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.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE COMPANY CLINICAL REPRESENTATIVE WAS INFORMED BY EMAIL THAT THE ROSA PUSHED ON THE PATIENT SKIN. THIS HAPPENED DURING THE REGISTRATION VALIDATION. ACCORDING TO THE DESCRIPTION OF THE SURGEON IT WAS DURING A COOPERATIVE MOVE TO CHECK THE ACCURACY OF THE FOREHEAD. THE SURGEON PLACED THE POINTER ON THE FOREHEAD AND THE ARM MOVED DOWN AND IT WAS ONLY WITH A LOT OF FORCE POSSIBLE TO GET THE ARM MOVED AWAY FROM THE PATIENT HEAD. THE REGISTRATION WAS ABORTED AND REDONE. DURING THE SECOND TIME, THE SYSTEM WAS WORKING NORMAL. THE SURGERY WAS CONTINUED. THERE WAS APPROXIMATELY 45 MINUTES DELAY, AND THE PATIENT EXHIBITED A RED PRESSURE MARK AFTER SURGERY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING REVIEW OF A LITERATURE ARTICLE INVOLVING DA VINCI ASSISTED ROBOTIC PROCEDURES TITLED ¿FIRST REPORT COMPARING THE TWO TYPES OF SINGLE-INCISION ROBOTIC SACROCOLPOPEXY: SINGLE SITE USING THE DA VINCI XI OR SI SYSTEM AND SINGLE PORT USING THE DA VINCI SP SYSTEM¿ , THE FOLLOWING EVENTS WERE REPORTED. THE ARTICLE INCLUDED 48 PATIENTS WHO UNDERWENT SINGLE-SITE ROBOTIC SACROCOLPOPEXY (SS-RSC) USING DA VINCI SI OR XI SYSTEM FOR SYMPTOMATIC APICAL PELVIC ORGAN PROLAPSE QUANTIFICATION (POP-Q) STAGE III-IV BETWEEN NOVEMBER 2015 AND SEPTEMBER 2019 AND 8 PATIENTS WHO UNDERWENT SINGLE-PORT ROBOTIC SACROCOLPOPEXY (SP-RSC) USING DA VINCI SP SYSTEM DURING JANUARY 2019. THE OPERATIVE TIME WAS COMPARABLE BETWEEN SS-RSC AND SP-RSC GROUPS. SIGNIFICANT DIFFERENCES WERE NOTED IN THE DOCKING AND CERVIX SUTURING TIMES BETWEEN THE TWO GROUPS (P < 0.05). THESE WERE LONGER IN THE SS-RSC GROUP THAN IN THE SP-RSC GROUP (5.0 ± 2.6 MIN VS 2.3 ± 1.3 MIN, P < 0.001; 4.5 ± 1.8 MIN VS 2.1 ± 1.9 MIN, P < 0.01, RESPECTIVELY). THE MEAN ESTIMATED BLOOD LOSS (EBL) WAS COMPARABLE AND BELOW 75.0 ML IN THE SS-RSC AND SP- RSC GROUPS (51.9 ± 33.7 ML VS 71.3 ± 41.2 ML). INTRAOPERATIVELY, THERE WAS NO TRANSFUSION OR CONVER

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE PATIENT WAS HAVING A REVISION SURGERY DUE TO A SCREW BEING PLACED INFERIORLY DURING A PROCEDURE ON (B)(6) 2020. THE S1 SCREW WAS DEVIATED. THE MANUFACTURER REPRESENTATIVE NOTED THAT IT WAS UNKNOWN HOW THE PLACEMENT BECAME INFERIOR AS ALL OTHER SCREW PLACEMENTS WERE NOTED TO BE FINE AND THERE WERE NO ISSUES WITH SKIVING OF THE SCREW. THE PROCEDURE WAS NOT DELAYED.

