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 UNDERGOING A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE, DISSECTION OF THE VAGINAL STUMP WAS PERFORMED, AND TISSUE WAS DAMAGED. ON (B)(6) 2020, INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT THE STUMP OF THE VAGINA WAS INJURED DURING THE PROCEDURE. THE CAUSE OF THE INJURY WAS ATTRIBUTED TO THE SURGEON¿S MISJUDGMENT. THE SURGEON CONFIRMED THAT ANOTHER STITCH SHOULD HAVE BEEN PLACED. IT IS UNKNOWN WHAT MEDICAL INTERVENTION WAS REQUIRED TO REPAIR THE VAGINAL STUMP. ADDITIONALLY, THE SURGEON STATED THAT THE EVENT DID NOT OCCUR AS A RESULT OF THE DA VINCI SURGICAL SYSTEM MALFUNCTION. THE SURGERY WAS COMPLETED AS PLANNED AND THE PATIENT HAS PROGRESSED WELL WITHOUT ANY PROBLEMS.

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 VIA A GENERAL PHYSICIAN INQUIRY THAT AFTER A COMPLETED DA VINCI-ASSISTED GYNECOLOGY PROCEDURE, POSSIBLY ON (B)(6) 2019, PATIENT INJURY WAS REPORTED. THE PATIENT RETURNED TO THE HOSPITAL SIX TO SEVEN DAYS POST DA VINCI PROCEDURE, POSSIBLY ON (B)(6)2019, FOR WHAT WAS DESCRIBED AS ¿REPAIR¿ AS THERE WAS AN OBSERVED ¿TROCAR INJURY¿ AND ¿BOWEL NECROSIS¿. FURTHER DETAIL WAS UNKNOWN. THE PATIENT¿S CURRENT STATUS IS ALSO UNKNOWN.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WHILE USING THE MAZOR NAVIGATION / ROBOTIC SYSTEM LEFT SIDE SCREWS OF A SPINAL FUSION WERE IN PLACE. THE RIGHT SIDED SCREWS WERE MEDIAL DISPLACED AND REQUIRED RE POSITIONING. 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: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

At 8:30 p.m. on November 14, 2019, an employee was working for a firm that made medical and surgical instruments. She supervised mechanics and repair technicians. She was working in the facility's HA department, where the HA1 and HA2 robotic work cells were located. She was changing out a plasma spray gun from the HA2 robot. The robot was still energized. It had not been locked out. As she was loosening a bolt to detach the plasma spray gun from the robot, the wrench she was using contacted a metal fitting on the spray gun water line. An arc flash ensued. The employee received second-degree burns on two fingers on her left hand and on her right wrist. She was treated without hospitalization. The employee had not been trained on lockout or the use of padlocks. The interlocked access doors to the cell were equipped with a limit switch that did not deenergize the robot or the spray gun. The employee entered the cell two to three times daily. A risk assessment had not been performed. The employer was not enforcing energy control procedures.

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.

At 8:35 p.m. on October 22, 2019, an employee working for a plastics plumbing fixtures manufacturer was receiving parts from a robot press machine. The robot press struck the employee in the head. The employee lacerated his head and sustained a concussion, requiring hospitalization.

At 8:00 a.m. on October 16, 2019, an employee was working on the paint line in Section 1200 and entered into an area that was chained off with LOTO signs to free a jammed pallet. The employee was struck by a fiber concrete board that was rejected by a Guidel Gantry Systems Robot and crushed between it and a stack of other rejected boards, killing him.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE SYSTEM PLACED SCREWS AT LL AND L4 ACCURATELY, BUT L2 AND L3 WERE WAY OFF. ACCORDING TO THE LOCAL TEAM, THE SURVEILLANCE WAS FINE AND THE MERGE WAS ACCEPTABLE. THE PATIENT IS DOING WELL BUT HAD A SMALL DURAL SCRATCH WHICH WAS REPAIRED INTRA-OPERATIVELY WITH NO SERIOUS LONG-TERM EFFECT TO THE PATIENT.

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 ALL OF THE SCREWS WERE NOT TO PLAN. ALL OF THE LEFT SIDE SCREWS WERE IN THE SPINAL CANAL AND THE RIGHT HAND SCREWS WERE LATERAL TO PLAN. PRIOR TO THE PROCEDURE, A 10 POINT ACCURACY CHECK WAS DONE AND THE GUIDANCE SYSTEM WAS ACCURATE ON ALL TRAJECTORIES. A SURGICAL ARM AND SHOULDER CHECK WERE ALSO DONE AND BOTH PASSED. THE TRAJECTORIES WERE PLANNED BY THE SURGEON AND THE C-ARM WAS CALIBRATED. THE GUIDANCE SYSTEM WAS PLACED ON THE BED AND DRAPED AS NORMAL. DURING THE PROCEDURE, EXPOSURE AND MARKING FILMS WERE DONE BEFORE THE SURGICAL SYSTEM WAS ATTACHED TO THE PATIENT. EXPOSE WAS GENEROUS AND THERE WERE NO ISSUE WITH SOFT TISSUE PRESSURE. A DUAL CLAMP WAS USED AT T4 AND T5. THE CONSTRUCT WAS RIGID BEFORE THE GUIDANCE SYSTEM WAS PLACED TO ATTACH TO THE CLAMP. A 3DEFINE SCAN AND DRAW SPINE WERE THEN COMPLETED. REGISTRATION WAS COMPLETED WITH TWO AP AND TWO OBLIQUE SHOTS. DURING IMAGING, RESPIRATION WAS SUSPENDED TO AVOID AN CROSS VIEW ERRORS. SEGMENTATION WAS ACHIEVED ON FIRST ATTEMPT AT LABELING AND ALL TRAJECTORIES WERE GREEN. REGISTRATION WAS APPROVED BY THE SURGEONS

