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 PROSTATECTOMY PROCEDURE, A BLACK FRAGMENT FROM A UNIVERSAL SEAL CAME OFF AND FELL INTO THE PATIENT. THE SURGEON WAS ABOUT ¾ COMPLETED WITH THE PROCEDURE WHEN A PIECE OF THE UNIVERSAL SEAL WAS OBSERVED TO HAVE FALLEN OFF AND WAS VIEWABLE IN THE PATIENT ANATOMY. THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN PIECE WITH NO INJURY OR HARM TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: DURING THE PROCEDURE, THE UNIVERSAL SEAL WAS INSPECTED AND PLACED ON THE TROCAR, WITH NO ABNORMALITIES OBSERVED AT THAT TIME. THE TROCAR, POSITIONED IN ARM #4 (THE SURGEON'S RIGHT ARM), WAS EXCHANGED MULTIPLE TIMES FOR SCISSORS, CLIPS, AND A NEEDLE HOLDER INSTRUMENTS. IT IS UNCLEAR EXACTLY WHEN THE FRAGMENT FELL INTO THE PATIENT. THE UNIVERSAL SEAL WAS IN USE FOR APPROXIMATELY 2 HOURS. THE SURGEON IS UNCERTAIN WHAT CAUSED THE PIECE TO FALL OFF. THE PORT REMAINED IN PLACE UNTIL THE END OF THE PROCEDURE AND FUNCTIONED PROPERLY THROUGHOUT THE PROCEDURE, WITH NO INDICATION OF A SEAL MALFUNCTION. THE FRAGMENT WAS SUBSEQUENTLY

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 PANCREATODUODENECTOMY PROCEDURE, THE BIPOLAR ENERGY SOURCE DID NOT WORK AS EXPECTED AND THE PATIENT EXPERIENCED UNIDENTIFIED BLEEDING LEADING TO A 1-LITER BLOOD LOSS. THE SURGEON REPORTS THAT THE E200 BIPOLAR ENERGY WAS INSUFFICIENT, CONTRIBUTING TO THE PATIENT'S BLOOD LOSS. BLOOD PRODUCTS WERE ADMINISTERED. THE BLEEDING WAS ABLE TO BE CONTROLLED ROBOTICALLY WITH BIPOLAR ENERGY AND SURGICEL PRODUCT. THE PROCEDURE WAS COMPLETED ROBOTICALLY. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) POSTOPERATIVELY AND HAS SINCE RECOVERED WELL AND HAS BEEN DISCHARGED HOME.

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 HARMONIC ACE INSTRUMENT BROKE AND A FRAGMENT FELL INSIDE THE PATIENT. IT IS UNKNOWN IF THE FRAGMENT WAS RETRIEVED. THE PROCEDURE WAS COMPLETED ROBOTICALLY.

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 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 CHOLECYSTECTOMY PROCEDURE, THE UNIVERSAL SEAL BROKE AND A SMALL ROUND PIECE OF RUBBER WAS FOUND INSIDE THE PATIENT'S ABDOMEN DURING THE PROCEDURE. THE SURGEON RETRIEVED THE FRAGMENT INTRAOPERATIVELY AND SUBSEQUENTLY INSPECTED BOTH THE SEAL AND THE FRAGMENT. THE CANNULA SEAL WAS INSPECTED PRIOR TO USE AND THERE WAS NO ISSUES. THIS ISSUE DID NOT RESULT IN LOSS OF INSUFFLATION AT ANY POINT DURING THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED ROBOTICALLY. THE PATIENT IS IN STABLE RECOVERY WITH NO REPORTED PERSISTENT ISSUES RELATED TO THE EVENT.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT DURING DRILLING ON THE RIGHT SIDE OF L2, BACKING OCCURRED. AFTERWARDS, THE PHYSICIAN DECIDED TO CONTINUE. THEY LEFT THE SITE AT THAT TIME. IN THE EVENING ON MARCH 25, THE MANUFACTURING REPRESENTATIVE (REP) REPORTED THAT THERE WAS A POSSIBILITY THAT THE ROOT WAS TOUCHED DURING DRILLING RATHER THAN BACKING AT SFDC. IN THE MORNING OF MARCH 26, THE PHYSICIAN FROM SPINE VISITED AND SAID THAT THE PATIENT HAD LOWER LIMB SYMPTOMS AND THAT THEY WOULD CONDUCT A DETAILED EXAMINATION. THERE WAS LESS THAN AN HOUR DELAY. IMPACT ON PATIENT OUTCOME WAS UNKNOWN. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE NERVE WAS DAMAGED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT AFTER THE EVENT, NORMAL OPERATION OF THE GUIDANCE SYSTEM WAS CONFIRMED.

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 HARMONIC ACE INSTRUMENT TIP BROKE OFF AND THE INSTRUMENT STOPPED WORKING. A FRAGMENT FELL INTO THE PATIENT. THE SINGLE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE USING A BOWEL GRASPER. NO WARNING SIGNS PRECEDED THE EVENT. POST-OPERATIVE IMAGING WAS NOT PERFORMED. THERE WERE NO COMPLICATIONS, AND NO FURTHER PROCEDURES WERE NECESSARY.

