At 7:45 a.m. on June 15, 2017, an employee was replacing a spring activated arm on a robot. When the employee removed the equipment's balancer, the robot's arm swung upward and struck the employee in the head. The employee lost consciousness and sustained a head contusion, 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: DURING THE SURGERY, THE REGISTRATION STEP HAD TO BE REPEATED THREE TIMES. DURING THE SECOND ATTEMPT IT WAS NOTICED A PATIENT SKIN SWELLING AROUND THE FOREHEAD FROM THE CRW STEREOTACTIC FRAME PINS, AND THE PATIENT CHEEKS WERE PRESSED UP AGAINST THE NOSE. THE 3RD REGISTRATION WAS PERFORMED AVOIDING THE CRW STEREOTACTIC FRAME PINS AND 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: SURGEON WAS UNABLE TO PERFORM THE PATIENT REGISTRATION DESPITE SEVERAL ATTEMPTS, SO HE REVERTED TO TRADITIONAL SURGERY TECHNIQUE WITHOUT THE ROBOT ASSISTANCE TO PERFORM SURGERY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED BY THE SURGEON THAT DURING A SURGICAL PROCEDURE OF "ROBOTIC-ASSISTED LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND CYSTOSCOPY" THAT THE SPRING BROKE IN DA VINCI FENESTRATED BIPOLAR FORCEPS. THE DEVICE WAS SWITCHED OUT AND NO HARM WAS REPORTED TO THE PATIENT. NO FURTHER DOCUMENTATION WAS GIVEN REFERENCE THE SPRING BREAK ON THE FORCEPS AND THE DEVICE IS AVAILABLE FOR REVIEW.

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 NISSEN FUNDOPLICATION PROCEDURE, THE INSUFFLATION WAS LOST AFTER THE SURGEON SWAPPED FROM ARM 1 TO ARM 3. AT THE TIME THE EVENT OCCURRED, A HARMONIC ACE CURVED SHEARS INSTRUMENT WAS INSTALLED ON ARM 1 AND A DOUBLE FENESTRATED GRASPER INSTRUMENT WAS INSTALLED ON ARM 3. AS A RESULT OF THE LOSS OF INSUFFLATION, THE PATIENT'S DIAPHRAGM SLID DOWN AND THE HARMONIC ACE CURVED SHEARS INSTRUMENT ALLEGEDLY PUNCTURED A HOLE IN THE PATIENT'S RIGHT VENTRICLE. ONCE THE SURGEON IDENTIFIED THE OPERATIVE COMPLICATION, A CARDIO SURGEON WAS CALLED FOR IMMEDIATE OPEN HEART SURGERY. ON 06/21/2017, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE SITE HAS NOT DETERMINED THE CAUSE OF THE LOSS OF INSUFFLATION DURING THE SURGICAL PROCEDURE. NO ISSUES WERE IDENTIFIED WITH THE INSUFFLATION TUBING, ASSIST PORT, CANNULAS, OR CANNULA SEALS. THE SURGEON BELIEVES THE PUNCTURE WOUND TO THE PATIENT'S RIGHT VENTRICLE OCCURRED AS A RESULT OF THE LOSS OF INSUFFLATION AND MOVEMENT OF DIAPHRAGM. NO INSTRUMENTS WERE MOVED AFTER INSUFFLATION WAS LOST. AT THE TIME THE EVENT OCCURRED, THE SURGEON WAS

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: FOLLOWING A SURGICAL PROCEDURE USING THE MAZOR X SYSTEM AT (B)(6), BACK ON (B)(6) 2017, IT WAS REPORTED TO MAZOR (ON (B)(6) 2018) BY (B)(4), THE MAZOR X DISTRIBUTOR, THAT THE PATIENT COMPLAINED THROUGH (B)(4) FACEBOOK THAT DURING THIS CASE NEARLY HALF OF THE SCREWS THAT WERE PLACED FROM T10-S1 WERE MISALIGNED TO VARYING DEGREES. THE SURGEON DECIDED TO DO A REVISION ON (B)(6) 2017. DURING THE REVISION SURGERY THE SURGEON REMOVED ALL THE DEVIATED SCREWS AND DID NOT PLACE NEW SCREWS OR ANY HARDWARE INSTEAD. THE CUSTOMER COMPLAINS ABOUT UNBEARABLE PAIN AND THE NEED TO DO ADDITIONAL REVISION SURGERIES IN THE NEAR FUTURE.