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 REVIEW OF A LITERATURE ARTICLE INVOLVING DA VINCI ASSISTED ROBOTIC PROCEDURES TITLED ¿FIRST REPORT COMPARING THE TWO TYPES OF SINGLE-INCISION ROBOTIC SACROCOLPOPEXY: SINGLE SITE USING THE DA VINCI XI OR SI SYSTEM AND SINGLE PORT USING THE DA VINCI SP SYSTEM,¿ THE FOLLOWING EVENTS WERE REPORTED: THE ARTICLE STUDY INCLUDED 48 PATIENTS WHO UNDERWENT SINGLE-SITE ROBOTIC SACROCOLPOPEXY (SS-RSC) USING DA VINCI SI OR XI SYSTEM FOR SYMPTOMATIC APICAL PELVIC ORGAN PROLAPSE QUANTIFICATION (POP-Q) STAGE III-IV BETWEEN NOVEMBER 2015 AND SEPTEMBER 2019 AND 8 PATIENTS WHO UNDERWENT SINGLE-PORT ROBOTIC SACROCOLPOPEXY (SP-RSC) USING THE DA VINCI SP SYSTEM DURING JANUARY 2019. THE OPERATIVE TIME WAS COMPARABLE BETWEEN SS-RSC AND SP-RSC GROUPS. PER THE ARTICLE, THERE WERE "SIGNIFICANT DIFFERENCES WERE NOTED IN THE DOCKING AND CERVIX SUTURING TIMES BETWEEN THE TWO GROUPS (P < 0.05). THESE WERE LONGER IN THE SS-RSC GROUP THAN IN THE SP-RSC GROUP (5.0 ± 2.6 MIN VS 2.3 ± 1.3 MIN, P < 0.001; 4.5 ± 1.8 MIN VS 2.1 ± 1.9 MIN, P < 0.01, RESPECTIVELY). FURTHERMORE, "THE MEAN ESTIMATED BLOOD LOSS (EBL) WAS COMPARABLE AND BELOW 75.0 ML IN THE SS-RSC AND SP- RSC GROUPS (51.9 ± 33.7 ML VS 71.3 ± 41.2 ML)."

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 6:00 a.m. on September 2, 2020, an employee was adjusting a robot used to make molds. The robot activated and struck the employee. The employee was hospitalized to treat fractures to the ribs and back area and a punctured lung.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE FIELD SERVICE ENGINEER (FSE) ATTEMPTED TO BOOT UP ROBOT PRIOR TO SURGERY. ROBOT PC WOULD NOT TURN ON, BUT CONTROLLER STARTED AS EXPECTED. THE FSE OPENED ROBOT AND CONFIRMED THAT ALL CONNECTIONS WERE CONNECTED PROPERLY, AND THAT ALL FUSES APPEARED TO BE INTACT. THE FSE ATTEMPTED TO RE-SEAT MEMORY, MOTHERBOARD, AND CONNECTIONS, BUT WITHOUT CORRECTING THE ISSUE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE ON AN UNKNOWN DATE, THE TIP COVER ACCESSORY OF THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT FELL INTO THE PATIENT'S ANATOMY AND WAS NOT RETRIEVED. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON 10-AUG-AND 19-AUG-2020 AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE EVENT DATE IS UNKNOWN. THE MCS INSTRUMENT WAS INSPECTED PRIOR TO USE. THE MCS TIP COVER ACCESSORY WAS INSTALLED PROPERLY WITH THE INSTALLATION TOOL. THERE WAS NO RESISTANCE FELT UPON REMOVAL OF THE MCS INSTRUMENT THROUGH THE CANNULA. THERE WERE NO ISSUES WITH FUNCTIONALITY OF THE MCS INSTRUMENT AND NO INSTRUMENT COLLISIONS. THE MCS INSTRUMENT WAS IN USE DURING THE WHOLE PROCEDURE. THE MCS TIP COVER ACCESSORY FELL INSIDE OF THE PATIENT AT THE END OF THE PROCEDURE AND IT COULD NOT BE FOUND. IT WAS NOT RETRIEVED. THERE WERE NO POST-OPERATIVE COMPLICATIONS. IT WAS UNKNOWN IF THERE WAS A DELAY IN PROCEDURE. THE PATIENT¿S STATUS WAS "NORMAL." THE PROCEDURE WAS NOT RECORDED ON VIDEO.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE ON AN UNKNOWN DATE, THE TIP COVER ACCESSORY OF THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT FELL INTO THE PATIENT'S ANATOMY AND WAS NOT RETRIEVED. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON 10-AUG-2020 AND 19-AUG-2020 AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE EVENT DATE IS UNKNOWN. THE MCS INSTRUMENT WAS INSPECTED PRIOR TO USE. THE MCS TIP COVER ACCESSORY WAS INSTALLED PROPERLY WITH THE INSTALLATION TOOL. THERE WAS NO RESISTANCE FELT UPON REMOVAL OF THE MCS INSTRUMENT THROUGH THE CANNULA. THERE WERE NO ISSUES WITH FUNCTIONALITY OF THE MCS INSTRUMENT AND NO INSTRUMENT COLLISIONS. THE MCS INSTRUMENT WAS IN USE DURING THE WHOLE PROCEDURE. THE MCS TIP COVER ACCESSORY FELL INSIDE OF THE PATIENT AT THE END OF THE PROCEDURE AND IT COULD NOT BE FOUND OR RETRIEVED. THERE WERE NO POST-OPERATIVE COMPLICATIONS. IT WAS UNKNOWN IF THERE WAS A DELAY IN PROCEDURE. THE PATIENT¿S STATUS WAS "NORMAL." THE PROCEDURE WAS NOT RECORDED ON VIDEO.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE BLADE OF A HARMONIC ACE INSTRUMENT BROKE WHEN IN A PATIENT; IT¿S THE 3RD TIME IT HAPPENED WITHIN THE MONTH. THERE WAS NO REPORT OF PATIENT INJURY. ON (B)(6) 2020, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE CONSOLE SURGEON: DURING A DA VINCI-ASSISTED TOTAL HYSTERECTOMY PROCEDURE, THE TIP OF A HARMONIC ACE INSTRUMENT FELL OFF INTO THE PATIENT WHILE THE SURGEON WAS OPENING A VAGINAL CUFF. THE BROKEN SINGLE PIECE WAS FOUND AND VISUALLY REMOVED WITH A LAPAROSCOPIC GRASPER INSTRUMENT; NO X-RAY WAS NEEDED AS THE FRAGMENT WAS SEEN AND RETRIEVED VISUALLY. THERE WERE NO INTRA-OPERATIVE COMPLICATIONS AND NO MEDICAL INTERVENTION, OTHER THAN FRAGMENT RETRIEVAL, WAS REQUIRED. THE INSTRUMENT DID TOUCH THE PLASTIC OF THE V-CARE MANIPULATOR. THE INSTRUMENT WAS NEVER REMOVED AND IT WAS IN USE INTERMITTENTLY FOR APPROXIMATELY 15 MINUTES PRIOR TO THE ISSUE. THE INSTRUMENT WAS NOT REMOVED AT ANY TIME PRIOR TO THE EVENT. THERE WERE NO POST-OPERATIVE COMPLICATIONS AND THE PATIENT IS RECOVERING APPROPRIATELY. THE PROCEDURE COMPLETED ROBOTICALLY WITH NO REPORTED IN