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 SINGLE PORT (SP) DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER CALLED TECHNICAL SUPPORT STATING THE ENERGY SHIELD MONITOR (ESM) FAULTED AND THE LEDS TURNED YELLOW. THE CUSTOMER POWER CYCLED AND THE SYSTEM RESTORED THE ESM HOWEVER IT FAULTED AGAIN AFTER A FEW MINUTES. THE TECHNICAL SERVICE ENGINEER (TSE) WALKED THE CUSTOMER THROUGH POWERING OFF AND CYCLING THE VISION SIDE CART (VSC) BREAKER AND THE ESM POWER CONNECTIONS AND POWERED UP WITHOUT FAULTS. THE ESM FUNCTIONED PROPERLY FOR A FEW MINUTES AND THEN FAULTED AGAIN. THE CUSTOMER STATED THEY MAY SWITCH TO THE MULTIPORT DA VINCI XI AND USE SINGLE PORT TECHNIQUE. ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER FOR ADDITIONAL INFORMATION; HOWEVER, NO RESPONSE HAS 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 GASTRIC BYPASS PROCEDURE, A RUBBER COMPONENT FROM THE INSIDE OF THE UNIVERSAL SEAL FELL INSIDE THE PATIENT AND THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. IT WAS A VERY SMALL PIECE. THE ACCESSORY HAD BEEN INSPECTED PRIOR TO USE, WITH NO DAMAGE OR ABNORMALITIES NOTED. DURING THE PROCEDURE, IT IS UNKNOWN AT WHAT SURGICAL TASK THE FRAGMENT FELL INTO THE PATIENT, THOUGH THE SURGEON SUGGESTED HIGHER TRAFFIC WITH NEEDLES IN AND OUT MAY HAVE CONTRIBUTED. IT WAS UNKNOWN IF THERE WAS A COLLISION. THE FRAGMENT WAS RETRIEVED, AND NO POST-OPERATIVE IMAGING WAS PERFORMED TO CONFIRM FRAGMENTS. THE PROCEDURE WAS COMPLETED AS EXPECTED, WITH NO REPORTED POST-SURGICAL COMPLICATIONS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HARTMANN¿S PROCEDURE, THE JAW OF THE HARMONIC ACE INSTRUMENT BROKE OFF INSIDE PATIENT. THE BROKEN PIECE WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE WHICH WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE HARMONIC ACE INSTRUMENT WAS PROPERLY INSPECTED BEFORE USE, WITH NO DAMAGE OR ABNORMALITIES OBSERVED. DURING THE SURGICAL PROCEDURE WHILE THE SURGEON WAS PERFORMING DISSECTION, A FRAGMENT FROM THE INSTRUMENT FELL INSIDE THE PATIENT. THE SURGEON ATTRIBUTED THE BREAKAGE TO POSSIBLE HEAT INTOLERANCE. THERE WERE NO PRIOR FUNCTIONAL ISSUES NOTED, AND THE INSTRUMENT DID NOT COLLIDE WITH OTHER INSTRUMENTS OR HARD MATERIALS. THE FRAGMENT WAS RETRIEVED BY THE SURGEON USING THE OPPOSITE ROBOTIC ARM. ALL FRAGMENTS WERE CONFIRMED RETRIEVED VIA VISUAL INSPECTION. NO ADDITIONAL SURGICAL PROCEDURES OR POST-OPERATIVE TESTS WERE REQUIRED. THE SURGERY WAS COMPLETED ROBOTICALLY WITH NO PATIENT INJURY OR POST-SURGICAL COMPLICATIONS REPORTED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) SHEATH CAME OFF OF THE INSTRUMENT WHEN THEY WERE REMOVING IT. THE SHEATH DID FALL INTO THE PATIENT, BUT IT WAS RETRIEVED. THE CUSTOMER PUT A NEW SHEATH ON THE SCISSORS AND PROCEEDED WITH THE CASE. THE PROCEDURE WAS COMPLETED.

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 SURGERY WITH THE EXCELSIUS GPS, WE HAVE HAD 2 DAYS IN A ROW OF ACCURACY ISSUES. MONDAY WE PLACED 4 QUARTEX SCREWS USING THE 6143.2932 DRIVER. WE DID A FOLLOW-UP 3D SPIN TO VERIFY PLACEMENT AND 3 OF 4 SCREWS WERE PLACED SEVERELY OFF PLAN AND HAD TO BE REPOSITIONED. THE 4TH SCREW WAS NOT PERFECT TO PLAN BUT ACCEPTABLE. OFFSET WAS MEDIAL-LATERAL TO THE LEFT AND INFERIOR. IT WAS THE 1ST,3RD AND 4TH SCREWS THAT NEEDED REPOSITIONING. THE SURGEON OPTED TO FREEHAND NAVIGATE THE REPOSITIONED SCREWS AND OBSERVED QUESTIONABLE ACCURACY DURING THAT. SPIN WAS PERFECT, NO ONE MOVED THE DRB. WE CAN THINK OF NOTHING WE DID THAT WOULD HAVE COMPROMISED ACCURACY.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AFTER SUCCESSFUL MONARCH BRONCHOSCOPY, THE PATIENT DEVELOPED A PNEUMOTHORAX REQUIRING HOSPITALIZATION AND WAS DISCHARGED ON (B)(6) 2026. NO DEVICE-RELATED ISSUES WERE IDENTIFIED.

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 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: IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM, THIS WAS A T3-T9 FUSION WITH THE ROBOT USING COMPETITIVE HARDWARE. ONLY NAVIGATED INSTRUMENTS WERE THE HSB, DRILL, TAP, AND AWL. A SPINOUS PROCESS CLAMP WAS PLACED AT T10, AND SM WAS PLACED ON TOP OF THE CLAMP. THE SURGEON WAS INFORMED ABOUT THE CAVEATS OF DOING THIS. AFTER THE HSB AND DRILL WERE USED ON THE FIRST TRAJECTORY ON THE RIGHT T3, THE SURGEON PLACED THE TAP AT THE BEGINNING OF THE PILOT HOLE AND PLACED A K-WIRE DOWN THE TAP WITHOUT THE USE OF ANY IMAGING. THE SURGEON REPORTED THAT K-WIRE FELT LIKE IT WAS "BOUNCING" AND NOT IN BONE. HE WAS CONCERNED THAT NAVIGATION WAS INACCURATE AND PLACED THE SCREW USING A PEDICLE FINDER AND C-ARM FOR IMAGING. SHORTLY AFTER MOVING TO THE LEFT, T3 ANESTHESIA REPORTED THE PATIENT'S BLOOD PRESSURE WAS DROPPING. THE SURGICAL TEAM QUICKLY CLOSED THE PATIENT AND FLIPPED TO THE STRETCHER. AFTER FLIPPING ONTO A STRETCHER, ANESTHESIA REPORTED THE PATIENT'S LUNG WAS COLLAPSING AND THAT SHE HAD A POSSIBLE PNEUMOTHORAX. A CHEST TUBE WAS PLACED, AND THE PATIENT WAS STABILIZED TO GET HER TO CT FOR IMAGING.

