Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THIS PI IS FOR REVISION OF PRIMARY. PATIENT HAD A RIGHT MAKO THA SURGERY ON (B)(6) 2019. SHE STARTED TO EXPERIENCE DRAINAGE FROM INCISION APPROX. (B)(6) 2019. THE INCISION OPENED ON (B)(6) 2019, PATIENT WENT TO THE ER AND WAS ADMITTED. PATIENT WAS PARTIALLY REVISED ON 2019. PATIENT WAS DISCHARGED A WEEK AFTER REVISION AND WAS GIVEN ANTIBIOTICS. ON (B)(6) 2019 PATIENT WENT FOR A FOLLOW-UP VISIT AND WAS TOLD TO FOLLOW UP WITH HER ORIGINAL SURGEON. PATIENT WENT TO SEE THE ORIGINAL SURGEON THE SAME DAY AND WAS ADMITTED TO THE HOSPITAL. DURING HER HOSPITAL STAY, MULTIPLE I&DS WERE PERFORMED APPROX. (B)(6) 2019, (B)(6) 2019 AND ON (B)(6) 2019. PATIENT WAS DISCHARGED ON (B)(6) 2019. PATIENT CONTINUED TO EXPERIENCE DRAINAGE AFTER BEING DISCHARGED. ALL COMPONENTS WERE REVISED ON (B)(6) 2019 AND A CEMENT SPACER WAS PLACED. ANOTHER I&D WAS PERFORMED ON (B)(6) 2019 AND WAS PLACED IN REHAB. ON (B)(6) 2019 THE SPACER WAS REMOVED, AND PATIENT WAS IMPLANTED WITH COMPETITOR PRODUCT.

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 FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A GUIDANCE DEVICE BEING USED IN A SPINAL PROCEDURE. IT WAS REPORTED THAT SHOULDER WILL NOT LOCK VIA PHYSICAL BUTTON OR SOFTWARE BUTTON. IT WAS NOTED THERE WAS NO PATIENT HARM BUT THE CASE WAS ABORTED. THERE WERE NO ADDITIONAL COMPLICATIONS REPORTED OR ANTICIPATED AS A RESULT OF 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 FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A GUIDANCE DEVICE BEING USED IN A SPINAL PROCEDURE. IT WAS REPORTED THAT THEY WERE DOING THE FIRST CASE WITH THE DEVICE ON THE DAY OF THE REPORT. THEY STARTED WITH L45 AND L3-4 INTRALIFS. THE L4-5 LEVEL WAS CONDUCTED AS A TRUE INTRALIF UTILIZING THE TRAJECTORY OF THE ROBOT ARM. THE HCP REMOVED THE INTERNAL DISSECTOR AND PLACED A 7.5 MM AND 6.5 MM DILATOR FROM JOIMAX AND PASSED A K-WIRE THROUGH IT. THEN, THEY TOOK OUT THE DILATORS AND PASSED THROUGH A GLOBUS 8/5 MM TUBE THAT WAS SURE-TRACKED. THE HCP USED THE ROBOT TO GUIDE TO BOTH DISC SPACES. IT WAS NOTED THAT THE ROBOT SYSTEM AND NAVIGATION PERFORMED AS PLANNED. THE DILATOR WAS ACCURATE ON THE NAVIGATION WHEN USED WITH THE INSTRUMENTS. THE PATIENT HAD A LEFT L3 NEUROPRAXIA. THE PSOAS BELLY WAS MORE POSTERIOR THAN THE HCP THOUGHT. IT WAS NOTED THAT THE INTRALIF MAY NEED NEUROMONITORING. THE LEFT L4-5 WENT SMOOTHLY BUT THE HCP DECIDED TO BE A LITTLE EXTRA FORAMINAL FOR L3-4. IT WAS NOTED THE HCP MAY HAVE CONVERTED THE INTRALIF ALMOST INTO A ROBOT-GUIDED ENDOSCOPIC XLIF. THERE WERE NO ADDITIONAL COMPLICATIONS REPORTE

