ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS THE LASER WAS BEING MOVED FROM THE MEDIAL CANTHUS TO THE NOSE DURING REGISTRATION, THE LASER LIGHT TURNED OFF WITHOUT PRESSING ANY SWITCH OR DISCONNECTING THE CABLE. AFTER MOVING THE ARM AND DISTANCE SENSOR WIRE AROUND, THE LIGHT CAME BACK ON. HOWEVER, WHEN TRYING TO RECORD A POINT AFTER THE LIGHT WENT OFF AND CAME BACK ON, THERE WAS A DISTANCE CALIBRATION ERROR. THE LASER HAS BEEN COLLECTED FORM THE HOSPITAL AND WILL BE SHIPPED BACK. A NEW LASER IS BEING ORDERED FOR THE HOSPITAL. THE PATIENT WAS ASLEEP AND UNDER ANESTHESIA.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE ROBOT WAS PUT IN AXIAL SLOW, THEN FREE AND FAST TO CLEAR THE ARM AWAY FROM THE PATIENT. THE SURGEON STARTED MANEUVERING THE ARM AND SPINNING IT. AS THE SURGEON WAS MOVING IT, THE FORCE SENSOR CABLE GOT CAUGHT IN THE JOINT CAUSING IT TO RIP OUT OF THE FORCE SENSOR BLOCK. IN THE PROCESS, IT BENT A COUPLE OF PINS. THE PINS WERE STRAIGHTENED AND THE CABLE PLACED BACK, BUT EVERY TIME THE ARM WAS SET TO AUTOMATIC MODE, IT DETECTED A COLLISION. THE PATIENT WAS ASLEEP AND INCISION HAD ALREADY BEEN MADE. THREE OUT OF 10 ELECTRODES WERE PLACED BEFORE THE SURGERY HAD TO BE ABORTED.

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 SENT TO THE FIELD SERVICE ENGINEER 2 PICTURES OF THE SCREEN OF THE ROBOT SHOWING THE ERROR VALUES OF THE INITIAL POINTS AND THE ERROR MESSAGE: "THE REGISTRATION COULD NOT BE COMPUTED. DO YOU WANT TO PERFORM AGAIN THE REGISTRATION OR RETRY BY MODIFYING THE INITIAL POINTS? ". THE INITALS POINTS WERE ALL RATED GREEN (CORRECT) ON THE RECOLLECTION OF INITIAL POINTS. THE SURGEON ASKED WHY EVERYTHING IS GREEN WHEREAS THE REGISTRATION IS NOT POSSIBLE. THE FSE ADVISED TO RETRY FIRST SETTING THE INITIAL POINTS AGAIN AND HAVE THE ERROR BELOW 2MM FOR EACH POINT. LATER, THE SURGEON INFORMED THE FSE THAT THE REGISTRATION WAS SUCCESSFUL.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A FIELD SERVICE ENGINEER WAS INFORMED THAT A PATIENT FROM THE WEEK BEFORE HAD EXPERIENCED A HEMORRHAGE DURING THE ROSA ASSISTED SEEG CASE. THE HOSPITAL WAS INDEPENDENT FOR THIS CASE SO THERE WERE NO ROSA REPRESENTATIVES IN THE CASE. THE DOCTOR MENTIONED THAT THE TRAJECTORY THAT HE THINKS CAUSED THE HEMORRHAGE WAS ONE THAT WAS PLANNED AT THE LAST MINUTE. THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM ON THE DAY OF SURGERY AND AN ADDITIONAL SURGERY WAS PERFORMED TO CLEAR THE HEMORRHAGE. ONLY ONE OF THE SEEG ELECTRODES WAS REMOVED IN THIS PROCESS. THE PATIENT IS DOING WELL AND THE NEUROLOGY TEAM IS CURRENTLY MONITORING THE REMAINING ELECTRODES.

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 A 3DEFINE SCAN WAS COMPLETED AND REGISTRATION WAS ACHIEVED WITH AN O-ARM. LEFT AND RIGHT L2 WERE MEDIAL DUE TO SOFT TISSUE PRESSURE. THE RIGHT L2 TRAJECTORY PENETRATED THE DURA AND THE NERVE ROOT. THE CASE WAS ABORTED AFTER CONFIRMATION OF RIGHT L2 DEVIATION.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON 2ND OCTOBER, DR (B)(6) (NEUROLOGIST) CALLED MEDTECH CUSTOMER SERVICE TO INFORM THAT DURING LAST SURGERY ON THE (B)(6) 2018, A BLEEDING APPEARED AT THE POST-OP CONTROL. THE SURGERY CASE WAS A SEEG AND WAS DONE BY DR (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: THE SURGEON CALLED THE FIELD SERVICE ENGINEER ON 20 SEP 2018 TO INFORM THAT SHE NOTICED SOME ELECTRODES IMPLANTED ON (B)(6) 2018 WERE MISPLACED. THE SURGEON STATED THAT THE TEMPORAL ELECTRODES WERE SHIFTED 4-5MM ON CORONAL PLAN. SHE ALSO STATED THE SURGERY WENT FINE: LASER REGISTRATION PASSED ON THE FIRST TIME, NO CORRECTIONS, VERIFICATION PASSED AND PATIENT INSTALLATION CHECKED. A FIELD SERVICE ENGINEER WAS ON SITE ON (B)(6)2018 TO PERFORM KINEVERIF TESTS (LASER, POINTER) AS WELL AS APPLICATIVE TEST, WHICH BOTH PASSED. THE SURGEON CONFIRMED THE PATIENT WAS DOING FINE.