At 11:00 a.m. on August 28, 2020, an employee was shredding cabbage with a food processing machine (Robot Coupe CL 50). The employee was hand-feeding cabbage into the food processing machine. The employee reached too far into the machine, and the tips of her right index and middle fingers contacted the rotating blade (point of operation) of the machine, causing amputation injuries. The employee was hospitalized.

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 19-MAY-2022, INTUITIVE SURGICAL, INC (ISI) RECEIVED FDA VOLUNTARY REPORT #MW5109945 WITH THE FOLLOWING EVENT DESCRIPTION: "BOWEL AND URETER PERFORATION; DA VINCI ASSIST HYSTERECTOMY PERFORMED AND NO PROBLEMS UNTIL 5 DAYS POST-OP. CT SCAN REVEALED PERITONITIS AND OPEN LAPAROTOMY BOWEL RESECTION WAS PERFORMED 7 DAYS POST-OP (REVEALED INJURY TO SMALL BOWEL) AND ADDITIONAL CT REVEALED THAT R URETER WAS ALSO SEVERED (STENT PLACED 9 DAYS POST-OP). URETERAL-VAGINAL FISTULA AND SEVERE UROSEPSIS IN (B)(6) 2020. I UNDERWENT 7 MORE SURGICAL PROCEDURES AND HAVE HAD 14 CT SCANS OF THE ABDOMEN IN 18 MONTHS FOLLOWING THE INJURY. STAGED URETERAL REIMPLANTATION WAS PERFORMED 6 MONTHS POST-OP AND ADDITIONAL TREATMENTS FOR SEVERE ABDOMINAL PAIN AND RIGHT AND LEFT KIDNEY HYDRONEPHROSIS, ADHESIONS, HERNIA AND INCONTINENCE REMAIN. SURGEONS SUSPECT THERMAL INJURY AS URETERS WERE SCOPED IN THE INITIAL PROCEDURE. NOT SURE ABOUT MODEL (SI, SP, X) BUT MONOPOLAR SCISSORS WERE USED AS WELL AS PK APPARATUS. REPEATED ATTEMPTS TO GET INFO FROM THE HOSPITAL AND INTUITIVE (MANUFACTURER) HAVE FAILED. OTHER THAN MY SURGEON'S OP REPORT, I HAVE NOT BEEN GIVEN THE INFORMATION I NEED TO RESEARCH THIS EQUIPMENT IN DETA

