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.

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.

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.

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 IMAGE FUSION WAS NOT WORKING. THE SURGEON STATED THAT THE MR WAS ACQUIRED IN AXIAL AND THE CT IN SAGITTAL. FIELD SERVICE ENGINEER REMINDED THAT BOTH IMAGES SHOULD BE RECORDED IN THE SAME AXIS, SO THE RADIOLOGIST TRANSFORMED THE CT TO AXIAL. AFTER THIS MODIFICATION SURGERY WAS ABLE TO BE PERFORMED. SURGEON ALSO REPORTED THAT SOFTWARE ONLY IMPORTS IMAGES WHEN THEIR NAME BEGINS WITH AN ASTERIX.

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 TWO DAYS POST A DA VINCI ASSISTED RIGHT HEMICOLECTOMY PROCEDURE THE PATIENT EXPERIENCE COMPLICATIONS AND VITAL SIGNS WERE FOUND TO BE POOR. THE PATIENT UNDERWENT A SECONDARY OPEN SURGICAL PROCEDURE AT WHICH TIME THE SURGEON DISCOVERED THAT THE PATIENT HAD SUSTAINED AN UNSPECIFIED BOWEL INJURY. THE SURGEON REPAIRED THE DAMAGE TO THE PATIENT¿S BOWEL. ON (B)(6) 2018 THE ISI CLINICAL SALES REPRESENTATIVE (CSR) STATED THAT THE PATIENT UNDERWENT THE PRIMARY SURGICAL PROCEDURE ON (B)(6) 2018 AND DURING THE SURGICAL PROCEDURE, THERE WERE NO INTRA-OPERATIVE COMPLICATIONS. ON POST-OPERATIVE DAY #2, THE PATIENT EXPERIENCED A HIGH FEVER, HAD LOW BLOOD PRESSURE, AND THE VITAL SIGNS WERE FOUND TO BE POOR. THE PATIENT WAS IMMEDIATELY FLOWN TO ANOTHER HOSPITAL WHERE THE PATIENT UNDERWENT AN OPEN SURGICAL PROCEDURE TO IDENTIFY THE CAUSE OF THE POST-OPERATIVE COMPLICATIONS. DURING THE SECONDARY PROCEDURE, THE SURGEON FOUND THAT THE PATIENT'S BOWEL HAD A PERFORATION LOCATED ON THE BACK OF THE DESCENDING COLON, WHERE AN ASSIST PORT WAS LOCATED. THE SURGEON REPAIRED THE DEFECT TO THE PATIENT'S BOWEL. THE CSR INDICATED THAT HE CONFIRMED WITH THE HOSPITAL THAT NO MALFUNCTION OF THE D

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REPORTED FROM OPERATING ROOM THAT THE PATIENT WAS HAVING A ROBOTIC-ASSISTED LAPAROSCOPIC LOW ANTERIOR RESECTION OF THE RECTUM AND THE DAVINCI ROBOT 45 STAPLER JAMMED WHILE ATTACHED TO TISSUE AND WOULD NOT RELEASE. EVEN WITH THE USE OF THE EMERGENCY UNLOCKING KEY. INSTRUMENT WOULD NOT RELEASE TISSUE INTRACAVITY. DAVINCI TROUBLESHOOTING WAS CALLED AND THE STAFF HAD TO PRY THE STAPLER HEAD OPEN VERY CAREFULLY TO RELEASE THE TISSUE. NO HARM OCCURRED AS A RESULT. IN THE REPORT ANOTHER TYPE OF STAPLER WAS USED TO COMPLETE THE PROCEDURE.

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 HAD AN HAEMORRHAGE.

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: FOLLOWING FIDUCIAL REGISTRATION WITH A GOOD ACCURACY VALUE, SURGEONS USED POINTER PROBE TO MARK ENTRY POINTS OF 4 TRAJECTORIES. MULTIPLE INACCURACIES OCCURED DURING SURGERY WITH INSTRUMENT HOLDER. ESTIMATED LOSS WAS APPROXIMATELY 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 WHILE TRYING TO REGISTER A PATIENT, WITH MARKERS, THE SYSTEM HAD A COMMUNICATION FAILURE. IT WAS NOTICED THAT THE CABLE TO THE FORCE SENSOR WAS ALMOST COMPLETELY DISCONNECTED. THE SURGERY WAS ABORTED.

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 HEAD HOLDER ON LOANER SYSTEM SEIZED AND COULD NOT BE USED.

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 AN UNRECOVERABLE ERROR OCCURED AFTER THE PLACEMENT OF A K-WIRE. THREE REBOOTS WERE NECESSARY TO RESTORE THE CONNECTION. THEN THE SURGEON PROCEEDED WITH THE CASE AND ADJUSTED THE ORIENTATION OF THE ROBOT ARM IN THE SOFTWARE.