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 DURING A KIDNEY OPERATION, THE CUSTOMER WAS PLACING THE SPECIMEN IN THE SPECIMEN BAG. THEN THE OPERATOR DISCOVERS A SMALL METAL RING/RUBBER RING LOOSE IN THE ABDOMEN AND WONDERS WHAT THIS WAS. THE CUSTOMER CHECKED THE ROBOTIC INSTRUMENTS AND CONCLUDED THAT THE SMALL RING COMES FROM THE SYNCHROSEAL. THE METAL RING WAS TAKEN OUT AND THE SYNCHROSEAL WAS SAVED FOR A COMPLAINT TO INTUITIVE. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE, AND NO ABNORMALITIES WERE NOTED. AFTER APPROXIMATELY TWO HOURS OF USE DURING A NEPHRECTOMY INVOLVING A LARGE KIDNEY AND SUBSTANTIAL SURROUNDING TISSUE, THE SURGEON REPORTED THE BREAKAGE ISSUE, BELIEVING IT STEMMED FROM AN INTERNAL PROBLEM WITH THE INSTRUMENT ITSELF. ALTHOUGH THE INSTRUMENT COLLIDED WITH OTHER INSTRUMENTS DURING THE PROCEDURE, NO ISSUES WITH ITS FUNCTIONALITY WERE OBSERVED, AND NO FRAGMENTS FELL INSIDE THE PATIENT. THE INSTRUMENT WAS NOT REMOVED BEFORE THE BREAKAGE AS ONLY THE SPECIMEN PLACEMENT REMAINED. NO POST-OPERATIVE IMAGING WAS PERFORMED TO CHECK FOR F

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MEDIAN ARCUATE LIGAMENT SYNDROME RELEASE (MALS) PROCEDURE, THE PATIENT EXPERIENCED INTRAOPERATIVE BLEEDING FROM THE AORTA AND ULTIMATELY EXPIRED. THE VESSEL SEALER CURVED (VSC) INSTRUMENT WAS BEING USED FOR BLUNT DISSECTION AND CAUTERY WHEN SIGNIFICANT BLEEDING OCCURRED FROM THE AORTA. THE PROCEDURE WAS EMERGENTLY CONVERTED TO AN OPEN APPROACH. WHEN AN ASSISTING VASCULAR SURGEON CROSS CLAMPED THE AORTA DURING REPAIR ATTEMPTS, THE PATIENT¿S PULSE WAS LOST AND CHEST COMPRESSIONS WERE STARTED. WITH NO RETURN OF A PULSE, THE CROSS CLAMPS ON THE AORTA WERE REMOVED AND BLEEDING CONTINUED WITH THE CHEST COMPRESSIONS. THE PATIENT EXPIRED IN THE OPERATING ROOM. THE SURGEON STATED THAT THE CAUSE OF THE AORTIC INJURY WAS UNKNOWN. THE SURGEON REPORTED THAT THROUGHOUT THE PROCEDURE, IT WAS NOTICED THAT THE VSC PRODUCED INCREASED THERMAL SPREAD AND INCREASED BLEEDING AFTER ENERGY ACTIVATION WHEN COMPARED TO THE VESSEL SEALER EXTEND. IT WAS ALSO STATED THAT THE VSC JAW MOVEMENT WOULD OPEN A LITTLE SLOWLY AT FIRST, THEN WOULD SPRING OPEN QUICKLY, WITH INCREASED BLEEDING FROM THE FAST JAW OPENING. NO ADDITIONAL INFORMATION WAS PROVIDED.

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 H11 FOR FOLLOW-UP INFORMATION.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED IN TWO SEGMENTS. THE SURGEON CREATED THE PLANNING INDEPENDENTLY AND INDICATED THAT THE TRAJECTORIES PROVIDED WERE MORE MEDIAL THAN IF THEY WERE TO FREEHAND, BUT CHOSE TO EXECUTE THE PLAN. T9-L1 SEGMENT WAS PERFORMED WITHOUT ISSUE. DURING THE SECOND SEGMENT, T4-T8, ALL SCREW ON THE LEFT WERE COMPLETED WITHOUT ISSUE. THE MANUFACTURER REPRESENTATIVE RECOMMENDED A REFERENCE FRAME ON A SPINOUS PROCESS CLAMP FOR NAVIGATIONAL ACCURACY, BUT THE SURGEON REFUSED CITING SPACE IN THE OPERATIVE FIELD. RIGHT T8 WAS EXECUTED WITHOUT AN ISSUE, BUT DURING RIGHT T6, THE SURGEON REPORTED A POSSIBLE COLLISION BETWEEN SCREW AND MOUNT, BUT ACCURACY WAS CONFIRMED. AT RIGHT T4, THERE WAS AN AUDIBLE CHANGE IN PITCH INDICATING THAT THE DRILL HAD EXITED AND RE-ENTERED THE CORTICAL BONE DURING DRILLING. WHEN THE DRILL WAS REMOVED A SIGNIFICANT CSF LEAK WAS OBSERVED. THE GUIDANCE SYSTEM WAS UNMOUNTED AND A SCAN SHOWED THAT RIGHT T4 AND T6 WERE MEDIAL. THESE SCREWS WERE REPLACED WITH NAVIGATION. A MOTOR CHECK FOUND WEAKNESS TO THE RIGHT SIDE, REQUIRING INCREASED STIMU