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: BOWEL AND URETER PERFORATION; DA VINCI ASSIST HYSTERECTOMY PERFORMED AND NO PROBLEMS UNTIL 5 DAYS POST-OP. CT SCAN REVEALED PERITONITIS AND OPEN LAPAROTOMY BOWEL RESECTION WAS PERFORMED 7 DAYS POST-OP (REVEALED INJURY TO SMALL BOWEL) AND ADDITIONAL CT REVEALED THAT R URETER WAS ALSO SEVERED (STENT PLACED 9 DAYS POST-OP). URETERAL-VAGINAL FISTULA AND SEVERE UROSEPSIS IN (B)(6) 2020. I UNDERWENT 7 MORE SURGICAL PROCEDURES AND HAVE HAD 14 CT SCANS OF THE ABDOMEN IN 18 MONTHS FOLLOWING THE INJURY. STAGED URETERAL REIMPLANTATION WAS PERFORMED 6 MONTHS POST-OP AND ADDITIONAL TREATMENTS FOR SEVERE ABDOMINAL PAIN AND RIGHT AND LEFT KIDNEY HYDRONEPHROSIS, ADHESIONS, HERNIA AND INCONTINENCE REMAIN. SURGEONS SUSPECT THERMAL INJURY AS URETERS WERE SCOPED IN THE INITIAL PROCEDURE. NOT SURE ABOUT MODEL (SI, SP, X) BUT MONOPOLAR SCISSORS WERE USED AS WELL AS PK APPARATUS. REPEATED ATTEMPTS TO GET INFO FROM THE HOSPITAL AND INTUITIVE (MANUFACTURER) HAVE FAILED. OTHER THAN MY SURGEON'S OP REPORT, I HAVE NOT BEEN GIVEN THE INFORMATION I NEED TO RESEARCH THIS EQUIPMENT IN DETAIL. ADHESIONS WERE EXTENSIVE, AND FOLEY CATHETER AS WELL AS URETERAL STENT WAS PLACED FOR POST-OP PERIOD. FDA SAFETY REPORT ID

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 THERE WAS EXCESSIVE MOBILITY OF THE TIP COVER CAUSING IT TO FALL INTO THE SURGICAL SITE. THE TIP COVER WAS RETRIEVED AND THERE WAS NO CONSEQUENCES TO THE PATIENT. INTUITIVE SURGICAL, INC. (ISI) PERFORMED MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION RELATED TO THIS EVENT. HOWEVER, AS OF THE DATE OF THIS REPORT, NO MORE DETAILS HAVE BEEN PROVIDED.

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 A POST-OP SCAN SHOWED THAT LEFT L1-L3 SCREWS WERE DEVIATED LATERALLY BETWEEN 3.5-10 MM. DURING THE IMPLANT PROCEDURE, A SINGLE SCHANZ PIN WAS USED TO MOUNT THE SURGICAL SYSTEM TO THE PATIENT. THE LEFT SIDE WAS DONE FIRST AND THE RIGHT SIDE WAS SECOND. THE THORACIC SCREWS ON THE RIGHT SIDE WERE ACCURATE. INTRA-OP IMAGING WAS DONE AND THE IMAGES LOOKED GOOD. THE MANUFACTURER REPRESENTATIVE THOUGHT THERE COULD BE A SHIFT THAT CAUSED THE DEVIATION. THE PATIENT EXPERIENCED SOME DISCOMFORT AFTER THE PROCEDURE AND THEY WERE BROUGHT BACK IN FOR A REVISION TO REPOSITION THE SCREWS ON THE FOLLOWING DAY. THE PROCEDURE WAS DELAYED LESS THAN AN HOUR.

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 4 SCREWS AT L2, L3, L5, AND S1 WERE NOT PLACED ACCORDING TO PLAN. THE SCREWS WERE REMOVED AND REPOSITIONED INTRA-OPERATIVELY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION PROCEDURE, A BURN INJURY WAS IDENTIFIED ON THE SMALL INTESTINE. THE INTRA-OPERATIVE COMPLICATION WAS FOUND WHILE THE SURGEON WAS CHECKING FOR BLEEDING TOWARDS THE END OF THE PROCEDURE. AFTER THE BURN INJURY WAS IDENTIFIED, THE SURGICAL STAFF INSPECTED THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY THAT WAS INSTALLED ON A MCS INSTRUMENT AND IDENTIFIED A HOLE. THE SITE BELIEVES THE BURN INJURY WAS RELATED TO THE HOLE FOUND ON THE MCS TIP COVER ACCESSORY. THE SURGICAL PROCEDURE WAS COMPLETED ROBOTICALLY WITH A BACKUP INSTRUMENT/ACCESSORY. ON 28-AUG-2020, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE SURGEON AND A NURSE: THE ISI CLINICAL SALES REPRESENTATIVE (CSR) REPORTEDLY REVIEWED A VIDEO OF THE PROCEDURE WITH THE SURGEON. PER THE CSR, A COLLISION WAS OBSERVED INTRA-OPERATIVELY BETWEEN THE MCS INSTRUMENT AND A TIP-UP FENESTRATED GRASPER INSTRUMENT INSTALLED ON ARM #4. THE MCS TIP COVER ACCESSORY WAS REPORTEDLY HIT AND A HOLE WAS IDENTIFIED IN THE GREY AREA OF THE TIP COVER. DURING THE COURSE OF THE PROCEDURE, ARCING OF ELECTRI

