATING ROOM STAFF CONFIRM THAT ALL OF THE PIECES WERE REMOVED FROM THE PATIENT, MATCHED UP, AND NO SMALL FRAGMENTS BROKE OFF. NO POST-OP X-RAY WAS COMPLETED. THEY REPLACED THE HARMONIC INSTRUMENT WITH A DIFFERENT HARMONIC TO COMPLETE THE PROCEDURE. INTUITIVE SURGICAL INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL RETROPERITONEAL NEPHRECTOMY PROCEDURE, A TIP COVER ¿SPLIT¿ ON THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WHICH RESULTED IN AN, ¿INVERTED BLEED FROM AN ARTERY¿. TO RESOLVE THE ISSUE, THE SURGEON CONVERTED THE PROCEDURE TO OPEN SURGERY TO CONTROL THE BLEEDING. THE PATIENT WAS REPORTED AS BEING IN STABLE CONDITION FOLLOWING THE PROCEDURE. ON 15-MAR-2021, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: DURING A DA VINCI-ASSISTED PARTIAL RETROPERITONEAL NEPHRECTOMY PROCEDURE, AN ¿MCS TIP COVER WAS TORN AT SOME POINT DURING THE PROCEDURE AND NOBODY NOTICED IT¿. THE SITE BELIEVED THAT THERE WAS ARCING THAT CAUSED, ¿EXCESSIVE BLEEDING TO AN UNSPECIFIED ARTERY WHICH REQUIRED A BLOOD TRANSFUSION¿, UNKNOWN AMOUNT, AND THE PROCEDURE CONVERTED TO OPEN SURGERY. THE SURGEON DID NOT KNOW WHERE THE BLEEDING WAS COMING FROM AND DID NOT KNOW WHAT CAUSED THE BLEEDING. THE DA VINCI-ASSISTED PARTIAL NEPHRECTOMY PROCEDURE CONVERTED TO OPEN RADICAL NEPHRECTOMY SURGERY. THE OPEN PROCEDURE COMPLETED. THE PATIENT WAS DESCRIBED AS DOING WELL POST-OPERATIVELY. INTUITIVE SURGICAL, INC

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 AFTER COMPLETION OF A DA VINCI-ASSISTED TOTAL BENIGN HYSTERECTOMY PROCEDURE, THERE WAS A ¿PORT SITE TROCAR BURN¿. THE ISSUE WAS FOUND WHEN UNDOCKING THE SYSTEM ARM AND THE SURGEON STARTED TO ¿SUTURE-CLOSE¿ THE PORT SITE. THE BURN WAS IN THE SHAPE OF A CIRCLE ABOUT 2MM WIDE ALL AROUND THE PORT SITE. THE SURGEON EXCISED THE BURNT SKIN AND SUTURED THE PORT SITE. THE PROCEDURE WAS REPORTEDLY COMPLETED ROBOTICALLY. ON (B)(6) 2021, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE SURGEON REPORTEDLY DID NOT KNOW WHAT CAUSED THE ISSUE TO OCCUR, BUT THE SURGEON DID STATE THAT ALL INSTRUMENTS WORKED AS EXPECTED AND AS INTENDED BUT THEN NOTICED THE PORT SITE TISSUE BURN AND COULD NOT EXPLAIN WHAT CAUSED IT. THE PORT IN WHICH THE SYNCHROSEAL (SS) INSTRUMENT WAS USED WAS UNKNOWN. IT WAS ALSO UNKNOWN WHICH PORT SITE WAS INVOLVED WITH THE EVENT. WHILE THE SEVERITY OF THE PORT SITE BURN WAS UNKNOWN, THE BURN WAS DESCRIBED AS ¿A DARK CIRCLE OF BURNT SKIN AROUND ONLY ONE OF THE PORT SITES AND IT WAS ABOUT 2MM WIDE¿ FOR WHICH THE SURGEON ¿EXCISED THE BURNT SKIN AND SUTURED THE PORT SITE AS USUAL¿. THE PROCEDURE WAS COM