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 LOW ANTERIOR RESECTION PROCEDURE, AN UNSPECIFIED INSTRUMENT INSTALLED ON ARM 3 STOPPED RESPONDING. AT THAT TIME, THE UNSPECIFIED INSTRUMENT WAS GRASPING FATTY TISSUE. IN ORDER TO REMOVE THE INSTRUMENT, THE SURGEON MADE THE DECISION TO DISSECT THE GRASPED TISSUE. WHEN THE EVENT OCCURRED, THE SURGICAL STAFF REPORTEDLY DID NOT ATTEMPT TO USE AN INSTRUMENT GRIP RELEASE TOOL. ACCORDING TO THE DA VINCI SI USER MANUAL, THE EMERGENCY GRIP RELEASE MECHANISM FACILITATES REMOVAL OF AN INSTRUMENT IN THE EVENT OF A SYSTEM FAULT. FOR EXAMPLE, IF THE INSTRUMENT TIPS ARE HOLDING TISSUE, THE EMERGENCY GRIP RELEASE ALLOWS THE PATIENT SIDE OPERATOR TO MANUALLY RELEASE THE GRIP. THE DA VINCI INSTRUMENT AND ACCESSORIES USER MANUAL STATES THE FOLLOWING GENERAL PRECAUTIONS AND WARNINGS: WARNING: DO NOT PERFORM GRIP RELEASE ON A NON-FAULTED SYSTEM WITHOUT FIRST PRESSING THE EMERGENCY STOP BUTTON. FAILURE TO OBSERVE THIS WARNING MAY RESULT IN UNINTENDED INSTRUMENT MOTION OR DAMAGE TO THE GRIP RELEASE MECHANISM. WARNING: IN CASE OF SYSTEM FAILURE WHILE THESE INSTRUMENTS ARE GRASPING TISSUE, THE GRIPS CAN BE MANUALLY OPENED BY INSERTING THE GRIP RELEASE TOOL IN

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ATTORNEYS HAVE ALLEGED THAT THEIR CLIENTS SUFFERED INJURIES ASSOCIATED WITH DA VINCI SURGICAL PROCEDURES. THESE CLAIMS DO NOT INVOLVED REPORTABLE DEATHS OR MALFUNCTIONS. THESE ALLEGATIONS WERE RECEIVED BY INTUITIVE SURGICAL, INC.(ISI) BETWEEN (B)(6) 2017. FOR THOSE CLAIMS WHERE PROCEDURE DATES ARE PROVIDED, THE DATES RANGE FROM (B)(6) 2011 - (B)(6) 2015.

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 DUE TO THE HEAD POSITION OF THE PATIENT THE SURGEON HAD TO PERFORM THREE TIMES THE PATIENT REGISTRATION.

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 BY SURGEON THAT DURING A DA VINCI XI HYSTERECTOMY PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT LOOKED LIKE A WIRE WAS BROKEN. THE SURGEON ALSO REVEALED THE GRASPS WOULD NOT OPEN OR CLOSE. THE DEVICE HAD TO BE SWITCHED OUT. NO PATIENT HARM WAS REPORTED. THE DEVICE WAS RETURNED TO THE MANUFACTURER.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING CONTACTLESS REGISTRATION, AUTOMATIC SCANNING OF THE PATIENT FOREHEAD WOULD NOT INITIATE. PATIENT WAS RE-MEASURED AND FOUND TO BE >70 CM AWAY FROM ROSA ARM. PATIENT POSITION WAS CORRECTED, AND CONTACTLESS REGISTRATION WAS REPEATED. AGAIN, AN ERROR OCCURRED AND THE PATIENT¿S FOREHEAD COULD NOT BE SCANNED AUTOMATICALLY. PATIENT WAS RE-POSITIONED AND WAS CHANGED THE ANGLE OF THE PATIENT¿S FACE SLIGHTLY AND THE SURGEON WAS ABLE TO PROCEED WITH NORMAL REGISTRATION AND IMPLANTATION.

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, DURING AN ANONYMOUS CONSUMER SURVEY, THAT THE PATIENT'S COLON WAS ALLEGEDLY NICKED BY AN UNSPECIFIED DEVICE WHILE UNDERGOING A DA VINCI-ASSISTED SURGICAL PROCEDURE. AS A RESULT, THE INITIAL REPORTER (THE PATIENT'S FRIEND) CLAIMED THAT THE PATIENT DEVELOPED AN UNSPECIFIED INFECTION AND WAS ADMITTED TO THE ICU FOR ABOUT 2 WEEKS BEFORE HE WAS RELEASED TO GO HOME. THE FOLLOWING NIGHT AFTER BEING DISCHARGED FROM THE HOSPITAL, THE PATIENT WAS READMITTED TO THE HOSPITAL FOR PAIN AND SUBSEQUENTLY EXPIRED.

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 AFTER UNDERGOING A DA VINCI-ASSISTED SLEEVE GASTRECTOMY WITH HIATAL HERNIA REPAIR PROCEDURE, THE PATIENT EXPERIENCED BLOOD LOSS ON AN UNSPECIFIED DATE. IN ADDITION, APPROXIMATELY 2 WEEKS POST-OPERATIVELY, THE PATIENT WAS READMITTED TO THE OR AND HAD PART OF HER STOMACH AND BOWEL REMOVED FOR AN UNKNOWN REASON. THE INITIAL REPORTER WAS UNSURE IF THE DA VINCI-ASSISTED SURGICAL PROCEDURE WAS PERFORMED ON (B)(6) 2017. ON 06/07/2017, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: AN ISI CLINICAL SALES REPRESENTATIVE (CSR) SPOKE TO THE SITE'S OR DIRECTOR. SHE WAS UNABLE TO CONFIRM IF THE DV PROCEDURE WAS PERFORMED ON (B)(6) 2017. ACCORDING TO THE OR DIRECTOR, THERE WERE NO INTRA-OPERATIVE COMPLICATIONS. THERE WERE ALSO NO REPORTS OF ANY MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. THE DA VINCI-ASSISTED SURGICAL PROCEDURE WENT SMOOTHLY AND WAS COMPLETED ROBOTICALLY. DUE TO UNSPECIFIED POST-OPERATIVE COMPLICATIONS AND POST-OPERATIVE BLEEDING FROM AN UNKNOWN SOURCE, THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY. THE CSR DID NOT KNOW WHY PARTS OF THE PATIENT'S STOMACH AND BOWEL WERE REMOVED. THE