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 MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY FELL INSIDE OF THE PATIENT. THE CUSTOMER STATED THAT THE PATIENT HAD A VERY LARGE UTERUS WHICH MADE THE CASE VERY DIFFICULT. THE MCS INSTRUMENT WAS DIFFICULT TO REMOVE; THE CUSTOMER FELT TENSION AND IT WAS NOTED THAT THE MCS TIP COVER ACCESSORY WAS MISSING. THE CUSTOMER PERFORMED AN X-RAY PRIOR TO CLOSING THE PATIENT AND THE MCS TIP COVER ACCESSORY WAS NOT IDENTIFIED. A CT SCAN WITHOUT CONTRAST WAS ALSO PERFORMED POST-PROCEDURE. THE MCS TIP COVER ACCESSORY WAS STILL MISSING AND IT WAS NOT CONFIRMED IF IT WAS INSIDE OF THE 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.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING SURGERY, BUT PRIOR TO FIRST INCISION, THE INSTRUMENT HOLDER (B)(6) COULD NOT BE PLACED ONTO THE END OF THE ROBOT ARM BY THE SURGEON. UPON FURTHER INSPECTION, THERE APPEARED TO BE NOTCHES/GROOVES AROUND THE CENTER INSET CIRCLE THAT FITS ONTO THE ROBOT ARM. THE INSTRUMENT HOLDER HAD TO BE FILED DOWN AROUND THIS CIRCLE INSET IN ORDER TO GET THE INSTRUMENT HOLDER TO SIT FLUSH ONTO THE ROBOT ARM. IT WAS DETERMINED THAT THE ROBOT ARM HAD NO ISSUE AS THE POINTER PROBE AND LASER ATTACHMENTS SAT FLUSH WITH NO FORCE NEEDED. THE PROCESS OF GETTING THE INSTRUMENT HOLDER ATTACHED TO THE ROBOT ARM DELAYED SURGERY BY 30-45 MINUTES WHILE THE PATIENT WAS UNDER ANESTHESIA.

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 THE CLOSED REDUCTION ON (B)(6) 2020. AS REPORTED: "PT DISCHARGED TO INPATIENT REHAB (B)(6) 2020. ON (B)(6) 2020 PT OUT OF BED UNASSISTED, BENT OVER TO PICK SOMETHING UP OFF FLOOR AND FELT SHARP PAIN IN HIP. XRAY SHOWED DISLOCATION, PT TAKEN TO OR FOR CLOSED REDUCTION. PT DISCHARGED HOME (B)(6) 2020. ON (B)(6) 2020 PT PRESENTED TO EMERGENCY DEPARTMENT WITH COMPLAINT OF HIP PAIN & SWELLING - PT ADMITTED W/ CELLULITIS. PT TO OPERATING ROOM (B)(6) 2020 FOR I&D - POSITIVE WOUND CULTURE - DEEP SURGICAL SITE INFECTION. PT LEFT AGAINST MEDICAL ADVICE POST-OP."

