ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: NEXT, AS WE BEGAN NAVIGATING, WE POSITIONED THE ROBOT NEAR THE PATIENT, AND GREEN BOXES APPEARED FOR OUR DESIRED LEVELS SIGNALING THAT TRAJECTORY WAS WITHIN RANGE. STABILIZERS WERE DEPLOYED, A SINGLE LEVEL WAS SELECTED, BUT AS THE SURGEON PRESSED THE FOOT PEDAL, A "TRAJECTORY WAS NOT WITHIN RANGE" WARNING APPEARED. WE ATTEMPTED TO REPOSITION THE ROBOT MULTIPLE TIMES, AND EACH TIME THE WARNING APPEARED. THIS PROHIBITED US FROM PROCEEDING.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MISSED S2AI SCREWS BOTH MEDIAL.

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 RADICAL TONSILLECTOMY SURGICAL PROCEDURE, THE INSTRUMENTS MOVED BACKWARDS WHEN PLACED ON THE ROBOT. PRIOR TO CALLING AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOR ASSISTANCE, THE CUSTOMER HAD CONVERTED THE PROCEDURE TO TRADITIONAL LAPAROSCOPIC SURGERY. THE SITE WAS USING A 0-DEGREE ENDOSCOPE WHEN THE ISSUE OCCURRED AND THEY WERE UNSURE IF THEY HAD CAMERA UP OR DOWN SELECTED. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE REPORTER CONFIRMED THE PATIENT TOLERATED THE CONVERSION WELL AND THERE WAS NO INJURY TO THE PATIENT.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MOTION CONTROL. COMMUNICATION FAILED ERROR. THIS KEEPS POPPING UP.

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 MYOMECTOMY SURGICAL PROCEDURE, A PORTION OF THE HARMONIC ACE INSTRUMENT BROKE OFF DURING USE. THE BROKEN PIECE WAS RETRIEVED DURING THE SAME PROCEDURE WHICH WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND THERE WAS NO NOTED DAMAGE. THE INSTRUMENT BROKE RIGHT AT THE JAW HINGE. THE INSTRUMENT WAS IN USE FOR ROUGHLY 10 MINUTES. THE SURGEON DID NOT NOTICE AN ISSUE WITH THE FUNCTIONALITY OF THE INSTRUMENT. THE INSTRUMENT DID NOT COLLIDE WITH ANOTHER INSTRUMENT. THE FRAGMENT FELL INSIDE THE ABDOMEN DURING THE PROCEDURE. THE INSTRUMENT WAS NOT REMOVED PRIOR TO BREAKAGE. THE BREAK WAS NOTICED IMMEDIATELY AS THE SURGEON SAW THE JAW FALL DOWN. THE SURGICAL STAFF GRABBED THE JAW FRAGMENT WITH GRASPERS AND REMOVED FRAGMENT THROUGH AN ASSIST PORT. AN ADDITIONAL SURGICAL PROCEDURE WAS NOT REQUIRED TO REMOVE FRAGMENT. THERE WERE NO POST-OPERATIVE TESTS. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO THE EVENT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT THE PATIENT UNDERWENT DA VINCI-ASSISTED SP EXTRAPERITONEAL PROSTATECTOMY ON (B)(6) 2023 AS PART OF THE CGMH URO SP CLINICAL STUDY. THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) ON (B)(6) 2023 WITH ABDOMINAL DISCOMFORT AND SWELLING WITH NO URINE OUTPUT INTO HIS URINARY BAG. THE PHYSICIAN AT THE EMERGENCY ROOM OBSERVED THAT THE PATIENT HAD ABDOMINAL SWELLING, DISCOMFORT IN ABDOMINAL AND GENITAL AREA WITH THE PAIN ASSESSMENT 1 OUT OF 10, AND MILD HEMATURIA. CYSTOGRAPHY AND CT OF UROGRAPHY (CTU) INITIALLY CONFIRMED ASCITES. SUPRAPUBIC CYSTOSTOMY WAS PERFORMED AS TREATMENT. THE STUDY INVESTIGATOR ASSESSED THIS EVENT AS NOT RELATED TO DA-VINCI DEVICES, AND POSSIBLY RELATED TO THE PROCEDURE. INTUITIVE SURGICAL INC (ISI) OBTAINED ADDITIONAL INFORMATION AS THE FOLLOWING: THERE WERE NO INTRA-OPERATIVE COMPLICATIONS NOR ANY OTHER POST-OPERATIVE COMPLICATIONS. THERE WERE NO ALLEGATIONS OF ANY MALFUNCTIONS OF ANY DA VINCI SYSTEMS, INSTRUMENTS OR ACCESSORIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED ADVERSE EVENT. THE PATIENT WAS LATER FOUND WITH PERIVESICAL FLUID INSTEAD OF ASCITES VIA CT SCAN. A PIGTAIL DRAIN WAS PLACED. AFTER ADMISSION, CYSTOGRAPHY SHOWED MINIMAL LEA

