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

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING NAVIGATION, WHILE MOVING TO TRAJECTORY FOR OUR L5 R AND S1 R SCREWS THE AXIAL SLICE WAS UNRECOGNIZABLE (COULD NOT MAKE OUT ANY PEDICLE, VERTEBRAL BODY, S.P). WE CHECK OUR LEFT SIDED SCREWS TRAJECTORY, AND EVERYTHING LOOKED PERFECT. I WENT BACK TO THE PLANNING PAGE TO CHECK OUR RIGHT SIDED SCREWS AXIAL IMAGES AND AGAIN, EVERYTHING LOOKED PERFECT. THOUGH, WHILE BRINGING INSTRUMENTS IN THE EE ALL INSTRUMENT TRACKED CORRECTLY DOWN PLANNED SCREW TRAJECTORY EVEN THOUGH IT DID NOT VISIBLY LOOK LIKE A CORRECT AXIAL SLICE (ANATOMY UNRECOGNIZABLE). AFTER A FEW SOFTWARE RESETS AND A HARD SHUT DOWN, AND SWITCHING EES I INFORMED DR. GENTRY IT WAS JUST THE SLICE OF THE SCAN WE WERE IN, AND I BELIEVED EVERYTHING WAS SAFE. WHEN ADDING LAYERS TO OUR AXIAL CUT THE IMAGE WAS IMPROVING (COULD MAKE OUT DISTINCT ANATOMY) BUT DOC STILL DID NOT TRUST IT. ADJUSTING THE PLAN HAD LITTLE TO NO EFFECT AS WELL. HE WOULD NOT MAKE AN INCISION TO CHECK TRAJECTORY OF INSTRUMENTS UNDER FLOURO AND BAILED ON THE ROBOT.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CHECKED THE SYSTEM AFTER REPLACING THE FUSES AND FOUND THAT THE POWER IS BACK ON THE SYSTEM WITH POWER AND BATTERY LED INDICATOR ON THE CONTROL PANEL. SYSTEM'S FANS WERE ALSO RUNNING BUT THERE WAS NO DISPLAY ON THE MONITOR. LED ON THE MONITOR IS RED. I.E. NO VIDEO SIGNALS FROM COMPUTER. 2. CONNECTED AN EXTERNAL HDMI CABLE FROM PC TO MONITOR DIRECTLY BUT STILL NO VIDEO SIGNAL ON MONITOR. 3. CONNECTED EXTERNAL MONITOR ON THE PC DIRECTLY AND NO DISPLAY ON THE EXTERNAL MONITOR TOO. 4. CHECKED THE VOLTAGE ON PC POWER SUPPLY AND IT WAS 54 VOLT DC. 5. PC FAN WAS ALSO RUNNING. 6. IT HAS BEEN OBSERVED THAT THE PC IS NOT BOOTING UP SO THERE IS NO DISPLAY ON THE MONITOR. KINDLY SUGGEST FURTHER.

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.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: FAILED MERGE OF L4 DURING AN L4-L5 SINGLE POSITION LATERAL. PATIENT WAS POSITIONED LEFT SIDE UP AND THE BED WAS BROKEN SLIGHTLY PRIOR TO DRAPING THE PATIENT. IMAGES WERE ACQUIRED FOR THE MERGE. WE WERE ABLE TO GET A GOOD/APPROVABLE MERGE FOR L5 ON THE FIRST ATTEMPT. DESPITE MULTIPLE ATTEMPTS AND EXTENSIVE TROUBLESHOOTING, WE WERE NOT ABLE TO GET A GOOD/APPROVABLE MERGE FOR L4. THE AP VIEW CONSISTENTLY HAD MORE SHIFT THEN IN THE LATERAL AT L4.