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: WE HAD A DIFFICULT TIME REGISTERING TODAY. WE USED THE MEDTRONIC BONE FIDUCIALS WITH AN OMNITOM CT SCANNER. THE FIDUCIALS WERE DIFFICULT TO DEFINE ON THE CT SCAN SO WE ENDED UP USING 4 FIDUCIALS AND WERE STILL UNABLE TO GET UNDER 1MM OF ACCURACY. THE SURGEON WANTED TO MOVE FORWARD WITH A 1.25MM RNS. THE VERIFICATION LOOKED GOOD THOUGH. WE ALSO HAD A RANDOM SHUTDOWN WHILE SITTING ON TRAJECTORY AND WERE FORCED TO DO A FULL SHUTDOWN AND REDRIVE TO THE TRAJECTORY. THE REGISTRATION DIFFICULTY CAUSED ABOUT A 30MIN DELAY IN SURGERY. THE FULL SHUTDOWN WAS ABOUT 8 MINUTES TO REDRIVE TO THE TRAJECTORY.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REPORTEDLY, THE ISO CENTRIC POINT CALIBRATION METHOD FOR THE ENDOSCOPIC MODE HAS CHANGED WITH THE RECENT SOFTWARE UPDATE. THEREFORE THE SURGEON DID NOT SET UP THE ISOCENTRIC POINT ON THE ENDOSCOPE BEFORE SENDING THE ROBOT ARM TO TRAJECTORY AND DID NOT ANTICIPATE THE ROBOT ARM TRAJECTORY. THE ENDOSCOPIC SHEATH WAS BEND BY THE ROSA ONE DEVICE . THE SURGERY WAS REVERTED TO TRADITIONAL SURGERY FOLLOWING THIS 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT WAS DAMAGED AND NON-FUNCTIONAL AFTER ONE HOUR OF USE. THERE WAS ¿DEBRIS¿ LEFT IN THE PATIENT. THE ¿DEBRIS¿ WAS RETRIEVED IN THE SAME PROCEDURE AND THE HARMONIC ACE WAS REMOVED. THERE WAS 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 DATE OF THIS REPORT.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE COMPANY REPRESENTATIVE WAS PRESENT FOR A BRAIN SURGERY CASE. AFTER GETTING THE MEASUREMENT, THE SURGEON WANTED TO BACK OUT IN AXIAL FAST. HE STARTED PEDALING THE VIGILANCE DEVICE BUT BEHIND THE PEDAL SCREEN, THERE WAS AN ERROR SAYING THAT THE ROBOT WAS IN A SINGULAR POSITION. WHEN IT GOT BACK TO THE INTERMEDIATE POSITION, THE SCREEN FROZE AT 1:12 PM. THEN THE COMPANY REPRESENTATIVE DID A HARD SHUTDOWN FROM THE MAIN POWER SWITCH AT THE BOTTOM OF THE ROBOT (THE SHUTDOWN/RESTARTS OCCURRED AT 1:17 PM/1:18 PM). THE COMPANY REPRESENTATIVE RESTARTED THE ROBOT AND IT WOULD NOT CONNECT SO WE DID A MANUAL RELEASE OF EACH PART OF THE ARM. THE COMPANY REPRESENTATIVE RESTARTED THE ROBOT AGAIN (ONLY OFF FOR 30 SEC.) AND IT WOULD NOT CONNECT. THEN, THE COMPANY REPRESENTATIVE HAD THE ROBOT UNPLUGGED FOR ABOUT 5-10 MINUTES, AND WE GOT IT TO CONNECT AND WERE ABLE TO CONTINUE ON WITH THE CASE. SURGERY DELAY WAS ABOUT 20-30 MINUTES FOR THIS COMPLAINT EVENT. THE ANESTHESIOLOGIST SAID SOME ADDITIONAL ANESTHESIA WAS GIVEN TO KEEP THE PATIENT ASLEEP.

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 ROSA SOFTWARE SHUTDOWN AFTER PERFORMING FIDUCIAL REGISTRATION, RMS 0.17. AFTER SHUTDOWN, SOFTWARE DISPLAYED INITIAL BOOT UP SCREEN. PATIENT FOLDER WAS NO LONGER VISIBLE. PATIENT FOLDER HAD TO BE RELOADED AND REGISTRATION REPERFORMED. SECOND REGISTRATION WAS DONE VIA CONTACTLESS METHOD. CASE PROCEEDED BUT HAD A SECOND SHUTDOWN DURING GUIDANCE. PATIENT FOLDER WAS STILL VISIBLE AFTER SECOND SHUTDOWN AND RECOVERING TIME WAS LESS THAN ONE MINUTE. REGISTRATION WAS STILL SAVED AND VERIFIED. CASE FINISHED WITHOUT ANY OTHER ERRORS. THERE WAS NO PATIENT IMPACT. DELAY TO CASE WAS AROUND 30 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 REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT TIP BROKE AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED 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 CUSTOMER ELECTED TO CANCEL THE RMA FOR THIS INSTRUMENT. NO FURTHER DETAILS WERE AVAILABLE.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ABSTRACT: TO REPORT OUR EXPERIENCE USING THE SCAN-AND-PLAN WORKFLOW AND REVIEW CURRENT LITERATURE ON SURGICAL EFFICIENCY, SAFETY, AND ACCURACY OF NEXT-GENERATION ROBOT-ASSISTED (RA) SPINE SURGERY. THE RECORDS OF PATIENTS WHO UNDERWENT RA PEDICLE SCREW FIXATION WERE REVIEWED. THE ACCURACY OF PEDICLE SCREW PLACEMENT WAS DETERMINED BASED ON THE RAVI CLASSIFICATION SYSTEM. TO EVALUATE WORKFLOW EFFICIENCY, 3 DEMOGRAPHICALLY MATCHED COHORTS WERE CREATED TO ANALYZE DIFFERENCES IN TIME PER SCREW PLACEMENT (DEFINED AS OPERATING ROOM [OR] TIME DIVIDED BY NUMBER OF SCREWS PLACED). GROUP A HAD 4 SCREWS PLACED, GROUP B HAD 4 SCREWS PLACED, AND GROUP C HAD >4 SCREWS PLACED. INTRAOPERATIVE ERRORS AND POSTOPERATIVE COMPLICATIONS WERE COLLECTED TO ELUCIDATE SAFETY. EIGHTY-FOUR RA CASES (306 PEDICLE SCREWS) WERE INCLUDED FOR ANALYSIS. THE MEAN NUMBER OF SCREWS PLACED WAS 2.1 +- 0.3 IN GROUP A AND 6.4 +- 1.2 IN GROUP C; 4 SCREWS WERE PLACED IN GROUP B PATIENTS. THE ACCURACY RATE (RAVI GRADE I) WAS 98.4%. SCREW PLACEMENT TIME WAS SIGNIFICANTLY LONGER IN GROUP A (101 +- 37.7 MINUTES) THAN GROUP B (50.5 +- 25.4 MINUTES) OR C (43.6 +- 14.7 MINUTES). THERE WERE NO INTRAOPERATIVE COMPLICATIONS, ROBOT FAILU