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 FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A GUIDANCE DEVICE BEING USED IN A SPINAL PROCEDURE. IT WAS REPORTED THAT THE TRAJECTORIES WERE LOW ON FIVE OF THE LAST 6 CASES. THE HCP PERFORMED AN MIS TLIF. THE ROBOT WAS SENT TO THE L5 AND S1 TRAJECTORIES ON THE LEFT AND RIGHT, THE SKIN WAS MARKED AND THEN INCISION WAS MADE. THE INNER AND OUTER DRILL GUIDE WAS PLACED AND THE PEDICLE WAS DRILLED. THE REDUCTION TUBE WAS INSERTED AND GUIDEWIRES PLACED THROUGH THE TUBES. THE C ARM WAS BROUGHT IN TO VERIFY GUIDEWIRE PLACEMENT. IT WAS NOTED THAT THE WIRES APPEARED LOW BUT SHOULD BE OK. A TLIF WAS PERFORMED AND THEN SCREWS INSERTED USING FLUOROSCOPY. ON SUNDAY (B)(6) 2019 THE PATIENT HAD TO BE BROUGHT BACK TO THE OR TO REMOVE THE L5 AND S1 SCREWS ON THE PATIENTS LEFT SIDE AS THEY WERE LOW AND THE L5 SCREW APPEARED TO BE IN THE FORAMEN. IT WAS DEEMED THAT THE SCREWS ON THE PATIENTS RIGHT SIDE WERE LOW BUT WERE STILL IN THE PEDICLE SO WERE LEFT IN. THERE WERE NO ADDITIONAL COMPLICATIONS REPORTED OR ANTICIPATED AS A RESULT OF 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 FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A GUIDANCE DEVICE BEING USED IN A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WERE 3 MISPLACED SCREWS WITH CANAL BREECHES AND DURAL TEARS. IT WAS NOTED THAT EXTREME SOFT TISSUE PRESSURE AND POOR TECHNIQUE LEAD TO THE EVENT. IT WAS NOTED THAT THE NAVIGATION DID NOT DEPICT THE DEVIATIONS TRUE AS THEY OVERLAID THE ARM TRAJECTORY AND GAVE A FALSE SENSE OF SECURITY. IT WAS NOTED THAT THE SURGERY WAS COMPLETED WITH FREE HAND NAVIGATION. ADDITIONAL INFORMATION RECEIVED FROM THE REP INDICATED THAT THE SCREW PLACEMENT WAS 10-11MM MIDLINE. CONTRIBUTING FACTORS TO THE TECHNIQUE ISSUES INCLUDED A DEEP BIG PATIENT AND LOTS OF TISSUE PRESSURE. MICROSCOPE AND SUTURE TO REPAIR TEARS WAS DONE TO RESOLVE THE DURAL TEARS. THERE WERE NO ADDITIONAL COMPLICATIONS REPORTED OR ANTICIPATED AS A RESULT OF 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 FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A GUIDANCE DEVICE BEING USED IN A SPINAL PROCEDURE. IT WAS REPORTED THAT 3DEFINE FAILED DURING THE PROCEDURE. A SECOND 3DEFINE WAS SUCCESSFUL. REGISTRATION WAS PERFORMED QUICKLY. UPON INSTRUMENTING FIRST TRAJECTORY (LEFT L4), THE WORKSTATION BEEPED AND GAVE AN INSTRUCTION TO LOCK THE ARM IN THE SOFTWARE. THE SURGEON DID NOT HAVE TOOLS IN THE ARM GUIDE WHEN THIS NOTIFICATION OCCURRED. THE ARM WAS RELOCKED IN THE SOFTWARE AND ANOTHER 3DEFINE WAS PERFORMED. THE 3DEFINE FAILED AGAIN ON THE FIRST ATTEMPT. THE SECOND ATTEMPT FOR 3DEFINE WAS SUCCESSFUL. REGISTRATION WAS PERFORMED QUICKLY, AND SURGEON INSTRUMENTED ALL 4 TRAJECTORIES. AP AND LATERAL X-RAY IMAGES VERIFIED WIRES WERE ACCURATELY PLACED. TWO DAYS FOLLOWING THE CASE, THE REP RECEIVED NOTIFICATION THAT THE RIGHT L4 SCREW HAD BEEN MISPLACED LATERAL AND SUPERIOR. REVISION PROCEDURE WAS SCHEDULED FOR SATURDAY (B)(6) 2019 TO REMOVE SCREW AND PLACE NEW ONE. IT WAS ALSO NOTED THAT THE WORKSTATION WOULD NOT ALLOW IMPORT OR EXPORT OF ANY DATA. THE PATIENT COMPLAINED OF RIGHT LEG PAIN POST OPERATIVELY. ADDITIONAL INFORMATI

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A "PARTIAL NEPHROTIC ROBOTIC LAPAROSCOPIC PROCEDURE" ON (B)(6)2019 WHO WAS READMITTED TO THE HOSPITAL "FOUR DAYS AFTER HER SURGERY" ON (B)(6) 2021 EXHIBITING POST-OPERATIVE SYMPTOMS OF ¿REGURGITATED APPROXIMATE 30 TIMES DURING THE PREVIOUS NINE HOURS"; VOMITING "BLACK COFFEE GROUND MATERIAL THAT SMELLED OF FECES." A RE-OPERATION WAS PERFORMED TO REPAIR AN "8MM HOLE" THAT HAD BEEN ¿LEFT BY THE ARM OF THE TROCHAR" CAUSING THE PATIENT¿S BOWEL TO BECOME "HERNIATED AND STRANGULATED." THE PATIENT WAS REPORTED AS STABLE AND THE PATIENT WAS DISCHARGED. IT WAS ALSO ALLEGED THAT A "BROKEN MACHINE" WAS NOT "ADEQUATELY REPAIRED" PRIOR TO THE INITIAL PROCEDURE ON (B)(6) 2019. IT WAS ALSO ALLEGED THAT DURING THE INITIAL PROCEDURE ON (B)(6) 2019, THERE WAS A "NEED TO CONVERT TO AN OPEN PROCEDURE," THERE WERE "ADDITIONAL OR LARGER INCISIONS," THAT THERE WAS ¿EQUIPMENT FAILURE," AND THERE WERE "UNCONTROLLED ELECTRICAL CURRENTS" WITH "PARTS OF THE ROBOT BEING LEFT BEHIND," AND THERE WERE "TISSUE BURNS" DUE TO "THE SURGEON NOT BEING IN TOTAL CONTROL OF THE ROBOT." THE FOLLOWING ADDITIONAL