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 PRIOR TO A SINGLE PORT (SP) DA VINCI-ASSISTED SIMPLE EXTRAPERITONEAL PROSTATECTOMY PROCEDURE, THE GREY NEUTRAL WIRE WHERE IT CONNECTS TO THE SINGLE PORT (SP) ENERGY SHIELD MONITOR (ESM) WAS STRIPPED AND HAD BEEN PULLED OUT. THE ISSUE WAS IDENTIFIED AFTER ANESTHESIA INDUCTION BUT PRIOR TO PORT PLACEMENT. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ADVISED THE CUSTOMER THAT NO MONOPOLAR ENERGY WOULD BE AVAILABLE WITHOUT THAT CONNECTION AND THE SYSTEM COULD NOT BE USED WITH A THIRD PARTY GENERATOR. THE CALLER INDICATED THAT THE CUSTOMER WAS PLANNING ON GETTING AN ESM FROM ANOTHER SYSTEM THAT WAS NOT IN USE AT ANOTHER SITE. HOWEVER, THE TSE ADVISED THE CALLER USING A DIFFERENT ESM WAS NOT RECOMMENDED AND SHOULD NOT BE PERFORMED. THE TSE INFORMED THE CALLER THAT AN FSE WOULD BE REQUIRED TO REPLACE THE ESM. DUE TO THE ISSUE, THE CUSTOMER ELECTED TO CONVERT THE CASE TO A DA VINCI MULTI-PORT SYSTEM WHICH REQUIRED MORE INCISIONS THAT ORIGINALLY PLANNED. IT WAS REPORTED THE PATIENT TOLERATED THE CONVERSION WITH NO POST-OPERATIVE COMPLICATIONS REPORTED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ABDOMINOPERINEAL PROCEDURE, ONE OF THE JAWS, SPECIFICALLY PART OF THE POSTERIOR PINCER OF THE JAW, ON THE HARMONIC ACE INSTRUMENT BROKE, CAME LOOSE, AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS SUCCESSFULLY RETRIEVED DURING THE SAME PROCEDURE, AND THE SURGERY WAS COMPLETED ROBOTICALLY. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL EXPERIENCING ANY POSTOPERATIVE COMPLICATIONS RELATED TO THE REPORTED 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 DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE BLACK RUBBER STOPPER ON THE PORT (COVER) TROCAR PART HAD DETACHED, SO THE ARM COULD NOT BE INSERTED. A FRAGMENT FELL INTO THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ACCESSORY WAS INSPECTED PRIOR TO USE AND NO DAMAGE OR ABNORMALITIES WERE OBSERVED. DURING THE PROCEDURE, WHILE INSERTING THE INSTRUMENT, A FRAGMENT BROKE OFF BUT DID NOT FALL INSIDE THE PATIENT DUE TO THE SMALL INCISION - IT LANDED ON THE PORT INSTEAD. THE SURGEON BELIEVES THE BREAKAGE WAS CAUSED BY A DEFECTIVE ACCESSORY, WHICH HAD BEEN IN USE FOR LESS THAN 30 MINUTES. NO COLLISION BETWEEN INSTRUMENT TIPS OR ACCESSORY OCCURRED, AND THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE WITH ALL PIECES VISUALLY CONFIRMED AS REMOVED. NO ADDITIONAL SURGICAL PROCEDURE OR POST-OPERATIVE IMAGING WAS NECESSARY, AND THE SURGERY WAS COMPLETED ROBOTICALLY WITHOUT ADDITIONAL INJURY TO THE PATIENT. THE PATIENT HAS NOT RETURNED WITH ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINED FRAGMENTS. BOTH

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 SURGICAL PROCEDURE, A PORTION OF THE HARMONIC ACE INSTRUMENT BROKE. HOWEVER, IT IS UNCLEAR IF A FRAGMENT FROM THE INSTRUMENT FELL INSIDE THE PATIENT. THE CUSTOMER REPLACED THE INSTRUMENT WITH A SECOND HARMONIC ACE INSTRUMENT FROM THE SAME LOT. THE SECOND HARMONIC ACE INSTRUMENT REPORTEDLY ALSO BROKE AND A FRAGMENT FELL INSIDE THE PATIENT. THE CUSTOMER THEN INSTALLED A THIRD HARMONIC ACE INSTRUMENT FROM A DIFFERENT LOT AND WAS ABLE TO COMPLETE THE PROCEDURE WITH NO ISSUES. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THE INSTRUMENTS AND BROKEN PIECES WERE DISCARDED BASED ON THE HOSPITAL'S DISPOSAL PROTOCOL. THERE WERE NO COLLISIONS BETWEEN INSTRUMENTS OR HARD OBJECTS REPORTED. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A PORTION OF THE HARMONIC ACE INSTRUMENT BROKE. HOWEVER, IT IS UNCLEAR IF A FRAGMENT FROM THE INSTRUMENT FELL INSIDE THE PATIENT. THE CUSTOMER REPLACED THE INSTRUMENT WITH A SECOND HARMONIC ACE INSTRUMENT FROM THE SAME LOT. THE SECOND HARMONIC ACE INSTRUMENT REPORTEDLY ALSO BROKE AND A FRAGMENT FELL INSIDE THE PATIENT. THE CUSTOMER THEN INSTALLED A THIRD HARMONIC ACE INSTRUMENT FROM A DIFFERENT LOT AND WAS ABLE TO COMPLETE THE PROCEDURE WITH NO ISSUES. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THE INSTRUMENTS AND BROKEN PIECES WERE DISCARDED BASED ON THE HOSPITAL'S DISPOSAL PROTOCOL. THERE WERE NO COLLISIONS BETWEEN INSTRUMENTS OR HARD OBJECTS REPORTED. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE FOLLOWING INFORMATION WAS PROVIDED: THIS PI IS FOR THE HIP CASE ROBOT REPORT TO HAVING ISSUES WITH REGISTRATION. BLADE REGISTRATIONS AND CHECK POINTS. CUTS WERE EXAMINED TO BE OFF ON KNEE - HIP REGISTRATION WAS OFF. CASE TYPE / APPLICATION: THA 5.0. WO: (COMPLETED ON 3/20 TO ADDRESS THIS ISSUE AND REPORTED ON 3/20) MPS REPORTED ISSUES REGISTERING THE ROBOT. PERFORMED A FULL PM PROCEDURE. ALL TESTS PASSED AND THE SYSTEM IS READY FOR USE. UPDATE: THE INITIAL CASE HAPPENED THURSDAY 3/19. AFTER THE PATIENT WAS IN POSTOP AN X-RAY WAS TAKEN AND IT WAS FOUND THAT THE CUP AND AUGMENT WAS NOT WHERE THE SURGEON HAD EXPECTED. THE PATIENT WAS RESCANNED THAT NIGHT AND WE PERFORMED ANOTHER MAKO HIP SURGERY THE NEXT DAY TO CORRECT PLACEMENT OF THE CUP AND AUGMENT.