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 A REVISION SURGERY WAS NEEDED TO REMOVE AND REPLACE MISPLACED SCREWS THAT WERE PLACED USING THE EXCELSIUS GPS SYSTEM. THIS EVENT OCCURED IN BELGIUM.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CENTROIDS WERE PLACED IN THE CENTER OF THE BODIES WITH THE SURGEON'S GUIDANCE. THE MERGE AT ALL LEVELS SHOWED A LARGE SHIFT OF THE VERTEBRAL BODIES IN THE AP VIEW. THE DRR FILE WAS NOTICEABLY A FEW CM TO THE RIGHT OF THE X-RAY ALL LEVELS. SOME TROUBLESHOOTING WAS PERFORMED, BUT THE ISSUE WAS NOT RESOLVED. THE SURGEON DECIDED TO PLACE CAGES WITHOUT NAVIGATION.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CASE L5-S2AI. THERE WAS BIG SHIFT AT S1, WE CONTINUED TO TAKE NEW PICTURES AND THERE CONTINUED TO BE A LARGE SHIFT AT S1, S2. WE HAD TO DO ANOTHER HARD SHUTDOWN. WE TOOK NEW PICTURES AND THERE IS STILL A BIG SHIFT AT S1, S2.

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.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING THE CASE, A MERGE COULD NOT BE OBTAINED. TRIED TO GET IT AFTER THE CASE BUT IT DID NOT WORK.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: UNSUCCESSFUL MERGE AT T1. MULTIPLE MERGES WERE ATTEMPTED WITH DIFFERENT FLUORO IMAGES AND CENTROID PLACEMENTS. AFTER FAILING T1-T3 MERGE MULTIPLE TIMES, WE TRIED MERGING C7-T2 WHICH WAS ALSO UNSUCCESSFUL.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IN THESE CASES, NO MATTER WHAT, THE MERGE BOUNCED SIMILAR TO E3D.

Senhance — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE COMPLAINANT, DR. (B)(6) REPORTED THAT ON (B)(6) 2022, A GASTROSCOPY WAS PERFORMED FOR DYSPHAGIA. THIS EVENT REVEALED A BOLUS OCCLUSION IN THE LOWER ESOPHAGUS WITH NECROSIS OF THE WALL TO INDICATE AN ESOPHAGEAL PERFORATION. THE PATIENT WAS TREATED VIA RE-LAPAROSCOPY, ESOPHAGEAL SUTURE, ESOSPONGE, AND SEVERAL VAC CHANGES. VAC THERAPY WAS COMPLETED ON (B)(6) 2022 ON (B)(6) 2022, AN X-RAY SWALLOW SHOWED TIGHTNESS AND AFTER A SLOW BUILD-UP OF FOOD, THE PATIENT WAS DISCHARGED ON (B)(6) 2022. AT HOME THE PATIENT WAS LISTLESS AND WAS RE-ADMITTED AS INPATIENT FROM (B)(6) 2022 THRU (B)(6) 2022 WHEN SHE WAS DISCHARGED. AFTER THIS PERIOD, PATIENT DID WELL WITH NO WEIGHT LOSS AND NO DYSPHAGIA. IT WAS REPORTED THAT CAUSALITY TO THE SENHANCE SURGICAL SYSTEM WAS CERTAIN. THIS EVENT DID NOT OCCUR WITHIN THE UNITED STATES. THE EVENT OCCURRED IN (B)(6). ADDITIONALLY, THIS EVENT OCCURRED ON (B)(6) 2022, AND ASENSUS SURGICAL WAS INTERNALLY MADE AWARE ON 02-DECEMBER- 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 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