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 SACROCOLPOPEXY PROCEDURE, THE SURGICAL STAFF ENCOUNTERED A NON-RECOVERABLE SYSTEM ERROR CODE 15. DURING THE REPORTED EVENT, THE SURGICAL STAFF USED AN INSTRUMENT RELEASE KIT (IRK) TO REMOVE THE PROGRASP FORCEPS INSTRUMENT. AFTER REMOVING ALL OF THE ROBOTIC INSTRUMENTS, THE SURGICAL STAFF POWER CYCLED THE DA VINCI SURGICAL SYSTEM. AFTER THE DA VINCI SURGICAL SYSTEM WAS REBOOTED, THE SYSTEM POWERED UP NORMALLY AND THE SURGEON WAS ABLE TO CONTINUE WITH THE SURGICAL PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT SUSTAINED UNSPECIFIED DAMAGE TO THE SIGMOID COLON DURING THE REPORTED EVENT. HOWEVER, THE ROOT CAUSE AND SEVERITY OF THE BOWEL INJURY ARE UNKNOWN. ON APRIL 25, 2017, AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE. THE FSE REVIEWED THE SITE'S SYSTEM LOGS AND VERIFIED THAT A SYSTEM ERROR CODE 15 OCCURRED DURING THE SURGICAL PROCEDURE. HOWEVER, THE FSE WAS UNABLE TO REPRODUCE THE CUSTOMER REPORTED FAILURE MODE. THE FSE REPLACED REMOTE ARM CONTROLLER (RAC2) AS A PRECAUTION AND MOVED THE RAC2 TO THE RAC1 POSITION. THE FSE TESTED THE DA VINCI SURGICAL SYSTEM AND VERIFIE

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 XZI HYSTERECTOMY PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT SPRING WAS BROKEN AFTER IT WAS HOOKED TO ROBOT. THE REPORT REVEALED THE GRASPS WOULD NOT OPEN OR CLOSE WITH THE SPRING PROTRUDED. NO PATIENT HARM WAS REPORTED. THE DEVICE WAS RETURNED TO THE MANUFACTURER.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS INITIALLY REPORTED THAT AFTER COMPLETION OF A DA VINCI-ASSISTED GASTRIC BYPASS PROCEDURE, THE PATIENT RETURNED TO THE EMERGENCY DEPARTMENT AND UNDERWENT AN UNSPECIFIED SURGICAL PROCEDURE. THE INITIAL REPORTER DID NOT KNOW IF THE SECONDARY OPERATION WAS RELATED TO THE DA VINCI-ASSISTED SURGICAL PROCEDURE. ON 05/09/2017, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO WAS PRESENT DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ABOUT THE COMPLAINT: THE CSR WAS PRESENT DURING THE ENTIRE DA VINCI-ASSISTED SURGICAL PROCEDURE WHICH WAS NOT RECORDED ON VIDEO. A PROCTOR WAS PRESENT DURING THE PROCEDURE. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO INTRA-OPERATIVE COMPLICATIONS. IN ADDITION, THERE WERE NO REPORTED ISSUES WITH THE DA VINCI SURGICAL SYSTEM DURING THE SURGICAL PROCEDURE. ACCORDING TO THE CSR, THE SURGEON INFORMED HIM THAT THE GJ AND JJ TUBES LOOKED GOOD. HOWEVER, THE SURGEON REPORTEDLY VOICED CONCERNS REGARDING THE POUCH THAT HE HAD MADE. THE CSR REITERATED THAT THERE WAS NO ALLEGATION FROM THE SURGEON OR SURGICAL STAFF THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUME

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 XI HYSTERECTOMY PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT SPRING WAS BROKEN AFTER IT WAS HOOKED TO ROBOT. THE REPORT REVEALED THE GRASPS WOULD NOT OPEN OR CLOSE WITH THE SPRING PROTRUDED. NO PATIENT HARM WAS REPORTED. THE DEVICE WAS RETURNED TO THE MANUFACTURER.

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 XI HYSTERECTOMY PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT SPRING WAS BROKEN AFTER IT WAS HOOKED TO ROBOT. THE REPORT REVEALED THE GRASPS WOULD NOT OPEN OR CLOSE WITH THE SPRING PROTRUDED. NO PATIENT HARM WAS REPORTED. THE DEVICE WAS RETURNED TO THE MANUFACTURER.

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 FOLLOWING AN USER ERROR A DELAY OF 30 MINUTES WAS OBSERVED FOR THE IMPOSSIBILITY TO LOAD IMAGES 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 AUTOMATIC SCAN COULD NOT BE PERFORMED TWICE DURING LASER REGISTRATION DUE TO PATIENT POSITIONING. IT WAS ALSO REPORTED THAT A COMMUNICATION FAILURE OCCURRED.