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 MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY FELL INSIDE THE PATIENT BUT WAS RETRIEVED. NO VISIBLE DAMAGE TO THE COVER WAS OBSERVED. IT WAS SUSPECTED THAT THE COVER MAY HAVE BEEN ACCIDENTALLY STRIPPED OFF BY ANOTHER INSTRUMENT, ALTHOUGH THIS WOULD BE VERY UNUSUAL, AS THE COVER IS DESIGNED TO FIT VERY TIGHTLY AND SECURELY. THE BATCH NUMBER CAN BE FOUND IN THE ATTACHED IMAGE (LOT: K12250904). THE AFFECTED TIP COVER WAS DISCARDED. THE CUSTOMER WAS INFORMED THAT A SIMILAR INCIDENT HAD PREVIOUSLY OCCURRED DURING ANOTHER PROCEDURE; IN THAT CASE, THE TIP COVER DID NOT FULLY DETACH BUT HAD ONLY SLIGHTLY ¿SHIFTED.¿ INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS A DELAY OF NO MORE THAN FIVE MINUTES, AS THE TIP COVER HAD TO BE RETRIEVED AND WAS, AS A PRECAUTION, REPLACED WITH A NEW ONE. THE SURGICAL SHEET HAD SHIFTED SLIGHTLY, AND THIS WAS NOTICED BECAUSE THE SCISSORS' BLADES WERE RESTRICTED IN THEIR MOVEMENT. THE SCISSORS WERE THEN REMOVED AND THE SHEET REPOSITIONED. AFTERWARD, THE SURGERY CONTINUED AS PLANNED. THE PATIENT WAS NOT I

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDICAL MALPRACTICE LINKS TO SURGICAL ERROR, MISUSED OF DA VINCI ROBOT, INADEQUATE PATIENT MONITORING, DELAYED DIAGNOSIS AND TREATMENT, SEPSIS. ON (B)(6) 2026, I UNDERWENT WHAT WAS SUPPOSED TO BE A ROUTINE LEFT INGUINAL HERNIA REPAIR AT (B)(6) HOSPITAL. AFTER SURGERY, I WAS DISCHARGED HOME THE FOLLOWING DAY BELIEVING EVERYTHING HAD GONE WELL. OVER THE NEXT SEVERAL DAYS, MY CONDITION RAPIDLY WORSENED. I BEGAN EXPERIENCING SEVERE ABDOMINAL PAIN, NAUSEA, VOMITING, DIARRHEA, FEVER, CHILLS, AND I BECAME UNABLE TO EAT OR DRINK PROPERLY. MY SYMPTOMS CONTINUED TO INTENSIFY, AND BY (B)(6) 2026, I RETURNED TO THE EMERGENCY ROOM IN CRITICAL CONDITION. EMERGENCY ROOM DOCTORS DISCOVERED THAT MY BOWEL HAD BEEN ACCIDENTALLY PUNCTURED DURING THE ORIGINAL HERNIA SURGERY AND THAT THE PERFORATION HAD NOT BEEN IMMEDIATELY RECOGNIZED OR TREATED. BECAUSE THE BOWEL PERFORATION WENT UNDIAGNOSED FOR SEVERAL DAYS, INFECTION SPREAD THROUGHOUT MY ABDOMEN, LEADING TO ABDOMINAL SEPSIS AND A LIFE-THREATENING EMERGENCY. ON (B)(6) 2026, I UNDERWENT EMERGENCY SURGERY TO REMOVE THE DAMAGED SECTION OF INTESTINE AND CONTROL THE INFECTION. I REQUIRED EXTENSIVE TREATMENT INCLUDING IV ANTIBIOTICS, IV FLUIDS, URINARY CATH