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 THE START OF A DA VINCI-ASSISTED MINIMALLY INVASIVE DIRECT CORONARY ARTERY BYPASS (MID CAB) PROCEDURE, A PATIENT EXPERIENCED DANGEROUS HEART RHYTHMS. THE OPERATIVE COMPLICATION REPORTEDLY OCCURRED UPON INITIAL ENTRY/INSERTION OF A TROCAR AND WHILE CONNECTING TO AN ERBE GENERATOR. AS A RESULT OF THE OPERATIVE COMPLICATION, THE PATIENT HAD TO BE SHOCKED TWICE IN ORDER TO GET BACK TO A REGULAR HEART RHYTHM. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: DURING THE START OF THE DA VINCI-ASSISTED MID CAB PROCEDURE, THE PATIENT EXPERIENCED DANGEROUS HEART RHYTHMS WHEN THE SURGEON APPLIED ENERGY THROUGH A BOVIE PEN (A 3RD PARTY MANUFACTURER PRODUCT) WHICH IS CONNECTED TO THE INTEGRATED ELECTROSURGICAL UNIT (IESU) OF THE DA VINCI XI SURGICAL SYSTEM. AT THE TIME THE EVENT OCCURRED, THE SURGEON WAS ATTEMPTING TO USE THE BOVIE PEN TO CREATE THE FIRST INCISION PORT. THE SURGICAL STAFF SHOCKED THE PATIENT IN ORDER TO ACHIEVE A REGULAR HEART RHYTHM. AT THE TIME THE EVENT OCCURRED, THE ROBOT WAS NOT DOCKED TO THE PATIENT YET. THE SURGICAL PROC

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 THE START OF A DA VINCI-ASSISTED MINIMALLY INVASIVE DIRECT CORONARY ARTERY BYPASS (MID CAB) PROCEDURE, THE PATIENT EXPERIENCED DANGEROUS HEART RHYTHMS. THE OPERATIVE COMPLICATION REPORTEDLY OCCURRED UPON INITIAL ENTRY/INSERTION OF A TROCAR AND WHILE CONNECTING TO AN ERBE GENERATOR. AS A RESULT OF THE OPERATIVE COMPLICATION, THE PATIENT HAD TO BE SHOCKED TWICE IN ORDER TO GET BACK TO A REGULAR HEART RHYTHM. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: DURING THE START OF THE DA VINCI-ASSISTED MID CAB PROCEDURE, THE PATIENT EXPERIENCED DANGEROUS HEART RHYTHMS WHEN THE SURGEON APPLIED ENERGY THROUGH A BOVIE PEN (A 3RD PARTY MANUFACTURER PRODUCT) WHICH IS CONNECTED TO THE INTEGRATED ELECTROSURGICAL UNIT (IESU) OF THE DA VINCI XI SURGICAL SYSTEM. AT THE TIME THE EVENT OCCURRED, THE SURGEON WAS ATTEMPTING TO USE THE BOVIE PEN TO CREATE THE FIRST INCISION PORT. THE SURGICAL STAFF SHOCKED THE PATIENT IN ORDER TO ACHIEVE A REGULAR HEART RHYTHM. AT THE TIME THE EVENT OCCURRED, THE ROBOT WAS NOT DOCKED TO THE PATIENT YET. THE SURGICAL PR