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 12-NOV-2020, INTUITIVE SURGICAL, INC. (ISI) RECEIVED MW 5096343 STATING: "SCISSOR TIP SHEATH ON INTUITIVE SCISSORS COMES OFF DURING SURGICAL PROCEDURE. FDA SAFETY REPORT ID#: (B)(4)." 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: IT WAS ANOTHER PREOP CASE IN (B)(6), SCREWS REVISION S1L AND S1R. THE FF WAS ATTACHED IN THE CENTER WITHOUT THE GAP BETWEEN THE DETECTOR AND FF. I HAVE CHECKED THE MARKER'S POSTS ON THE FF AND THE GPS INSTRUMENTS, AND NO BENT POSTS WERE SEEN. DRB AND SM WERE PLACED AS USUAL ON THE RIGHT AND LEFT SIDE. DESPITE A GOOD REGISTRATION SCORE(8,9), WE GOT SHIFT IN THE AP SHOTS. NOTHING WAS MOVED DURING THE REGISTRATION, THE C-ARM WAS BRAKED, AND THE PATIENT AND TABLE WERE NOT MOVED. DURING THE X-RAYS THE MOVEMENT BAR WAS MOVING FROM GREEN TO YELLOW. WE TOOK A SECOND ATTEMPT, AND TRIED TO GET THE SHOTS, HAVING THE GREEN BAR. AFTER NEW LATERAL SHOOTS THE MERGE WAS GOOD, AND WE COULD PROCEED TO THE NAVIGATION. 3. AT THIS POINT THE SM TURNED TO RED AND THEN TO YELLOW, DESPITE NOTHING BEING MOVED OR CHANGED. THE SURGEON CHECKED THE NAVIGATION ACCURACY AT THE SKIN LEVEL AND DECIDED TO DO THE SKIN INCISION, WITHOUT TO RESET THE SM. HE CHECKED THE ACCURACY INSIDE THE WOUND, TAPING THE SPINAL PROCESS AND SCREWS HEADS. THE ACCURACY WAS GOOD, AND SM WAS DEACTIVATED AND ACTIVATED AGAIN AND WAS GREEN. DURING THE CASE, SURGEON CHECKED MULTIPLE TIMES THE NAVIGATION ACCURACY AND IT WAS GOOD. THE CONTROL X

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SACROCOLPOPEXY WITH HYSTERECTOMY PROCEDURE, THE SYSTEM LOST POWER MID- PROCEDURE. THE SYSTEM HAD AN UNSPECIFIED NON-RECOVERABLE FAULT AND THE ARMS WERE RED. THE SURGEON ELECTED NOT TO POWER CYCLE OR ATTEMPT TO RECOVER AND INSTEAD, DECIDED TO CONVERT THE PROCEDURE TO TRADITIONAL LAPAROSCOPY DUE TO THE FACILITY POWER LOSS. THE SURGEON MENTIONED THAT THERE WAS A POSSIBLE PATIENT INJURY; HOWEVER, NO DETAILS WERE PROVIDED REGARDING THE POTENTIAL INJURY. THE INTUITIVE SURGICAL INC. (ISI) FIELD SERVICE ENGINEER (FSE) FOLLOWED UP WITH THE CUSTOMER ABOUT THE POWER LOSS AND WAS INFORMED THAT A LIGHTNING STRIKE CAUSED THE POWER OUTAGE TO THE ENTIRE OPERATING ROOM (OR). WHEN THE POWER OUTAGE OCCURRED, THE PATIENT SIDE CART (PSC) REVERTED TO BATTERY BACKUP AS DESIGNED. WHEN THE POWER WAS RESTORED, THE SYSTEM BOOTED BACK UP BECAUSE OF THE PSC STILL BEING ON AND THE SYSTEM GENERATED A NON-RECOVERABLE ERROR DUE TO THE LOSS OF COMMUNICATION TO THE VISION SIDE CART (VSC). THE CUSTOMER POWER CYCLED ALL SUBSYSTEMS, AND BROUGHT THEM UP TOGETHER, AND THE SYSTEM WORKED PROPERLY. PER THE FSE, THE SYSTEM WAS WORKING AS INTENDED AND NO ADDITIONAL ACTION WAS RE

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING SURGERY, THE ROSA SOFTWARE SHUTDOWN. UPON RESTART, THE CONTROLLER WOULD NOT CONNECT. THE SURGEON, NOTIFIED THE CLINICAL REPRESENTATIVE. THE SITE WAS INSTRUCTED TO POWER OFF THE ROBOT PC, SWITCH THE CONTROLLER SWITCH TO THE OFF POSITION, AND UNPLUG THE POWER CORD FROM THE WALL FOR 30 SECONDS. UPON RESTART, THE CONTROLLER DID CONNECT AND THE CASE COULD CONTINUE. THIS INCIDENT DID CAUSE A DELAY IN OF ABOUT 30 MINUTES TO THE SURGERY WHILE THE PATIENT WAS ALREADY IN THE ROOM AND ASLEEP.

At 10:04 a.m. on August 16, 2020, an employee was unsticking a pallet and adjusting sensors on an industrial robot. The sensors were activated causing the robot to begin its cycle. The robot grabbed the employee and pulled him to the floor attempting to complete its cycle. The employee's leg was broken and required hospitalization for treatment.