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) 2021, IT WAS REPORTED THAT DURING A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE, A PNEUMOTHORAX WAS IDENTIFIED. THE LOCATION OF THE TARGET WAS IN THE LOWER LEFT LOBE. THE LOCATION OF THE PNEUMOTHORAX WAS IN UPPER LEFT LOBE. THE CUSTOMER DID REPORT THAT THE PATIENT WAS IN SOME PAIN. A CHEST TUBE WAS PLACED IN THE PATIENT, AND THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE PATIENT WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2021. IT WAS REPORTED THAT THE PATIENT IS DOING WELL.

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 TWO SOFTWARE CRASHES OCCURRED DURING A SURGERY. THIS EVENT CAUSED A 45 MINUTES DELAY BECAUSE REGISTRATION HAD TO BE PERFORMED TWICE AND THE SURGEON HAD TO REMOVE THE BIOPSY NEEDLE IN ORDER TO RESTART THE 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: AN O-ARM SCAN WAS TAKEN FOR MARKER/FIDUCIAL REGISTRATION. HOWEVER, THE IMAGE WOULD NOT MERGE AUTOMATICALLY ¿ THE IMAGE WAS ROTATED (MAY BE DUE TO A GANTRY TILT). THE SURGEON HAD TO MANUALLY MERGE THE IMAGE. ALSO, PRIOR TO THIS, LEKSELL FRAME REGISTRATION WAS TRIED, AND ALTHOUGH AN ERROR OF 0.39 WAS OBTAINED, WHEN THE FOREHEAD SKIN WAS CHECKED IT WAS ABOUT 1-2 MM OFF IN DEPTH SO THAT¿S WHY REGISTRATION WAS PERFORMED A SECOND TIME WITH MARKERS. THAT ERROR COULD HAVE BEEN DUE TO A MERGE ISSUE AS WELL. THE SURGEON ALSO COMPLAINED THAT THE WINDOW AND LEVEL OF THE IMAGE/BONE WINDOW COULDN'T BE CHANGED WITHIN THE MERGE SCREEN (ONLY THE TOP LEFT IMAGE) ¿THE ONLY WAY TO CHANGE WINDOW/LEVEL OF THE ORIGINAL IMAGE WAS THROUGH THE CONTRAST BUTTON IN THE REGULAR PART OF THE SOFTWARE. ALL OF THESE IMAGING ISSUES CAUSED A 1-1.5 HOUR DELAY IN THE CASE.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON 2/19/2021, IT WAS REPORTED THAT DURING A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE ON (B)(6) 2021, A PNEUMOTHORAX WAS IDENTIFIED. THE PATIENT HAD A SMALL PNEUMOTHORAX IN THE RIGHT UPPER LOBE THAT DID NOT REQUIRE INTERVENTION. THE PATIENT WAS RELEASED FROM THE HOSPITAL ON THE SAME DAY. DURING A POST-PROCEDURE FOLLOW-UP ON (B)(6) 2021, IT WAS OBSERVED THAT THE PNEUMOTHORAX HAD GROWN ABOUT 40 TO 50% FROM THE ORIGINAL SIZE. A CHEST TUBE WAS PLACED AND THE PATIENT WAS RELEASED THE SAME DAY. IT WAS REPORTED THAT THE PATIENT IS DOING FINE AND DID NOT REQUIRE ANY ADDITIONAL CARE.