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 PLANNED DA VINCI-ASSISTED MINIMALLY INVASIVE DIRECT CORONARY ARTERY BYPASS (MID CAB) PROCEDURE, A PATIENT EXPERIENCED DANGEROUS HEART RHYTHMS. THE OPERATIVE COMPLICATION REPORTEDLY OCCURRED UPON INITIAL ENTRY/INSERTION OF A TROCAR AND WHILE CONNECTING TO AN ERBE GENERATOR. AS A RESULT OF THE OPERATIVE COMPLICATION, THE PATIENT HAD TO BE SHOCKED TWICE IN ORDER TO GET BACK TO A REGULAR HEART RHYTHM. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: DURING THE START OF THE DA VINCI-ASSISTED MID CAB PROCEDURE, THE PATIENT EXPERIENCED DANGEROUS HEART RHYTHMS WHEN THE SURGEON APPLIED ENERGY THROUGH A BOVIE PEN (A 3RD-PARTY MANUFACTURER PRODUCT) WHICH IS CONNECTED TO THE INTEGRATED ELECTROSURGICAL UNIT (IESU) OF THE DA VINCI XI SURGICAL SYSTEM. AT THE TIME THE EVENT OCCURRED, THE SURGEON WAS ATTEMPTING TO USE THE BOVIE PEN TO CREATE THE FIRST INCISION PORT. THE SURGICAL STAFF SHOCKED THE PATIENT IN ORDER TO ACHIEVE A REGULAR HEART RHYTHM. AFTER THE EVENT OCCURRED, THE SURGEON MADE THE DECISION TO CONVERT THE PLANNED SURGICAL PROCEDURE 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: IT WAS REPORTED THAT DURING THE DA VINCI-ASSISTED RIGHT HEMICOLECTOMY PROCEDURE, A VESSEL SEALER INSTRUMENT WAS ALLEGEDLY NOT SEALING. AT THE TIME THE INITIAL REPORTER CONTACTED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOR ASSISTANCE, THE SURGICAL STAFF HAD ALREADY CONVERTED THE SURGICAL PROCEDURE TO OPEN SURGERY. ACCORDING TO THE INITIAL REPORTER, THE SURGICAL STAFF PULLED THE VESSEL SEALER INSTRUMENT OUT AND CLAIMED THAT THE INSTRUMENT WOULD HEAT UP ON A CLOTH. HOWEVER, WHEN THE VESSEL SEALER INSTRUMENT WAS REINSERTED BACK INTO THE PATIENT, IT WAS ALLEGED THAT THE INSTRUMENT WOULD NOT SEAL A VESSEL. THE INITIAL REPORTER INDICATED THAT THE VESSEL IN QUESTION SEEMED TO BE NORMAL IN SIZE. THE INITIAL REPORTER ALSO CLAIMED THAT WHEN THE EVENT OCCURRED, THE AUDIBLE TONES INDICATING THAT THE SEALING CYCLE WAS COMPLETE WERE HEARD. THE TSE CHECKED THE SYSTEM LOGS AND DID NOT FIND ANY RELATED SYSTEM ERRORS. ON (B)(6) 2018, ISI CONTACTED THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE SURGEON HAD REPORTEDLY TESTED THE VESSEL SEALER INSTRUMENT ON FAT TISSUE TO CONFIRM ENERGY DELIVERY PRIOR TO ATTEMPTING TO SE

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A ROSA TECHNICIAN WORKING FOR THE (B)(6) DISTRIBUTOR INFORMED A FIELD SERVICE ENGINEER BY EMAIL ON SEPTEMBER 10TH 2018 THAT THE SURGICAL TEAM HAD A COUPLE OF REBOOTS DURING THE LAST MONTHS. LOG FILES WERE SENT FOR THE PERIOD (B)(6) TO (B)(6) 2018 AND WERE ANALYZED. ONE OCCURENCE HAS BEEN FOUND ON (B)(6). LOG FILES SHOW THAT 3 SOFTWARE CRASHES AND ONE COMMUNICATION ERROR OCCURRED DURING A SURGERY.