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 CYSTECTOMY SURGICAL PROCEDURE, ERRORS OCCURRED ON THE HARMONIC ACE INSTRUMENT, AND THE INSTRUMENT BLADE BROKE OFF AND FELL INSIDE THE PATIENT AFTER TEN MINUTES INTO THE OPERATION. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE CUSTOMER REPLACED THE HARMONIC ACE INSTRUMENT WITH A BACK-UP INSTRUMENT OF THE SAME KIND AND COMPLETED THE PROCEDURE WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) PERFORMED FOLLOW-UP AND OBTAINED THE FOLLOWING ADDITIONAL/UPDATED INFORMATION REGARDING THE REPORTED EVENT: THE HARMONIC ACE INSTRUMENT WAS REPORTEDLY INSPECTED PRIOR TO USE, AND NO ISSUE WAS NOTED. THE HARMONIC ACE INSTRUMENT PERFORMED AS INTENDED UP UNTIL IT BROKE WHILE THE SURGEON WAS DISSECTING UNSPECIFIED TISSUE. THE HARMONIC ACE INSTRUMENT DID NOT MAKE CONTACT WITH ANY OTHER INSTRUMENT OR HARD MATERIAL DURING THE SURGICAL PROCEDURE. AFTER THE HARMONIC ACE BLADE BROKE OFF AND FELL INSIDE THE PATIENT, THE FRAGMENT WAS VISUALLY LOCATED AND RETRIEVED DURING THE SAME PROCEDURE. THE CUSTOMER CONFIRMED ALL FRAGMENTS WERE RETRIEVED BY MATCHING THE BROKEN FRAGMENT TO THE INSTRUMENT. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED,

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 SURGICAL STAFF OBSERVED INVERTED IMAGING WHILE USING A 30 DEGREE ENDOSCOPE PLUS. THE ISSUE OCCURRED ONCE DURING THE PROCEDURE. THE SURGEON INDICATED THAT THE ENDOSCOPE MOVED WITH UNINTUITIVE MOVEMENTS AND WITH REVERSED CONTROL DESPITE CORRECT ALIGNMENT AND INSTALLATION. THE ENDOSCOPE WAS PULLED OUT OF THE PATIENT SIDE CART (PSC) AND RESEATED WHICH SUCCESSFULLY CLEARED THE ISSUE. PER THE SURGEON, THERE WAS A "PROLONGATION OF THE PROCEDURE" BY 15 MINUTES AND "MINIMALLY INCREASED BLOOD LOSS, BUT NO LASTING HARM." THE ESTIMATED BLOOD LOSS ASSOCIATED WITH THE EVENT IS UNKNOWN. IN ADDITION, THE SOURCE OF THE BLEEDING AND WHAT MEDICAL INTERVENTION, IF ANY, WAS RENDERED DUE TO THE COMPLICATION ARE UNKNOWN AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE LOGS AFTER PROCEDURE COMPLETION AND FOUND AN ERROR POINTING TO A SCOPE ENGAGEMENT ISSUE.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CASE INFO: DR. (B)(6). L4-S2AI CORTICAL TRAJECTORY OPEN FUSION. 1.1R4 EGPS SOFTWARE. SETUP; DR. (B)(6)' PA, DAMIEN, IMPLANTED THE DRB VIA THE QUATTRO SPIKE INTO THE RIGHT PSIS. (B)(6) THEN IMPLANTED THE SM IN THE LEFT PSIS. EGPS POSITIONED ON THE SAME SIDE AS DAMIEN AND THE C-ARM OPPOSITE THE OR DOOR. CAMERA WAS POSITIONED AT THE FOOT OF THE BED. EXTRA MONITOR FROM SSI USED FOR DR. (B)(6) DURING REGISTRATION THEN FOR (B)(6) FOR SCREW PLACEMENT. (B)(6) THEN VERIFIED SURVEILLANCE. REGISTRATION; THE REGISTRATION TOOK 5 MINUTES. AFTER A SUCCESSFUL MERGE, (B)(6) COMPLETED A LANDMARK CHECK. IMPLANTATION; (B)(6) IMPLANTED EACH SCREW USING; FIRST, THE 4.5 HS DRILL/3.5 TIPPED DRILL, FOLLOWED BY THE SCREW- EVENTUALLY SKIPPING THE 4.5MM HS DRILL. SCREW PLACEMENT FROM L4-S1 TOOK 10 MINUTES. FOR S2AI IT TOOK 30 MINUTES. DR. (B)(6) USED THE TIPPED 5.0/6.0MM CREO MCS DRILL WITH THE 60MM HARD STOP THEN USED A TAP TO GET ACROSS THE JOINT. S2AIL IMPLANTATION WAS SUCCESSFUL BUT S2AIR BREACHED ANTERIORLY. ***WE BELIEVE THAT THE STARTING POSITION FOR S2AIR BEING MORE INFERIOR (PLANNED BELOW 3X SI-BONE SCREWS) THE SI JOINT WAS FURTHER THAN THE HARD STOP PREVENTING THE TIPPED DRILL FROM SUCCESSFULLY CROS

