da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL TONSILLECTOMY SURGICAL PROCEDURE, WHEN ATTEMPTING TO DOCK THEY WERE GETTING A CANNULA INVALID MESSAGE. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WALKED THE CUSTOMER THROUGH EMERGENCY POWER OFF (EPO) OF THE PATIENT SIDE CART (PSC) AND ERROR 1162 PERSISTED. THE TSE REVIEWED ONSITE LOGS AND CONFIRMED ERROR CODE 1162. TSE THEN WALKED THE CALLER THROUGH ADDITIONAL EPO OF PSC AND POWERING SYSTEM BACK ON WITH CANNULA INSTALLED AND SYSTEM POWERED ON AND ERROR DID NOT PERSIST. THE CALLER REPORTED THAT THE SURGEON HAD PERFORMED THE SURGERY ¿MANUALLY¿ AND THE CASE WAS COMPLETED WITHOUT THE DAVINCI ROBOT. THERE WAS NO REPORTED PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGEON¿S NAME WAS PROVIDED. THE SURGEON WAS REQUIRED TO CHANGE THE SURGICAL APPROACH TO OPEN SURGERY. THERE WAS NO INJURY TO THE PATIENT.

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 NISSEN FUNDOPLICATION-ISOLATED SURGICAL PROCEDURE, A SMALL ROUND FRAGMENT ATTACHED TO THE WRIST OF THE SYNCHROSEAL INSTRUMENT FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED ROBOTICALLY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYNCHROSEAL INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO DAMAGE FOUND. THE SURGEON DID NOT KNOW WHEN THE FRAGMENT FELL EXACTLY. THE SURGEON FOUND THE SMALL ROUND FRAGMENT ON THE TISSUE, AND THEN REALIZED IT WAS FROM THE SYNCHROSEAL INSTRUMENT. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE AND THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE PROCEDURE. THE SURGEON TRIED TO RETRIEVE THE FRAGMENT THROUGH THE CANNULA BUT WAS UNABLE TO DO SO. THE CUSTOMER TRIED TO FIND THE FRAGMENT INSIDE THE PATIENT AGAIN BUT COULD NOT FIND IT. NO FRAGMENTS WERE RETRIEVED. NO POST-OPERATIVE TESTS WERE PERFORMED AS THE FRAGMENT WAS TOO SMALL TO BE REVEALED BY X-RAY. THE PATIENT HAS NOT EXPERIENCED ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT.

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 HIATAL HERNIA SURGICAL PROCEDURE, THE PROGRASP FORCEPS INSTRUMENT SCREW AT THE DISTAL MECHANISM CAME LOOSE AND FELL INSIDE THE PATIENT. THE SCREW WAS RETRIEVED DURING THE SAME PROCEDURE FROM THE PATIENT WITHOUT INJURY. THE PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUES. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROGRASP FORCEPS INSTRUMENT WAS INSPECTED PRIOR TO USE AND THERE WAS NO DAMAGE FOUND. THE INSTRUMENT WAS BEING INSERTED WHEN THE SCREW FELL OUT. THE PROCEDURE HAD JUST STARTED WHEN THE REPORTED ISSUE OCCURRED. THE SURGEON DID NOT NOTICE ANY FUNCTIONALITY ISSUES BEFORE THE INSTRUMENT BROKE. THE INSTRUMENT DID NOT COLLIDE WITH OTHER INSTRUMENTS. A NEW INSTRUMENT WAS OPENED AFTER THE SCREW WAS REMOVED AND THE PROCEDURE WAS COMPLETED ROBOTICALLY. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING POST-SURGICAL COMPLICATIONS RELATED TO FOREIGN OBJECTS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER FELL OFF IN THE PATIENT. THE TIP COVER WAS RETRIEVED DURING THE SAME PROCEDURE. THE NURSE COMMENTED THAT THE TIP COVER WAS EASIER TO PUT ON THAT DAY. THE PROCEDURE WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF DATE OF THIS REPORT.

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 ENDOMETRIOSIS RESECTION PROCEDURE, THERE WAS A DELAY IN INSTRUMENT MOVEMENT AND THE ENDOSCOPE WAS NOT FLIPPING NORMAL ANGLE UP AND DOWN. THE ENDOSCOPE WAS OBSERVED TO BE ROTATING ON ITS OWN. THIS OCCURRED AT THE START OF THE PROCEDURE AND ONLY OCCURRED ONCE. TECHNICAL SUPPORT (TS) WAS CONTACTED AND RECOMMENDED TO TRY A DIFFERENT ENDOSCOPE. THE ISSUE WAS RESOLVED WITH A PHONE FIX. DUE TO THE ISSUE, THE PATIENT SUSTAINED AN UNSPECIFIED LARGE BOWEL INJURY. THE TYPE AND SEVERITY OF THE BOWEL INJURY ARE UNKNOWN. IT IS ALSO UNCLEAR HOW THE COMPLICATION OCCURRED AND WHAT TASK WAS BEING PERFORMED AT TIME OF THE INJURY. A GENERAL SURGEON WAS CALLED IN AND REPAIRED THE LARGE BOWEL INJURY WITH SUTURES AND STITCHES. THE ESTIMATED BLOOD LOSS WAS CONSIDERED NEGLIGIBLE AND WAS LESS THAN 15 MILLILITERS. THERE WAS A DELAY OF 15-20 MINUTES. THE SURGEON INDICATED THAT AFTER THE ENDOSCOPE WAS CHANGED, THE SURGICAL STAFF WAS ABLE TO COMPLETE THE CASE ROBOTICALLY WITH NO FURTHER ISSUES. THE PATIENT HAD NO POST-OPERATIVE COMPLICATIONS AND IS DISCHARGED FROM THE HOSPITAL.