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT IS REPORTED THAT DURING KNEE ARTHROPLASTY WHEN THE SURGEON WAS VALIDATING THE TIBIAL CUTS, THE SYSTEM WAS STATING THAT NOT ENOUGH WAS CUT PER THE PLAN AND THE ROD SHOWED BAD ALIGNMENT. THE SURGEON MADE ADDITIONAL CUTS TO BRING THE TIBIA INTO NEUTRAL ALIGNMENT WHEN HE SWITCHED TO CONVENTIONAL INSTRUMENTATION.

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 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 (B)(6) 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. THIS PI IS FOR MULTIPLE I&D¿S WHILE HOSPITALIZED.

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 STEALTH EDITION CAMERA UPGRADE WAS PERFORMED THIS PAST FRIDAY. THE 4.2 SOFTWARE HAD BEEN INSTALLED FOR A FEW MONTHS. STEALTH EDITION WAS NOT USED FOR THIS CASE. THE PATIENT WAS PLACED IN THE LATERAL POSITION FOR LATERAL PROCEDURE WITH THE LEFT SIDE UP. A SCHANZ PIN WAS PLACED IN LEFT PSIS AND 3DEFINE ATTEMPT WAS SUCCESSFUL. THE ARM WAS THEN SENT TO DRAPE FOR DRAW SPINE, BUT AN ERROR MESSAGE INDICATED THAT DRAPE POSITION WAS UNREACHABLE. THE 3D WORKING VOLUME WAS THOUGHT TO HAVE BEEN THE REASON FOR THIS. THE ARM WAS REMOUNTED WITH THE ELBOW JOINT ANGLE ADJUSTED SLIGHTLY. THE SECOND 3DEFINE WAS SUCCESSFUL AND THE ARM WAS SUCCESSFULLY SENT TO DRAPE MODE. DRAW SPINE WAS SUCCESSFUL. 3D MARKER SENT TO AP. THE 3D MARKER WAS ADJUSTED ANTERIOR TO BETTER CAPTURE THE AP. ERROR 295 APPEARED WHEN ATTEMPTING TO SEND THE ARM TO TAKE OBL IMAGE: ¿OBL POSITION IS UNREACHABLE. CONSIDER RE-DRAWING SPINE USING A DIFFERENT VERTEBRAL BODY.¿ THE ARM WAS MANIPULATED POSTERIOR AND THEN SUCCESSFULLY SENT TO THE OBL I

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 THAT DURING AN INITIAL KNEE SURGERY, METAL SHAVINGS WERE NOTICED WHEN DRILLING A TROCHAR PIN THROUGH ONE OF THE HOLES OF THE CUT GUIDE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: NO ADDITIONAL INFORMATION REPORTED.

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 SURGEON PERFORMED AN L3-5 LATERAL MAZOR X CASE. PREPLANNING WAS DONE WITH THE SURGEON PRIOR TO THE PROCEDURE. SPECIAL ATTENTION WAS PAID TO AXIAL ANGLES AND SKIVE POTENTIALS. L3-5 OLIF WAS PERFORMED PRIOR TO USING THE MAZOR X. THE PATIENT WAS POSITIONED FOR A LATERAL PROCEDURE. THE SCHANZ PIN WAS PLACED IN LEFT PSIS. AND THE SCHANZ ARM WAS ATTACHED. 3DEFINE AND DRAW SPINE WERE SUCCESSFUL. REGISTRATION WAS SUCCESSFUL USING AUTO REGISTRATION AND THE BASIC ALGORITHM. ALL 6 WIRES WERE PLACED STARTING WITH RIGHT L3. ALL RIGHT SIDE TRAJECTORIES WERE INSTRUMENTED PRIOR TO LEFT SIDE TRAJECTORIES. LATERAL CONFIRMATION FLOURO IMAGES WERE TAKEN FOR EACH TRAJECTORY AND APPEARED ACCURATE. A FINAL AP CONFIRMATION SHOWED RIGHT L3 WAS LATERAL. RIGHT L3 WAS ADJUSTED IN THE PLAN AND DRILLED AGAIN. FINAL AP AND LATERAL FLOURO IMAGES WERE TAKEN AND ALL 6 SCREWS APPEARED TO BE PLACED ACCURATELY. THE POST-OP CT SHOWED LEFT SIDE SCREWS MISPLACED MEDIALLY AND RIGHT SIDE SCREWS MISPLACED LATERALLY. UPON CASE COMPLE