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE HOSPITAL JUST PURCHASED TWO NEW CT MACHINES AND HAS A SLIGHT TURNOVER OF CT TECH STAFF. THE FIRST SCAN LOADED ONTO THE ROBOT WITH A YELLOW WARNING. I CLICKED THROUGH IT NOT THINKING TWICE BECAUSE THE SCAN POPULATED ON THE IMAGE LOCAL PAGE/ALLOWED ME TO PROCEED TO PLAN. WHEN REGISTERING THE X-RAYS TO THE SCAN (PREP CUT WORKFLOW), THE ERROR "FLUORO-CT IMAGE REGISTRATION FAILED" IN YELLOW POPULATED THE SCREEN. I TRIED RESETTING THE SOFTWARE, RESTARTING THE ROBOT, EVEN CHANGING THE SCAN TO ANOTHER ONE TITLED "THINS" (INSTEAD OF THE PRESET "GLOBUS 1MM BY 1MM") AND RE-REGISTERING. NOTHING WORKED, AND THE SURGEON ENDED UP BAILING ON THE ROBOT.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: POWER NOT GETTING TO ROBOT. APPEARS TO BE A FUSE 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: 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 SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT SUDDENLY DID NOT WORK. A FRAGMENT FROM AN UNSPECIFIED LOCATION OF THE INSTRUMENT ALLEGEDLY FELL INSIDE THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. 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: THERE WAS NO FRAGMENT LEFT.

Monarch Platform — 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 MONARCH BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A PNEUMOTHORAX, HEMOPTYSIS, AND DYSPNEA. A PIGTAIL (CHEST TUBE) WAS PLACED AND THE PATIENT WAS HOSPITALIZED AND LATER RELEASED. NO MALFUNCTION, FAULT OR ERRORS WERE 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 AFTER PORT PLACEMENT BUT PRIOR TO DOCKING FOR A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE SITE WAS HAVING ISSUES WITH ENDOSCOPE ENGAGEMENT. PRIOR TO CALLING IN, INTUITIVE REP HAD THE STAFF RE-DRAPE TWICE AND TRY TWO DIFFERENT ENDOSCOPES. TECHNICAL SUPPORT ENGINEER (TSE) WALKED THE REP THROUGH A HARD POWER CYCLE OF THE PATIENT SIDE CART (PSC) AND REINSTALLATION OF CAMERA ARM STERILE ADAPTER. TSE RECOMMENDED CUSTOMER ATTEMPT A THIRD ENDOSCOPE, BUT SYSTEM WOULD NOT ACCEPT THE THIRD ENDOSCOPE. THE PROCEDURE WAS ABORTED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: CONFIRMED THAT PORTS WERE PLACED. THEY WERE PREPARING TO DOCK AND ENTER DIRECTLY INTO THE BLADDER. THEY CUT FACIA AND ENTERED DIRECTLY INTO THE BLADDER. THE REST OF THE INSTRUMENTS WERE DOCKED, BUT THE NONE OF THE ENDOSCOPES WOULD ENGAGE. CONFIRMED THERE WERE NO POST-OP COMPLICATIONS.