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-EXTRAPERITONEAL PROSTATECTOMY PROCEDURE, A PREVIOUSLY USED SHEATH WAS FOUND TO BE STUCK ON THE INSTRUMENT. THE CUSTOMER WAS ABLE TO RECOVER ALL THE PIECES. THE CUSTOMER REPLACED THE INSTRUMENT IN USE AND COMPLETED THEIR CASE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO GATHER ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT; HOWEVER, NO RESPONSE HAS 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 DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A PIECE FROM A HARMONIC ACE INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT. THE INSTRUMENT AND BROKEN PIECE WERE DISCARDED BY THE CUSTOMER BASED ON THE HOSPITAL'S DISPOSAL PROTOCOL. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND CONFIRMED THAT THE A WHITE PLASTIC FRAGMENT FROM THE TIP OF THE HARMONIC ACE INSTRUMENT BROKE AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE. THERE WAS NO COLLISION BETWEEN INSTRUMENTS OR HARD OBJECTS REPORTED. A HARMONIC ACE INSTRUMENT WITH A DIFFERENT LOT NUMBER WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A RUBBER PIECE FROM A CANNULA SEAL BROKE OFF AND FELL INSIDE THE PATIENT. THE CUSTOMER WAS ABLE TO RETRIEVE THE RUBBER PIECE BUT WAS NOT SURE IF ALL FRAGMENTS WERE RETRIEVED. AN X-RAY WAS BEING PERFORMED; HOWEVER, THE RESULTS OF THE RADIOLOGICAL TEST ARE UNKNOWN. THE PROCEDURE WAS COMPLETED WITH A SLIGHT DELAY AND THERE WAS NO KNOWN INJURY TO THE PATIENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CANNULA SEAL WAS VISUALLY INSPECTED BEFORE USE, WITH NO DAMAGE OR ABNORMALITIES NOTED; HOWEVER, THE INTERNAL COMPONENTS OF THE CAP COULD NOT BE EXAMINED DUE TO PACKAGING CONSTRAINTS. THE RUBBER FRAGMENT WAS DISCOVERED INCIDENTALLY AT THE END OF THE ROBOTIC SURGERY, AS THE ARMS AND SPONGES WERE REMOVED AND THE CHEST WALL WAS INSPECTED. THE SURGEON COULD NOT DETERMINE THE EXACT CAUSE OF THE FRAGMENTATION, NOTING THAT THE PROCEDURE WAS ROUTINE AND THAT ONLY ONE PORT SHOWED EVIDENCE OF MISSING MATERIAL. THE ACCESSORY WAS USED THROUGHOUT THE ENTIRE SURGERY, WHICH LASTED APPROXIMATELY FOUR AND A HALF HOURS, AND NO FUNCTIONAL ISSUES WERE OBSERVED DU

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 CUSTOMER WAS UNABLE TO USE A STAPLER INSTRUMENT. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) IDENTIFIED THAT THE CUSTOMER WAS NOT RUNNING THE APPROPRIATE SOFTWARE WITH THE DA VINCI SP SYSTEM IN ORDER TO USE THE STAPLER INSTRUMENT. DUE TO THE INCOMPATIBLE SOFTWARE, THE CUSTOMER ELECTED TO CONVERT THE CASE TO OPEN SURGERY. IT IS UNKNOWN HOW THE PATIENT TOLERATED THE CONVERSION. NO PATIENT INFORMATION IS AVAILABLE.

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 AN EXCELSIUSGPS SURGERY THE SURGEON BELIEVED THAT THE EGPS NAVIGATION WAS OFF TRAJECTORY. BOTH THE DOCKING WITH THE RETRACTOR AND IMPLANT PLACEMENT RESULTING IN ANTERIOR PLACEMENT, ALTHOUGH PLANNING AND REAL TIME NAVIGATION WERE DISPLAYING MIDLINE PLACEMENT. THE SURGEON HAD TO CLOSE RETRACTOR, RE-MERGE, AND ADJUST PLACEMENT OF THE RISE-L CAGE. HE WAS UNEASY ABOUT THE DANGERS OF GOING TOO ANTERIOR AT THE L2-4 LEVELS WITH THE GREAT VESSELS BEING THERE AND THE POSSIBILITY OF PUNCTURING/RUPTURING THE ALL. THE IMPLANT WAS REMOVED AND REDIRECTED. THE NAV IMAGING SHOWED THE SURGEON WAS PLACING THE IMPLANT MIDLINE BETWEEN THE TWO VERTEBRA AS PRE PLANNED. THE XR AFTER PLACEMENT SHOWED THE IMPLANT SIGNIFICANTLY MORE ANTERIOR. THE ALL DID NOT SEEM TO BE COMPROMISED, BUT WE REMERGED AND USED THE SAME IMPLANT TO COLLAPSE AND REDIRECT. ULTIMATELY, SURGERY WAS COMPLETED WITH NO PATIENT COMPLICATIONS.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: TWENTY SIX PATIENTS UNDERWENT A SPINAL PROCEDURE TO ADDRESS SCOLIOSIS AND/OR KYPHOSIS OF MORE THAN FOUR SEGMENTS. IT WAS NOTED THAT TWENTY EIGHT SCREWS WERE BREACHED LESS THAN TWO MILLIMETERS(GRADE B), NINE SCREWS BREACHED TWO TO FOUR MILLIMETERS(GRADE C), TWO SCREWS BREACHED FOUR TO SIX MILLIMETERS(GRADE D), AND TWO SCREWS BREACHED GREATER THAN SIX MILLIMETERS(GRADE E). THIRTEEN SCREWS WERE CONSIDERED CLINICALLY SIGNIFICANT. IN REGARDS TO PATIENTS, FIFTEEN PATIENTS HAD A GRADE B BREACH, NINE PATIENTS HAD A GRADE C TO E BREACH, AND THREE PATIENTS HAD A GRADE D TO E BREACH. SIX PATIENTS EXPERIENCED A WOUND INFECTION, ONE PATIENT HAD AN IMPLANT RELATED COMPLICATION, AND ONE PATIENT HAD AN ADJACENT SEGMENT PATHOLOGY. THERE WERE THREE PATIENTS WITH DURAL TEARS, WHICH WERE REPAIRED DURING THE INITIAL SURGERY. THERE WERE NINE PATIENTS THAT REQUIRED A REVISION SURGERY. ONE WAS SCREW RELATED ISSUE, ONE WAS DUE TO AN IMPLANT FAILURE, SIX WERE DUE TO INFECTION RELATED COMPLICATIONS, AND ONE WAS DUE TO THE ADJACENT SEGMENT.