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 A MONARCH BRONCHOSCOPY CASE, AT APPROXIMATELY 3:20 PM, THERE WAS A NAVIGATION FUSION ERROR (FAULT 1224) THAT REQUIRED THE USER TO RE-REGISTER. THE NAVIGATION ERROR (FAULT 1224) OCCURRED 58MM AWAY FROM THE ENDOBRONCHIAL TUMOR AND DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S PROCEDURE-RELATED INJURY. THE FAULT MESSAGE ON THE CART: FAULT ID 711-50-0-0: SCOPE DISCONNECTED WAS REPORTED DUE TO THE BRONCHOSCOPE BEING REMOVED FROM THE PATIENT. THE USE OF THE MONARCH SYSTEM WAS ENDED TO CONTROL BLEEDING. THE CUSTOMER USED COLD SALINE AND TAMPONADE TO CONTROL THE BLEEDING. THE PHYSICIAN STATED THE BLEEDING WAS NOT CAUSED FROM THE MONARCH DEVICE, IT WAS CAUSED FROM A UNIQUE TYPE OF ENDOBRONCHIAL TUMOR THE PATIENT HAD AND WAS BLEEDING FROM THIS TUMOR. AFTER THE BLEEDING WAS CONTROLLED, THE PHYSICIAN SAMPLED THE LYMPH NODES VIA EBUS (ENDOBRONCHIAL ULTRASOUND BRONCHOSCOPY). IT REQUIRED TWO REBOOTS TO RESOLVE ERROR AND ENABLE USER TO MOVE FORWARD WITH MONARCH PROCEDURE AND COMPLETE CASE SUCCESSFULLY.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: T10 -PELVIS WITH S2AI SCREW CASE. ROBOT WAS FINICKY THROUGHOUT CASE, HAD TROUBLES WHEN DROPPING THE DRIVER ARRAY IN. WHEN PUTTING THE DRIVER DOWN THE END EFFECTOR THE SCREW ALIGNMENT WAS OFF, AND THE OFFSET WAS RED. TRIED FIXING THE BALLS AND SWITCHING DRIVER ARRAY. WHEN WE GOT DOWN TO S2AI SCREWS, THE SCREW WAS NOT ALIGNED WITH THE PLAN AND SURGEON HAD TO ABORT THE S2AI SCREWS. SUBMITTED CASE LOGS TODAY.

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

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. THE TARGET WAS A LOWER LOBE. PATIENT HAD SEVERE EMPHYSEMA, WHICH THE DOCTOR STATED AT THE BEGINNING OF THE CASE CAN LEAD TO AN INCREASED RISK FOR A PNEUMOTHORAX. THE PNEUMOTHORAX WAS DISCOVERED POST OP AND DID NOT REQUIRE A CHEST TUBE. NO MALFUNCTION, FAULT OR ERRORS WERE REPORTED. A MEDTRONIC ARCPOINT NEEDLE WAS ALSO USED DURING THE PROCEDURE. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY.

CyberKnife — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PATIENT EXPERIENCED URINARY AND FECAL RETENTION AND INCONTINENCE AFTER CYBERKNIFE TREATMENTS.

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

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 THE PATIENT EXPERIENCED BLEEDING IN THE LEFT LOWER LOBE DURING THE MONARCH BRONCHOSCOPY PROCEDURE. THE BLEEDING WAS CONTROLLED BY EXOCRINE PANCREATIC INSUFFICIENCY (EPI) ADMINISTRATION. THE PATIENT WAS HOSPITALIZED FOR HYPOXIA AND PLACED ON OXYGEN. PRIOR TO THE PROCEDURE THE PATIENT WAS ON OXYGEN AND CURRENTLY ON OXYGEN AT HOME. THE PATIENT WAS RELEASED THE FOLLOWING DAY.

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 PRIOR TO A MONARCH BRONCHOSCOPY PROCEDURE, THE ANESTHESIOLOGIST NOTED THAT THE PATIENT¿S BLOOD PRESSURE WAS ELEVATED. ONCE THE PATIENT¿S BLOOD PRESSURE WAS UNDER CONTROL, THE PHYSICIAN BEGAN THE BIOPSY. DURING THE PROCEDURE THE ANESTHESIOLOGIST NOTED THE PATIENT WAS NOT DOING WELL AND THE PATIENT WENT INTO CARDIAC ARREST. THE PHYSICIAN PERFORMED AN EMERGENT CONVERSION AND ABORTED THE CASE. THE PATIENT WAS INTUBATED. ON (B)(6) 2022 THE PHYSICIAN REPORTED 3 X-RAYS WERE TAKEN AND THERE WAS NO SIGN OF A PNEUMOTHORAX. THE PATIENT HAS RECOVERED. THERE WERE NO ISSUES OR FAULTS WERE REPORTED FROM THE 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 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.