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON 28-MAR-2023, INTUITIVE SURGICAL BECAME AWARE OF A JOURNAL OF BREAST CANCER ARTICLE TITLED, ¿DEVELOPMENT OF ROBOTIC MASTECTOMY USING A SINGLE-PORT SURGICAL ROBOT SYSTEM¿ (PARK, H.S., ET AL., 2020). WITHIN THE JOURNAL ARTICLE, IT WAS MENTIONED AFTER A BILATERAL DA-VINCI ASSISTED MASTECTOMY PERFORMED ON (B)(6) 2018 ON A PATIENT WITH DUCTAL CARCINOMA IN SITU (DCIS), THERE WAS A MINOR SKIN BURN FOUND ON THE RIGHT BREAST. THERE WAS NO MENTION OF MEDICAL TREATMENT TO ADDRESS THE MINOR SKIN BURN IN THE ARTICLE. THERE WERE NO OTHER IMMEDIATE POSTOPERATIVE COMPLICATIONS. THE PATIENT WAS DISCHARGED ON POSTOPERATIVE DAY 15 AND DRAIN WAS REMOVED ON DAY 24. PATIENT RE-VISITED THE CLINIC ON DAY 55 BECAUSE OF REDNESS AND HEATING SENSATION OF THE RIGHT BREAST. ANTIBIOTICS AND CONSERVATIVE TREATMENT INCLUDING DRESSING AND RE-INSERTION OF THE DRAIN WERE APPLIED. HER SYMPTOMS SUBSIDED AFTER 1 DAY OF TREATMENT AND NO MAJOR SURGICAL INTERVENTION WAS NEEDED. THERE WAS NO MENTION OF ANY MALFUNCTIONS OF ANY DV SYSTEMS, INSTRUMENTS OR ACCESSORIES. FENESTRATED BIPOLAR FOCEPS (FBF) INSTRUMENT, MARLAND FORCEPS INSTRUMENT AND MONOPOLAR CURVED SCISSORS (MCS) WERE INSTALLED ON UNIVERSAL SURGICAL MANIPULATOR(US

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: SURGEON NOTICED A FEMUR DURING PRIMARY TKA.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT PATIENT'S RIGHT MEDIAL KNEE WAS REVISED TO A PS TOTAL KNEE DUE TO PAIN AND OSTEOARTHRITIS.

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 INNOVATIONS JOURNAL ARTICLE TITLED, "EARLY CLINICAL EXPERIENCES OF ROBOTIC ASSISTED AORTIC VALVE REPLACEMENT FOR AORTIC VALVE STENOSIS WITH SUTURELESS AORTIC VALVE¿ (NAGAOKA, E. ET. AL. 2020). IN THIS ARTICLE, STUDY DATA WAS RETROSPECTIVELY COLLECTED FROM 2 PATIENTS WHO UNDERWENT DA VINCI-ASSISTED AORTIC VALVE REPLACEMENT (AVR) IN A SINGLE INSTITUTION BETWEEN MAY AND JUNE 2018. THERE WERE NO MAJOR COMPLICATIONS REPORTED AND NO CONVERSIONS TO STERNOTOMY. WITHIN THE ARTICLE, THE FOLLOWING IS NOTED: "ONE PATIENT HAD FLUID OVERLOAD POSTOPERATIVELY DUE TO VASODILATATION AND REQUIRED AGGRESSIVE DIURESIS. OTHERWISE, POSTOPERATIVE CONVALESCENCE WAS UNCOMPLICATED. THEY WERE DISCHARGED HOME AT DAYS 4 AND 10 AFTER OPERATION, DUE TO POSTOPERATIVE ATRIAL FIBRILLATION RESPECTIVELY (TABLE 3)." ISI FOLLOWED UP WITH THE AUTHOR AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE ARTICLE: "THE POST-OPERATIVE OUTCOME WAS UNRELATED TO THE FUNCTION OF THE DA VINCI SYSTEM." HE FURTHER INDICATED THAT "THERE ARE NO SUCH ALLEGATIONS" THAT A MALFUNCTION OF A DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE INVOLVING THE

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PATIENT HAD A MAKO UNI AND PATELLA FEMORAL REPLACEMENT ON (B)(6) 2017 AND RECENTLY PRESENTED WITH PERSISTENT PAIN. DOCTOR REMOVED IMPLANTS AND REVISED WITH A TOTAL KNEE.

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.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT PATIENT'S LEFT MAKO UNICOMPARTMENTAL KNEE WAS REVISED DUE TO MCL INSTABILITY.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: SURGEON DID AN I&D WITH AN INSERT SWAP OF THE LEFT KNEE DONE AS A MAKO MEDIAL ORIGINALLY ON (B)(6) 2017.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A SIZE 5X9MM ONLAY TIBIAL INSERT WAS INSERTED ON A SIZE 6 TIBIAL BASE PLATE. UPDATE AS PER SALES RESPONSE RECEIVED ON 09-DEC-2016: "REASON FOR REVISION WAS: SURGEON PUT A 5X9 POLY ON A SIZE 6 TIBIA BASE PLATE. IT WAS NOT PRODUCT ERROR. THE 5X9MM WAS REMOVED AND A 6X9MM WAS PUT IN PLACE."