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 PROCEDURE, THE TIP OF AN UNSPECIFIED SINGLE PORT (SP) INSTRUMENT APPEARED TO BE BROKEN AT THE SHAFT. THE FRAGMENT IS IN A BAG THAT THE ROBOTICS COORDINATOR IS IN POSSESSION OF AND WILL BE RETURNED WITH THE INSTRUMENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI ASSISTED LIVER RESECTION SURGICAL PROCEDURE, THE SURGEON EXPERIENCED A TUMOR RUPTURE DUE TO THE PATIENT¿S TISSUE BEING TOO DELICATE AND THAT THEY COULDN¿T MANIPULATE IT WITH THE INSTRUMENTS PROPERLY. THE SURGEON THEN DECIDED TO CONVERT TO AN OPEN PROCEDURE. AS REPORTED, THE PATIENT¿S VITAL PARAMETERS WERE FINE, THERE WERE NO INSTRUMENT FAILURE OR LIFE-THREATENING SITUATION. NO REPORT OF PATIENT HARM, ADVERSE OUTCOME OR INJURY AND NO DELAYS. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED-UP WITH THE REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS EVENT: THE TUMOR RUPTURED DUE TO TISSUE BEING TOO DELICATE AND FRAGILE. THERE WAS NO MALFUNCTION OF THE DA VINCI SYSTEM OR ANY INSTRUMENTS. THE REPORTER CONFIRMED THE PATIENT WAS STABLE AND HAD SINCE LEFT THE HOSPITAL WITH NO OTHER ISSUES 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 AS PART OF A CLINICAL STUDY THAT A PATIENT UNDERWENT A DA VINCI-ASSISTED LEFT UPPER LOBECTOMY PROCEDURE FOR A 4CM LESION WITH THE DIAGNOSIS OF A PRIMARY LUNG CANCER. THERE WERE DENSE ADHESIONS BETWEEN A CALCIFIED LYMPH NODE AND THE INTERLOBAR PULMONARY ARTERY (PA). TEARING OVER THE LINGUAL-INTERLOBAR PA JUNCTION WAS ENCOUNTERED DURING THE SURGERY. IT IS UNKNOWN WHAT SPECIFIC INSTRUMENTS WERE BEING USED WHEN THE INJURY OCCURRED. THE PROCEDURE WAS CONVERTED TO A THORACOTOMY FOR HILAR BLEEDING CONTROL AND THE PA WAS REPAIRED BY A CARDIAC SURGEON. THE BLOOD LOSS VOLUME ASSOCIATED WITH THE INTRA-OPERATIVE COMPLICATION IS UNKNOWN. THE LOBECTOMY WAS PERFORMED AFTER PA REPAIR. THE PATIENT WAS HEMODYNAMICALLY STABLE AFTER THE PROCEDURE WAS COMPLETED WITH NO OBVIOUS SEQUELAE. THE SURGEON ASSESSED THE CAUSALITY OF THE EVENT WITH DA VINCI SP AS UNLIKELY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE SURGEON. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY PROCEDURE, THE ENDOSCOPE IMAGE BECAME INVERTED AND RESULTED IN UNEXPECTED MOTION OF AN INSTRUMENT. THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES ASSOCIATE (CSA), WHO WAS PRESENT DURING THE CASE, REPORTED THAT THE INSTRUMENTS WERE MOVING IN THE OPPOSITE DIRECTION THAN THE SURGEON INTENDED. WHEN THE SURGEON TRIED TO PULL AN INSTRUMENT AWAY, THE INSTRUMENT ALLEGEDLY MOVED FORWARD AND DAMAGED THE LIVER. THE CSA SAID THE CUSTOMER WAS ABLE TO RESOLVE THE ISSUE BE REMOVING AND RESEATING THE ENDOSCOPE TWO TIMES. THE PROCEDURE WAS REPORTEDLY COMPLETED AS PLANNED. ISI CONTACTED THE SURGEON OF THIS PROCEDURE AND ADDITIONAL INFORMATION WAS OBTAINED ABOUT THE COMPLAINT: THE INDICATION FOR THIS PROCEDURE WAS ACUTE CHOLECYSTITIS/CHOLEDOCHOLITHIASIS. THE SURGEON SAID THIS EVENT OCCURRED IMMEDIATELY AFTER THEY TOOK CONTROL AT THE SURGEON SIDE CONSOLE (SSC) WHILE THEY WERE TRYING TO SET-UP THE RETRACTION. THE PROGRASP FORCEPS INSTRUMENT REPORTEDLY WAS THE INSTRUMENT THAT MOVED DURING THIS EVENT. THE SURGEON REPORTED THAT THE PATIENT LOST 50CC OF BLOOD DUE TO THIS EVENT AND NO BLOOD TRANSFUSION WAS ADMINISTERED. THIS EVENT DELAYED TH

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE GENERATOR ALARMED THAT THE TIP OF THE HARMONIC ACE INSTRUMENT WAS OVER-STRESSED. THE PRESSURE WAS RELIEVED AND THEN THE CUSTOMER REINSTALLED THE HARMONIC ACE INSTRUMENT. THE BLADE OF THE HARMONIC ACE INSTRUMENT SUDDENLY BROKE WHEN THE USER REACTIVATED IT. A FRAGMENT FROM THE INSTRUMENT FELL INSIDE THE PATIENT BUT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC (ISI) FOLLOWED UP WITH THE SITE NURSE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE INSTRUMENT FUNCTIONALITY WAS INSPECTED BEFORE USE. IT IS UNKNOWN WHAT SURGICAL TASK WAS BEING PERFORMED WHEN THE FRAGMENT FELL INSIDE THE PATIENT. IT IS ALSO UNKNOWN HOW LONG THE INSTRUMENT WAS IN USE PRIOR TO THE EVENT. NO ISSUES WERE NOTED WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR HARD MATERIAL. THE INSTRUMENT WAS NOT REMOVED BEFORE THE BREAKAGE OCCURRED. THE STAFF DID NOT FEEL RESISTANCE UPON THE REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. THERE WAS NO DAMAGE NOTED TO THE CANNULA.

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 UROLOGIC PROCEDURE, THE SURGEON EXPERIENCED NON-INTUITIVE MOTION OF INSTRUMENTS INVOLVING THE USE OF A 30-DEGREE ENDOSCOPE. THE ISSUE OCCURRED WHEN THE SURGEON GAVE THE COMMAND TO TURN THE ENDOSCOPE 180 DEGREES, WHICH CAUSED THE INSTRUMENTS TO START WORKING IN THE OPPOSITE, OR MIRRORED, DIRECTION. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) VIEWED THE LIVE LOGS AND DID NOT NOTE ANY ASSOCIATED ERRORS. THE SYSTEM WAS RESTARTED, AND THE ENDOSCOPE WAS RESEATED. THERE WAS A PROCEDURAL DELAY DUE TO TROUBLESHOOTING. AFTER THE REVERSED MOTION OF THE INSTRUMENTS, A HEMATOMA FORMED ON THE KIDNEY. THE SURGEON MADE THE CLINICAL DECISION TO ABORT THE PROCEDURE AFTER DETERMINING THAT PROCEEDING WAS TOO RISKY DUE TO THE HEMATOMA. PER THE SITE, THE PROCEDURE WILL BE RESCHEDULED TO ANOTHER DAY AFTER THE HEMATOMA HAS DISSIPATED.

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) RECEIVED FDA VOLUNTARY MEDWATCH REPORT (MDR REPORT #MW5115834) WITH THE FOLLOWING EVENT DESCRIPTION: "PATIENT HAD A ROBOTIC HYSTERECTOMY ON (B)(6) 2022 AT THE SURGICAL HOSPITAL SINCE HER SURGERY PATIENT HAD CONTINUED ABDOMINAL PELVIC PAIN. ON (B)(6) 2023, A CT WAS OBTAINED WHEN PATIENT PRESENTED TO THE ED AND THERE WAS CONCERN FOR A FOREIGN BODY. PATIENT WAS TAKEN TO THE OPERATING ROOM FOR A LAPAROSCOPIC REMOVAL OF FOREIGN BODY ON (B)(6) 2023. THE FOREIGN BODY WAS RETRIEVED AND IDENTIFIED AS A TIP COVER ACCESSORY PLACED OVER THE MONOPOLAR CURVED SCISSOR INSTRUMENT USED IN ROBOTIC PROCEDURES. THE INSTRUMENT USED ON (B)(6) 2022 WAS MONOPOLAR CURVED SCISSOR 8MM DA VINCI XI SERIAL NUMBER (B)(6). THE INSTRUMENT IS NO LONGER IN OUR INVENTORY. THE MONOPOLAR IS CONSIDERED A SEMIDISPOSABLE WHICH CAN BE USED UP TO 10 TIMES. IT WAS UTILIZED AGAIN ON (B)(6) 2022, (B)(6) 2022, (B)(6) 2022, AND (B)(6) 2022." THE DATES OF THE CT SCAN AND THE ADDITIONAL PROCEDURE WERE NOT PROVIDED. IT WAS UNKNOWN IF THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT AND THE MCS TIP COVER ACCESSORY WERE INSPECTED PRIOR TO USE. THE MCS TIP COVER ACCESSORY FELL INSIDE THE PATIENT WHILE 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: PATIENT HAD A ROBOTIC HYSTERECTOMY ON (B)(6) 2022 AT THE SURGICAL HOSPITAL SINCE HER SURGERY PATIENT HAD CONTINUED ABDOMINAL PELVIC PAIN. ON (B)(6) 2023, A CT WAS OBTAINED WHEN PATIENT PRESENTED TO THE ED AND THERE WAS CONCERN FOR A FOREIGN BODY. PATIENT WAS TAKEN TO THE OPERATING ROOM FOR A LAPAROSCOPIC REMOVAL OF FOREIGN BODY ON (B)(6) 2023. THE FOREIGN BODY WAS RETRIEVED AND IDENTIFIED AS A TIP COVER ACCESSORY PLACED OVER THE MONOPOLAR CURVED SCISSOR INSTRUMENT USED IN ROBOTIC PROCEDURES. THE INSTRUMENT USED ON (B)(6) 2022 WAS MONOPOLAR CURVED SCISSOR 8MM DA VINCI XI SERIAL NUMBER (B)(4). THE INSTRUMENT IS NO LONGER IN OUR INVENTORY. THE MONOPOLAR IS CONSIDERED A SEMI-DISPOSABLE WHICH CAN BE USED UP TO 10 TIMES. IT WAS UTILIZED AGAIN ON (B)(6) 2022, (B)(6) 2022, (B)(6) 2022, AND (B)(6) 2022.