Monarch Platform — 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 MONARCH BRONCHOSCOPY PROCEDURE, THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE PATIENT WAS ADMITTED FOR IN-PATIENT HOSPITALIZATION. SUPPLEMENTAL OXYGEN WAS ADMINISTERED. THE PATIENT WAS RELEASED TWO (2) DAYS LATER. THE HOSPITAL CLINICAL RESEARCH COORDINATOR REPORTED THAT THE PATIENT RECOVERED WITHOUT SEQUELAE. AFTER THE PROCEDURE, THE PATIENT REPORTED HAEMOPTYSIS. THE PATIENT¿S HAEMOPTYSIS WAS REPORTED AS POSSIBLY RELATED TO USE OF THE MONARCH SYSTEM. THE PATIENT¿S SYMPTOM WAS REPORTED AS HAVING A CAUSAL RELATIONSHIP TO THE BRONCHOSCOPY PROCEDURE. THE HAEMOPTYSIS WAS REPORTED AS RESOLVED WITHOUT SEQUALAE. IN ADDITION, THE PATIENT REPORTED SHORTNESS OF BREATH. THE PATIENT¿S SHORTNESS OF BREATH WAS REPORTED AS NOT RELATED TO USE OF THE MONARCH SYSTEM. HOWEVER, THE PATIENT¿S SYMPTOM WAS REPORTED AS POSSIBLY RELATED TO THE BRONCHOSCOPY PROCEDURE. ON FEBRUARY 17, 2023, THE PATIENT¿S SHORTNESS OF BREATH WAS REPORTED AS RESOLVED WITHOUT SEQUALAE. THERE WAS NO REPORTED MALFUNCTION OF THE MONARCH BRONCHOSCOPY SYSTEM.

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 BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE SYNCHROSEAL INSTRUMENT HAD A PIECE OF METAL THAT BROKE OFF AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO ADDITIONAL REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAD 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 WITH LYMPHADENECTOMY PROSTATECTOMY SURGICAL PROCEDURE THAT THE BIPOLAR ENERGY WAS NOT WORKING. THE STAFF TRIED TWO DIFFERENT BIPOLAR INSTRUMENT CORDS BEFORE CALLING. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ASKED THE STAFF TO CYCLE THE ERBE GENERATOR POWER. THE SURGEON CONVERTED TO AN OPEN PROCEDURE. ISI MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DR. (B)(6) FIRST DBS PROCEDURE WITH EGPS AND E3D HAD TO BE ABORTED DUE TO MISSED TRAJECTORIES, THAT IS BELIEVED TO BE DUE TO MERGE ISSUES WITH THE PRE-OP T1 MRI. THE PATIENT WAS ATTACHED TO THE PSS WITH A LEKSELL HEAD-FRAME, AND A THE LEKSELL FRA WAS USED FOR REFERENCE. A NON-STERILE INTRAOP REGISTRATION WAS PERFORMED WITH E3D AND LANDMARKS WERE CHECKED SHOWING AN ACCURATE REGISTRATION. THE PATIENT WAS PREPPED AND DRAPED AND INCISION AND BURR-HOLES WERE MADE. THE ROBOT WAS BROUGHT BACK INTO POSITION AND A THIRD LANDMARK VERIFICATION WAS PERFORMED, A TEST TRAJECTORY WAS SET UP AND THE ROBOT SHOWED ACCURATE PLACEMENT. THE ROBOT WAS SENT TO THE LEFT GPI TRAJECTORY AND THE LEAD WAS PLACED. A STERILE EVALUATION SPIN WAS COMPLETED WITH E3D AND SHOWED AN ANTERIOR TO POSTERIOR LEAD PLACEMENT, BISECTING THE INTENDED TRAJECTORY. LANDMARK CHECKS WERE PERFORMED AGAIN SHOWING A SLIGHTLY DEEP INSTRUMENT IN THE CT SCAN. IT WAS ALSO NOTICED THAT THE ALPHA OMEGA XY BASE STAGE WAS LOOSE AND ROCKING BACK AND FORTH. IT WAS DECIDED TO RE-REGISTER THE PATIENT WHICH WAS SUCCESSFULLY PERFORMED. LANDMARK CHECKS SHOWED AN ACCURATE REGISTRATION. THE ROBOT WAS SENT BACK TO THE TRAJECTORY AND THE LEAD WAS REPL