CyberKnife — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A SYSTEM TECHNICIAN RECEIVED AN ELECTRIC SHOCK WHILE MAKING ADJUSTMENTS IN THE EQUIPMENT ROOM.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MAKO ROBOT BY STRYKER ORTHO FAILED. THE SENSORS STOPPED COMMUNICATING WITH THE COMPUTER. THIS HAPPENED AFTER BEGINNING A SURGERY FOR A KNEE REPLACEMENT. THE HOSPITAL HAD TO CALL IN ANOTHER COMPANY TO USE THEIR INSTRUMENTS AND IMPLANTS INSTEAD OF THE MAKO/STRYKER WHICH COULD NOT BE FIXED AFTER 15 MINUTES OF FAILED ATTEMPTS IN THE OPERATING ROOM.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: SURGEON REVISED LEFT MAKO KNEE DUE TO PAIN AND INFECTION.

CyberKnife — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED BY AN ACCURACY EMPLOYEE, THAT A FIELD SERVICE ENGINEER RECEIVED AN ELECTRICAL SHOCK WHILE SERVICING THE SYSTEM MODULATOR CABINET AT THE POINT OF THE CIRCUIT BREAKER THREE. THE FIELD SERVICE ENGINEER REPORTED BURNS ON HIS FINGERS AT THE POINT OF ENTRY, ALONG WITH HEART PALPITATIONS AND AN "UNUSUAL REACTION OF THE NERVOUS SYSTEM." THERE IS NO REPORT OF SERIOUS INJURY OR DEATH.

CyberKnife — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A PATIENT CONTACTED ACCURAY AND PROVIDED THE FOLLOWING INFORMATION: HAD CYBERKNIFE TREATMENT IN 2014 AT (B)(6) HOSPITAL. SHORTLY AFTER THE TREATMENT THE I HAD URINARY INCONTINENCE FOLLOWED BY LATER FECAL INCONTINENCE. BOTH ARE UNCONTROLLABLE. THERE ARE SURGERIES TO HELP CORRECT THIS PROBLEM HOWEVER I DO NOT WISH TO GO THIS ROUTE AND VERY DISSATISFIED WITH THE OUTCOME.

CyberKnife — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A CLINICAL RESEARCH SITE REPORTED THAT STUDY PT (B)(6) RECEIVED CYBERKNIFE TREATMENT FOR PROSTATE CANCER ON (B)(6) 2009. IN (B)(6) 2013, THE PT WAS DIAGNOSED WITH A GRADE 3 PAPILLARY BLADDER TUMOR.

CyberKnife — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A PT ENROLLED IN A NON ACCURACY SPONSORED STUDY, UNDER (B)(4) OVERSIGHT, EXPERIENCED COMPLICATIONS. THE PT EXPERIENCED PELVIC PAIN AND PROSTATE SLOUGHING AND UNDERWENT A CYSTOPROSTATECTOMY. THE PHYSICIAN INDICATED THERE WAS NO MALFUNCTION OF THE DEVICE. DUE TO THE NATURE OF THE FOLLOW UP INTERVENTION, AND THE LACK OF RELATED DETAILS, THIS IS BEING REPORTED.

CyberKnife — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: COMPLICATIONS WERE DESCRIBED IN A ORAL PRESENTATION (B)(6). ACCURAY PREVIOUSLY CONTACTED THE PHYSICIAN AND CONFIRMED THAT THE REPORTED COMPLICATIONS WERE NOT DUE TO A MALFUNCTION OF THE CYBERKNIFE SYS. THE PTS HAD RECEIVED PRIOR RADIOTHERAPY AND WERE UNDERGOING RE-IRRADIATION BY THE CYBERKNIFE SYS IN AN ATTEMPT TO CONTROL RECURRENT DISEASE. DUE TO THE NATURE AND EXTENT OF DISEASE, CYBERKNIFE TREATMENT WAS THE ONLY TREATMENT OPTION FOR THE PTS IN THE STUDY. THE TOXICITIES EXPERIENCED BY THE PTS ARE KNOWN TO BE ASSOCIATED WITH RE-IRRADIATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON 26-NOV-2020, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF THE GENERAL THORACIC AND CARDIOVASCULAR SURGERY ARTICLE TITLED, ¿IS LEFT-SIDE DAVINCI PROCEDURE CHALLENGING? INITIAL EXPERIENCES OF A SINGLE INSTITUTE.¿ WITHIN THE ARTICLE, THE FOLLOWING IS NOTED: CASE #2 INVOLVED A 66-YEAR OLD FEMALE PATIENT WITH STAGE 1A CANCER WHO UNDERWENT A DA VINCI-ASSISTED LEFT UPPER LOBECTOMY PROCEDURE ON AN UNSPECIFIED DATE. THE CAUSE OF THE CONVERSION PER TABLE 3 IN THE ARTICLE WAS AN ¿INJURY OF AORTA.¿ ¿IN CASE 2, THE AORTA WAS PARTIALLY STAPLED UPON DIVIDING THE INTERLOBAR FISSURE BETWEEN THE APICO-POSTERIOR SEGMENT OF THE LEFT UPPER LOBE AND THE APICAL SEGMENT OF THE LEFT LOWER LOBE, WHICH WAS REPAIRED BY END-TO-END ANASTOMOSIS UNDER BYPASSING WITH EXTRACORPOREAL MEMBRANOUS OXYGENATION. IN BOTH CASES CONVENTIONAL ENDOSCOPIC STAPLING DEVICES WERE EMPLOYED.¿ THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED IN RELATION TO THE REPORTED EVENT. FURTHERMORE, IT WAS NOTED IN REFERENCE TO CASE #2 (AND CASE #1), "IN BOTH CASES, CONVENTIONAL ENDOSCOPIC STAPLING DEVICES WERE EMPLOYED." ADDITIONALLY, THE ARTICLE STATES THE FOLLOWING: "WE EXPERIENCED TWO C