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 REVIEW OF A LITERATURE ARTICLE INVOLVING DA VINCI ASSISTED ROBOTIC PROCEDURES TITLED, ¿ROBOT-ASSISTED SPLEEN PRESERVING DISTAL PANCREATECTOMY (RA-SPDP): A SINGLE CENTER EXPERIENCE,¿ THE FOLLOWING EVENTS WERE REPORTED: A RETROSPECTIVE DATABASE ANALYSIS OF 54 PATIENTS WHO RECEIVED RA-SPDP BETWEEN APRIL 2008 TO OCTOBER 2017 AT A SINGLE INSTITUTION SHOWED OPERATIVE COMPLICATIONS AS FOLLOWS: INTRA-OPERATIVELY OUTCOME MEASURES SHOWED FOUR (7.4%) PATIENTS RECEIVED BLOOD TRANSFUSION, THE MEDIAN NUMBER OF BLOOD UNIT TRANSFUSED PER PATIENT WAS 1 UNIT. ADDITIONALLY, THE ARTICLE STATES, "IN THREE PATIENTS, THE SPLENIC VESSELS HAD TO BE RECONSTRUCTED TO AVOID A WARSHAW PROCEDURE OR A SPLENECTOMY. FURTHERMORE, THE ARTICLE NOTES, "THERE WERE TWO ELECTIVE RECONSTRUCTIONS, CAUSED BY DIFFICULT DETACHMENT OF THE SPLENIC VESSELS FROM THE TUMOR AND ONE URGENT RECONSTRUCTION DUE TO INJURY TO THE SPLENIC VEIN." POST-OPERATIVE OUTCOME MEASURES SHOWED FIVE PATIENTS REQUIRED POST-OPERATIVE BLOOD TRANSFUSIONS AND 21 PATIENTS HAD GRADE 0 CLAVIEN-DINDO COMPLICATIONS, 32 PATIENTS DEVELOPED GRADE I-II COMPLICATIONS AND 1 PATIENT HAD A CLAVIEN-DINDO GRADE III-IV COMPLICATION. IT WAS MENTIONED THAT TWO PATI

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 PANCREATICODUODENECTOMY PROCEDURE, A PSEUDOANEURYSM ALLEGEDLY OCCURRED DUE TO A POST-OPERATIVE PANCREATIC LEAK. IT WAS NOTED THAT A BRANCHED BLOOD VESSEL FROM THE SUPERIOR MESENTERIC ARTERY (SMA) HAD ¿BEEN LEFT CUT OFF BY THE SYNCHROSEAL¿ INSTRUMENT AFTER SEALING AND A PANCREATIC LEAK OCCURRED IN THE SURROUNDING AREA. FURTHERMORE, THE TISSUE TREATED WITH THE SYNCHROSEAL INSTRUMENT WAS BURNED AND APPEARED WHITE. IT WAS SUSPECTED THAT IT WAS DUE TO DAMAGE TO ¿J1V¿ (FIRST JEJUNAL VEIN). THE SURGEON COMMENTED THAT HE/SHE SHOULD HAVE USED THE SYNCHROSEAL INSTRUMENT WITH CAUTION. ON 27-AUG-2020, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE DA VINCI-ASSISTED SURGICAL PROCEDURE WAS RECORDED ON VIDEO. HOWEVER, THE SITE CANNOT PROVIDE THE VIDEO TO ISI FOR REVIEW. IT WAS EXPLAINED THAT AFTER A BRANCHED VESSEL FROM THE SMA WAS SEALED COMPLETELY WITH THE SYNCHROSEAL INSTRUMENT, THE SURGEON THEN CUT THE VESSEL. ALTHOUGH IT WAS NOTED THAT THE SITE BELIEVES NO MALFUNCTION OF THE SYNCHROSEAL INSTRUMENT OCCURRED, THE SITE CLAIMS THAT THE SYNCHROSEAL INSTRUMENT HAS A LARGE TH