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 PATIENT'S VAS DEFERENS WAS INJURED. THE ISSUE OCCURRED DURING THE END OF THE PROCEDURE WHILE PERFORMING THE ANASTOMOSIS. THE SURGEON ROTATED THE 0 DEGREE ENDOSCOPE PLUS SEVERAL TIMES WHILE LOOKING FOR A SUTURE NEEDLE, AFTER WHICH THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT ALLEGEDLY WENT OUT OF CONTROL TOWARDS THE VAS DEFERENS AND UNINTENTIONALLY TRANSECTED IT. IT IS UNCLEAR IF THE VAS DEFERENS WAS REPAIRED. THE ARTERY AND VEIN NEXT TO THE VAS DEFERENS DID NOT CONTACT THE MCS AND WERE THEREFORE NOT INJURED. WHILE ROTATING THE ENDOSCOPE, AN UNSPECIFIED ¿BAD SOUND¿ WAS HEARD. NO ERROR MESSAGE DISPLAYED. ALL THE INSTRUMENTS WERE THEN REMOVED FROM THEIR RESPECTIVE UNIVERSAL SURGICAL MANIPULATORS (USM)S AND REINSTALLED. THE SURGICAL STAFF THEN CONTINUED THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING AN 8MM 30 DEGREE ENDOSCOPE. THE SURGEON BELIEVES THE CAUSE OF THE INTRA-OPERATIVE COMPLICATION WAS DUE TO A PROBLEM WITH THE 0 DEGREE ENDOSCOPE PLUS FOLLOWED BY FEELING UNEXPECTED MOVEMENTS WITH THE USMS. THE PATIENT DID NOT EXPERIENCE POST-OPERATIVE COMPLICATIONS AND WAS REPORTED TO BE ¿OKAY¿. THE INTU

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 TRIAL THAT 2 DAYS AFTER A DA VINCI-ASSISTED LOW ANTERIOR RESECTION (LAR) WITH TOTAL MESORECTAL EXCISION (TME), THE PATIENT EXPERIENCED LIGHTHEADEDNESS WITH NAUSEA AND VOMITING. A NASOGASTRIC WAS PLACED, AND ILEUS WAS SHOWN ON X-RAY. BLOOD WORK SHOWED NO CONCERNS OF BLEEDING OR INFECTION. IV FLUIDS WERE GIVEN TO THE PATIENT. NO MALFUNCTIONS OF SP SYSTEM OR INSTRUMENTS WERE REPORTED, AND THERE WERE NO INTRA-OPERATIVE COMPLICATIONS DURING THE SURGERY. ON POST-OPERATIVE DAY (POD) #5, THE PATIENT WAS REPORTED RESOLVED FROM ILEUS. THE PATIENT WAS DISCHARGED ON POD #6 WITH NORMAL BOWEL FUNCTION AND WAS TOLERATING A GENERAL DIET.

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.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: SYSTEM WILL NOT BOOT ALL THE WAY UP. RED LIGHT ON SCREEN. SUBTLE BEEPING NOISE COMING FROM THE CABINET.

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.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE DOCTOR'S PATIENT HAD A GRADE 4 SPONDY AT L5-S1 WITH A PLAN TO PUT PEDICLE SCREWS AT L5-S1 AND THEN A SI-BONE DOWEL POSTERIORLY THROUGH S1 GOING ANTERIORLY TO L5 BODY. HE PLANNED A S2A1 SCREW FOR THE SI BONE, WE PLANNED A L4 MCS SCREW OVER HIS S2AI PLAN BECAUSE HE WANTED TO SEE A PROPER CAD OF MCS DRILL. HIS PLAN WAS TO USE THE ROBOT FOR TRAJECTORY, MCS DRILL, AND PLACING A K-WIRE. WENT TO MERGE, PLACED CENTROIDS, IMMEDIATELY NOTICED A SHIFT. HAD MORE SHOTS TAKEN LATERALLY AND AP, STILL HAD LOW MERGE SCORES AND SHIFT. SURGEON AT THIS POINT DECIDED TO BAIL ON ROBOT, AFTER TAKING ROBOT OUT I PLANNED SCREWS WHERE THEY SHOULD BE GOING AND GOT A SUCCESSFUL MERGE.

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.