CyberKnife — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A PT TREATED FOR A MID-PARENCHYMAL LEFT LOWER LOBE MASS EXPERIENCED A COLLAPSE OF THE LEFT LOWER LOBE EIGHT MONTHS AFTER TREATMENT. THIS EVENT IS CONSIDERED A KNOWN RISK OF TREATING SUCH A TUMOR IN THIS LOCATION AND IS NOT ATTRIBUTED TO MALFUNCTION OF THE CYBERKNIFE SYSTEM. THE PT HAS DEMONSTRATED FAVORABLE RESPONSE TO TREATMENT WITH MARKED REGRESSION IN TUMOR SIZE AND IMPROVED CONTROL OF DISEASE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON 26-NOV-2020, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF THE GENERAL THORACIC AND CARDIOVASCULAR SURGERY ARTICLE TITLED, ¿IS LEFT-SIDE DAVINCI PROCEDURE CHALLENGING? INITIAL EXPERIENCES OF A SINGLE INSTITUTE.¿ WITHIN THE ARTICLE, THE FOLLOWING IS NOTED: CASE #1 INVOLVED A 48-YEAR OLD FEMALE PATIENT WITH STAGE 1B CANCER WHO UNDERWENT A DA VINCI-ASSISTED LEFT UPPER LOBECTOMY PROCEDURE ON AN UNSPECIFIED DATE. THE CAUSE OF THE CONVERSION PER TABLE 3 IN THE ARTICLE WAS AN ¿INJURY OF PA¿ (PULMONARY ARTERY).¿IN CASE 1, THE CAUSE OF CONVERSION WAS UNCONTROLLABLE BLEEDING FROM AN INJURY TO THE LINGUAL SEGMENTAL PULMONARY ARTERY DURING STAPLING OF THE INCOMPLETE INTERLOBAR FISSURE.¿ FURTHERMORE, IT WAS NOTED IN REFERENCE TO CASE #1 (AND CASE #2) "IN BOTH CASES, CONVENTIONAL ENDOSCOPIC STAPLING DEVICES WERE EMPLOYED." ADDITIONALLY, THE ARTICLE STATES THE FOLLOWING: "WE EXPERIENCED TWO CONVERSIONS IN STAPLING THE FISSURE OF THE LEFT UPPER LOBE. BOTH CONVERSIONS WERE CAUSED BY FAILURE TO CONFIRM THAT THE TIP OF THE STAPLER WAS FREE FROM THE ADJACENT STRUCTURES. THIS IS PARTLY ATTRIBUTABLE TO THE SPECIFIC CHARACTERISTICS OF THE 30 DEGREE ANGLED SCOPE: IT IS DIFFICULT TO OBSERVE LATERALLY U

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: UROLOGIST CALLED TO REPORT PROBLEMS WITH ROBOTIC EQUIPMENT. THE UROLOGIST HAD TO CONVERT THE ROBOTIC PROSTATECTOMY CASE TO OPEN WHEN THE SYSTEM STOPPED WORKING. THE NEXT WEEK, THE SURGEON HAD TWO ROBOTIC PROSTATECTOMIES. DURING THE FIRST CASE THERE WERE 10 ALARMS WITH THE ERROR #20013, THAT SAID PRESS FAULT OVERRIDE BUTTON. DESPITE THIS PROBLEM THE FIRST CASE WENT AS PLANNED WITHOUT ANY OTHER ISSUES. DURING THE SECOND CASE THE SAME PROBLEM WITH THE FAULT ALARM OCCURRED THREE TIMES; ON THE THIRD TIME THE FAULT DID NOT OVERRIDE. THE MANUFACTURER WAS CONTACTED USING THE DAVINCI HELP NUMBER. WE WERE INSTRUCTED TO UNDOCK THE ROBOT COMPLETELY AND POWER DOWN. I WAS INSTRUCTED TO CHECK SOME CONNECTIONS ON THE CONSOLE, WHICH WERE FINE. THEN WE TURNED ON THE ROBOT AND STARTED AGAIN. WE HAD ANOTHER FAULT THAT WE COULD NOT OVERRIDE, SO I CALLED THE COMPANY AGAIN, HAD THE SURGEON PRESS THE EMERGENCY STOP BUTTON AND THEN FAULT OVERRIDE. THIS WAS TO RELEASE THE INSTRUMENTS' GRASPS ON THE TISSUE. AT THAT TIME THERE WAS A BLEEDER THAT HADN'T FULLY GOTTEN UNDER CONTROL BECAUSE THE ROBOT WAS FROZEN. THERE WERE THREE MORE FAULTS BEFORE WE HAD ANOTHER IRRECOVERABLE FAULT. THE SURGEON DECIDED TO COMPLET

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 POST A DA VINCI SI THYROIDECTOMY PROCEDURE, THE PATIENT EXPERIENCED NUMBNESS DUE TO RADIAL NERVE DAMAGE.