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 PLAN FOR THE CASE WAS TO PERFORM A SCAN AND PLAN AND EXECUTE SCREWS AT T11, T12, L2, AND L3. THIS WAS TO BACK UP A L1 BURST FRACTURE. ONCE THE SURGEON EXPOSED THE REGION OF INTEREST, THE REP SUGGESTED USING THE DUAL CLAMP AND CLAMPING AT T12 AND L2 SPINOUS PROCESSES. THIS WAS TO AVOID THE INSTABILITY OF L1. THE DUAL CLAMP WAS PLACED, 3DEFINE PERFORMED, SNAPSHOT TAKEN AND THEN STAR MARKER PLACED. DUE TO THE SIZE OF THE PATIENT AND HEIGHT OF THE DUAL CLAMP, IT TOOK THREE SPINS OF THE O-ARM TO ACHIEVE REGISTRATION. SCREWS WERE THEN PLANNED AND REVIEWED WITH THE SURGEON. THORACIC SCREWS WERE PLANNED BETWEEN 8-10 DEGREES OFF MIDLINE TO ACCOUNT FOR ANY SOFT TISSUE PROBLEMS, WITH LUMBAR SCREWS PLANNED SLIGHTLY MORE LATERAL. THE REP NOTED THE SMALL PEDICLES TO THE SURGEON AND ASKED IF THEY WOULD LIKE TO ADJUST TO 4.5MM SCREWS AND THEY OPTED TO KEEP THEM AT 5.5MM. THE SCREWS WERE THEN EXECUTED STARTING WITH T11 ON THE RIGHT AND WORKING DOWN, FOLLOWED BY T11 ON THE LEFT AND WORKING DOWN. NAVIGATION S

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 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 (B)(6) 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. ON (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. THIS PI IS FOR REVISION OF 1ST REVISION.

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 — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED VIA SOCIAL MEDIA (I.E. (B)(6) POST) THAT A PATIENT UNDERWENT AN UNSPECIFIED DA VINCI-ASSISTED ¿BIOPSY¿ PROCEDURE AND ALLEGEDLY EXPERIENCED OPERATIVE COMPLICATIONS. PER THE INITIAL (B)(6) POSTING, THE FOLLOWING WAS NOTED: ¿MY FATHER DIED TWO YEARS AGO WHEN A DAVINCI-AIDED BIOPSY CAUSED MASSIVE BLEEDING. HE MADE ME PROMISE I WOULD NOT SUE. HE DID NOT MAKE ME PROMISE I WOULD NOT TALK ABOUT IT.¿ ON (B)(6) 2019, THE INITIAL REPORTER POSTED THE FOLLOWING SUBSEQUENT (B)(6) POSTING: ¿(B)(6). YOU CAN TAKE IT FROM THERE.¿ REFER TO THE FOLLOWING LINK FOR THE (B)(6) POSTINGS: "(B)(6)".

At 7:00 p.m. on March 21, 2019, an employee was realigning robot arm and ring on Press #30. The employee's hand was in the machinery when the ejector plate/ring retracted into the press which caught the employee's left hand between the mold and the ring. The employee suffered fingertip amputations to the index and middle fingers on his left-hand. Hospitalization was not required.

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 INITIALLY REPORTED THAT AFTER UNDERGOING A DA VINCI-ASSISTED NISSEN FUNDOPLICATION PROCEDURE, A PUNCTURE WOUND WAS FOUND ON THE PATIENT'S SIGMOID COLON. THE PATIENT WAS REPORTEDLY STILL IN THE HOSPITAL. ON (B)(4) 2019, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT WAS OBTAINED: THE CSR WAS PRESENT DURING THE DA VINCI-ASSISTED NISSEN FUNDOPLICATION PROCEDURE WHICH WAS NOT RECORDED ON VIDEO. NO INTRA-OPERATIVE COMPLICATIONS WERE IDENTIFIED. THERE WERE ALSO NO REPORTS OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. THE SURGICAL PROCEDURE WAS COMPLETED ROBOTICALLY. ON POST-OPERATIVE DAY #1, THE PATIENT HAD COMPLAINTS OF ABDOMINAL PAIN. THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM (OR) AND A PUNCTURE WOUND ON THE SIGMOID COLON WAS IDENTIFIED. A BOWEL RESECTION WAS PERFORMED BY A COLORECTAL SURGEON TO ADDRESS THE BOWEL INJURY. ON AN UNSPECIFIED DATE POST-OPERATIVELY, THE CSR WAS INFORMED THAT THE PATIENT ULTIMATELY EXPIRED. THE CSR SPOKE TO THE SURGEON ABOUT THE POST-OPERATIVE COMPLICATION (I.E. BOWEL INJURY). ACCORDING TO THE CSR, THE SURGEON DID NOT K

At 3:15 p.m. on January 30, 2019, an employee was working at a full-service restaurant. She was operating a Robot Coupe food processor. She was feeding a piece of cabbage into the chute of the food processor. As she was aligning the piece, her finger was caught and sucked into the chute. Her finger came into contact with the blade. The tip of the middle finger on her right hand was amputated. She was hospitalized.