Senhance — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE EVENT WAS REPORTED AS A COMPLAINT ON (B)(6) 2021. THE EVENT OCCURRED AT (B)(6) HOSPITAL, WHICH IS LOCATED IN THE (B)(6). THE EVENT INVOLVED TWO SENHANCE MANIPULATOR ARMS (X9000005, UDI: (B)(4), SERIAL NUMBERS (B)(4)) AND TWO JOHAN GRASPERS 15 MM Ø 5 MM X 310 MM (X0007005, UDI: (B)(4), LOT: 1845171). THE TIME OF OCCURRENCE WAS DURING A SURGICAL CASE AND THE SURGICAL PROCEDURE WAS FOR TREATMENT OF MALROTATION VOLVULUS. THE PATIENT WAS A (B)(6) CAUCASIAN FEMALE WITH WEIGHT OF (B)(6) AND BMI OF 29.2. THE SENHANCE SYSTEM AND ASSOCIATED DEVICES ARE NOT INDICATED FOR PEDIATRIC USE IN THE US. AS INITIALLY REPORTED BY THE COMPLAINANT, DURING THE CASE THE SMALL INTESTINE WAS PERFORATED 2 TIMES WITH THE JOHAN GRASPER. WHEN HOLDING THE TISSUE WITH THE GRASPER, THE TISSUE TURNED WHITE DUE TO THE GRASPING FORCE. AFTER STITCHING BOTH PERFORATIONS, THE SURGEON COULD CONTINUE WITH THE CASE. THE USE OF TWO JOHAN GRASPING FORCEPS CAUSED HEMATOMA OF THE SEROSA AND EVENTUALLY 2 PERFORATIONS OF THE SMALL INTESTINE. THE FOOTPRINT OF EVERY BITE WAS VISIBLE ON THE TISSUE. THE PROCEDURAL DELAY WAS LESS THAN 15 MINS. ADDITIONAL QUESTIONS WERE POSED TO FURTHER INVESTIGATE THE IMPACT ON THE PATIENT. THERE

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) 2021, ITS WAS REPORTED THAT AFTER A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE, A PNEUMOTHORAX WAS IDENTIFIED DURING POST-PROCEDURE SCREENING. INITIALLY, THE PATIENT HAD A 5 TO 10% PNEUMOTHORAX IN THE LEFT UPPER LOBE. DURING THE CASE, MONARCH FORCEPS AND MEDTRONIC ARCPOINT NEEDLE WERE USED. THE PATIENT WAS RELEASED FROM THE HOSPITAL THE SAME DAY BUT WAS ASKED TO RETURN THE FOLLOWING DAY FOR AN X-RAY. DURING THE X-RAY, IT WAS OBSERVED THAT THE PNEUMOTHORAX WAS GROWN 40 TO 50% FROM THE ORIGINAL SIZE. A CHEST TUBE WAS PLACED AND THE PATIENT WAS RELEASED THE SAME DAY. IT WAS REPORTED THAT THE PATIENT IS DOING FINE AND DID NOT REQUIRE ANY ADDITIONAL CARE OR INTERVENTION.

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 THE COMPLETION OF A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE SURGEON NOTICED THAT THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY WAS NOT INSTALLED ON THE MCS INSTRUMENT. THE CUSTOMER STATED THAT THE SURGEON SEARCHED FOR THE MCS TIP COVER ACCESSORY BUT COULD NOT LOCATE IT. THE CUSTOMER ALSO STATED THAT THE SURGEON INSERTED A PORT INTO THE PATIENT, CHECKED INSIDE OF THE PATIENT'S ABDOMINAL CAVITY, AND FOUND THAT THE MCS TIP COVER ACCESSORY HAD FALLEN INSIDE THE PATIENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE MCS TIP COVER ACCESSORY WAS INSPECTED PRIOR TO USE AND NO ABNORMALITIES WERE NOTED WITH IT. THE MCS TIP COVER ACCESSORY WAS NOT INSTALLED BEYOND THE ORANGE SURFACE DURING THE SURGICAL PROCEDURE. ALL PORTS HAD BEEN REMOVED FROM THE PATIENT AND THE SURGEON HAD ALREADY CLOSED THE PATIENT'S ABDOMEN AT THE TIME OF IDENTIFYING THE ISSUE. A PORT WAS RE-INSERTED INTO THE PATIENT TO RETRIEVE THE MCS TIP COVER ACCESSORY AND THE ITEM WAS RETRIEVED SUCCESSFULLY WITH NO INJURY OCCURRING TO THE PATIENT.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WERE DEVIATIONS DURING A L5-S1 CASE. A SCHANZ PIN WAS CONNECTED TO A SCHANZ ARM TO MOUNT THE SURGICAL SYSTEM TO THE PATIENT. THE SURGEON BEGAN WITH LEFT L5 AND LEFT S1 AND A ROD WAS INSERTED WITH NO MOVEMENT DETECTED. RIGHT L5 AND S1 TRAJECTORIES WERE COMPLETED NEXT AND A ROD WAS PLACED. THE MANUFACTURER REPRESENTATIVE NOTED THAT THE SCREW TRAJECTORIES WERE ALTERED DURING THE PROCEDURE TO ACCOMMODATE SOFT TISSUE PRESSURE. AP AND LATERAL IMAGES WERE TAKEN AND PLACEMENT WAS APPROVED BY THE SURGEON. THE DEVIATION COULD NOT BE SEEN ON THE IMAGES. AFTER THE CASE, THE PATIENT EXPERIENCE RIGHT SIDED FOOT DROP AND CHANGES IN SENSATIONS. THE SCREWS WERE REMOVED LATER IN THE DAY DUE TO BEING MISPLACED ON THE RIGHT SIDE IN THE SPINAL CANAL. THE SCREWS WERE DEVIATED BY MORE THAN 10 MM. THE PATIENT EXPERIENCED SOME RECOVERY WITH FORCED EVERSION AND SOME IMPROVEMENT IN SENSATION. THE REPRESENTATIVE SUSPECTED THE DEVIATION WAS CAUSED BY ANATOMY SHIFT, PLATFORM MOUNTING AND SOFT TISSUE PRESSURE. THE PROCEDURE WAS DELAYED MORE THAN AN 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 TONGUE BASE RESECTION SURGICAL PROCEDURE, THE HARMONIC ACE CURVED SHEARS INSTRUMENT BLADE BROKE OFF. A BACKUP INSTRUMENT OF THE SAME TYPE WAS USED AND THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION. THE CUSTOMER REPORTED THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO ISSUES IDENTIFIED. THE INSTRUMENT WAS IN USE WITHOUT ISSUE FOR APPROXIMATELY 20 MINUTES FOR HEMOSTASIS WHEN THE INSTRUMENT BLADE BROKE AND 1 FRAGMENT FELL INTO THE PATIENT'S ORAL CAVITY AND WAS RETRIEVED DURING THE SAME PROCEDURE. REPORTEDLY, NO INTRAOPERATIVE COLLISIONS OCCURRED AND NO RESISTANCE WAS FELT REMOVING THE INSTRUMENT THROUGH THE CANNULA. THE CUSTOMER STATED THERE WAS NO INJURY AND THE PATIENT HAS NOT RETURNED TO THE HOSPITAL WITH ANY POST-SURGICAL COMPLICATIONS.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: SURGEON NOTED THAT TRAJECTORY PLACEMENT SEEMED INCORRECT - CONCERNED THAT EXPORT WAS INCORRECT. SURGEON RE-OPENED LAPTOP TO CONFIRM THAT TRAJECTORY PLACEMENT WAS CORRECTLY PLANNED ON PLANNING SOFTWARE. SURGEON NOTED THAT HE BELIEVED THAT PLANNING HAD NOT SAVED PROPERLY, BUT IT MIGHT BE POSSIBLE THAT HE FORGOT TO SAVE PRIOR TO EXPORT. SURGEON CONFIRMED TRAJECTORIES BEFORE PROCEEDING, DELAY 15 MINUTES.