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 A PATIENT WAS UNDERGOING A MONARCH BRONCHOSCOPY DEVELOPED A PNEUMOTHORAX AND WAS VERIFIED VIA CHEST X-RAY. THE TARGET WAS A RML LESION ON THE FISSURE. A CHEST TUBE PLACED, THE PATIENT WAS ADMITTED OVERNIGHT, AND DISCHARGED ON (B)(6) 2022. A MEDTRONIC ARCPOINT NEEDLE AND MONARCH FORCEPS (WHICH WERE DISCARDED) WERE USED DURING THIS CASE. THE PHYSICIAN REPORTED THAT THEY DON'T BELIEVE THE PNEUMOTHORAX WAS CAUSED BY THE MONARCH SYSTEM, BUT RATHER BY THE LOCATION OF THE NODULE IN RELATION TO THE FISSURE. THE CASE WAS COMPLETED SUCCESSFULLY.

Senhance — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE COMPLAINANT, PROF. (B)(6), REPORTED A TRANSABDOMINAL PREPERITONEAL REPAIR (RTAPP) WAS PERFORMED ON (B)(6) 2022, AND NEXT DAY THE PATIENT WAS DISCHARGED WITHOUT PROBLEMS. ON (B)(6) 2022 THE PATIENT HAD ABDOMINAL PAIN AND INFLAMMATION FOR WHICH AN ORGAN LESION WAS SUSPECTED AND THE PATIENT WAS RE-OPERATED. THE RE-SURGERY FOUND A THERMIC LESION OF THE SMALL BOWEL (3CM) WITH ABSCESS FOR WHICH AN OPEN RESECTION AND ILEOASCENDOSTOMY WERE PERFORMED. THE PATIENT FOLLOW-UP WAS UNEVENTFUL NOTING A (B)(6) 2022 DATE OF RESOLUTION. IT WAS REPORTED THAT CAUSALITY TO THE SENHANCE SURGICAL SYSTEM WAS POSSIBLE. THIS EVENT DID NOT OCCUR WITHIN THE UNITED STATES. THE EVENT OCCURRED IN (B)(6) IN GERMANY. ADDITIONALLY, THIS EVENT OCCURRED ON (B)(6) 2022, AND ASENSUS SURGICAL WAS INTERNALLY MADE AWARE ON 25-SEPTEMBER-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 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

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2022 THE PATIENT HAD SPINAL SURGERY WITH USE OF MAZOR ROBOTIC ASSISTANCE. PER THE SURGEON, DURING THE PROCEDURE THE EXPANDING TECHNOLOGY FAILED. ALSO POST OP, IT WAS SUSPECTED THAT THE SCREWS PLACED BY THE MAZOR WERE MALPOSITIONED FROM THE PLANNED TRAJECTORY. ANOTHER PROCEDURE WAS REQUIRED FOR SCREW REVISION AND COMPRESSION OF THE EXPANDABLE CAGE. 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 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.

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 MONARCH BRONCHOSCOPY PROCEDURE PATIENT EXPERIENCED PNEUMOTHORAX. LESION IN THE LINGULA 1.7 X 9 CM. LESION WAS PERIPHERAL. CHEST TUBE WAS PLACED, THE PATIENT WAS HOSPITALIZED, AND RELEASED ON (B)(6) 2022. THE CASE WAS COMPLETED AND THE PHYSICIAN DID NOT ATTRIBUTE THE EVENT TO THE MONARCH SPECIFICALLY. OTHER INSTRUMENTS USED IN THIS CASE WERE THE ARCPOINT NEEDLE, OLYMPUS CYTOLOGY BRUSH, OLYMPUS MICRO BRUSH, AND OLYMPUS ENDOJAW DISPOSABLE BIOPSY FORCEPS.

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.