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 NOTICED THAT SEVERAL TRAJECTORIES WERE INACCURATE. PATIENT WAS UN-DRAPED AND RE-DRAPED WITH CARE AND ROBOT ARM WITH INSTRUMENT HOLDER ATTACHED WAS DRIVEN TO ALL TRAJECTORIES SUCCESSFULLY. TOTAL TIME LOST WAS MORE THAN 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: DURING SURGERY THERE WERE THREE DEVICE SHUTDOWNS. AFTER EACH SHUTDOWN THE DEVICE WAS RESTARTED TO PURSUE SURGERY.

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 MITRAL VALVE REPAIR PROCEDURE, PERFORMED ON (B)(6) 2017, THE PATIENT EXPERIENCED INTRA-OPERATIVE COMPLICATIONS. AFTER AN INITIAL ECHOGRAPHIC CONTROL WAS PERFORMED INTRA-OPERATIVELY, UNSPECIFIED LEAKAGES WERE OBSERVED. AS A RESULT, THE SURGICAL STAFF RE-OPENED AND RE-SUTURED AROUND THE VALVE. AFTER A SECOND ECHOGRAPHIC CONTROL WAS PERFORMED INTRA-OPERATIVELY, LEAKAGES WERE STILL OBSERVED. AS A RESULT, THE SURGICAL STAFF DECIDED TO CHANGE A VALVE FOR A NEW ONE. AFTER A THIRD ECHOGRAPHIC CONTROL WAS PERFORMED INTRA-OPERATIVELY, LEAKAGES WERE STILL FOUND AND THE DECISION WAS MADE TO CONVERT THE DA VINCI-ASSISTED SURGICAL PROCEDURE TO A STERNOTOMY PROCEDURE. AFTER THE SURGICAL PROCEDURE WAS CONVERTED TO OPEN SURGERY, THE INITIAL REPORTER LEFT THE OR ROOM. AT THIS TIME, THE ROOT CAUSES OF THE INTRA-OPERATIVE COMPLICATIONS ARE UNKNOWN. THERE WAS NO ALLEGATION DURING THE SURGICAL PROCEDURE THAT A MALFUNCTION OF THE DA VINCI SYSTEM, INSTRUMENTS, OR ACCESSORIES HAD OCCURRED. APPROXIMATELY NINE HOURS AFTER THE CASE WAS CONVERTED TO OPEN SURGERY, THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY FOR AN UNSPECIFIED REASON. AT THIS FACILITY, THE PATI

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DR NOTICED FRAYED WIRE STICKING OUT AND THE INSTRUMENT WAS NOT WORKING PROPERLY. REMOVED THE INSTRUMENT FROM USE.

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 INGUINAL HERNIA REPAIR PROCEDURE, THE PATIENT'S INTESTINES WERE ALLEGEDLY NICKED AND THE PATIENT PASSED AWAY WITHIN 48 HOURS FROM SEPTIC POISONING. ON (B)(6)2017, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE CSR WAS PRESENT DURING THE SURGICAL PROCEDURE WHICH WAS NOT RECORDED ON VIDEO. THE DA VINCI-ASSISTED INGUINAL HERNIA REPAIR PROCEDURE WAS COMPLETED WITH NO REPORTS OF ANY INTRA-OPERATIVE COMPLICATIONS. DURING THE SURGICAL PROCEDURE, NO MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY WAS REPORTED. TO HIS RECOLLECTION, THE CSR INDICATED THAT THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE SAME DAY THE SURGICAL PROCEDURE WAS PERFORMED. ON AN UNSPECIFIED DATE POST-OPERATIVELY, THE PATIENT CAME BACK TO THE HOSPITAL FOR AN UNKNOWN REASON. THE CSR SPOKE TO THE SURGEON ABOUT THE REPORTED EVENT. ACCORDING TO THE CSR, THE SURGEON INFORMED HIM THAT THE PATIENT SUPPOSEDLY SUSTAINED A BOWEL INJURY AND THEN PASSED AWAY. THE SURGEON DID NOT INITIALLY ALLEGE THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED DURING