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 PATIENT EXPERIENCED A NEAR DEATH EXPERIENCE.

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 THERE WAS A DEVIATION DURING A L4-S1 CASE. THE SCREWS WERE PLACED ACCURATELY ON THE LEFT SIDE OF THE PATIENT. ON THE RIGHT SIDE, THERE WAS A SUSPECTED MEDIAL SKIVE AT L5. WHEN THE SURGEON WAS TAPPING AT L5, THE TAP WAS PLACED MEDIAL AND DEVIATED 10 MM MEDIALLY FROM PLAN. THE TAP WAS INSERTED INTO THE CANAL AND THERE WAS NOTICEABLE CEREBROSPINAL FLUID (CSF) COMING FROM FROM THE TRAJECTORY. THE SURGEON REPAIRED THE CSF LEAK AFTER REMOVING ABORTING THE USE OF THE GUIDANCE SYSTEM AND REMOVING IT FROM THE TABLE. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS DELAYED LESS THAN AN HOUR.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DR (B)(6) CONTACTED A FIELD SERVICE ENGINEER (FSE) BY PHONE FOLLOWING AN ISSUE ON HIS PATIENT FOLDER. THE PLANNING MADE FOR HIS CASE WAS NOT SEEN BY ROSA BRAIN ON THE PLANNING STATION AND ON ROSA DEVICE. THE PATIENT WAS ALREADY IN THE OPERATING ROOM AND THE CASE WITHOUT THE SURGERY WILL BE DONE IN ABOUT 3H (SEEG ¿ 15 ELECTRODS). BY CONSEQUENCE, THE FSE AND DR (B)(6) CONTACTED A SERVICING ENGINEER TO FIND A SOLUTION OR AT LEAST A WORKAROUND. AFTER TESTING MANY WAYS THROUGH THE MAINTENANCE SESSION: COPY OF THE FOLDER ON USB KEY AND TRANSFER THE PATIENT FOLDER TO THE DEVICE, OR UNENCRYPT THE PATIENT FOLDER, OPEN THE FOLDER SINCE THE MAINTENANCE SESSION, EVERYTHING FAILED. WITH HELP OF A SOFTWARE ENGINEER, IT WAS DISCOVERED THAT IT WAS AN ISSUE WITH THE .ROS FILE. THIS FILE MOVED FROM .ROS TO .DEL, AFTER REPLACING .DEL BY .ROS EVERYTHING WAS FIXED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AT 10:45 AM, THE ROBOT ARM WAS DRIFTING WHEN IN AXIAL AND FREE AND FAST (WHERE THE ARM WAS MOVING ON ITS OWN WITHOUT TACTILE INTERACTION FROM THE USER). AFTER THE FIRST ELECTRODE, THE SURGEON CHECKED THE BONE FIDUCIAL PLACEMENT BY MAKING A TRAJECTORY AND DRIVING THERE, AND THE TRAJECTORY TO THE BONE FIDUCIAL APPEARED TO BE ABOUT 1 MM OFF SO THE ROBOT WAS UNDRAPED, THE PATIENT WAS RE-REGISTERED AND THE ROBOT WAS RE-DRAPED. AT THAT POINT, EVERYTHING WAS ACCURATE FOR THE REST OF THE CASE AND NO DRIFTING. THERE COULD HAVE BEEN A CALIBRATION ISSUE WHEN THE SURGEON CALIBRATED THE INSTRUMENT HOLDER THE FIRST TIME. INITIALLY THE USER USED INSTRUMENT HOLDER MT-02- 158 (B)(4) THEN AFTERWARDS WHEN WE RE-DRAPED THE USER USED MT-2-158 (B)(4). THIS CAUSED ABOUT A 30-MINUTE DELAY.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DR (B)(6) CONTACTED A FIELD SERVICE ENGINEER (FSE) BY PHONE FOLLOWING AN ISSUE ON HIS PATIENT FOLDER. THE PLANNING MADE FOR HIS CASE WAS NOT SEEN BY ROSA BRAIN ON THE PLANNING STATION AND ON ROSA DEVICE. THE PATIENT WAS ALREADY IN THE OPERATING ROOM AND THE CASE WITHOUT THE SURGERY WILL BE DONE IN ABOUT 3H (SEEG ¿ 15 ELECTRODS). BY CONSEQUENCE, THE FSE AND DR (B)(6) CONTACTED A SERVICING ENGINEER TO FIND A SOLUTION OR AT LEAST A WORKAROUND. AFTER TESTING MANY WAYS THROUGH THE MAINTENANCE SESSION: COPY OF THE FOLDER ON USB KEY AND TRANSFER THE PATIENT FOLDER TO THE DEVICE, OR UNENCRYPT THE PATIENT FOLDER, OPEN THE FOLDER SINCE THE MAINTENANCE SESSION, EVERYTHING FAILED. WITH HELP OF A SOFTWARE ENGINEER, IT WAS DISCOVERED THAT IT WAS AN ISSUE WITH THE .ROS FILE. THIS FILE MOVED FROM .ROS TO .DEL, AFTER REPLACING .DEL BY .ROS EVERYTHING WAS FIXED.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS REPORTED: "I RECEIVED SOME INFORMATION REGARDING A SURGEON OUT OF (B)(6) WHO IS AN AVID MAKO SUPPORTER AND USER. HE EXPRESSED SOME CONCERNS OVER PRESS-FIT FEMORAL FIT" CASE 1: PATIENT COMPLAINED OF PAIN SO THEY THOUGHT IT WAS LOOSENING OF FEMUR BUT THEY DIDN¿T HAVE TO DO ANYTHING.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS REPORTED: "I RECEIVED SOME INFORMATION REGARDING A SURGEON OUT OF KNOXVILLE, TN WHO IS AN AVID MAKO SUPPORTER AND USER. HE EXPRESSED SOME CONCERNS OVER PRESS-FIT FEMORAL FIT". CASE 2: FEMUR LOOSENING WAS OBSERVED.