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 A PATIENT UNDERWENT A DA VINCI-ASSISTED PULMONARY WEDGE RESECTION PROCEDURE AND WAS THEN CLOSED UP. THE SURGEON REPORTEDLY LEFT THE OPERATING ROOM (OR); HOWEVER, AN UNSPECIFIED TIME LATER, THE PATIENT TURNED GRAY IN COLOR. THE SURGEON WAS CALLED IN AND AN EXPLORATORY LAPAROTOMY WAS PERFORMED. IT WAS FOUND THAT A SEAL WHERE A SYNCHROSEAL INSTRUMENT WAS USED FAILED, RESULTING WITH EXCESSIVE BLEEDING. THE SURGEON WAS ABLE TO STOP THE BLEEDING. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED AS PART OF A CLINICAL STUDY THAT AFTER UNDERGOING A DA VINCI-ASSISTED RIGHT LOWER LOBECTOMY PROCEDURE, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT ON POST-OPERATIVE DAY (POD) #4 WITH ABNORMAL SECRETION AND FLUID COMING OUT FROM THE CLOSURE WOUND. THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS AND HOSPITALIZATION. THE FOLLOWING DAY THE PATIENT WAS DIRECTED TO OUTPATIENT CARE. THE INTENSITY OF SECRETION WAS REDUCED ON POD #5 AND WAS ABSORBED WITHOUT A CHEST DRAIN. PER EVALUATION BY TWO PHYSICIANS, THE POSSIBLE CAUSE OF THE COMPLICATION WAS DUE TO THE PATIENT NOT FOLLOWING AGREED THORACIC EXPANSION EXERCISES. THE PLAN WAS TO ENCOURAGE THE PATIENT TO STICK TO REHABILITATION MEASURES, RE-EVALUATE THE DRAINAGE POSITION AND CONDUCT AN-PATIENT ULTRASOUND CHECK-UP BEFORE REMOVING THE CHEST DRAIN. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, FURTHER DETAILS HAVE YET TO BE RECEIVED AS OF THE DATE OF THIS REPORT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS INITIALLY REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED BILATERAL INGUINAL HERNIA SURGICAL PROCEDURE THAT A U-02 ERROR OCCURRED AGAINST THE ERBE INTEGRATED ELECTROSURGICAL UNIT (IESU) GENERATOR, SHORTLY AFTER POWERING ON THE GENERATOR. THE SITE TRIED TO POWER CYCLE THE IESU SEVERAL TIMES PRIOR TO CALLING, BUT THE ERROR KEPT RETURNING. THE TECH SUPPORT ENGINEER (TSE) WALKED THE CUSTOMER THROUGH POWERING DOWN THE SYSTEM AND THE IESU. THE CUSTOMER DISCONNECTED ALL OF THE CABLES AT THE BACK OF THE IESU, THEN POWERED IT ON WITHOUT THE FOOT SWITCHES CONNECTED. THE ERROR SEEMED TO GO AWAY, BUT SOON RETURNED. THERE WERE NO REPORTS OF PATIENT INJURY. AT THIS TIME THE PROCEDURE OUTCOME IS UNKNOWN. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION. THE SURGICAL PORTS HAD BEEN PLACED ON THE PATIENT WHEN THE IESU ERRORS OCCURRED. THE PROCEDURE WAS ULTIMATELY CONVERTED TO AN OPEN PROCEDURE DUE TO THE GENERATOR ISSUE. THERE WAS NO REPORTED HARM TO THE PATIENT AS A RESULT OF THE CONVERSION.

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 A DA VINCI ASSISTED RIGHT MIDDLE LOBE PULMONARY LOBECTOMY PROCEDURE, THE PATIENT, WHO WAS PART OF A COMPLETED PILOT STUDY OF SINGLE PORT ROBOTIC SURGERY FOR ANATOMICAL LUNG RESECTION, EXPERIENCED HEMOPTYSIS. AN X-RAY DONE ON THE PATIENT SHOWED PLEURAL EFFUSION. THE PATIENT UNDERWENT A RE-OPERATION. INTRA-OPERATIVELY, SEVERE PULMONARY CONGESTION WAS FOUND DUE TO A "MAL-RESECTION" OF PREVIOUS S2 SEGMENTAL VEIN DRAINAGE. THE PLEURAL EFFUSION AND BLOOD CLOT WERE RETRIEVED BY SINGLE PORT VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS) TECHNIQUE. THE SURGEON THEN DISSECTED THE POSTERIOR PART OF THE LUNG FISSURE AND EXPLORED THE A2 ( POSTERIOR ASCENDING BRANCH OF PULMONARY ARTERY). ECCHYMOSIS OF A2 WAS FOUND. THE SURGEON COMPLETED THE ANTERIOR HORIZONTAL FISSURE USING THE HARMONIC SCALPEL TO LOOSEN THE HILAR AREA AND USED TWO HEM-O-LOCKS CLIPS AS WELL AS THE HARMONIC SCALPEL TO RESECT THE A2 BRANCH. THEN THE RIGHT UPPER LOBE CONGESTION CONDITION IMPROVED. THE SURGEON BELIEVES THAT THE CAUSE OF THE POST-OPERATIVE COMPLICATION WAS DUE TO THE UNCOMMON ANATOMY CAUSING BLOOD FROM UPPER LOBE TO FLOW BACK TO MID-LOBE, RESULTING IN THE BLOOD CLOT. THE SUSPECTED DEVICE INVOL

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT TIP BROKE. THE CUSTOMER REMOVED THE FRACTURED PART OF THE INSTRUMENT COMPLETELY AND NO FRAGMENTS REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED USING A BACKUP HARMONIC ACE INSTRUMENT WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE FRAGMENT WAS RETRIEVED. THERE WAS NO ADDITIONAL SURGICAL PROCEDURE NEEDED. AN ULTRASOUND WAS PERFORMED TO CONFIRM THERE WERE NO REMAINING FRAGMENTS. THE SURGEON BELIEVES THE BREAK WAS THE RESULT OF A PRODUCT QUALITY PROBLEM. THE HARMONIC ACE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO ABNORMALITIES WERE FOUND. THE INSTRUMENT WAS USED FOR 15 MINUTES PRIOR TO THE BREAK. THE SURGEON WAS USING THE INSTRUMENT FOR DISSECTING WHEN THE ISSUE OCCURRED. THERE WAS NO INSTRUMENT COLLISION, AND THE INSTRUMENT WAS NOT REMOVED DURING THE PROCEDURE PRIOR TO THE BREAKAGE. UPON FINAL REMOVAL OF THE CANNULA, THERE WAS NO RESISTANCE, NO DAMAGE TO THE CANNULA, AND NO FURTHER DAMAGE TO THE INSTRUMENT. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO COMPLICATIONS FROM RETAI