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 A PATIENT WAS BLEEDING IN THE RIGHT MIDDLE LOBE FOLLOWING THE USE OF A MEDTRONIC ARCPOINT NEEDLE AND THE MONARCH FORCEPS. THE BLEEDING OBSTRUCTED THE PHYSICIAN¿S VIEW AND WAS NOTED IN THE ENDOTRACHEAL TUBE. THE MONARCH PORTION OF THE CASE WAS ABORTED, AND THE PHYSICIAN PERFORMED AN EMERGENT CONVERSION TO REMOVE THE ROBOT AND ATTEMPTED TO CONTROL THE BLEEDING. THE PATIENT WAS GIVEN A BLOOD TRANSFUSION AND TRANSPORTED TO THE OPERATING ROOM (OR). WHEN IN THE OR, THE PHYSICIAN, WHILE UNDER BRONCHOSCOPIC GUIDANCE, WAS ABLE TO CONTROL THE BLEEDING VIA BRONCHOSCOPE VISUALIZATION AND EPINEPHRINE. PATIENT WAS DISCHARGED TWO DAYS LATER AND IS DOING WELL. NO FAULTS OR MALFUNCTIONS WERE REPORTED FROM SYSTEM. THE MONARCH FORCEPS WERE DISCARDED DURING THE EVENT AND WILL NOT BE RETURNED FOR FAILURE ANALYSIS.

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 THE FIRST, AND ONLY CASE OF THE DAY (1:45PM), THE RIGHT LOWER LOBE (RLL) LESION 1.5CM EXPECTED INFECTION, PHYSICIAN DID 4 BRUSHES AND PATIENT SUSTAINED A SMALL PNEUMOTHORAX. A CHEST TUBE WAS PLACED TAKING A WEEK TO RESOLVE. AURIS FORCEPS, A MICRO BRUSH (BRAND WAS NOT RECORDED), AND AN OLYMPUS PERIVIEW FLEX TBNA NEEDLE WERE ALL USED IN THIS CASE. PATIENT WAS ADMITTED AND A CHEST TUBE WAS PLACED. THE CHEST TUBE WAS REMOVED ON (B)(6) 2022 AND THE PATIENT WAS DISCHARGED THE SAME DAY. THE PATIENT IS CURRENTLY DOING WELL. THE PHYSICIAN DOES NOT ATTRIBUTE THE PNEUMOTHORAX TO THE MONARCH SYSTEM.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THE SURGEON QUESTIONED THE ALIGNMENT ON POST OP X-RAY GIVEN THE PLANNED AND VALIDATED CUTS MEASURED DO NOT CORRELATE. PLANNED FOR NEUTRAL TO SLIGHT VALGUS KNEE OVERALL, STARTED AT 18 DEG VALGUS. VALIDATED CUTS SUGGEST WE SHOULD HAVE ENDED UP AT NEUTRAL OR CLOSE TO HOWEVER ON POST OP X-RAYS HAVE ENDED AT 10 DEG VARUS. THE PATIENT HAS ALSO REPORTED SIGNS OF PAIN AND INSTABILITY. THE PATIENT IS BEING CONSIDERED FOR A REVISION. NO 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 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