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER UNDERGOING A DA VINCI-ASSISTED VENTRAL HERNIA REPAIR PROCEDURE, THE PATIENT WAS FOUND TO HAVE SUSTAINED A GASTRIC PERFORATION ON POST-OPERATIVE DAY 1. PRIOR TO UNDERGOING THE DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT HAD ALSO UNDERGONE A DIAGNOSTIC LAPAROSCOPY PROCEDURE WITH ADHESIOLYSIS. A SURGEON REPAIRED THE GASTRIC PERFORATION VIA OPEN SURGERY AND HAD TO REMOVE MESH. AFTER GOING HOME, THE PATIENT REPORTEDLY DEVELOPED AN UNSPECIFIED EMBOLISM AND GI BLEED. NO FURTHER CLINICAL INFORMATION WAS PROVIDED.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI-ASSISTED TOTAL HYSTERECTOMY PROCEDURE ON (B)(6) 2017. THE PLAINTIFF'S ATTORNEY ALLEGES THAT THE PATIENT EXPIRED AS A RESULT OF UNDERGOING THE DA VINCI-ASSISTED SURGICAL PROCEDURE. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. ISI WAS NOT PROVIDED WITH THE OPERATIVE REPORT OR ANY OF THE PATIENT'S MEDICAL RECORDS.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE, THE PATIENT EXPERIENCED BLEEDING AND SUBSEQUENTLY EXPIRED. THERE WERE NO REPORTS OF ANY ISSUES WITH THE DA VINCI SURGICAL SYSTEM DURING THE SURGICAL PROCEDURE. ON 03/24/2017, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE CSR WAS PRESENT DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE WHICH WAS NOT RECORDED ON VIDEO. DURING THE SURGICAL PROCEDURE, THE PATIENT EXPERIENCED BLEEDING FROM AN UNSPECIFIED VESSEL. AS A RESULT OF THE BLEEDING, THE SURGEON MADE THE DECISION TO CONVERT TO OPEN SURGERY. AT THAT TIME THE CSR REPORTEDLY LEFT THE OR. AFTER THE EVENT OCCURRED, THE CSR SPOKE TO THE SURGEON. ACCORDING TO THE CSR, THERE WAS NO ALLEGATION FROM THE SURGEON THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE OR CAUSED/CONTRIBUTED TO THE PATIENT'S INTRA-OPERATIVE BLEEDING AND SUBSEQUENT DEATH. THE PATIENT REPORTEDLY EXPIRED ON THE OR TABLE.

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, THE CT SCAN WAS LOADED ON THE DEVICE FROM AN USB DRIVE. ONCE OPENED ON THE DEVICE, THE IMAGES HAD AN INCORRECT APPEARANCE AND THE RESULT OF THE CT AND MRI AUTOMATIC MERGE WAS INCORRECT. TO BE ABLE TO PERFORM THE SURGERY, A NEW CT SCAN WAS ACQUIRED.

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 PULMONARY LOBECTOMY PROCEDURE, THE PATIENT EXPERIENCED BLEEDING FROM THE PULMONARY ARTERY. AT THE TIME THE BLEEDING WAS IDENTIFIED, THERE WAS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY HAD OCCURRED. WHEN THE EVENT OCCURRED, THE SURGEON WAS ABLE TO CONTROL THE BLEEDING BY USING TACHOSIL SPONGES. THE PULMONARY ARTERY WAS REPORTEDLY SEWN. NO BLOOD TRANSFUSIONS WERE ADMINISTERED. IT WAS NOTED THAT DUE TO THE COMPLEXITY AND LENGTH OF THE SURGICAL PROCEDURE, THE SURGEON MADE THE DECISION TO CONVERT THE SURGICAL PROCEDURE TO OPEN SURGERY. THE SURGEON REPORTEDLY FELT MORE SECURE COMPLETING THE SURGICAL PROCEDURE VIA OPEN SURGERY. ACCORDING TO THE INITIAL REPORTER, THE SURGEON WAS ABLE TO COMPLETE THE SURGICAL PROCEDURE 10-15 MINUTES AFTER THE CASE WAS CONVERTED TO OPEN SURGERY. IT IS UNCLEAR IF THE SURGEON REPAIRED THE PULMONARY ARTERY BEFORE OR AFTER THE SURGICAL PROCEDURE WAS CONVERTED TO OPEN SURGERY. THE PATIENT EXPERIENCED AN UNSPECIFIED RESPIRATION ISSUE POST-OPERATIVELY. HOWEVER, IT WAS REPORTED THAT THE RESPIRATION ISSUE WAS UNRELATED TO THE INTRA-OPERATIVELY BLEEDING EXPERIENCED BY THE P

At 5:20 p.m. on February 16, 2017, an employee was assisting a coworker with the robot. The employee cut a piece of metal and was going to grind the edges to smooth the edge when his glove was caught and pulled his right hand/thumb into the vertical grinding wheel. The coworker disconnected the power. The employee suffered a severe laceration to his right thumb which later resulted in an amputation of the right thumb pad and nail.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING THE PRE-OPERATIVE PLANNING PHASE OF THE SURGERY, THE PLANNING STATION WAS NOT WORKING ANYMORE. SURGEON COULD HAVE PERFORMED THIS PRE-OPERATING PLANNING DIRECTLY ON THE DEVICE BUT DECIDED TO ABORT SURGERY.

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, ROBOT ARM COLLIDED WITH THE MAYFIELD HEAD HOLDER ADAPTER. THE COLLISION WAS DETECTED BY THE SOFTWARE AND DEVICE SHUTDOWN. BECAUSE OF THE CONTACT OF THE ROBOT ARM AGAINST THE MAYFIELD HEAD HOLDER ADAPTER, ROBOT ARM HAD TO BE RELEASED MANUALLY.