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 SUBTOTAL GASTRECTOMY PROCEDURE, THE POSTERIOR GASTRIC ARTERY WAS DISSECTED WITH A HARMONIC ACE INSTRUMENT. THE ISSUE OCCURRED WHEN THE SURGEON WAS ABOUT TO ANASTOMOSE THE STOMACH AND SUDDENLY EXPERIENCED BLEEDING FROM THE POSTERIOR GASTRIC ARTERY. THE SURGEON WAS UNABLE TO STITCH THE BLEEDING SECTION USING THE ROBOT. THE BLEEDING WAS SUPPRESSED WITH AN UNSPECIFIED INSTRUMENT INSTALLED ON UNIVERSAL SURGICAL MANIPULATOR (USM) 4. THE SURGEON MADE THE CLINICAL DECISION TO CONVERT TO OPEN SURGERY DUE TO BLEEDING. THE AMOUNT OF BLOOD LOSS AT THE TIME OF THE DECISION WAS ABOUT 100ML. THE TOTAL AMOUNT OF BLOOD LOSS WAS ABOUT 500ML. THE OPEN PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT THE PATIENT REQUIRING A BLOOD TRANSFUSION.

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 SIGMOID COLECTOMY SURGICAL PROCEDURE, A PIECE OF THE CANNULA SEAL FELL INTO THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED VENTRAL HERNIA SURGICAL PROCEDURE, THE CUSTOMER STATED THAT THE CAUTERY WAS NOT WORKING, AND A QUESTION MARK WAS DISPLAYED ON THE INTEGRATED ELECTROSURGICAL UNIT (IESU/ERBE) FRONT PANEL, INDICATING THAT THE ERBE COULD NOT DETERMINE WHICH UNIVERSAL SURGICAL MANIPULATOR (USM) THE INSTRUMENT WAS ENGAGED ON. THE CUSTOMER HAD REPLACED THE CORDS AND EXHAUSTED THEIR SUPPLY. THE CUSTOMER TRIED DIFFERENT CAUTERY INSTRUMENTS, STILL THE ISSUE PERSISTED. THE CUSTOMER POWER CYCLED THE SYSTEM AND REMOVED AC POWER FROM THE ERBE AND THE ISSUE PERSISTED. THE SYMPTOMS INDICATED BAD ENERGY CORD(S) OR BAD ENERGY CONNECTORS ON THE ERBE. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY WITH NO REPORTS OF PATIENT INJURY. AN INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY PROCEDURE, THE MONOPOLAR CURVED SCISSOR (MCS) TIP COVER ACCESSORY CAME LOOSE WHEN REMOVING THE MCS INSTRUMENT AND FELL INSIDE THE PATIENT'S ABDOMEN. AT THE TIME THE EVENT OCCURRED, THE SURGICAL STAFF WAS IN THE PROCESS OF EXCHANGING THE MCS INSTRUMENT WITH A LARGE NEEDLE DRIVER INSTRUMENT. THERE WAS NO DIFFICULTY FELT WHILE REMOVING THE MCS INSTRUMENT. AFTER THE EVENT OCCURRED, THE MCS INSTRUMENT REMAINED OUTSIDE THE PATIENT FOR THE REMAINDER OF THE PROCEDURE AND WAS NO LONGER USED DURING THE PROCEDURE. PER THE SURGEON, THE MCS TIP COVER ACCESSORY LIKELY CAME LOOSE DURING THE INSTRUMENT CHANGE. THE MSC TIP COVER ACCESSORY APPEARED TO HAVE BEEN PROPERLY INSTALLED DURING THE SURGICAL PROCEDURE WITH NO PART OF THE ORANGE SURFACE VISIBLE AFTER INSTALLATION NOR WAS IT INSTALLED BEYOND THE ORANGE SURFACE. THE INSTALLATION TOOL HAD BEEN USED; ELECTROLUBE OR ANY OTHER LUBRICANT HAD NOT BEEN APPLIED PRIOR TO INSTALLATION OF THE MCS TIP COVER ACCESSORY. THE MCS INSTRUMENT AND MCS TIP COVER ACCESSORY HAD BEEN INSPECTED PRIOR TO USE. THE SURGEON DID NOT NOTICE ISSUES WITH THE FUNCTIONALITY OF THE MCS INS

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ANTERIOR RESECTION SURGICAL PROCEDURE, THE CUSTOMER REPORTED THAT THE VISION WAS LOST. THEY ATTEMPTED TO RECONNECT THE CAMERA TO THE ENDOSCOPE CONTROLLER (EC), BUT THE CAMERA HAD A SELF-TEST FAILURE, AND THE COLOR BAR WAS DISPLAYED. THEY REPLACED THE CAMERA WITH A BACKUP ONE, BUT ALL THE AVAILABLE CAMERAS HAD THE SAME SYMPTOM. LASTLY, THEY REBOOTED THE SYSTEM AND CLEANED THE CAMERA CONNECTOR; HOWEVER, THE ISSUE PERSISTED. THE CUSTOMER ELECTED TO CONVERT TO LAPAROSCOPIC PROCEDURE. NO KNOWN IMPACT OR PATIENT CONSEQUENCE REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP ON 19-OCT-2022 AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CAMERAS WERE INSPECTED PRIOR TO USE WITH NO ABNORMALITY. DURING THE PROCEDURE, THE VISION LOSS OCCURRED ON BOTH OF THE SURGEON SIDE CONSOLE (SSC) AND VISION SIDE CART (VSC). INFORMATION REGARDING PATIENT DEMOGRAPHICS, RELEVANT TESTING, AND MEDICAL HISTORY WERE REQUESTED; HOWEVER, THE REPORTER WAS NOT ABLE TO PROVIDE THAT INFORMATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED DURING A DA VINCI-ASSISTED PROCEDURE THAT ARM 3 OF THE SINGLE PORT (SP) SYSTEM ENCOUNTERED INSTRUMENT ENGAGEMENT ISSUES. THE OR STAFF STATED THEY UNDOCKED THE ARM AND RE-DRAPED BEFORE CALLING. THEY HAD ALSO POWER CYCLED AND TRIED MORE THAN ONE INSTRUMENT ON ARM 3, BUT ISSUES PERSISTED. THE PATIENT WAS ON THE TABLE, UNDER ANESTHESIA, AND PORTS HAD BEEN PLACED AT THE TIME. THE TSE REVIEWED THE LIVE LOGS AND FOUND ERRORS 23300 AND 31009. THE TSE INFORMED THE OR STAFF THAT ALL TROUBLESHOOTING STEPS HAD BEEN PERFORMED AND ARM 3 NEEDS SERVICE. IT WAS CONFIRMED FOLLOWING A FOLLOW-UP CALL THAT THE SURGEON CONVERTED TO AN XI MULTIPORT SYSTEM. THERE WAS NO REPORT OF PATIENT INJURY. AN ATTEMPT HAS BEEN MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER CONCERNING THE REPORTED EVENT WITH NO SUCCESS.