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 TIP BROKE ON THE HARMONIC ACE. A FRAGMENT FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND FOUND TO BE IN NORMAL CONDITION WITH NO DAMAGE OBSERVED. DURING A LYMPH NODE DISSECTION, A FRAGMENT FELL INSIDE THE PATIENT AFTER THE INSTRUMENT HAD BEEN IN USE FOR ABOUT 10 MINUTES. THE SURGEON DID NOT NOTICE ANY FUNCTIONAL ISSUES DURING USE, NOR DID THE INSTRUMENT COLLIDE WITH OTHER OBJECTS OR GET REMOVED PRIOR TO THE BREAKAGE. THE FRAGMENT WAS RETRIEVED USING A NEW HARMONIC INSTRUMENT, AND COMPLETE RECOVERY WAS CONFIRMED BY MATCHING THE BROKEN TIP TO THE NEW INSTRUMENT. NO ADDITIONAL SURGICAL PROCEDURE OR POST-OPERATIVE IMAGING WAS REQUIRED, AND THE PROCEDURE WAS COMPLETED ROBOTICALLY WITHOUT INJURY TO THE PATIENT. THERE HAVE BEEN NO POST-SURGICAL COMPLICATIONS OR RETURNS TO THE HOSPITAL RELATED TO RETAINED FRAGMENTS. BOTH THE INSTRUMENT AND RETRIEVED FRAGMENT WILL BE RETURNED TO ISI FOR EVALUATION.

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 NEPHRECTOMY SURGICAL PROCEDURE, A SMALL PIECE OF THE WHITE CERAMIC PROTECTIVE COATING ON THE JAWS OF THE HARMONIC ACE INSTRUMENT BROKE OFF. THIS PIECE, A FEW MILLIMETERS IN SIZE, ENDED UP IN THE PATIENT'S ABDOMEN. AS THE FORCEPS WERE STILL FUNCTIONING CORRECTLY, THEY WERE RETAINED FOR THE REMAINDER OF THE PROCEDURE. IT WAS UNKNOWN IF THE FRAGMENT WAS RETRIEVED.

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 PROCEDURE, THE RUBBER COMPONENT OF THE UNIVERSAL SEAL BROKE AND A FRAGMENT FELL INTO THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING A DIFFERENT PROCEDURE. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO FURTHER DETAILS WERE AVAILABLE REGARDING THE REPORTED 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: REFER TO 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 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 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 CHOLECYSTECTOMY PROCEDURE, ONE OF THE CAPS OF THE UNIVERSAL SEAL FELL INSIDE THE PATIENT DURING A DA VINCI ASSISTED PROCEDURE. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE FRAGMENT FELL INSIDE THE PATIENT DURING INSERTION OF AN INSTRUMENT THROUGH THE ACCESSORY. THE SURGEON DID NOT OBSERVE ANY FUNCTIONAL ISSUES WITH THE ACCESSORY DURING USE, AND THE FRAGMENT WAS RETRIEVED USING A LAPAROSCOPIC INSTRUMENT. ALL FRAGMENTS WERE VISUALLY CONFIRMED AS RETRIEVED, WITH NO POST-OPERATIVE IMAGING PERFORMED. THE PROCEDURE WAS COMPLETED ROBOTICALLY. IT WAS UNKNOWN WHETHER THE PATIENT HAD RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AFTER FOLLOWING A SUCCESSFUL MONARCH BRONCHOSCOPY, THE PATIENT DEVELOPED A PNEUMOTHORAX AND WAS SUBSEQUENTLY HOSPITALIZED AND RELEASED ON (B)(6) 2026. NO DEVICE-RELATED ISSUES WERE REPORTED.

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 AN EXCELSIUS GPS SURGERY THERE WAS 4 SCREW CREO MIS BACKUP OF ALIF. THE SM ON RIGHT PSIS DRB ON LEFT PSIS, ICT PLACE ON DRB LP QUATRO SPIKE. THE INTRA OP SPIN WITH O-ARM AND FILES TRANSFERER TO EGPS VIA USB. ALL 4 SCREWS PLANNED BY SURGEON. THE ICT WAS REMOVED AND SM VERIFIED. THE POSTOP SPIN SHOWED 4 SCREWS HAD SHIFTED OF PLAN BY APPROX 2-3MM LATERAL. NO IOM ISSUES. THE SURGEON DECIDED TO REPOSITION THE L5 SCREWS BY HAND.

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 LEFT HEMICOLECTOMY PROCEDURE, TISSUE ADHERED TO THE JAWS OF THE SYNCHROSEAL INSTRUMENT FOLLOWING ENERGY ACTIVATION. MANUAL REMOVAL OF THE TISSUE BY PULLING RESULTED IN BLEEDING. TO ADDRESS THE ISSUE AND CONTINUE THE PROCEDURE, THE VESSEL SEALER EXTEND (VSE) INSTRUMENT WAS USED. THIS INCIDENT CAUSED A 15-MINUTE DELAY; HOWEVER, THE PROCEDURE WAS SUCCESSFULLY COMPLETED ROBOTICALLY. AN INTUITIVE SURGICAL INC. (ISI) FIELD SERVICE ENGINEER (FSE) HAS BEEN REQUESTED TO FURTHER INVESTIGATE AND RULE OUT THE E-100 GENERATOR AS A POTENTIAL CAUSE. ADDITIONALLY, AN ISI TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE SYSTEM LOGS AND CONFIRMED THAT NO ERRORS WERE PRESENT.