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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND POST OP CT SCAN SHOWS A MEDIAL BREACH OF THE RIGHT L2 SCREW.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE CASE WAS SCHEDULED AS PREOP CT WORKFLOW FOR POSTERIOR PERCUTANEOUS SCREW PLACEMENT WITH THE ROBOT AT L4 AND L5 FOLLOWING AN L4/5 LLIF. THE SCAN UPLOADED WITH NO ISSUES AND WAS CONFIRMED TO BE TO PROTOCOL. THE SURGEON PLANNED SCREWS AT L4 AND L5 WHILE THE PATIENT WAS REPOSITIONED PRONE. DRB AND SM WERE PLACED IN PSIS IN STANDARD ORIENTATION WITH CAMERA AT THE FOOT. THE SM WAS REGISTERED PRIOR TO X-RAY COMING INTO THE FIELD. IMAGES WERE INITIALLY OBTAINED FOR L4 AND L5, BUT THE MERGE WAS UNSUCCESSFUL - WAGGING UP AND DOWN IN THE LATERAL IMAGES AND SLIGHT ROCKING IN THE AP. L3 AND S1 WERE ADDED IN THE WORKFLOW PAGE AND "DUMMY" SCREWS WERE QUICKLY PLANNED AT L3 AND S1. IMAGES WERE OBTAINED FOR L3 AND S1 WITH THE SAME RESULT - UNSUCCESSFUL MERGE WITH WHAT SEEMED LIKE EQUAL MOVEMENT WHEN VERIFYING. NEW SHOTS WERE THEN OBTAINED FOR L4 AND L5 AND ONCE AGAIN WE COULD NOT GET A MERGE, WE WERE CONFIDENT IN ACCEPTING. THE SURGEON BAILED TO TRADITIONAL JAMSHID PLACEMENT, ALREADY FRUSTRATED WITH HIS EXPERIENCES OF THE DAY, ALTHOUGH FLUORO WORKFLOW WAS OFFERED TO HIM.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: HAD A VERY DIFFICULT TIME GETTING A MERGE. THE DRR WAS LESS THAN SUFFICIENT AS FAR AS QUALITY/BEING ABLE TO MERGE WITH OUR FLUORO SHOTS. OUR FLUORO SHOTS I THOUGHT WERE GREAT, BUT ULTIMATELY HAD NO EXPLANATION FOR NOT BEING ABLE TO GET A MERGE. WE WENT BACK ADJUSTED THE WINDOWING ON THE CT. THAT DIDN'T HELP. "DEEP SEARCH" AND "AUTO MERGE" WERE ATTEMPTED SEVERAL TIMES AFTER MOVING THE DRR INTO WHAT I FELT/COULD MAKE OUT TO BE THE MATCHING ANATOMY OF THE FLUORO SHOTS. THERE WAS SOME WEIRD BOX IN THE DRR THAT I COULD NOT EXPLAIN EITHER.

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.

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 CALLED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THAT TWO DIFFERENT UNSPECIFIED STAPLER INSTRUMENTS WERE INSTALLED AND FELL APART WHILE INSIDE THE PATIENT. THE TSE REVIEWED LOGS AND NOTED STERILE ADAPTER ENGAGEMENT CODES IN THE LOGS. THE TSE ASKED IF ALL PIECES WERE COLLECTED AND ACCOUNTED FOR AND THE CUSTOMER STATED THAT ACCORDING TO THE OPERATING ROOM NIGHT STAFF THAT THEY WERE. THE TSE THEN ASKED IF THE STAPLERS WERE AVAILABLE TO BE SENT BACK FOR ANALYSIS AND THE CUSTOMER DOES NOT BELIEVE STAPLERS WERE KEPT. THE TSE ALSO ASKED IF THERE WAS ANY PATIENT INJURY AND THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT INJURY. THE SITE WAS REQUESTING FOR ISI FIELD SERVICE ENGINEER (FSE) TO FOLLOW UP AS SITE WAS WARY OF USING SYSTEM AFTER THE ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY AND WITH A LESS THAN A 15-MINUTE DELAY.

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 BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A PNEUMOTHORAX DURING THE REMOVAL BRONCHOSCOPE. THE PATIENT WAS HOSPITALIZED, AND A CHEST TUBE WAS PLACED. THE CHEST TUBE WAS REMOVED, AND THE PATIENT WAS DISCHARGED TWO DAYS LATER. THE TARGET LOCATION WAS LEFT UPPER LOBE (LUL). IT WAS REPORTED THAT A HUGE SNAPPING AND STRAIGHTENING OF THE BRONCHOSCOPE OCCURRED DURING THE REMOVAL.