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 A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE SCRUB COUNT WAS OFF, AND THE CUSTOMER WAS MISSING A MONOPOLAR CURVED SCISSORS (MCS) TIP COVER. THE CUSTOMER LOCATED THE MCS TIP COVER INSIDE OF THE PATIENT AND REMOVED IT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE ON (B)(6) 2022 AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER STATED THAT THE ISSUE WAS IDENTIFIED WHILE CLOSING THE PATIENT. THE MCS INSTRUMENT AND TIP COVER WERE INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE MCS TIP COVER WAS RETRIEVED BY GOING BACK IN THE ABDOMEN. ALL FRAGMENTS WERE RETRIEVED, AND THIS WAS CONFIRMED THROUGH INSPECTION OF THE MCS TIP COVER. THE CASE WAS EXTENDED FOR A FEW MINUTES DUE TO THE ISSUE. IT WAS UNKNOWN WHAT TASK WAS PERFORMED WHEN THE MCS TIP COVER FELL INTO THE PATIENT. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE MCS INSTRUMENT DURING THE PROCEDURE. THE MCS INSTRUMENT DID NOT COLLIDE WITH ANOTHER INSTRUMENT. A REDUCER WAS NOT USED. THERE WAS NO DIFFICULTY REMOVING THE MCS INSTRUMENT. THE MCS INSTRUMENT WRIST WAS STRAIGHTENED UPON REMOVAL. NO 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: A LITERATURE ARTICLE DESCRIBED A CASE STUDY OF A 73-YEAR-OLD FEMALE PATIENT WHO UNDERWENT A DA VINCI-ASSISTED ROBOTIC POSTERIOR MEDIASTINAL MASS RESECTION ON THE LEFT CHEST. A CHEST DRAINAGE TUBE WAS PLACED. MAGNETIC RESONANCE IMAGING (MRI) OF THE THORACIC SPINE SHOWED A POST-OPERATIVE ABNORMAL SIGNAL AND A LEFT PARAMASS OF THE 10TH THORAX VERTEBRAE. CEREBROSPINAL FLUID LEAKAGE OCCURRED AFTER SURGERY DUE TO THE CLOSE RELATIONSHIP BETWEEN THE MEDIASTINAL MASS AND THE INTERVERTEBRAL FORAMINA, RESULTING IN A DURAL TEAR. BEDREST WAS ORDERED. MRIS WERE REPEATED AT ONE AND TWO WEEKS AFTER THE SURGERY. THE ABNORMAL SIGNAL WAS SMALLER THAN BEFORE. THE CHEST DRAIN WAS REMOVED, AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL 15 DAYS AFTER SURGERY. THE PATIENT REMAINED ON BEDREST FOR TWO WEEKS AFTER DISCHARGE. THE EVENT WAS REPORTED AS CURED AFTER THREE WEEKS OF BEDRIDDEN TREATMENT. THERE WERE NO DA VINCI DEVICE MALFUNCTIONS REPORTED.

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 A PATIENT UNDERWENT A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE ON AN UNSPECIFIED DATE AND DIED FROM CANCER IN 2016. ACCORDING TO THE INITIAL REPORTER, THE PATIENT'S TREATMENT WAS NEGATIVELY AFFECTED BY THE DA VINCI-ASSISTED SURGERY. THE INITIAL REPORTER INDICATED THAT THE PATIENT UNDERWENT THE HYSTERECTOMY FOR CANCER THAT REOCCURRED FOR A SECOND TIME. PER THE INITIAL REPORTER, IT IS BELIEVED THAT THE ROBOTIC PROCEDURE "STIRRED UP THE CANCER" AND EXPEDITED HER DEATH BY SPREADING. THE PATIENT REPORTEDLY DIED WITHIN SIX MONTHS OF THE SURGERY. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A REVIEW OF AN ARTICLE WAS PERFORMED THAT EVALUATED THE CASE OF A PATIENT THAT SUSTAINED AN AORTIC INJURY DURING A DA VINCI-ASSISTED RETROPERITONEAL LYMPHADENECTOMY PROCEDURE. THE CAUSE OF THE AORTIC INJURY IS UNKNOWN. REPAIR OF THE COMPLICATION COULD NOT BE PERFORMED LAPAROSCOPICALLY; HOWEVER, GRASPER INSTRUMENTS WERE USED TO MAINTAIN HEMOSTASIS WHILE A CONVERSION TO OPEN SURGERY WAS INITIATED. SAFETY MECHANISMS LOCKED THE GRASPERS IN PLACE, PREVENTING TISSUE RELEASE, BUT RESULTING IN ADDITIONAL AORTIC INJURY. FORCEFUL REMOVAL OF THE GRASPERS WAS EVENTUALLY SUCCESSFUL, AND DEFINITIVE AORTIC REPAIR WAS THEN PERFORMED. THE PATIENT REPORTEDLY DID WELL POST-OPERATIVELY AND WAS DISCHARGED HOME. THE ARTICLE NOTES: "PATHOLOGIC EXAMINATION REVEALED A MALIGNANT MIXED MÜLLERIAN TUMOR OF THE ENDOMETRIUM WITH LYMPH NODE METASTASIS. ONE YEAR LATER, SHE HAD COMPLETED CHEMOTHERAPY, WAS LIVING INDEPENDENTLY, AND WAS IN REMISSION. SHE HAD NO ABDOMINAL COMPLAINTS OR CLAUDICATION. SURVEILLANCE AXIAL IMAGING DID DEMONSTRATE A 35% REDUCTION IN VESSEL DIAMETER AT THE SITE OF REPAIR." MULTIPLE ATTEMPTS TO CONTACT AUTHOR AND REPORTER WERE MADE, NO RESPONSE WITH ADDITIONAL INFORMATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE CLINICAL SALES REPRESENTATIVE (CSR) CALLED AN INTUITIVE SURGICAL INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT THAT THE CANNULA KEPT SLIPPING OUT AND THE SURGEON HAD TO CONVERT TO OPEN SURGERY. THE PATIENT STAYED IN THE HOSPITAL AN EXTRA COUPLE OF DAYS BECAUSE OF THE OPEN SURGERY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF AN UROLOGY JOURNAL ARTICLE TITLED, ¿SINGLE PORT VS MULTIPORT ROBOTIC PYELOPLASTY: PROPENSITY-SCORE MATCHED ANALYSIS OF PERIOPERATIVE AND FOLLOW-UP OUTCOMES¿ (HARRISON, R., AHMED, M., ET AL., 2022). WITHIN THE JOURNAL ARTICLE, OPERATIVE COMPLICATIONS INVOLVING SINGLE-PORT (SP) ROBOTIC-ASSISTED PYELOPLASTY (RAP) PROCEDURES WERE NOTED. IN THE ARTICLE, THE FOLLOWING IS NOTED: ¿AN INTRAOPERATIVE COMPLICATION OCCURRED DURING ONE SP-RAP CASE. WHILE INCISING THE PERITONEUM TO ACCESS THE ABDOMINAL CAVITY, A SMALL ENTEROTOMY WAS NOTED IN A PORTION OF THE SMALL BOWEL THAT WAS ADHERENT TO THE PERITONEUM IN A PATIENT WITH PRIOR ABDOMINAL SURGERY. THE INJURED AREA WAS REPAIRED IN TWO LAYERS, USING 3-0 VICRYL FOR THE MUCOSA, AND 3-0 SILK FOR THE SEROSA IN A LEMBERT FASHION.¿ ADDITIONALLY, IT IS DOCUMENTED: ¿ONE SP-RAP PATIENT UNDERWENT SURGICAL DEBRIDEMENT FOR A POORLY HEALING, LEFT LOWER ABDOMINAL QUADRANT WOUND (CLAVIEN CLASS IIIB)." INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE AUTHOR. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY PROCEDURE, THERE WAS AN ORIENTATION ISSUE WITH THE 30-DEGREE ENDOSCOPE 2 HOURS INTO THE PROCEDURE. THE ENDOSCOPE WAS NOT ABLE TO SWITCH BETWEEN UP AND DOWN VIEW AND ONLY ONE ENDOSCOPE WAS AVAILABLE FOR THIS SURGERY. THERE WAS A BEEP EVERY TIME THE SURGEON WANTED TO CHANGE THE SCOPE ORIENTATION. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) DID NOT FIND ANY RELATED ERRORS IN THE LIVE LOGS. PRIOR TO CALLING ISI TECHNICAL SUPPORT, THE CUSTOMER HAD ALREADY DISCONNECTED FROM THE VISION SIDE CART (VSC) AND PATIENT SIDE CART (PSC) AND RESEATED THE ENDOSCOPE. THE TSE ASKED THE CUSTOMER IF THEY HAD ALREADY RESEATED THE STERILE ADAPTER, BUT THE CUSTOMER HAD NOT, AND THEY DID NOT WANT TO DO SO AS THE SURGERY WAS IN PROGRESS. NO MECHANICAL SOUND WAS PRESENT FROM THE ENDOSCOPE WHEN THE 30 DEGREE UP/DOWN BUTTON WAS PRESSED. THE CUSTOMER DECIDED TO CONTINUE THE PROCEDURE AS IS. ISI FOLLOWED UP WITH THE INITIAL REPORTER (SURGEON) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGEON INDICATED THAT THE PROBLEM AROSE AT THE TIME OF PERFORMING A RETRO-BLADDER ANASTOMOSIS ON A PROST