Senhance — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE EVENT WAS MADE AWARE ON 12/19/2023. THE EVENT OCCURRED AT (B)(6). AS INITIALLY REPORTED BY THE COMPLAINANT, ON THURSDAY, (B)(6) 2022, DOCTOR VISSCHERS, PERFORMED A FUNDOPLICATION ON A PEDIATRIC FEMALE PATIENT. THE PATIENT WAS DOING WELL AND WAS DISCHARGED ON FRIDAY, (B)(6) 2022. NO CHANGE TO THE SURGICAL APPROACH OR ADDITIONAL PORTS WERE NEEDED. ON SUNDAY, (B)(6) 2022 THE PATIENT WAS READMITTED TO THE HOSPITAL WITH PERSISTENT ABDOMINAL PAIN, WHICH REQUIRED A SECOND OPERATION. THE SURGEONS DIAGNOSED A PERFORATION OF THE WRAP, SURROUNDING THE ESOPHAGUS, DEEMED TO BE RELATED TO A THERMAL LESION AFFECTING THE VASA PREVIA, NAMELY THE BRANCHES OF SPLENIC ARTERY AND VEIN THAT RUN TO THE GREATER CURVATURE OF THE STOMACH. THE PATIENT WAS THEREFORE TREATED WITH ANTIBIOTICS AND 2 DRAINS WERE APPLIED ON THE STOMACH AND SMALL PELVIS. SUBSEQUENT ECHOGRAPHY AND GASTROSCOPY REVEALED NO INDICATION OF A PERSISTENT PERFORATION. ON FRIDAY,(B)(6) 2022 THE PATIENT WAS DOING WELL AND WAS REPORTED TO BE LIVELY AND ACTIVE. THE SURGEON AND THE COMPLAINANT REPORTED THAT THE ISSUE WAS NOT RELATED TO THE USE OF THE SENHANCE SYSTEM USED IN THE FIRST PROCEDURE PERFORMED BUT RATHER INDUCED BY ELECTROCAUTERY.

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.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WHILE A FIELD SERVICE ENGINEER WAS ON SITE FOR ANOTHER COMPLAINT, THE SURGEON MENTIONED TO ENGINEER THAT HE HAD MISPLACED SCREWS DURING HIS THIRD CASE OF THE DAY.

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.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative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

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

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WHEN ROBOT WAS PLUGGED IN, IT WOULD POWER UP BUT THEN START BEEPING AND BATTERY STATUS BAR WAS STUCK ON 2 BARS AND NOT CYCLING LIKE NORMAL. TURNED OFF ROBOT AND POWERED UP AGAIN AND BEEPING STOPPED BUT STILL WAS NOT WORKING PROPERLY. SHUT DOWN ONE LAST TIME AND POWERED BACK UP AND STARTED BEEPING AGAIN.

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: 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.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A PROCEDURE USING THE EXCELSIUS CRANIAL APPLICATION, SEVERAL BIOPSY SAMPLES WERE TAKEN AND CAUSED BLEEDING THAT WAS FIXED INTRAOPERATIVELY. THIS EVENT OCCURRED IN POLAND.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CALLED SERVICE WHEN THE ROBOT BATTERY WOULD NOT CHARGE. WAS TOLD THE ROBOT WOULD STILL GET POWER WHILE PLUGGED IN, IT WAS WORKING FOR AROUND AN HOUR THEN POWERED DOWN BEFORE REGISTRATION AND WOULD NOT START. SURGERY ABORTED.

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.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE AURIS PROGRAM DEVELOPMENT MANAGER (PDM) REPORTED THAT FOLLOWING A MONARCH BRONCHOSCOPY PROCEDURE (THE NEEDLE USED WAS A SUPER D 19-GAUGE NEEDLE), THE PATIENT WAS COMPLAINING OF WITH SHORTNESS OF BREATH. A POST-OP X-RAY CONFIRMED PNEUMOTHORAX. A CHEST TUBE WAS PLACED, AND THE PATIENT WAS ADMITTED FOR OVERNIGHT OBSERVATION. THE PHYSICIAN ATTRIBUTES THE PNEUMOTHORAX TO THE LESION BEING IN A DIFFICULT POSITION NEAR THE PLEURA. HE IS NOT ATTRIBUTING IT DIRECTLY TO MONARCH. THERE WERE NO REPORTED MALFUNCTIONS OF THE DEVICE.

Monarch Platform — 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 MONARCH BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED PNEUMOTHORAX ON THE LEFT SIDE A CHEST TUBE WAS PLACED, THE PATIENT WAS HOSPITALIZED AND DISCHARGED THE NEXT DAY. THE MEDTRONIC ARCPOINT WAS ALSO USED. PHYSICIAN ATTRIBUTES THIS PNEUMOTHORAX TO USE OF THE MONARCH.

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