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 END OF THE CASE WHEN THE SURGEON WAS TRYING TO MOVE THE ARM CLEAR IN FREE/ FAST MODE, THE FORCE SENSOR CABLE GOT STUCK AND BENT. A COMMUNICATION ERROR THEN OCCURRED AND THE ROBOT SHUT DOWN. SINCE THIS WAS THE END OF THE CASE AND THE ROBOT WAS NOT ATTACHED TO THE PATIENT (PATIENT¿S HEAD HOLDER WAS ONLY ATTACHED TO THE BED), THE LASERS WERE PLACED BEFORE RESTARTING THE ROBOT AND ROLLING IT AWAY FROM THE PATIENT. A MEDTECH REPRESENTATIVE WAS PRESENT AT THE TIME OF THE EVENT AND ATTEMPTED TO RESOLVE THE ISSUE, HOWEVER THE DAMAGE SUSTAINED BY THE CABLE CAUSED FURTHER COLLISION ERRORS. AS THIS ISSUE OCCURRED AFTER THE ROSA PORTION OF THE SURGERY WAS FINISHED, THERE WAS NO DELAY AND THE PATIENT WAS NOT AFFECTED. HOWEVER, DUE TO THE DAMAGE, THE NEXT SCHEDULED SURGERY WITH ROSA WAS CANCELLED. THE SURGEON HAD ANOTHER NAVIGATION SYSTEM THAT HE USED INSTEAD.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THREE DAYS AFTER SURGERY, THE NEUROSURGERY FELLOW NOTIFIED A REPRESENTATIVE OF MEDTECH, THE CST, THAT THE PATIENT HAD A HEMORRHAGE AND WAS IN THE INTENSIVE CARE UNIT. THE FELLOW BELIEVED HIGH BLOOD PRESSURE DURING SURGERY MAY HAVE PLAYED A ROLE AND INDICATED THAT BLOOD WAS PRESENT ON LEFT SIDE, WHERE ONLY THREE ELECTRODES WERE PLACED, DESPITE THE HIGHER CONCENTRATION OF ELECTRODES ON THE RIGHT SIDE. ELECTRODES FOR TRAJECTORIES ¿LA¿ AND ¿LPH¿ APPEAR BENT BUT ACCURATE, AND TRAJECTORY ¿LAH¿ APPEARS 2 MILLIMETERS DEEP. INACCURATE ELECTRODE PLACEMENTS ON THE RIGHT SIDE LIKELY DID NOT CONTRIBUTE TO THIS ISSUE. INFORMATION WAS ALSO RECEIVED FROM THE SURGEON THAT THE PATIENT'S PRIOR CONDITION (CARDIOVASCULAR DISEASE) WAS LIKELY A CONTRIBUTORY FACTOR.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A POST PROCEDURE X-RAY INDICATED A 10% PNEUMOTHORAX. A CHEST TUBE WAS USED AND THE PATIENT WAS ADMITTED FOR OBSERVATION OVERNIGHT. THE CHEST TUBE WAS REMOVED AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY WITHOUT INCIDENT.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING REGISTRATION A SLOWDOWN ERROR OCCURRED. FIELD SERVICE ENGINEER PRESSED THE "OK" BUTTON TO CONTINUE. THEY WERE ABLE TO CONTINUE, BUT THE ERROR WINDOW STAYED PRESENT IN THE BACKGROUND AND THE ERROR CHIME PERSISTED. THEY PROGRESSED FURTHER IN THE REGISTRATION PROCESS HOPING TO REACH A POINT WHERE PROGRESS COULD BE SAVED. HOWEVER, "ROSANNA" CRASHED DURING THE ACCESSIBILITY CHECK. THIS CRASH CAUSED A LOSS OF SOME DATA BECAUSE IT WAS NOT SAVED BEFORE STARTING REGISTRATION. THE SURGEON HAD MADE MODIFICATIONS TO SOME TRAJECTORIES THAT WAS LOST. THE FIDUCIAL MARKERS HAD TO BE RE-DEFINED. THE REGISTRATION WAS NOT SAVED AND HAD TO BE REPEATED. OVERALL, THIS SOFTWARE CRASH DELAYED THE CASE BY ABOUT 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 INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A NURSE'S HAND WAS POSSIBLY FRACTURED WHILE POSITIONING A PATIENT SIDE CART (PSC). ACCORDING TO THE INITIAL REPORTER, WHEN THE CART DRIVE SWITCH AND THROTTLE WERE RELEASED, THE PSC ALLEGEDLY KEPT MOVING AND THE NURSE'S HAND WAS CAUGHT BETWEEN THE CART DRIVE HANDLE AND THE WALL. ON (B)(6) 2018, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE AND THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT WAS OBTAINED: THE REPORTER, A NURSE, INDICATED THAT THE EVENT OCCURRED ON (B)(6) 2018. ACCORDING TO THE REPORTER, ANOTHER NURSE WAS ATTEMPTING TO MOVE THE PSC OUT OF THE WAY SINCE IT WAS INTERFERING WITH A BACK TABLE. THE DAY THE EVENT OCCURRED, THE NURSE'S HAND REPORTEDLY WAS SWOLLEN. THE FOLLOWING DAY, HER HAND KEPT "BOTHERING HER" SO SHE HAD AN X-RAY PERFORMED. A BROKEN BONE WAS IDENTIFIED AROUND THE KNUCKLE AREA OF ONE OF HER FINGERS ON THE RIGHT HAND. IN ADDITION, THE REPORTER INDICATED THAT A TORN LIGAMENT WAS IDENTIFIED. AS A RESULT, A HARD CAST WAS INITIALLY PLACED ON THE NURSE'S HAND. HOWEVER, THE NURSE WAS APPARENTLY ALLERGIC TO SUBSTANCES ON THE CAST. THEREFORE, THE HARD CAST WAS REPLACE

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON THE (B)(6) 2018, A PATIENT WAS BROUGHT IN FOR BILATERAL SEEG IMPLANTATION, AND WHEN THE CRW FRAME WOULD NOT FIT THE PATIENT¿S HEAD DUE TO THE SIZE OF THE HEAD, A MAYFIELD WAS USED AND ROSA WAS ATTACHED. THE PATIENT WAS REGISTERED, BUT WAS TOO FAR FROM THE ROBOT BASE TO REACH SOME OF THE TRAJECTORIES, SO THE PATIENT WAS REPOSITIONED AND REGISTERED AGAIN. THIS TIME, ALL TRAJECTORIES WERE ACCESSIBLE, BUT UPON VERIFICATION, THE POINTS ON THE LEFT SIDE OF THE HEAD WERE ABOUT 6MM AWAY FROM THE SKIN ON THE CT SCAN. REGISTRATION WAS CANCELED AND RESTARTED. THIS TIME A DIFFERENT PORTION OF THE LEFT TEMPLE WAS SCANNED FURTHER AWAY FROM THE MAYFIELD PIN, AND THE REGISTRATION COULD NOT BE COMPUTED. REGISTRATION WAS ATTEMPTED AGAIN, WITH ANOTHER PORTION OF THE TEMPLE SCANNED. THE VERIFICATION RESULTS WERE THE SAME AS BEFORE, WITH ALL OF THE POINTS VERIFIED, EXCEPT FOR THE POINTS ON THE LEFT SIDE OF THE HEAD. ONE LAST REGISTRATION WAS DONE AND THE LEFT TEMPORAL SCAN WAS SKIPPED. THE VERIFICATION SHOWED THE SAME RESULTS AS BEFORE. THIS PATIENT WAS EXTREMELY OVERWEIGHT AND IT WAS DECIDED THAT THERE WAS TOO MUCH RELAXED SKIN AND MUSCLE THAT WAS SHIFTING AROUND, SO THE FACE NO LONGER MATCHED THE