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 THE PATIENT UNDERWENT DA VINCI-ASSISTED THYMECTOMY FOR A MALIGNANT THYMOMA ON (B)(6) 2022 AS PART OF THE SP THORACIC CLINICAL STUDY. THE PATIENT EXPERIENCED DELAYED MILD PHRENIC NERVE INJURY WITH ELEVATED LEFT HEMIDIAPHRAGM ON (B)(6) 2022. NO MEDICAL ACTION OR INTERVENTION WAS REQUIRED FOR THE REPORTED EVENT, AND WAS ASSESSED AS CLAVIEN-DINDO GRADE I. THERE WERE NO INTRA-OPERATIVE COMPLICATIONS NOR ANY MALFUNCTIONS OF DV SYSTEMS, INSTRUMENTS OR ACCESSORIES OCCURRED DURING THE PROCEDURE. THE PATIENT WAS DESCRIBED AS HAVING A LARGE THYMOMA IN THE AORTOPULMONARY WINDOW. ACCORDING TO THE SURGEON, THE THYMOMA DID NOT INVADE THE PHRENIC NERVE, BUT THE NERVE WAS UNDER SOME TRACTION DURING DISSECTION. THE STUDY INVESTIGATOR ASSESSED THE EVENT AS RELATED TO THE DA-VINCI ASSISTED PROCEDURE BUT NOT RELATED TO THE DV SYSTEMS, INSTRUMENTS OR ACCESSORIES.

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 PARASTOMAL HERNIA REPAIR, THE SURGEON WAS USING A MONOPOLAR CURVED SCISSOR (MCS) INSTRUMENT AND POTENTIAL ARCING OCCURRED AGAINST A PROGRASP FORCEPS INSTRUMENT. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE SURGEON STATED HE WAS TAKING DOWN ADHESIONS WITH THE MCS AND THE PROGRASP FORCEPS INSTRUMENTS. THE SURGEON INDICATED THAT HE DID NOT WITNESS ARCING FROM THE MCS INSTRUMENT; HOWEVER, HE SAW SMOKE. THERE WAS CHARRED TISSUE ON THE BASE OF THE ABDOMEN ON VISCERAL TISSUE NEAR THE PROGRASP FORCEPS INSTRUMENT. UPON EXAMINATION, HE DID NOT NOTICE ANY HOLES IN THE TISSUE AND HENCE DID NOT WARRANT ANY REPAIR. THE SURGEON ASKED FOR THE PROGRASP FORCEPS INSTRUMENT TO BE SWAPPED, AND NO ISSUE WAS REPORTED AFTERWARDS. THE SURGEON CONFIRMED NO FRAGMENTS FELL INSIDE THE PATIENT FROM THE PROGRASP FORCEPS INSTRUMENT. ON POST-OPERATIVE DAY (POD) #6, THE PATIENT UNDERWENT A SECOND OPEN PROCEDURE FOR UNSPECIFIED SYMPTOMS. THE PATIENT WAS IDENTIFIED WITH A BOWEL INJURY ON THE LARGE INTESTINE, RIGHT BELOW THE CANNULA INSTALLATION (INFERIOR LEFT) WHERE THE PROGRASP FORCEPS INSTRU

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY THE USER EXPERIENCED AN INCOMPLETE SEAL USING THE SYNCHROSEAL INSTRUMENT (LOT #L10220711-0413) AND ENCOUNTERED AN ¿INSPECT JAWS FOR DAMAGE¿ ERROR MESSAGE. A SECOND SYNCHROSEAL INSTRUMENT (LOT #L10220711-0396) WAS INSTALLED BUT ALSO DISPLAYED THE SAME ERROR MESSAGE. ACCORDING TO THE INITIAL REPORTER, AT THE TIME THE EVENT OCCURRED, THE SURGEON WAS ATTEMPTING TO DISSECT TISSUE WHICH HAD EXCESS MOISTURE AND BLEEDING OCCURRED. AS A RESULT, THE PROCEDURE WAS CONVERTED TO OPEN SURGERY IN ORDER TO CONTROL THE BLEEDING. THE BLEEDING WAS DESCRIBED AS BEING MILD TO MODERATE AND THE ESTIMATED BLOOD LOSS WAS 50 CC. ACCORDING TO THE SURGEON, THE INSTRUMENT FUNCTIONED PROPERLY FOR ONE HOUR AT WHICH POINT THE CUSTOMER EXPERIENCED IMPROPER/INCOMPLETE SEALING AND TISSUE STICKING TO THE INSTRUMENT JAWS. THERE WAS MINIMAL TO NO TENSION ON THE LUNG VESSEL BEING SEALED. NO EVIDENCE OF VESSEL CALCIFICATION WAS NOTED. THE VESSEL WAS NOT GREATER THAN 5MM IN DIAMETER. TISSUE EFFECT WAS OBSERVED DURING THE SEALING CYCLE(S). THE INSTRUMENT JAWS DID NOT COME INTO CONTACT WITH A CLIP, SUTURE, STAPLE, OR OTHER METAL OBJECTS WHEN THE REPORTED IS