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 POST A DA VINCI MYOMECTOMY PROCEDURE, THE PATIENT EXPERIENCED NUMBNESS IN HER HANDS AND FINGERS AND SHARP PAIN AND TINGLING IN HER LEGS. PER THE SURGEON THAT PERFORMED THE OPERATION, THE MYOMECTOMY PROCEDURE TOOK LONGER THAN ANTICIPATED, APPROXIMATELY 5 HOURS, WITH THE PATIENT IN THE TRENDELENBURG POSITION. PER THE OPERATIVE REPORT THE PATIENT TOLERATED THE ENTIRE PROCEDURE WELL WITH GOOD HEMOSTASIS AND MINIMAL BLOOD LOSS.

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 APPROXIMATELY 45 MINUTES INTO A DA VINCI PROSTATECTOMY PROCEDURE, WHILE THE SURGEON WAS PERFORMING A DISSECTION, THE MONOPOLAR FOOT PETAL WAS PRESSED, HOWEVER, THE BIPOLAR ENERGY BECAME ACTIVATED. THE BIPOLAR INSTRUMENT WAS HOLDING TISSUE AND CREATED A SUPERFICIAL LACERATION TYPE BURN TO THE PATIENT'S BOWEL. A GENERAL SURGEON REVIEWED THE INJURY AND DETERMINED THAT THE BURN WAS NOT THROUGH AND THROUGH AND DID NOT REQUIRE REPAIR, HOWEVER, THE SURGEON PLACED ONE SUTURE IN THE PATIENT'S BOWEL AS A PRECAUTION. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH THE SAME EQUIPMENT AND NO FURTHER INSTANCES OF THE EVENT WAS 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 SI PROSTATECTOMY PROCEDURE, THE PHYSICIAN AT THE SURGEON SIDE CONSOLE INTERMITTENTLY FELT A SHOCK IN HIS FINGERTIPS FROM THE RIGHT MASTER TOOL MANIPULATOR (MTMR). THE SURGEON SWITCHED TO THE SITE'S SECOND SURGEON SIDE CONSOLE TO COMPLETE THE PLANNED PROCEDURE AND NO FURTHER OCCURRENCES OF SHOCK WERE REPORTED. NO HARM TO THE PHYSICIAN OR PATIENT WAS 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 APPROXIMATELY 2.5 HOURS INTO A DA VINCI SI HYSTERECTOMY PROCEDURE, THE SURGEON BEGAN TO INITIATE A TOOL CHANGE TO SWITCH INSTRUMENTS. AT THIS TIME THE NURSE ASSISTANT WHO WAS RETRACTING THE PATIENT'S UTERUS, DROPPED THE UTERUS CAUSING THE SURGEON TO LOSE SITE OF THE TENNACULUM FORCEPS INSTRUMENT IN USE. THE PATIENT SIDE MANIPULATOR (PSM) ARM THAT THE TENNACULUM FORCEPS INSTRUMENT WAS INSTALLED ON BECAME UNRESPONSIVE. THE ISI REPRESENTATIVE ONSITE HAD THE SURIGCAL STAFF EMERGENCY STOP THE SYSTEM AND PERFORM A FAULT OVER-RIDE, HOWEVER, THE PSM CONTINUED TO BE UNRESPONSIVE. THE PATIENT'S UTERUS WAS MOVED, AND THE SURGICAL STAFF FOUND THAT THE TENNACULUM FORCEPS INSTRUMENT WAS CLOSED ON THE PATIENT'S RECTUM AND THEY WERE UNABLE TO RELEASE THE INSTRUMENT. WITH THE ASSISTANCE OF AN ISI TECHNICAL SUPPORT ENGINEER, THE INSTRUMENT WAS RELEASED AND REMOVED FROM THE PSM. A GENERAL SURGEON WAS REQUESTED TO ATTEND THE PROCEDURE AND ALTHOUGH THERE WERE NO VISIBLE HOLES, TEARS, OR PINCHES IN THE PATIENT'S RECTUM, HE PLACED A FEW SUTURES AS A PRECAUTION. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH OUT ANY FURTHER PATIENT HARM, INJURY OR ADVERSE OUTCOME 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 WHILE MOBILIZING THE LEFT INTERNAL MAMMARY ARTERY DURING A DA VINCI S CABG PROCEDURE, THE MICRO BIPOLAR FORCEPS (MBF) INSTRUMENT JUMPED FORWARD AND PUNCTURED THE PATIENT'S ARTERY. THE DAMAGED SECTION OF THE ARTERY WAS TRANSECTED AND THE HEALTHY PORTION OF THE ARTERY WAS USED TO COMPLETE THE BYPASS. IT WAS ALSO REPORTED THAT THROUGHOUT THE CASE, PNEUMO WAS ESTABLISHED AND LOST SEVERAL TIMES. THE ISI REPRESENTATIVE PRESENT DURING THE PROCEDURE INDICATED THAT PRIOR TO THE MBF INSTRUMENT JUMP, THE SURGEON NOTED THAT WHEN THE MASTER TOOL MANIPULATOR WAS MOVED, THE INSTRUMENT FELT STUCK AND THEN MOVED. IT IS BELIEVED THAT THE SURGEON CAUGHT THE MBF INSTRUMENT IN THE PATIENT'S RIB. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUES OR PATIENT HARM.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED BY THE PT THAT SHE RECENTLY HAD A DA VINCI HYSTERECTOMY PROCEDURE AND WAS UNDER ANESTHESIA FOR 8 HOURS INSTEAD OF THE EXPECTED 4 HOURS DUE TO HER BEING SEVERELY OVERWEIGHT. SHE STATED THAT SHE WOKE UP AND WAS UNABLE TO MOVE EITHER OF HER ARMS, HOWEVER, AFTER TIME, SHE WAS ABLE TO GET FULL USE OF HER LEFT ARM. SHE STATED HER RIGHT ARM IS STILL IN A LOT OF PAIN.