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 ON THE (B)(6) 2018 FROM A SURGEON IN THE OR. HE CLAIMED THE SUPPORT ARM HAD BECOME "CROSS THREADED" AND THEREFORE BROKEN AND UNABLE TO USE (SPECIFICALLY AT THE POINT WHERE ROSA CONNECTS TO THE MAYFIELD HEAD HOLDER). HE STATED HE, AT THE CURRENT MOMENT WOULD BE UNABLE TO PERFORM THE SURGERY. THE FIELD SERVICE ENGINEER LATER TEXTED A NURSE, THAT LET HIM KNOW THAT THE MAYFIELD HEAD HOLDER ADAPTOR WAS STUCK. THE SURGERY WAS ABORTED.

At 12:45 p.m. on June 22, 2018, an employee was troubleshooting and performing maintenance on Robot #50. During work, the employee's right index finger became caught between the drive belt and pulley of the robot. The finger was amputated, which he was hospitalized and received treatment.

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 CALLED THE FIELD SERVICE ENGINEER ON (B)(6) 2018 DURING AN SEEG SURGERY. THE SURGEON REPORTED THAT TWO COMMUNICATION FAILURES OCCURRED DURING THE SURGERY. THE FIELD SERVICE ENGINEER WHO WAS NOT ON SITE RECEIVED THE CALL AND BEGAN TROUBLESHOOTING. THE ROBOT WAS UNPLUGGED AND MOVED TO A DIFFERENT OUTLET AND REBOOTED. THE ISSUE APPEARED TO RESOLVE AND THE ROBOT WAS ABLE TO BEGIN REGISTRATION. TROUBLESHOOTING TOOK APPROXIMATELY 20 MINUTES ON THE PHONE. THE DELAY TOTALED TO BE 115 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 BY THE SURGEON THAT DURING A SURGERY THE DEVICE HAD MULTIPLE COMMUNICATION ERRORS. THE DELAY IS CURRENTLY IS ESTIMATED AT 1-2 HOURS.

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 TESTED ALL TRAJECTORIES SUCCESSFULLY BEFORE HE STARTED THE SURGERY. DURING THE SURGERY, WHEN THE SURGEON SENT THE ROBOT ON THE LAST TRAJECTORY, THE ROBOT CRASHED. THE SURGEON RESTARTED THE ROBOT AND SENT IT ON TRAJECTORY AGAIN, BUT THE ROBOT WOULD NOT GO TO THE RIGHT PLACE. THE SURGEON TESTED ALL OTHER TRAJECTORIES AND THESE WORKED. THE SURGEON WAS UNABLE TO COMPLETE THE IMPLANT FOR THE LAST TRAJECTORY. A 90 DELAY OCCURRED DURING SURGERY WHILE ATTEMPTING TO REACH THE FINAL TRAJECTORY.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WHEN TRYING TO LOAD EXAM, SCREEN POPPED UP SAYING "IMPOSSIBLE TO LOAD EXAM". THE FIELD SERVICE ENGINEER COULDN'T EXIT FROM EXAM MANAGER, SO HE HAD TO HARD REBOOT THE SYSTEM. ROBOT FUNCTIONED PROPERLY AFTER HARD REBOOT.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: SURGEON CALLED THE FIELD SERVICE ENGINEER BECAUSE SHE NEEDED TECHNICAL ASSISTANCE ABOUT THE PLANNING PC. THIS WAS IMPOSSIBLE TO CHARGE WITH THE ASSOCIATED POWER SUPPLY CORD. THE FIELD SERVICE ENGINEER ASKED HER TO CHECK ALL PART OF THE POWER CORD, TEST THE GOOD FUNCTIONING OF THE WALL OUTLET. THE POWER IS SUSPECTED TO BE NON-USABLE.