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 ESOPHAGECTOMY SURGICAL PROCEDURE, BLEEDING OCCURRED FROM ONE OF THE TWO BRANCHES OF THE AORTIC ARCH LEADING TO THE ESOPHAGUS. THE ISSUE OCCURRED 15 MINUTES AFTER SEALING AND TRANSECTING THE SIDE BRANCH WITH A SYNCHROSEAL INSTRUMENT. THE SIDE BRANCH WAS PROPERLY FREED FORM SURROUNDING TISSUE AND THEN SEALED WHILE DEEP IN THE JAWS OF THE SYNCHROSEAL. THE SURGEON PERFORMED A FULL CYCLE OF SEALING, OBSERVED TISSUE EFFECT DURING THE SEALING PROCESS, AND THEN TRANSECTED. THE SURGEON BELIEVES THE SEAL COULD NOT HANDLE THE PRESSURE FROM THE AORTIC BRANCH AND BEGAN BLEEDING 15 MINUTES LATER. THE SURGEON WAS ABLE TO TAMPONADE THE BLEEDING WITH AN UNSPECIFIED INSTRUMENT INSTALLED ON UNIVERSAL SURGICAL MANIPULATOR 1 (USM1) BY USING COMPRESSION. USM2, 3, AND 4 WERE THEN REMOVED. THE SURGEON MADE THE CLINICAL DECISION TO CONVERT TO A THORACOTOMY TO CONTROL THE HEMORRHAGE. THE SURGEON PERFORMED SUTURE LIGATION OF THE BLEEDING SITE ON THE AORTA AND THE PATIENT WAS TRANSFUSED 2 UNITS OF PACKED CELLS. BLOOD LOSS WAS ESTIMATED TO BE BETWEEN 500 AND 600ML. THE SURGEON INDICATED THAT THE PATIENT WAS DOING FINE AND RECOVERING POST-OPERATIVELY. HOWEVER, THE

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI-ASSISTED LOW ANTERIOR RESECTION (LAR) PROCEDURE, THE PATIENT'S URINE OUTPUT WAS BORDERLINE LOW, SO BASIC LABS WERE ASSESSED. ON POSTOPERATIVE DAY (POD) #1 (B)(6) 2022), THE PATIENT HAD LOW URINE OUTPUT AND WAS ENCOURAGED TO TRY CLEAR FLUIDS. THE PATIENT'S CREATININE LEVELS WERE NOTED TO HAVE RISEN TO 2.32 (FROM 1.02), SODIUM WAS 127 AND THE HEMOGLOBIN WAS NOTED TO BE LOW AT 8.8. THE PATIENT WAS STARTED ON IV FLUIDS AND CANDESARTAN, CHLORTHALIDONE AND SPIRONOLACTONE WERE HELD AT THIS TIME. THE PATIENT WAS DIAGNOSED WITH ACUTE KIDNEY INJURY DUE TO HYPOVOLEMIA, AND HYPONATREMIA. ON POD #2 (B)(6) 2022), SHE WAS AGAIN ENCOURAGED TO INCREASE ORAL INTAKE. THE CREATININE WAS TRENDING DOWNWARD AT 1.81, SODIUM WAS 129 AND HEMOGLOBIN WAS STABLE AT 8.3. DIARRHEA WAS ALSO NOTED (STARTED ON POD #2). ON POD #3 (B)(6) 2022), THE PATIENT'S URINE OUTPUT WAS NOTED TO BE ADEQUATE. THE PATIENT WAS DISCHARGED THAT SAME DAY WITH A RECOMMENDATION TO FOLLOW UP WITH HER PRIMARY CARE PHYSICIAN IN 1-2 WEEKS ON AN OUT-PATIENT BASIS WITH BMP FOLLOW UP. A PATHOLOGY REPORT ON (B)(6) 2022 DEMONSTRATED INVASIVE MODERATELY DIFFERENTIATED ADENOCARCINOMA ARISING IN A

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 A POST-PROCEDURE CXR (CHEST X-RAY) REVEALED A PNEUMOTHORAX, IN THE LEFT UPPER LOBE, IN A PATIENT HAD COME IN FOR A BRONCHOSCOPY PROCEDURE. THE PATIENT WAS HOSPITALIZED, AND A CHEST TUBE WAS PLACED. THE CHEST TUBE WAS REMOVED, AND THE PATIENT WAS DISCHARGED ON (B)(6) 2022. THERE WERE NO FAULTS OR DEVICE MALFUNCTIONS REPORTED DURING THE PROCEDURE.