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY THE USER EXPERIENCED AN INCOMPLETE SEAL USING THE SYNCHROSEAL INSTRUMENT (LOT #L10220711-0413) AND ENCOUNTERED AN ¿INSPECT JAWS FOR DAMAGE¿ ERROR MESSAGE. A SECOND SYNCHROSEAL INSTRUMENT (LOT #L10220711-0396) WAS INSTALLED BUT ALSO DISPLAYED THE SAME ERROR MESSAGE. AS A RESULT, THE PROCEDURE WAS CONVERTED TO OPEN SURGERY IN ORDER TO CONTROL BLEEDING. THERE WAS NO PATIENT HARM REPORTED. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING REVIEW OF A LITERATURE ARTICLE INVOLVING DA VINCI ASSISTED ROBOTIC PROCEDURES TITLED, ¿ROBOTIC SINGLE-PORT SURGERY: PRELIMINARY EXPERIENCE IN GENERAL SURGERY", THE FOLLOWING EVENTS WERE REPORTED. A REVIEW OF THE DATABASE WAS PERFORMED ON THE PATIENTS WHO UNDERWENT SINGLE INCISION SURGERY WITH THE DA VINCI SP SURGICAL SYSTEM FROM JULY 2019 TO SEPTEMBER 2021 WAS PERFORMED ACCORDING TO THE ARTICLE. PROCEDURES PERFORMED INCLUDED 141 SINGLE PORT CHOLECYSTECTOMY (SP-C) AND 77 SINGLE PORT TRANSABDOMINAL PREPERITONEAL INGUINAL HERNIA REPAIR (SP-TAPP). MOST OF THE PATIENTS WERE DISCHARGED THE SAME DAY. THERE WERE TWO PATIENTS REQUIRED ADMISSION IN THE SP-TAPP COHORT AND WERE THE COMBINED CASES WITH THE UROLOGY TEAM (PARTIAL NEPHRECTOMY AND PROSTATECTOMY). IN THE SP-C GROUP, 2 PATIENTS WERE ADMITTED POSTOPERATIVELY DUE TO PERSISTENT NAUSEA AND VOMITING. ALL THE POST-OPERATIVE COMPLICATIONS WERE CLAVIEN-DINDO GRADE II OR LESS AND INCLUDED 3 SEROMAS (RESOLVED SPONTANEOUSLY), 2 PROLONGED POSTOPERATIVE ILEUS (MANAGED CONSERVATIVELY), 1 URINARY RETENTION (REQUIRED FOLEY CATHETER), AND 1 URINARY TRACT INFECTION (ANTIBIOTIC TREATMENT). THERE WERE NO MAJOR COMPLICATIONS, URGENT REOPERATIONS,

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI ASSISTED SURGICAL PROCEDURE, A SMALL RETAINING SCREW IN THE RUBBERIZED SECTION PROXIMAL TO THE SYNCHROSEAL INSTRUMENT JAW APPEARED TO BECOME DETACHED AND WAS LOST WITHIN THE PATIENT. THE CUSTOMER HAS USED X-RAY ON THE PATIENT BUT WAS UNABLE TO IDENTIFY A FOREIGN OBJECT. THE CUSTOMER HAVE ASKED INTUITIVE SURGICAL (IS) TO CONFIRM THE MATERIAL TYPE OF THE SCREW TO ADD IN ITS LOCATION AND POTENTIAL RETRIEVAL. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT INJURY. ON 17-AUG-2022, ADDITIONAL INFORMATION WAS PROVIDED BY THE SPECIALTY SALES MANAGER: DURING THE SURGERY, THEY NOTICED A CIRCULAR WASHER LYING INSIDE THE PATIENT, WHICH WAS REMOVED. UPON INSPECTION OF THE SYNCHROSEAL INSTRUMENT THEY NOTICED THAT THERE IS A SMALL PIN SIZED HOLE ON THE INSTRUMENT WHICH COULD HAVE HAD A PIN INSIDE. THEY WERE NOT SURE AT THIS POINT AS TO WHETHER IT HAD A PIN INSIDE EARLIER. THEY NOTICED THAT THE OTHER SIDE HAD A PIN AND WASHER. THEY THEN TOOK OUT ANOTHER INSTRUMENT AND INSPECTED IT TO UNDERSTAND THE STRUCTURE. ONCE THEY UNDERSTOOD THAT THERE IS A MISSING PIN, THEY NEEDED TO KNOW HOW BIG IT WAS AND WHAT SHAPE THEY SHOULD SEARCH FOR WITHIN THE PATIENT. IT

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 MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, A CUSTOMER REPORTED THAT SYNCHROSEAL INSTRUMENT WAS BROKEN. A FRAGMENT FELL INTO THE PATIENT¿S ANATOMY AND WAS RETRIEVED IN THE SAME PROCEDURE. THE PROCEDURE CONTINUED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE FRAGMENT WAS REMOVED WITH A FORCEPS INSTRUMENT. IT WAS CONFIRMED VIA ENDOSCOPE THAT ALL FRAGMENTS WERE RETRIEVED. NO ADDITIONAL SURGICAL PROCEDURE WAS PERFORMED. AN X-RAY WAS PERFORMED AFTER THE PROCEDURE AS USUAL. THE SURGEON BELIEVED THAT THE SYNCHROSEAL INSTRUMENT COLLIDING WITH ANOTHER INSTRUMENT WAS THE CAUSE OF THE FRAGMENT FALLING INTO PATIENT. THE SYNCHROSEAL WAS INSPECTED PRIOR TO USE WITH NO ISSUE. A VESSEL SEALING TASK WAS BEING PERFORMED WHEN THE FRAGMENT FELL INSIDE THE PATIENT. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE. THE CUSTOMER DID NOT REMOVE THE INSTRUMENT PRIOR TO THE INSTRUMENT BREAKAGE. UPON FINAL REMOVAL OF THE INSTRUMENT, THE WRIST OF THE INSTRUMENT WAS STRAIGHTENED. THE SURGICAL S

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE RUBBER WASHER FROM THE 8 MM SYNCHROSEAL FELL OFF INSIDE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY SURGICAL PROCEDURE, A SMALL METAL RING FROM THE SYNCHROSEAL INSTRUMENT FELL INTO THE PATIENT. THE FRAGMENT WAS REPORTEDLY RETRIEVED DURING A DIFFERENT PROCEDURE. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UNILATERAL INGUINAL HERNIA PROCEDURE, THE SURGEON NOTICED CAUTERIZED TISSUE WHERE ENERGY WAS NOT INTENTIONALLY APPLIED. IT WAS NOTED THAT NOTHING WAS VISIBLY WRONG WITH THE INSTRUMENT. IT IS UNKNOWN WHAT SPECIFIC TISSUE WAS UNINTENTIONALLY CAUTERIZED AND IF ANY MEDICAL INTERVENTION WAS RENDERED DUE TO THE COMPLICATION. ADDITIONALLY, THE SEVERITY OF THE BURN INJURY IS UNKNOWN. FURTHERMORE, IT IS UNKNOWN WHAT SPECIFIC INSTRUMENT WAS INVOLVED WITH THE COMPLICATION. THE SURGICAL PROCEDURE WAS REPORTEDLY COMPLETED WITH NO PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY PROCEDURE, THE SURGEON WAS UNABLE TO FOCUS THE ENDOSCOPE. AT THE TIME THE ISSUE OCCURRED, THE PATIENT WAS ANESTHETIZED AND PORTS WERE PLACED. THE CUSTOMER HAD POWER CYCLED THE SYSTEM, TRIED TO FOCUS BOTH FROM THE SURGEON SIDE CONSOLE (SSC) AND CAMERA HEAD BUTTONS, AND PERFORMED 3D CALIBRATION BUT THE FOCUSING ISSUE WAS STILL NOT IMPROVED. THE CUSTOMER CONTACTED AN ISI TECHNICAL SUPPORT ENGINEER (TSE) FOR TROUBLESHOOTING ASSISTANCE AND WAS ADVISED TO TIGHTEN THE CAMERA CABLE AND TRY TO REFOCUS AGAIN. THE CUSTOMER REPORTED THAT THE CAMERA CABLE WAS NOT LOOSE AND MECHANICAL SOUND WAS HEARD WHEN HE PRESSED ON THE FOCUS BUTTON OF THE CAMERA HEAD. THE IMAGE STILL COULD NOT BE FOCUSED. THE CUSTOMER WAS ADVISED THAT THE ISSUE MAY BE FROM THE CAMERA HEAD. THE PATIENT REMAINED ANESTHETIZED FOR APPROXIMATELY THREE HOURS BEFORE THE BACKUP CAMERA HEAD ARRIVED. AFTER THE CAMERA HEAD WAS REPLACED BY AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE), THE PROCEDURE WAS RESUMED AND COMPLETED WITHOUT FURTHER ISSUES. THERE WAS NO INTRAOPERATIVE PATIENT HEALTH DAMAGE OBSERVED; HOWEVER, THE PATIENT ORIGINALLY HAD INTERSTI