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 AN EXCELSIUS GPS SURGERY, WE DID A INTRA-OP SPIN WITH DRB IN PSIS WITH OPEN INCISION, DOING A PARTIAL REVISION AND ADDING A LEVEL ABOVE AT L2. THE SURGEON REMOVED SCREWS AT L3 LEFT AND L4 LEFT BEFORE SPIN. WE DID OUT INTRA-OP SPIN WITH E3D AND THEN PLANNED SCREWS. THE PATIENT HAD SOME SCOLIOSIS AT THE LOWER LEVELS AND WE PLANNED THE NEW SCREW TRAJECTORIES A LITTLE MORE LATERAL. ALL OF THE SCREWS WERE PLACED CORRECTLY EXCEPT L4 LEFT (LAST SCREW) WHICH ENDED UP BEING DEEP. WE CHECKED NAV BEFORE PLACING SCREWS AND EVERYTHING LOOKED CORRECT. AS WE WERE DOING LAST SCREW, THE REP TOLD SURGEON THAT IT LOOKED LIKE THEY WERE DOWN EVEN THOUGH THEY DID NOT RECEIVE "CHECK MARK" FOR IMPLANT PLACED. THE SURGEON PROCEEDED TO CONTINUE TWISTING SCREW AND UP ON X-RAY THE SCREW WAS DEEP. THE REP BELIEVES THAT THE SCREW FELL INTO THE OLD HOLE TRAJECTORY AND THEN THEY OVER TIGHTENED SCREW.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE SURGERY WAS CONDUCTED ON (B)(6) 2026. AFTER SURGERY, THE PATIENT IS UNABLE TO DORSIFLEX THE ANKLE AND IS PERONEAL NERVE PALSY. THE PHYSICIAN COMMENTED THAT HE SUSPECT THAT THE SCIATIC NERVE, WHICH IS CONNECTED TO THE PERONEAL NERVE, MAY HAVE BEEN COMPRESSED DURING THE SURGERY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE FORCEPS WERE PROPERLY FITTED, BUT WHEN THE SCISSORS WERE REMOVED FROM THE PORT, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY CAME OFF AND REMAINED INSIDE THE PORT. IT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: DURING THE SURGICAL EVENT, IT REMAINS UNKNOWN HOW THE MCS TIP COVER ACCESSORY WAS RETRIEVED, WHETHER THE MCS INSTRUMENT COLLIDED WITH OTHER INSTRUMENTS, IF ANY LUBRICANT WAS APPLIED BEFORE INSTALLATION, WHETHER THERE WAS DIFFICULTY IN REMOVAL, WHETHER THE INSTRUMENT WRIST WAS STRAIGHTENED PRIOR TO REMOVAL, OR IF ANY IMMEDIATE DAMAGE WAS OBSERVED ON THE ACCESSORY, INSTRUMENT, OR CANNULA. HOWEVER, IT WAS NOTED THAT THE TIP COVER ACCESSORY APPEARED TO BE PROPERLY INSTALLED, WITH NO PART OF ITS ORANGE SURFACE VISIBLE AFTER INSTALLATION, WHICH IS CONSISTENT WITH RECOMMENDED PRACTICE FOR ENSURING ELECTRICAL INSULATION AND SAFETY. THE TIP COVER ACCESSORY HAS BEEN RETURNED TO INTUITIVE SURGICAL FOR FURTHER EVALUATION, THOUGH THE ACCOMPANYING MCS INSTRUMENT 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, A RUBBER PIECE/FRAGMENT WAS OBSERVED IN THE PATIENT'S ABDOMEN AND SUBSEQUENTLY RETRIEVED. THE CUSTOMER REPLACED A CANNULA SEAL AND CONTINUED WITH THE PROCEDURE. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: IT WAS CONFIRMED THAT THE RUBBER PIECE ORIGINATED FROM A CANNULA SEAL. INSTRUMENTS HAD BEEN IN USE FOR ABOUT ONE HOUR PRIOR TO THE ISSUE AND NO FUNCTIONAL PROBLEMS WERE OBSERVED. THERE WERE NO INSTRUMENT COLLISIONS. THE FRAGMENT DID NOT FALL AS A RESULT OF A COLLISION, AND INSTRUMENTS WERE REMOVED WITH WRISTS STRAIGHTENED BEFORE BREAKAGE. NO POST-OPERATIVE TESTS LIKE X-RAY OR ULTRASOUND WERE PERFORMED BECAUSE THE MISSING PIECE MATCHED THE RETRIEVED FRAGMENT, AND NO INJURY OR POST-SURGICAL COMPLICATIONS OCCURRED.

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 SALPINGO-OOPHORECTOMY SURGICAL PROCEDURE, A CANNULA SEAL BROKE AND A PLASTIC PIECE FELL INTO THE PATIENT. THE CUSTOMER RETRIEVED THE BROKEN PIECE, REPLACED THE CANNULA SEAL, AND CONTINUED WITH THE PROCEDURE WHICH WAS COMPLETED ROBOTICALLY.

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 MONOPOLAR CURVED SCISSORS (MCS) TIP COVER BECAME LOOSE, FALLING INTO THE CAVITY TWICE EVEN AFTER REPOSITIONING. THE MCS TIP COVER WAS TORN. THE PROCEDURE WAS COMPLETED. A FRAGMENT FELL INTO THE PATIENT, HOWEVER IT WAS UNKNOWN IF IT WAS RETRIEVED. 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.

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 DEVELOPED A PNEUMOTHORAX. PATIENT WAS HOSPITALIZED AND CHEST TUBE WAS PLACED. THE PNEUMOTHORAX RESOLVED AND THE PATIENT WAS RELEASED . NO DEVICE ISSUES WERE REPORTED.