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) 2021, IT WAS REPORTED THAT DURING A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE THE PATIENT WAS OBSERVED TO HAVE A PNEUMOTHORAX. THE TARGET LOCATION WAS RIGHT UPPER LOBE. THERE WAS NO ALLEGATION OF DEVICE FAILURE. A CHEST TUBE WAS PLACED AND THE PATIENT WAS HOSPITALIZED. CHEST TUBE WAS REMOVED ON (B)(6) 2021. THE PNEUMOTHORAX WAS RESOLVED, AND THE PATIENT WAS DISCHARGED ON (B)(6) 2021.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: COMPANY REPRESENTATIVE (CRÀ WAS PRESENT FOR A BIOPSY AND ABLATION CASE. THE SURGEON POSITIONED THE PATIENT PRONE USING A REGULAR MAYFIELD AND ATTACHED TO THE ROSA. THE SURGEON THEN PLACED FIDUCIALS AND GOT AN O-ARM SPIN (FIRST GENERATION) OF THE FIDUCIALS FOR REGISTRATION. WHEN CR WENT TO LOAD THE SCAN INTO THE ROSA USING A USB, THE MERGE SCREEN SHOWED THAT SOME OF THE SLICES HAD BEEN CUT OUT, SO THAT THERE WAS A STRANGE JUMP IN BONE AT THE TOP OF THE HEAD. WHEN LOADING IN THE SCAN, THE CR HAD RECEIVED AN ERROR THAT THERE WERE GAPS BETWEEN SLICES. CR THOUGHT THAT THE SCAN HAD NOT COPIED CORRECTLY ONTO THE USB, AND SO PULLED THE SAME EXAM FROM PACS. CR CONFIRMED THAT 191 SLICES WERE PRESENT IN THE EXAM IN THE IQVIEW TEMPORARY FOLDER. HOWEVER, THE SAME PROBLEM OCCURRED ON THE MERGE SCREEN, BUT THE CR DID NOT RECEIVE ANY ERRORS THIS TIME FROM THE ROSA SOFTWARE. THE SURGEON NOTED THAT THE PATIENT HAD HARDWARE FROM A SHUNT LOCATED AT THE SAME LEVEL WHERE THE SLICES SEEMED TO JUMP. THE SURGEON DECIDED TO GET ANOTHER SCAN AND TILT THE GANTRY OF THE O-ARM SLIGHTLY TO ALLOW FOR CLEAR VISUALIZATION OF THE FIDUCIALS BELOW THE PROBLEM AREA. THE 2ND SCAN WAS TRANSFERRED BY USB TO THE ROBOT AND