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 DIDN'T MANAGE TO TRANSFER PATIENT FOLDER FROM THE PLANNING STATION TO ROSA DEVICE WITH HER USB FLASHDRIVE. A MESSAGE APPEARED: "IMPOSSIBLE TO LOAD EXAM". THE PATIENT WAS UNDER ANAESTHESIA. THE FIELD SERVICE ENGINEER HELP THE DOCTOR BY PHONE: RETRIEVAL OF THE LICENCE ON A FORMER PATIENT FOLDER AND REPLACEMENT OF THE LICENCE IN .ROS OF THE NEW PATIENT FOLDER WHERE THE LICENCE WAS DIFFERENT. REGENERATION OF THE CRC CODE. THE PROBLEM WAS SOLVED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF AN INNOVATIONS JOURNAL ARTICLE TITLED, "EARLY CLINICAL EXPERIENCES OF ROBOTIC ASSISTED AORTIC VALVE REPLACEMENT FOR AORTIC VALVE STENOSIS WITH SUTURELESS AORTIC VALVE¿ (NAGAOKA, E. ET. AL. 2020). IN THIS ARTICLE, STUDY DATA WAS RETROSPECTIVELY COLLECTED FROM 2 PATIENTS WHO UNDERWENT DA VINCI-ASSISTED AORTIC VALVE REPLACEMENT (AVR) IN A SINGLE INSTITUTION BETWEEN MAY AND JUNE 2018. THERE WERE NO MAJOR COMPLICATIONS REPORTED AND NO CONVERSIONS TO STERNOTOMY. WITHIN THE ARTICLE, THE FOLLOWING IS NOTED: "ONE PATIENT HAD FLUID OVERLOAD POSTOPERATIVELY DUE TO VASODILATATION AND REQUIRED AGGRESSIVE DIURESIS. OTHERWISE, POSTOPERATIVE CONVALESCENCE WAS UNCOMPLICATED. THEY WERE DISCHARGED HOME AT DAYS 4 AND 10 AFTER OPERATION, DUE TO POSTOPERATIVE ATRIAL FIBRILLATION RESPECTIVELY (TABLE 3)." ISI FOLLOWED UP WITH THE AUTHOR AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE ARTICLE: "THE POST-OPERATIVE OUTCOME WAS UNRELATED TO THE FUNCTION OF THE DA VINCI SYSTEM." HE FURTHER INDICATED THAT "THERE ARE NO SUCH ALLEGATIONS" THAT A MALFUNCTION OF A DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE INVOLVING THE

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 REGISTRATION FAILED TWICE DUE TO THE IMAGE USED FOR THE 3D RECONSTRUCTION. WHEN A DIFFERENT IMAGE WAS USED, THE REGISTRATION WAS COMPLETED SUCCESSFULLY, AND THE CASE CONTINUED AS PLANNED. A SURGICAL DELAY OF 1 HOUR WAS REPORTED.

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, THE PATIENT CLAIMED THAT HE WAS INJURED. THE PATIENT CONTACTED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOR ASSISTANCE AND WANTED TO KNOW IF THE ROBOT IS DESIGNED TO PROTECT AGAINST A SURGEON PUNCTURING THE VENA CAVA. DURING THE CALL WITH THE TSE, THE LINE UNEXPECTEDLY DISCONNECTED. NO FURTHER 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: IT WAS REPORTED THAT THE MRI WOULD NOT MERGE CORRECTLY LEADING THE SURGEON TO USE PATIENT'S MRI THAT WAS USED A YEAR AGO. A DELAY GREATER THAN 30 MINUTES 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: IT WAS REPORTED THAT WHEN TRYING TO LOAD THE PATIENT FILE ON THE COMPUTER FOR PRE-OPERATIVE PLANNING THERE WAS AN ERROR MESSAGE. A FIELD SERVICE ENGINEER DISCOVERED THAT THERE WAS AN IMAGE BAD CONTRAST VALUE, BUT ALSO THAT ALL THE TRAJECTORIES WERE DELETED. TO MOVE FORWARD WITH SURGERY, THE SURGEON HAD TO RE-LOAD ALL IMAGES AND CREATE THE SURGICAL PLAN AGAIN WHILE THE PATIENT WAS ASLEEP. THIS RESULTED IN A 2 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: ROBOTIC MEGA NEEDLE DRIVER WIRE BREAKS WHILE INSIDE THE PATIENT. NO INJURY NOTED TO THE PATIENT. NEW NEEDLE DRIVER OPENED.