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 SINGLE-SITE DA VINCI-ASSISTED CHOLECYSTECTOMY PROCEDURE PERFORMED ON (B)(6) 2017, THE SURGEON EXPERIENCED A LOT OF RESISTANCE WITH INSTRUMENT MOVEMENT. ON 02/07/2017, AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE. THE FSE WAS UNABLE TO REPLICATE THE CUSTOMER REPORTED FAILURE MODE. THE FSE TESTED THE DA VINCI SURGICAL SYSTEM AND VERIFIED THAT THE SYSTEM WAS READY FOR USE. DURING THE FIELD EVALUATION, THE FSE REPORTEDLY SPOKE TO THE SITE'S ROBOTICS COORDINATOR REGARDING THE REPORTED EVENT. THE ROBOTICS COORDINATOR CLAIMED THAT DUE TO RESISTANCE WITH THE UNIVERSAL SURGICAL MANIPULATOR (USM) AND RESTRICTED MOTION, THE SURGEON HAD TO TARGET BELOW THE ANATOMY. THE ROBOTICS COORDINATOR CLAIMED THAT THERE WAS LIMITED SPACING AND MOVEMENT. ON 02/09/2017, THE ISI CLINICAL SALES REPRESENTATIVE (CSR) INDICATED THAT THE PATIENT CAME BACK TO THE HOSPITAL WITH A POST-OPERATIVE BILE LEAK AND WAS GOING THROUGH UNSPECIFIED TESTING. THE CSR INDICATED THAT THE SURGEON PERFORMED TWO SUBSEQUENT DA VINCI-ASSISTED SURGICAL PROCEDURES THE DAY THE REPORTED EVENT OCCURRED AND THERE WERE NO REPORTED ISSUES DURING

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ATTORNEYS HAVE ALLEGED THAT THEIR CLIENTS SUFFERED INJURIES ASSOCIATED WITH DA VINCI SURGICAL PROCEDURES. THESE CLAIMS DO NOT INVOLVE REPORTABLE DEATHS OR MALFUNCTIONS. THESE ALLEGATIONS WERE RECEIVED BY INTUITIVE SURGICAL, INC.(ISI) BETWEEN (B)(6) 2016 - (B)(6) 2017. FOR THOSE CLAIMS WHERE PROCEDURE DATES ARE PROVIDED, THE DATES RANGE FROM (B)(6) 2008 - (B)(6) 2015.

At 7:20 p.m. on January 25, 2017, an employee was located inside a plastic injection molding press to adjust a gripper on the Fanuc Robot. While exiting the press, the employee slipped on a grated surface that was oily. He struck his right elbow on the grating and sustained a severe laceration. The employee was hospitalized and treated for his injury.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE HOSP USED A DA VINCI MACHINE AND IT TORE MY LEFT ROTATOR CUFF, STILL BEING TESTED TO SEE IF CANCER IS GONE ON MY RIGHT KIDNEY. FDA SAFETY REPORT ID# (B)(4).

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED BILIARY PANCREATIC DIVERSION PROCEDURE, THE PATIENT HAD AN ARTERIO-VENOUS LESION, A CADIERE FORCEPS INSTRUMENT WAS USED AS A CLAMP, AND THE SURGICAL PROCEDURE WAS CONVERTED TO OPEN SURGERY. IN ORDER TO REMOVE THE CADIERE FORCEPS INSTRUMENT, THE SURGICAL STAFF USED AN INSTRUMENT RELEASE KIT (IRK). ON (B)(6) 2017, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE SURGEON INDICATED THAT THE PATIENT SUSTAINED AN UNSPECIFIED INJURY AND HE USED THE CADIERE FORCEPS INSTRUMENT TO CONTROL BLEEDING FROM THE CAVERNOMA PORTAL VEIN. THE SURGEON DID NOT PROVIDE DETAILS REGARDING THE INJURY SUSTAINED BY THE PATIENT OR THE CAUSE OF THE BLEEDING FROM THE BLOOD VESSEL. DUE TO THE UNSPECIFIED INJURY, THE SURGEON MADE THE DECISION TO CONVERT THE DA VINCI-ASSISTED SURGICAL PROCEDURE TO OPEN SURGERY. DURING THE CONVERSION TO OPEN SURGERY, THE SURGICAL STAFF WAS ABLE TO UNDOCK THREE OF FOUR ROBOTIC ARMS THAT WERE INSTALLED ON THE PATIENT SIDE CART (PSC). HOWEVER, THE SURGICAL STAFF HAD DIFFICULTY OPENING THE JAWS OF A CADIERE FORCEPS INSTRUMENT THAT WAS INSTALLED ON THE FO