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE SURGEON INFORMED, AND REPORTED AT STARTING UP THE SYSTEM, ROSA SAYS THE ARM IS NOT FREE. BEFORE THAT HAPPENS THE SYSTEM WAS NORMALLY SHUT DOWN. THE SURGEON HAD PUSH EMERGENCY BUTTON AND IN MAINTENANCE MODE SHE WAS ABLE TO MOVE THE ROSA ARM. IN THEATRE/PATIENT UNDER ANESTHESIA/BEFORE SURGERY PROCEDURE AND INCISION DELAY IN MINUTES: 35, SYSTEM HAD RESTARTED MULTIPLE TIMES, TO START PROCEDURE.

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 SURGICAL PROCEDURE, THE CUSTOMER CONTACTED THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) REGARDING A MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY. THE CUSTOMER REACHED OUT WHEN AN MCS TIP COVER ACCESSORY CAME OFF OF A ROBOTIC INSTRUMENT THAT WAS BEING USED. THE CUSTOMER WAS ASKING IF IT WOULD SHOW UP ON AN X-RAY IF THEY COULD NOT FIND IT. THE CUSTOMER ALSO INDICATED THEY DID NOT USE ANY KIND OF LUBRICANT WITH THE MCS INSTRUMENT AND COULD NOT BELIEVE IT CAME OFF. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE MCS INSTRUMENT AND MCS TIP COVER ACCESSORY WERE INSPECTED PRIOR TO USE AND NO DAMAGE WAS NOTED ON EITHER. THE MCS TIP COVER ACCESSORY FELL INSIDE THE PATIENT, AND WAS RETRIEVED USING A LAPAROSCOPIC GRASPER. THE CUSTOMER WAS REMOVING THE INSTRUMENT FROM THE PATIENT WHEN THE TIP COVER FELL. SURGEON DID NOT NOTICE ANY ISSUE WITH INSTRUMENT FUNCTIONALITY AND THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENT. UPON REMOVAL OF THE MCS, THE TIP WAS STRAIGHTENED AND THERE WAS NO RESISTANCE. THERE WAS

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS NOTED THAT THE L1 SCREW WAS 4.5MM MEDIAL AND THE L2 SCREW WAS 1.5-2MM LATERAL. THE L2 SCREW WAS NOT REDIRECTED OR REVISED. NO PERMANENT HARM WAS DONE TO THE PATIENT DUE TO THE DEVIATIONS.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT MULTIPLE ACCURATE CASES HAVE BEEN COMPLETED SINCE THE EVENT. THE REPRESENTATIVE HAD MADE SUGGESTIONS ABOUT THE SURGEONS TECHNIQUE, THE POSSIBILITY OF THE SPINE "TORQUING" WITH INSTRUMENTATION AND USING THE CLAMP VERSUS PELVIC FIXATION, BUT THE SURGEON DISAGREED WITH THESE AS THE CAUSE OF THE DEVIATIONS.

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, IT WAS REPORTED THAT DURING A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE THE PATIENT WAS OBSERVED TO HAVE A PNEUMOTHORAX. THE TARGET LOCATION WAS RIGHT LOWER LOBE, BUT THE PNEUMOTHORAX WAS SEEN IN THE RIGHT UPPER LOBE, AND THE USER DID NOT DRIVE IN THE RIGHT UPPER LOBE. THE CAUSE OF THE PNEUMOTHORAX IS UNKNOWN. THE INSTRUMENTS USED WERE AN OLYMPUS NEEDLE AND AURIS FORCEPS. AN ENDOBRONCHIAL ULTRASOUND (EBUS) AND X-RAY WAS PERFORMED AFTER THE CASE. A CHEST TUBE WAS PLACED AND THE PATIENT WAS CHECKED INTO THE HOSPITAL. THE PNEUMOTHORAX WAS RESOLVED, AND THE PATIENT WAS DISCHARGED 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.

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 ON 25-NOV-2020 THAT AFTER A DA VINCI-ASSISTED GYNECOLOGY PROCEDURE IN 2018, THERE WAS A ¿SURGICAL SITE INFECTION¿. THE CUSTOMER (INFECTION CONTROL) SUBSEQUENTLY REQUESTED A MEETING WITH INTUITIVE SURGICAL, INC. (ISI) TO FOLLOW UP ON THE REPORT. AT THIS TIME, THE PROCEDURE TYPE, THE DATE OF THE PROCEDURE, THE SEVERITY OF THE INFECTION, AND THE STEPS TAKEN TO ADDRESS THE INFECTION REMAIN UNKNOWN. ISI HAS REACHED OUT TO THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION BUT HAS NOT YET RECEIVED A RESPONSE. ALL FOLLOW-UP ATTEMPTS HAVE BEEN EXHAUSTED.