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 DAY FOLLOWING A SUCCESSFUL DA VINCI SI PROSTATECTOMY PROCEDURE, THE PT DEVELOPED COMPARTMENT SYNDROME IN THEIR RIGHT ARM. A SURGICAL PROCEDURE WAS PERFORMED TO RELIEVE PRESSURE TO THE PT'S AFFECTED AREA. NO ADD'L PT HARM, ADVERSE OUTCOME OR INJURY WAS 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: ON SEPTEMBER 18, 2009, A REUTERS ARTICLE TITLED "MEDICAL SOCIETIES PUSH STANDARDS FOR ROBOTIC SURGERY" WAS PUBLISHED. THE ARTICLE INCLUDES QUOTES FROM DR. KEVIN ZORN AND MENTIONS HIS RECOUNT OF A CASE WHERE A PATIENT DIED POST A DA VINCI PROSTATECTOMY PROCEDURE: "HE RECOUNTED ONE CASE OF A SURGEON WHO WAS USING THE SYSTEM FOR THE FOURTH TIME. AFTER EIGHT HOURS OF SURGERY, THE PROCTOR -- AN EXPERIENCED SURGEON WHO SUPERVISES THE OPERATION -- TOLD THE SURGEON THAT PROGRESS WAS TOO SLOW. HE RECOMMENDED THE SURGEON SWITCH TO CONVENTIONAL SURGERY, WHERE AN INCISION IS MADE FROM THE NAVEL TO THE PUBIC BONE TO ACCESS THE PROSTATE. AFTER THE PROCTOR LEFT THE OPERATING ROOM, THE SURGEON CONTINUED USING THE ROBOT. THE PATIENT LATER DIED FROM COMPLICATIONS." ON SEPTEMBER 29, 2009, UPON FOLLOWING UP, IT WAS DISCOVERED THAT ANOTHER DR WAS THE PROCTOR.

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 TOWARD THE END OF A DA VINCI S SACRALCOPOPEXY PROCEDURE, THE CONSOLE SURGEON EXPERIENCED USER MESSAGE "LIGHTEN GRIP". THE CONSOLE SURGEON ATTEMPTED TO TROUBLESHOOT THE SYSTEM ERROR BY RELEASING THE GRIPS ON THE MASTER TOOL MANIPULATORS (MTM); HOWEVER, THE SYSTEM ERROR PERSISTED. THE CONSOLE SURGEON THEN PLACED THEIR HEAD BACK INTO THE HIGH RESOLUTION STEREO VIEWER (HSRV) LOCATED ON THE SURGEON'S CONSOLE AND ACCIDENTLY CLUTCHED AND CHANGED CONTROL OF THE PATIENT SIDE MANIPULATOR (PSM) FROM PSM 2 TO PSM 3. THE SURGEON WAS UNCLEAR WHY THE INSTRUMENT ON THE PSM 2 WAS NOT MOVING WHEN SHE NOTICED THAT SHE HAD ACCIDENTLY CLUTCHED AND GAINED CONTROL OF THE INSTRUMENT IN PSM 3. AT THIS POINT, THE SURGEON HAD ALREADY MOVED PSM 3 WITH INSTRUMENT DOWN CAUSING THE INSTRUMENT TO MAKE CONTACT AND INJURING THE PATIENT'S SACRAL. THE CASE WAS CONVERTED TO A TRADITIONAL OPEN PROCEDURE AND THE PATIENT'S INJURY WAS REPAIRED AND THE PROCEDURE WAS COMPLETED. AS OF 2009, THE PATIENT WAS REPORTED AS DOING WELL WITH NO FURTHER ISSUES.

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 4 DAYS POST OP, A DA VINCI SI HYSTERECTOMY PROCEDURE, A 5MM PERFORATION OF THE PT'S BOWEL WAS OBSERVED DURING A LAPAROSCOPIC COLOSTOMY PROCEDURE. IN 2009, THE SURGEON PROVIDED THE FOLLOWING ADDITIONAL INFO: PRE-OPERATIVELY, THE PT EXPERIENCED COMPLICATIONS OF SEVERE BOWEL IMPACTION (HARD STOOL) THROUGHOUT THE ENTIRE LARGE INTESTINE DUE TO DIVERTICULOSIS. THE PT'S BOWEL WAS INFUSED WITH AN ENEMA AND CONTRAST ALL THE WAY TO THE CECUM TO AID IN THE MOVEMENT OF THE PT'S BOWEL. IN ADDITION, THE PT HAD A COLOSTOMY TUBE THAT PRESENTED LEAKAGE THUS CAUSING THE PT TO DEVELOP AN INFECTION. IT IS UNK HOW DAMAGE TO THE PT'S BOWEL OCCURRED; HOWEVER, THE PERFORATION MAY HAVE BEEN INTRODUCED DURING THE ENEMA AND CONTRAST PROCEDURE. THE PT REMAINS HOSPITALIZED AS OF THE SAME DAY. IN ADDITION, THE INFECTION IS UNDER CONTROL AND THE PT IS REPORTED TO BE DOING WELL.