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TONGUE BASE RESECTION-BENIGN SURGICAL PROCEDURE, THE RIGHT MASTER TOOL MANIPULATORS (MTM) WERE NOT MOVING. THE OPERATING ROOM STAFF, CALLED TECHNICAL SUPPORT TO REPORT THAT THE RIGHT-HAND CONTROL ON THE SP WAS FROZEN. PRIOR TO CALLING IN, THE SITE CONVERTED TO OPEN SURGICAL PROCEDURE. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) WAS UNABLE TO VIEW LIVE LOGS FROM THE SYSTEM. THE ISI TSE ASKED IF THE CALLER COULD VERIFY INSTRUMENT ASSIGNMENTS, BUT THE CALLER STATED THAT THE SYSTEM HAD BEEN TAKEN AWAY. THE CALLER STATED THAT THEY PERFORMED A REBOOT ON THE SYSTEM WITH NO CHANGE. THE CALLER WAS REQUESTING THE FIELD SERVICE ENGINEER (FSE) TO FOLLOW UP. ISI MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIMPLE PROSTATECTOMY SURGICAL PROCEDURE THAT THE SYNCHROSEAL INSTRUMENT ARCED WHILE USING THE SEAL FUNCTION. THE PROCEDURE WAS COMPLETED WITH NO REPORTS OF PATIENT INJURY. INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE CUSTOMER TO CONFIRM THAT THE INSTRUMENT WAS INSPECTED BEFORE THE PROCEDURE WITH NO ISSUES NOTICED. THE SURGEON WAS SEALING PROSTATE TISSUE WITH NO SPECIFIC VESSEL. THERE WAS A WARNING MESSAGE REGARDING INCOMPLETE SEALING FOLLOWED BY VISIBLE ARCHING. IT WAS WORKING FOR ABOUT 60 MINUTES PRIOR TO THIS ISSUE. THERE WAS MILD RETENTION / RETRACTION DURING SEALING. THE VESSELS WERE SMALL, ABOUT LESS THAN 5MM. SOME CHAR HAD BUILT UP ON THE INSTRUMENT. THERE WAS SOME UNEXPECTED BLEEDING, APPROXIMATELY 50CC ESTIMATED BLOOD LOSS (EBL), AFTER SWITCHING TO THE MARYLAND BIPOLAR FORCEPS INSTRUMENT. THERE WAS NO TRANSFUSION PERFORMED. THE BLEEDING WAS RESOLVED WITH BIPOLAR AND MONOPOLAR CAUTERY. THE INITIAL REPORTER ALSO STATED THE FOLLOWING; ¿ MAY HAVE FOUND THE CULPRIT FOR THE BROKEN SYNCHROSEALS HERE AT CENTRAL MAINE MEDICAL CENTER (CMMC). FOOTE DOES A LOT OF INSTRUMENT TO INSTRUMENT INTRA-OPERATIVE CLEANING WHICH I IMAGINE IS W

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 DAVINCI 30MM ENDOWRIST STAPLER WAS PLACED ON THE PULMONARY ARTERY AND FIRED. WHEN THE STAPLER WAS PROMPTED TO UNCLAMP, AN ERROR SHOWED THAT THE ACTION THAT UNCLAMPS THE STAPLER WAS UNABLE TO FUNCTION. THE ROBOT WAS MANUALLY PUT INTO FAULT MODE TO ALLOW THE BEDSIDE ASSIST TO USE THE WRENCH, WHICH IS THE FALLBACK/SAFETY MEASURE WHEN THIS HAPPENS. WHEN GOING IN THE PROPER ORDER, THE WRENCH WAS UNABLE TO FULLY SPIN, WHICH PREVENTED THE STAPLER FROM UNCLAMPING THE PA. THE DAVINCI REPS WERE ON THE PHONE WITH THEIR TECHNICAL TEAM WORKING THE PROBLEM, AND COMMUNICATING WITH THE SURGEON AND BEDSIDE ASSIST ON HOW TO GET THE STAPLER TO UNCLAMP. 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 REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITHOUT LYMPHADENECTOMY PROCEDURE, A SPARK OCCURRED BETWEEN THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT AND SYNCHROSEAL INSTRUMENT. THE SYNCHROSEAL INSTRUMENT STOPPED WORKING COMPLETELY. THE CUSTOMER REMOVED THE INSTRUMENTS AND OBSERVED CRACKS IN THE BLADE PORTION OF THE SYNCHROSEAL INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYNCHROSEAL INSTRUMENT REPORTEDLY ARCED DURING THE CASE. THERE WERE CRACKS AND CHAR OBSERVED ON THE INSTRUMENT'S BLADES. THE INSTRUMENTS WERE REPORTEDLY CLOSE TO EACH OTHER DURING THE CASE. IT WAS HARD TO TELL WHERE THE ELECTRICAL ENERGY ARCED TO. THE CUSTOMER REPORTED UNEXPECTED MINOR BLEEDING DURING THE EVENT BUT WAS NOT REALLY SURE WHAT WAS THE CAUSE OF THE BLEEDING. THE CUSTOMER SUSPECTED THAT BLEEDING WAS CAUSED DUE TO THE TIME IT TOOK TO USE THE MARYLAND BIPOLAR FORCEPS INSTRUMENT INSTEAD OF THE SYNCHROSEAL INSTRUMENT AS THE SYNCHROSEAL INSTRUMENT SEALS FASTER. THE PATIENT LOST MINIMAL AMOUNT OF BLOOD, AROUND 50CC¿S. NO BLOOD TRANSFUSION WA

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH OUT LYMPHADENECTOMY PROCEDURE, A SPARK OCCURRED BETWEEN THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT AND SYNCHROSEAL INSTRUMENT. THE SYNCHROSEAL INSTRUMENT STOPPED WORKING COMPLETELY. THE CUSTOMER REMOVED THE INSTRUMENTS AND OBSERVED CRACKS IN THE BLADE PORTION OF THE SYNCHROSEAL INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYNCHROSEAL INSTRUMENT ARCED DURING THE CASE. THERE WERE CRACKS AND CHAR OBSERVED ON THE INSTRUMENT'S BLADES. THE INSTRUMENTS WERE REPORTEDLY CLOSE TO EACH OTHER DURING THE CASE. IT WAS HARD TO TELL WHERE THE ELECTRICAL ENERGY ARCED TO. THE CUSTOMER REPORTED UNEXPECTED MINOR BLEEDING DURING THE EVENT BUT WAS NOT REALLY SURE WHAT WAS THE CAUSE OF THE BLEEDING. THE CUSTOMER SUSPECTED THAT BLEEDING WAS CAUSED DUE TO THE TIME IT TOOK TO USE THE MARYLAND BIPOLAR FORCEPS INSTRUMENT INSTEAD OF THE SYNCHROSEAL INSTRUMENT AS THE SYNCHROSEAL INSTRUMENT SEALS FASTER. THE PATIENT LOST MINIMAL AMOUNT OF BLOOD, AROUND 50CC¿S. NO BLOOD TRANSFUSION WAS NEEDED.