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 ON 25-NOV-2020 THAT AFTER A DA VINCI-ASSISTED GYNECOLOGY PROCEDURE IN 2019, THERE WAS A ¿SURGICAL SITE INFECTION¿. THE CUSTOMER (INFECTION CONTROL) SUBSEQUENTLY REQUESTED A MEETING WITH INTUITIVE SURGICAL INC. (ISI) TO FOLLOW UP ON THE REPORT. AT THIS TIME, THE PROCEDURE TYPE, THE DATE OF THE PROCEDURE, THE SEVERITY OF THE INFECTION, AND THE STEPS TAKEN TO ADDRESS THE INFECTION REMAIN UNKNOWN. INTUITIVE SURGICAL, INC. (ISI) HAD REACHED OUT TO THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION BUT HAS NOT YET RECEIVED A RESPONSE. ALL FOLLOW-UP ATTEMPTS HAVE BEEN EXHAUSTED.

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 2 SCREWS WERE MISPLACED. UPON REMOVAL OF THE SECOND SCREW, THE INTERNAL ILIAC ARTERY WAS PERFORATED CAUSING BLOOD LOSS TO THE PATIENT. THIS WAS RESOLVED AND THE PATIENT IS RECOVERING. THIS EVENT OCCURRED IN BELGIUM.

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 TOTAL BENIGN HYSTERECTOMY SURGICAL PROCEDURE, A PLASTIC PART OF THE SYNCROSEAL JAW FELL OFF WHILE THE INSTRUMENT WAS IN THE SURGICAL FIELD. THE OPERATING ROOM (OR) STAFF WAS ABLE TO REMOVE THE PIECE FROM THE PATIENT WITHOUT ANY ISSUES AND THERE WAS NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) COMPLETED FOLLOW-UP AND OBTAINED THE FOLLOWING INFORMATION: PER THE REPORTER, ALL FRAGMENTS WERE RETRIEVED USING A LAPAROSCOPIC GRASPER. THERE WAS NO ADDITIONAL SURGICAL PROCEDURE REQUIRED TO REMOVE THE FRAGMENT NOR WERE THERE ANY POST-OPERATIVE TESTS PERFORMED. THE SURGEON WAS USING THE MONOPOLAR CURVED SCISSORS TO CLEAN TISSUE OFF THE SYNCHROSEAL WHEN THE REPORTED ISSUE OCCURRED. THE INSTRUMENT WAS REMOVED PROPERLY AND THERE WAS NO REPORT OF PATIENT INJURY, NOR HAS THE PATIENT RETURNED TO THE HOSPITAL DUE TO POST-OPERATIVE COMPLICATIONS.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED BY A REPRESENTATIVE FROM (B)(6) THAT 2 SCREWS WERE MISPLACED. UPON REMOVAL OF THE SECOND SCREW, THE INTERNAL ILIAC ARTERY WAS PERFORATED CAUSING BLOOD LOSS TO THE PATIENT. THIS WAS RESOLVED AND THE PATIENT IS RECOVERING.

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: DURING REVIEW OF A LITERATURE ARTICLE INVOLVING DA VINCI ASSISTED ROBOTIC PROCEDURES TITLED, ¿SINGLE PORT ROBOTIC RADICAL PROSTATECTOMY VERSUS MULTI-PORT ROBOTIC RADICAL PROSTATECTOMY: A HUMAN FACTOR ANALYSIS DURING THE INITIAL LEARNING CURVE¿ THE FOLLOWING EVENTS WERE REPORTED: FROM (B)(6) 2018 TO (B)(6) 2019, THE FIRST 20 CONSECUTIVE SINGLE PORT (SP) ROBOTIC ASSISTED LAPAROSCOPIC PROSTATECTOMIES (RALPS) PERFORMED BY A SINGLE EXPERIENCED ROBOTIC SURGEON WERE COMPARED AGAINST 20 MULTIPORT (MP) RALPS PERFORMED AT ANOTHER SITE IN ITALY. OF THE 20 CASES THAT WERE PERFORMED USING THE DA VINCI SINGLE PORT (SP), ONE INTRA-OPERATIVE COMPLICATION OF SEROSAL INJURY DUE TO EXTENSIVE LYSIS OF ADHESIONS WAS REPORTED. EIGHTEEN POST-OPERATIVE COMPLICATIONS WERE MENTIONED IN THE ARTICLE, WHICH INCLUDES CLAVIEN-DINDO GRADE I TO GRADE IVB. EIGHT PATIENTS DEVELOPED GRADE I POST-OPERATIVE COMPLICATIONS INVOLVING SHOULDER PAIN, ILEUS, ELECTROLYTE DERANGEMENT, NAUSEA, AND/OR VOMITING. SIX PATIENTS EXPERIENCED GRADE II COMPLICATIONS INVOLVING URINARY TRACT INFECTION (UTI), HEALTHCARE ACQUIRED PNEUMONIA (HCAP), EPIDIDYMOORCHITIS, AND/OR PELVIC HEMATOMA WHICH REQUIRED TRANSFUSION. TWO PATIENTS HAD GRADE I

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: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.