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 POST A DA VINCI S THYROIDECTOMY PROCEDURE, THE PATIENT EXPERIENCED NUMBNESS, DUE TO RADIAL NERVE DAMAGE.

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 S HYSTERECTOMY PROCEDURE, THE SURGEON ACTIVATED THAT MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WHILE IT WAS OUT OF THEIR FIELD OF VIEW AND ACCIDENTLY LACERATED THE PATIENT'S RIGHT EXTERNAL ILIAC ARTERY. THE PLANNED SURGICAL PROCEDURE WAS CONVERTED TO AN OPEN PROCEDURE AND THE DAMAGE TO THE PATIENT'S ARTERY WAS REPAIRED USING A PRIMARY CLOSURE TECHNIQUE. THE PATIENT WAS REPORTED TO BE DOING WELL AND HAS NOT EXPERIENCED ANY POST OPERATIVE COMPLICATIONS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IN 2008, IT WAS REPORTED THAT AFTER A SUCCESSFUL DA VINCI S MITRA VALVE REPAIR PROCEDURE, THE PT DEVELOPED COMPLICATIONS RELATED TO A HEPARIN INDUCED THROMBOCYTOPENIA. AS A RESULT, THE PT'S LEG WAS AMPUTATED. NO ADDITIONAL INFO HAS BEEN PROVIDED BY THIS SITE DESPITE ATTEMPTS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING A ROBOTIC DAVINCI CASE THE INSTRUMENT ARM GRASPER BROKE INSIDE PT, BUT STAYING INTACT. AFTER COMPLETION OF CASE A CUTDOWN WAS PERFORMED AT THE INCISION SITE ALLOWING REMOVAL OF INSTRUMENT. OP REPORT: INSTRUMENT THROUGH 3RD DAVINCI ARM SNAPPED AT LEVEL OF PORT AND GIVEN ANGULATION; WAS DIFFICULT TO REMOVE THROUGH POA. AT THE END OF THE CASE, ARM WAS MANIPULATED AND INSTRUMENT WAS PULLED ALONG WITH ARM AFTER EXTENDING INCISION BY 2-3CM. PELVIC CAVITY WAS IRRIGATED, FRAGMENTS FROM INSTRUMENT SHEATH WERE REMOVED.

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 THREE DAYS AFTER A SUCCESSFUL DA VINCI S HYSTERECTOMY PROCEDURE, THE PT WAS RE-ADMITTED TO THE HOSP WITH A TEMPERATURE AND PERITONITIS SYMPTOMS. TWO DAYS AFTER BEING ADMITTED, A DIAGNOSTIC LAPAROSCOPY PROCEDURE WAS PERFORMED, RESULTING IN THE DISCOVERY OF EIGHT SITES ON THE PT'S SIGMOID COLON NEEDING OVER SEWING. SIX OF THE EIGHT SITES WERE IDENTIFIED AS THERMAL BURNS. NO ADDITIONAL PT HARM, ADVERSE OUTCOME OR INJURY WAS 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 POST A DA VINCI HYSTERECTOMY PROCEDURE, THE PT DEVELOPED RIGHT SHOULDER PARALYSIS. REPORTEDLY, PRIOR TO STARTING THE PLANNED SURGICAL PROCEDURE, THE SITE EXPERIENCED DIFFICULTIES PLACING THE PT IN THE TRENDELENBURG POSITION AND THE PT EXPERIENCED LABORED BREATHING.

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 POST A DA VINCI S SACROCOLPOPEXY PROCEDURE, THE PT DEVELOPED DEEP VIN THROMBOSIS (DVT). NO ADDITIONAL PT HARM OR ADVERSE OUTCOME WAS 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 POST A DA VINCI S PROSTATECTOMY PROCEDURE, THE PATIENT DEVELOPED BILATERAL LEG NERVE PALSY. NO ADDITIONAL PATIENT HARM OR ADVERSE OUTCOME WAS 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 SURGICAL PROCEDURE, THE ENDOSCOPE TIP BECAME VERY HOT AND BURNT THE PATIENT'S BOWEL. SURGICAL INTERVENTION WAS NOT REQUIRED, AND THE PLANNED PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER ISSUES.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AFTER A DA VINCI HYSTERECTOMY PROCEDURE, DURING THE CYSTOSCOPY, IT WAS FOUND THAT THE PATIENT'S URETER HAD BEEN DAMAGED. THE URETER WAS REPAIRED VIA A URETERONEOCYSTOTOMY PROCEDURE, AND THE PATIENT WAS DISCHARGED TWO DAYS LATER. NO ADDITIONAL PATIENT HARM OR ADVERSE OUTCOME WAS 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 8 DAYS AFTER A DA VINCI S HYSTERECTOMY PROCEDURE, THE PT UNDERWENT AN EXPLORATORY LAPAROSCOPY PROCEDURE WHERE A BOWEL PERFORATION WAS DISCOVERED. THE PERFORATION WAS REPAIRED, HOWEVER, THE PT BECAME SEPTIC DUE TO A BILIOUS FLUID LEAKAGE. THE PT WAS IN CRITICAL CARE FOR 2 WEEKS AND WAS THEN TRANSFERRED TO LONG TERM CARE. NO ADD'L PT HARM OR ADVERSE OUTCOME WAS REPORTED.