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 WARNED ABOUT A NOT LOADABLE MRT IMAGE DURING PRE-OPERATIVE PLANNING. HE STATED THAT THE IMAGE INCLUDED MORE THAN 300 SLIECES. THE SURGERY WAS FINALLY PERFORMED WITH A STEREOTAXIC FRAME AND WITHOUT ROSA.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CYSTECTOMY PROCEDURE, THE PATIENT SUSTAINED AN UNSPECIFIED BOWEL INJURY. DUE TO THE INTRA-OPERATIVE COMPLICATION, THE SURGICAL PROCEDURE WAS REPORTEDLY CONVERTED TO OPEN SURGERY. ON AN UNSPECIFIED DATE, THE PATIENT REPORTEDLY EXPIRED. THE CAUSE OF THE DEATH WAS NOT PROVIDED. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING A SURGICAL PROCEDURE USING THE MAZOR X SYSTEM AT (B)(6) HOSPITAL CENTER (US), ON (B)(6) 2018, (REPORTED TO MAZOR ON APR. 23, 2018), INACCURATE SCREW PLACEMENT RESULTED IN A REVISION SURGERY.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CASE WAS PLACING TWO MONTERIS LASER FIBERS FOR ABLATION FOLLOWING AN SEEG CASE FOR THE PATIENT. AFTER THE FIRST FIBER WAS PLACED, IT WAS NOTED ON THE MRI THAT THERE WAS A HEMORRHAGE. THIS WAS NOT IN FACT DUE TO THE LASER FIBER, BUT ACTUALLY DUE TO THE PREVIOUS SEEG CASE, TWO DAYS BEFORE. SURGEON HAD NOT SEEN IT UNTIL THIS POINT. IT WAS NOTED THAT IT WAS EITHER RELATED TO TRAJECTORY 'LPC 2' OR 'RC', MORE LIKELY LPC 2. THE ELECTRODES WERE VERY ACCURATE FROM THE CASE. SURGEON STATED THAT HE DID NOT BELIEVE ANY FAULT SHOULD BE ATTRIBUTED TO ROSA.

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 THREE COMMUNICATION ERRORS OCCURRED DURING THE SURGERY. THE FIRST ONE OCCURRED DUE TO A COLLISION BETWEEN THE ROBOT ARM AND THE ARM OF THE COMPUTER MONITOR. THE SECOND AND THIRD ONES OCCURRED DURING THE REGISTRATION PHASE, DURING THE AUTOMATIC SCAN PORTION OF THE FRAMELESS REGISTRATION. THE TOTAL REPORTED DELAY WAS OVER 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 THAT SURGEON WAS NOT ABLE TO LOAD IMAGES INTO THE PATIENT FOLDER THROUGH PACS. THE IMAGES WERE THEN BURNED TO A CD AND STILL COULD NOT BE READ. THE IMAGE WOULD NOT APPEAR ON THE IMAGE LOAD SCREEN AFTER THE CD HAD BEEN READ. THE IMAGE SERIES WAS TAKEN FROM THE CD AND MOVED INTO A DICOM FOLDER ON A USB DRIVE, AND TWO SLICES WITH DIFFERENT FILES SIZES FROM THE REST OF THE IMAGES WERE REMOVED. THE IMAGE WAS THEN ABLE TO LOAD AND BE VIEWED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WHILE INSTALLING THE LOANER SYSTEM THE DISTANCE SENSOR FAILED THE KINEVERIF TEST MULTIPLE TIMES. THE POINTER PROBE PASSED ON THE FIRST TRY, SO IT WAS CONFIRMED THAT THE ARM WAS CORRECTLY CALIBRATED. ANOTHER DISTANCE SENOR WAS BROUGHT IN FROM ANOTHER SITE AND IT ALSO FAILED MULTIPLE KINEVERIF TESTS. AFTER SPEAKING TO A NUMBER OF PEOPLE ON THE TEAM, IT WAS SUGGESTED THAT THE PROBLEM WAS DUE TO THE FACT THAT WE HAD AN OLD DISTANCE SENSOR ATTACHING TO A NEW FORCE SENSOR INTERFACE. AFTER THE ISSUE WAS RESOLVED, THE DISTANCE SENSOR PASSED THE KENIEVERIF TEST TWICE AND PASSED THE APPLICATIVE TEST. IN TOTAL THIS POSTPONED THE CASE 8 HOURS, BUT THE PATIENT WAS NOT BROUGHT INTO THE ROOM UNTIL ALL TESTS WERE PASSED. ONCE THE ROBOT WAS IN THE OPERATING ROOM THE CASE WENT SMOOTHLY, REGISTRATION WAS GOOD, AND THE CASE PROCEEDED WITHOUT ANY OTHER DELAYS. IN ORDER TO KEEP THIS FROM HAPPENING AGAIN, A NEW DISTANCE SENSOR HAS BEEN ORDERED SO THAT IT FITS THE NEW FORCE SENSOR INTERFACE WITHOUT ANY ADJUSTMENTS.

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 A PATIENT SUFFERED AN HEMORRHAGE DURING A VISUALASE SURGERY.