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 FIVE DAYS AFTER COMPLETION OF AN UNSPECIFIED DA VINCI-ASSISTED SURGICAL PROCEDURE PERFORMED IN (B)(6) 2016, THE PATIENT EXPERIENCED POST-OPERATIVE HEMORRHAGING IN HER ROOM. THE CAUSE AND SOURCE OF THE HEMORRHAGING IS CURRENTLY UNKNOWN. CARDIAC MASSAGES WERE ADMINISTERED TO THE PATIENT A LITTLE OVER FOUR HOURS IN HER ROOM. ONCE THE PATIENT WAS STABLE, THE PATIENT WAS TAKEN TO THE OR. HOWEVER, THE SURGICAL STAFF WAS UNABLE TO SAVE THE PATIENT. THE PATIENT REPORTEDLY EXPIRED FIVE DAYS AFTER UNDERGOING THE DA VINCI-ASSISTED SURGICAL PROCEDURE. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. THE FOLLOWING INFORMATION IS UNKNOWN: THE ACTUAL DATE THAT THE DA VINCI-ASSISTED SURGICAL PROCEDURE WAS PERFORMED, WHAT SPECIFIC TYPE OF SURGICAL PROCEDURE WAS PERFORMED, WHAT DATE THE HEMORRHAGE WAS IDENTIFIED, AND WHAT DATE THE PATIENT EXPIRED.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ABSTRACT: WE SOUGHT TO COMPARE INTRAOPERATIVE SURGICAL INSTRUMENTATION TECHNIQUES WITH IMAGE-GUIDANCE VERSUS ROBOTIC-GUIDED PROCEDURES FOR POSTERIOR SPINAL FUSION. METHODS: A RETROSPECTIVE REVIEW OF INSTITUTIONAL DATA COLLECTED FROM A SINGLE SURGEON WAS USED TO COMPARE SURGICAL OUTCOMES BETWEEN O-ARM NEURONAVIGATION AND THE MAZOR X ROBOTIC-ASSISTANCE SYSTEM FOR PLACEMENT OF POSTERIOR SPINAL INSTRUMENTATION IN A CONSECUTIVE SERIES OF PATIENTS. UNIVARIATE STATISTICAL SIGNIFICANCE TESTING COMPARED TIME SPENT IN THE OPERATING ROOM, BLOOD LOSS, SCREW ACCURACY, AND WOUND HEALING. RESULTS: BETWEEN JANUARY 2017 AND FEBRUARY 2019, 46 O-ARM CASES (MEAN AGE 59.6 YEARS ± 13.7 YEARS) AND 39 MAZOR X CASES (MEAN AGE 59.5 YEARS ± 12.4 YEARS) WERE CONDUCTED. CASES WERE CLASSIFIED AS DEGENERATIVE, INFECTIOUS, ONCOLOGIC, AND TRAUMA WITH A MEAN OF 4.57 AND 5.43 LEVELS OPERATED ON USING O-ARM NEURONAVIGATION AND MAZOR X, RESPECTIVELY. MEAN OPERATIVE TIMES (P = 0.124), ESTIMATED BLOOD LOSS (P = 0.212), WOUND REVISION RATES (P = 0.560), AND CLINICALLY ACCEPTABLE INSTRUMENTATION PLACEMENT (P = 0.076) DID NOT DEMONSTRATE SIGNIFICANCE BETWEEN THE 2 GROUPS. HOWEVER, SCREW PLACEMENT WAS SIGNIFICANTLY MORE A C

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: HYSTERECTOMY WITH DA VINCI ROBOT AT (B)(6) HOSPITAL FOR 3.75 HOURS. WOKE WITH GRADE 4 ANNULAR TEAR IN L5-S1 LUMBAR DISC, CAUSING IMMEDIATE SEVERE PAIN AND REQUIRING ARTIFICIAL DISC REPLACEMENT 7 MONTHS LATER.

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 THORACOTOMY PROCEDURE PERFORMED ON AN UNSPECIFIED DATE IN (B)(6) 2016, THE PATIENT WAS IDENTIFIED TO HAVE A HEMOTHORAX ON POST-OPERATIVE DAY 1. THE SURGEON INDICATED THAT THE INTERNAL MAMMARY ARTERY (IMA), WHICH WAS HARVESTED DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE, WAS FOUND TO BE BLEEDING. THE SURGEON HAD TO PLACE SUTURES ON THE IMA IN ORDER TO CONTROL THE BLEEDING. THE SURGEON COULD NOT CONFIRM A ROOT CAUSE FOR THE POST-OPERATIVE COMPLICATION. HOWEVER, THE SURGEON INITIALLY ATTRIBUTED THE POST-OPERATIVE COMPLICATION TO POSSIBLE SURGEON-ERROR. ACCORDING TO THE SURGEON, THE PATIENT HAS BEEN DOING VERY WELL SINCE THEN. THE SURGEON STATED THAT A POSSIBLE CAUSE OF THE POST-OPERATIVE COMPLICATION WAS DUE TO A SETTING ON THE ERBE GENERATOR WHICH IS INTEGRATED WITH THE DA VINCI XI SURGICAL SYSTEM. THE SURGEON EXPLAINED THAT THE INTEGRATED ERBE GENERATOR DOES NOT GIVE THE OPTION OF INCREASING THE SETTINGS IN SMALLER INCREMENTS WHICH WOULD HELP WITH PURE COAGULATION. DURING THE SURGICAL PROCEDURE, THE SURGEON STATED THAT HE HAD SET THE ERBE GENERATOR AT 2 BUT WOULD HAVE PREFERRED TO SET IT AT 1.5 WHICH IS NOT AN AVAILABL