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 WAS NOT ABLE TO CONNECT THE ROBOT TO (B)(6), AS HE WAS BEGINING A BRAIN BIOPSY. A MEDTECH FIELD SERVICE ENGINEER WENT ON SITE TO INVESTIGATE AND CHANGED THE POSITION OF THE STARC BOARD INSIDE THE CONTROLLER'S MODULE WHICH RESOLVED THE ISSUE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PATIENT WAS ADMITTED FOR A ROBOT ASSISTED LAPAROSCOPIC TRANSABDOMINAL RETROPERITONEAL LYMPH NODE DISSECTION AND LEFT SPERMATIC CORD RESECTION. A BLUNT TROCHAR WAS PLACED, AND 6 PORTS WERE PLACED UNDER DIRECT VISION. THE ROBOT ARMS WERE PLACED IN STANDARD FASHION TO TRIANGULATE THE RETROPERITONEUM. THE DA VINCI XI ROBOTIC SYSTEM WAS THEN DOCKED OVER THE PATIENT'S FLANK. INITIAL INSPECTION OF THE BOWEL AND ABDOMINAL CONTENTS WERE UNCOMPLICATED, WITH NO EVIDENCE OF INJURY. THE PROCEDURE WAS INITIATED WITH MOBILIZATION OF THE COLON TO REVEAL THE RETROPERITONEUM. THE SPERMATIC CORD WAS THEN IDENTIFIED AT ITS ORIGIN ON THE LEFT RENAL VEIN. AT THIS POINT THE ROBOTIC SYSTEM ALERTED AND AN UNRECOVERABLE FAULT IN THE 3RD ROBOTIC ARM WAS DISCOVERED. THE ARM WAS LOCKED IN PLACE AND THE PROCEDURE COULD NOT CONTINUE. THE ERROR CODE 319 WAS NOTED AND THE ARM COULD NOT BE MOVED. THE SURGEON AND TEAM FOLLOWED THE INSTRUCTIONS ON THE SCREEN AND REBOOTED THE SYSTEM THREE TIMES WITHOUT RESOLUTION. THEY CALLED THE INTUITIVE INC. SUPPORT AND THE DA VINCI REP TRIED TO TROUBLE SHOOT THE PROBLEM WITHOUT SUCCESS. THE FINAL ADVICE WAS A ROBOTIC ARM REPLACEMENT THE FOLLOWING DAY. THE SURGEON WAS TOLD THAT IT

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 ATTEMPTED TO START THE DEVICE, BUT THE ROBOT ARM WOULD TURN ON AUDIBLY AND THEN SHUTDOWN AS IT APPROACHED THE PATIENT. THE SURGERY WAS CANCELLED.

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 MULTIPLE 3D RECONSTRUCTION PROBLEMS OCCURRED DURING THE PREPARATION OF THE 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 MULTIPLE DEVICE SHUTDOWN AND A COLLISION OCCURED INTRA-OPERATIVELY. THE FIRST SHUTDOWN OCCURRED DURING REGISTRATION PHASE. THEN ONE TRAJECTORY WAS BEING DRIVED TO DESPITE THE FACT IT WAS APPARENT THAT THE TRAJECTORY WOULD BE INACCESSIBLE DUE TO THE STABILIZING ARM. SURGEON DECIDED TO ATTEMPT THE TRAJECTORY ANYWAY AND A COLLISION OCCURRED. FOLLOWING AN ATTEMPTED DEVICE RE-BOOT, THE ROBOT ARM WAS UNABLE TO CONNECT DUE TO THE COLLISION. AFTER MULTIPLE ATTEMPTS, A FULL DEVICE BREAK DOWN WAS REQUIRED AND POSTERIOR TRAJECTORIES WERE RE-PLANNED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING SURGERY, IT WAS REPORTED THAT THE ROBOT HIT THE PATIENT'S FOREHEAD, WHEN THE ROBOT ARM WAS SENT ON TRAJECTORY WITH THE LASER TO MARK THE ENTRY POINT. THE PATIENT HAS A SMALL MARK WHERE THE ROBOT HIT HIM, THE SURGERY CONTINUED AS PLANNED.

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 THE ROBOTIC PORTION OF THE SURGERY, THE TIP-UP FENESTRATED GRASPER STOPPED WORKING AND WAS REMOVED FROM THE ABDOMEN BY DR. (B)(6). UPON VISUAL INSPECTION OF THE INSTRUMENT, ONE OF THE WIRES WAS NO LONGER INTACT. THE INSTRUMENT WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. WIRE THOUGHT TO HAVE SNAPPED IN HALF DURING CASE. PT RETURNED TO ED FOR BACK PAIN AND AN X-RAY WAS TAKEN FOR THAT CC. AT THAT TIME A SMALL (LESS THAN 9MM) PIECE OF FRAYED WIRE WAS SEEN IN PT - RFO.