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 ROBOT ARM HAD A COLLISION WITH THE MAYFIELD HEAD HOLDER AND CRASHED. AFTER THE COLLISION THE ROBOT DID NOT LOAD THE PATIENT FOLDER ANY MORE. THE SURGEON HAD TO IMPORT THE PATIENT FOLDER AGAIN FROM THE USB STICK, BUT LOST THE REGISTRATION OF THE PATIENT. THIS HAPPENED 2 TIMES.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ROBOTIC PROGRASP INSTRUMENT WAS HOLDING TISSUE AND WOULD NOT RELEASE FROM THE TISSUE. THE INSTRUMENT HAD TO BE UNLOCKED TO RELEASE THE TISSUE.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WHILE TURNING THE ROBOT ON FOR A LASER ABLATION SURGERY, THE ROBOT WAS MAKING A BEEPING NOISE. THEY PUSH DOWN AND RELEASE THE EMERGENCY STOP BUTTON AND THEN POWER THE ROBOT DOWN, TURN THE ROBOT OFF, UNPLUG THE DEVICE, WAIT, AND THEN TURN THE ROBOT BACK ON. AFTER THE ROBOT WAS TURNED BACK ON, THE CONTROLLER BEGAN TO BEEP AGAIN AND THEN THE MONITOR WOULD NOT TURN ON. THE SURGEON TRIED TO PRESS THE PC RESET BUTTON A FEW TIMES AND ROBOT WAS STILL BEEPING, THE SCREEN STILL DID NOT TURN ON, AND THE DVD DRIVE OPENED AND CLOSED, MEANING THAT THE PC WAS ON.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WHILE TURNING THE ROBOT ON FOR A LASER ABLATION SURGERY, THE ROBOT WAS MAKING A BEEPING NOISE. THEY PUSH DOWN AND RELEASE THE EMERGENCY STOP BUTTON AND THEN POWER THE ROBOT DOWN, TURN THE ROBOT OFF, UNPLUG THE DEVICE, WAIT, AND THEN TURN THE ROBOT BACK ON. AFTER THE ROBOT WAS TURNED BACK ON, THE CONTROLLER BEGAN TO BEEP AGAIN AND THEN THE MONITOR WOULD NOT TURN ON. THE SURGEON TRIED TO PRESS THE PC RESET BUTTON A FEW TIMES AND ROBOT WAS STILL BEEPING, THE SCREEN STILL DID NOT TURN ON, AND THE DVD DRIVE OPENED AND CLOSED, MEANING THAT THE PC WAS ON.

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 IN PRONE POSITION, REGISTERED WITH FIDUCIAL MARKERS, AND ENTRY POINTS MARKED WITH POINTER PROBE. PATIENT WAS DRAPED AND SURGEON ATTEMPTED TO DRIVE TO SEVERAL TRAJECTORIES WITH INSTRUMENT HOLDER BUT NOTICED THE ENTRY POINTS WERE DIFFERENT THAN THE ONES PREVIOUSLY MARKED. SURGEON CREATED TRAJECTORY WITH TARGET POINT INSIDE OF A FIDUCIAL MARKER, AND THE DRIVE TO THIS TARGET LOOKED ACCURATE; HOWEVER, SURGEON NOTED THAT THIS FIDUCIAL WAS FAR FROM OTHER TRAJECTORIES. NOTE: VIGILANCE DEVICE MAY HAVE MALFUNCTIONED DURING DRIVE TO PARK POSITION. PATIENT WAS UNDRAPED AND REGISTRATION REPEATED. SURGEON NOTED THAT THE BED MOVED SLIGHTLY, AND THAT THESE INACCURACIES MAY HAVE BEEN DUE TO SKIN SHIFT CAUSED BY BODY SHIFT. SURGEONS PROCEEDED WITH SURGERY AND TOLD MEDTECH REPRESENTATIVE THAT POST-OPERATIVE CT SCANS INDICATED ACCURATE PLACEMENT OF ELECTRODES AND THEREFORE NO CLINICAL CONSEQUENCES. ESTIMATED TIME LOST WAS 60 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 THAT DURING REGISTRATION OF THE PATIENT A COMMUNICATION FAILURE MESSAGE AND SHUTDOWN OCCURRED TWICE CAUSING A TOTAL DELAY OF THIRTY FIVE MINUTES. THE CASE WAS COMPLETED AS SCHEDULED.

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 SHUT DOWN DURING AUTOMATIC MOVEMENTS TWICE DURING A SURGERY.

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 STARTING THE CONTACTLESS REGISTRATION, AT INITIALIZATION OF THE SYSTEM, A MESSAGE APPEARED "IMPOSSIBLE TO CONNECT WITH ROBOT ARM". AFTER FEW TRIES, THEY DECIDED TO CANCEL THE SURGERY USING THE DEVICE AND DEVICE WAS PUT OUT OF THE OR. A FIELD SERVICE ENGINEER THAT WAS PRESENT WAS INFORMED BY THE MEDICAL TEAM THAT THE ROSA DEVICE IS NOT PLUG ON A SECURITY WALL OUTLET DURING SURGERIES.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: SURGEON REPORTED THAT HE COULD NOT RETRIEVE IMAGES FROM THE PACS. HE STATED THAT HE ATTEMPTED TO RETRIEVE IMAGES FROM 4 DIFFERENT PORTS WITHIN THE OR AND THAT NONE OF THE PORTS WORKED. HE STATED THAT THIS HAS CAUSED A 1 HOUR DELAY.

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 REGISTRATION PHASE THE ROBOT ARM LOST COMMUNICATION WITH CONTROLLER AND THE SURGEON DECIDED TO ABORT THE SURGERY.