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 THERE WERE SEVERAL DEVICE PC PERFORMANCES ISSUES DURING A SURGERY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TOTAL BENIGN HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE ENERGY WAS ALLEGEDLY CUTTING TOO MUCH TISSUE. THE INITIAL REPORTER CLAIMED THAT BIPOLAR AND MONOPOLAR ENERGY WAS NOT STOPPING AND WAS BURNING THROUGH TOO MUCH TISSUE. ON (B)(6) 2016, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE'S OR ASSISTANT DIRECTOR AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE OR ASSISTANT DIRECTOR STATED THAT THE ENERGY TRAVELED DURING THE PROCEDURE, WHICH RESULTED IN A THERMAL BURN ON A FALLOPIAN TUBE AND THE SIGMOID COLON ADJACENT TO IT. IT WAS CONFIRMED THAT THERE WAS NO ARCING SEEN BY THE SURGEON OR THE BEDSIDE ASSISTANTS; HOWEVER, WHEN THE FALLOPIAN TUBE WAS MOVED THE SURGEON SAW EVIDENCE OF A BURN ON IT AND ON THE SIGMOID COLON. AT THIS TIME THE SURGEON INSPECTED THE SIGMOID COLON AND FOUND IT HAD A LEAK, THE SURGEON APPLIED SUTURES TO STOP THE LEAK. PHOTOGRAPHIC IMAGES OF THE PATIENT'S INJURY WERE REVIEWED BY THE HOSPITAL STAFF AND IT WAS REPORTED THAT THERE WAS A LARGE DISTANCE BETWEEN THE INJURED TISSUE AND THE INSTRUMENTS USED. THE SITE REPORTED THAT THE INSTRUMENTS ARE ALWAYS EXAMINED PRIO

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: TWO ELECTRODES IMPLANTED DURING (B)(6) 2016 SURGERY WERE NOT POSITIONED AS PLANNED, AND COULD NOT BE USED FOR EPILEPSY DIAGNOSTICS. THOSE TWO ELECTRODES WERE EXPLANTED AND TWO NEW ELECTRODES WERE IMPLANTED ON PATIENT ON (B)(6) 2016 SURGERY.

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 DEVICE ROBOT ARM WAS GOING TO A PLANNED TRAJECTORY. THE OPERATOR NOTICED THAT THE ROBOT ARM WOULD HAVE COLLIDED WITH THE PATIENT'S HEAD DURING THIS MOVEMENT, SO HE RELEASED THE VIGILANCE DEVICE WHICH PREVENTED THE COLLISION.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING THE CONTACTLESS REGISTRATION PART OF THE SURGERY, A COMMUNICATION ERROR APPEARED. THE ROBOT ARM WAS IN EXCESSIVE EXTENSION WHEN IT WAS MOVING TO TEMPORAL SIDE. THIS ISSUED APPEARED BECAUSE TELESCOPIC ARM WAS TOO MUCH EXTENDED AND SO, PATIENT¿S HEAD WAS LOCKED TOO FAR FROM THE ROBOT ARM. THE DEVICE WAS RESTARTED AND THE TELESCOPIC ARM LENGTH WAS REDUCED IN ORDER TO ENSURE ACCESSIBILITY OF ALL SIDE OF THE PATIENT¿S HEAD. AFTER THIS MODIFICATION THERE WAS NO MORE REPORTED ISSUES.

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 SURGERY WAS ABORTED DUE TO BAD PLACEMENT OF LASER FIBER.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON 10/18/2016, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF THE OPEN MEDICINE JOURNAL ARTICLE TITLED, MALFUNCTIONS OF ROBOTIC SYSTEM IN SURGERY: ROLE AND RESPONSIBILITY OF SURGEON IN LEGAL POINT OF VIEW (FERRARESE, ET AL., 2016). THE PURPOSE OF THE JOURNAL ARTICLE WAS TO ESTIMATE THE IMPACT OF DEVICE MALFUNCTIONS IN ROBOTIC SURGERY AND ITS CONSEQUENT LEGAL IMPLICATIONS. WITHIN THE ARTICLE, THE FOLLOWING IS STATED: FROM A RS MALFUNCTION, 16 CAUSED PATIENT DAMAGE, OF WHICH 13 WERE MILD AND RESOLVED WITHOUT SEQUELAE, AND 3 WERE COMPLEX, INCLUDING AN EXTERNAL ILIAC VEIN LESION, ILEAL PERFORATION, AND URETHRAL LESION. THE LATTER WERE TREATED INTRA-OPERATIVELY WITH DIRECT ILIAC VEIN AND ILEAL SUTURE AND REIMPLANTATION OF THE URETHRAL LESION. NO FURTHER INFORMATION WAS PROVIDED WITHIN THE ARTICLE REGARDING THE OPERATIVE COMPLICATIONS.

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 PARATHYROID GLAD SURGICAL PROCEDURE, THE PATIENT EXPERIENCED COMPLICATIONS. THE PATIENT'S SPOUSE CONTACTED AN INTUITIVE SURGICAL, INC. (ISI) REPRESENTATIVE AND STATED THAT HIS WIFE HAD NERVE DAMAGE AND ALMOST LOST HER VOICE. THE SPOUSE FURTHER STATED THAT NOT ALL THE PARATHYROID GLANDS WERE REMOVED. ON 4/4/2017, ISI RECEIVED ADDITIONAL INFORMATION CONFIRMING THE DATE OF THE PROCEDURE. ON 4/10/2017 ISI RECEIVED ADDITIONAL INFORMATION FROM THE SURGEON WHO STATED THAT THERE WERE NO MALFUNCTION OF THE ISI SYSTEM, INSTRUMENT, OR ACCESSORIES. NO FURTHER DETAILS HAVE BEEN OBTAINED AS OF DATE OF THIS REPORT.