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 INTRA-OPERATIVELY OF A SPINAL PROCEDURE. IT WAS REPORTED THAT A SCREW DEVIATION WAS DISCOVERED. THE SCREWS WERE IMPLANTED DURING A L3-L4 CASE ON (B)(6) 2020 WITH NO ISSUES. THE SITE HAD TAKEN AP SHOTS TO CONFIRM SCREW PLACEMENT AFTER THE CASE; HOWEVER, THEY WERE UNABLE TO IDENTIFY THE DEVIATION FROM THOSE SHOTS. ON (B)(6) 2020, IT WAS DISCOVERED THAT THERE WAS A DEVIATION WHEN THE PA DID A FOLLOW UP VISIT WITH THE PATIENT SINCE THEY WERE STILL EXPERIENCING NERVE PAIN AND WEAKNESS IN THEIR LEGS. IT APPEARS THAT THE LEFT AND RIGHT L3 SCREWS ARE LATERAL BY 6 MM AND ARE NOT WITHIN THE PEDICLE. THE RIGHT L4 IS LATERAL BY 6 MM. BOTH MEASUREMENTS ARE APPROXIMATE FROM THE DISTAL END OF THE SCREW. THE REVISION PROCEDURE HAD NOT BEEN SCHEDULED. THE INITIAL PROCEDURE WAS NOT DELAYED.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT L5 WAS ACTUALLY S1 AND THE L4 AND S1 SCREWS HAD EQUAL SHIFTS OFF THE CENTER OF THE PEDICLE.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE CLINICAL REPRESENTATIVE REPORTED THAT : 'AFTER THE 4TH ELECTRODE WAS PLACED IN AN SEEG SURGERY, THE ROBOT ARM WAS MOVED TO THE 5TH TRAJECTORY. THE RESIDENT NOTED THAT THE ENTRY POINT WOULD HIT THE PREVIOUSLY PLACED BOLT WHICH DID NOT MATCH THE PLAN. THE TRAJECTORY WAS SKIPPED AND THE ARM WAS MOVED TO THE NEXT TRAJECTORY. THE RESIDENT NOTED THAT THE ARM POINTED TO A SPOT ONE MM AWAY FROM THE MARK MADE PRIOR TO DRAPING. SEVERAL OTHER POINTS WERE CHECKED AND ALL APPEARED TO BE OFF IN DIFFERENT DIRECTIONS AND BETWEEN 1 ¿ 5MM. THE SURGEON DECIDED TO BREAK THE STERILE DRAPES TO TAKE AN INTRAOP CT WITH THE AIRO TO CHECK THE PLACEMENTS. ALL LOCKS WERE CHECKED ON THE ROBOT AND HEAD FRAME AND IT APPEARED THE LEKSELL HEAD FRAME WAS LOOSE AT THE LEKSELL ADAPTOR (THE PIECE THAT CONNECTS THE LEKSELL FRAME TO THE ROSA MAYFIELD ADAPTOR). THE SURGEON WHO FIXATED THE FRAME SAID THAT HE WAS CERTAIN IT WAS NOT LIKE THIS PRIOR TO SURGERY AND THAT HE HAD CONFIRMED IT WAS LOCKED. A SCAN WAS TAKEN AND THE FOUR PLACED ELECTRODES ALIGNED WITH THE PLANNED TRAJECTORIES. THE SURGEON RE-REGISTERED WITH FRAME REGISTRATION. THE POSTOP SCAN SHOWED THE MAJORITY OF THE REMAINING TRAJECTORIES WERE PLACED CORRECTL

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE PARTIAL KNEE CUTS WERE WAY OFF AND WE HAD TO BAIL TO A TKA. WE HAD COMPLETED THE CASE AND TRIALING WHEN THE SURGEON TOOK A CLOSER LOOK AND DID NOT LIKE THE WAY THE IMPLANTS WERE POSITIONED. WHAT IT LOOKED LIKE ON THE PLAN WAS NOT WHAT IT LOOKED LIKE ON THE PATIENT. WE HAD NO PROBLEMS WITH ANY CHECK POINTS OR MOVED ARRAYS DURING THE CASE AT ALL BUT THE CUTS WERE OFF CASE TYPE / APPLICATION: PKA (MICS). SURGICAL DELAY<= 15 MINUTES.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE FOLLOWING EVENT OCCURRED DURING AN SEEG CASE AT (B)(6) HOSPITAL. AFTER FINISHING THE SEEG CASE WHERE THE PATIENT HAD BEEN CONNECTED TO THE ROSA VIA THE MAYFIELD ADAPTOR CLAMPED ONTO THE LEKSELL FRAME, A POST-OP SCAN WAS TAKEN IN THE OPERATING ROOM (WHILE THE PATIENT WAS STILL UNDER ANESTHESIA) UTILIZING AN O-ARM. THE SCAN WAS THEN TRANSFERRED TO THE ROBOT VIA USB AND SUBSEQUENTLY MERGED TO AN MRI SCAN, WHICH WAS USED FOR INITIAL PLANNING. THE SURGEON VERIFIED THE MERGE AND THEN COMPARED THE SCAN TO THE PLAN. THE SURGEON NOTED THAT THE ELECTRODES DEVIATED ANTERIORLY FROM THE PLANNED TRAJECTORIES (THIS DEVIATION WAS NOTICED ON EACH TRAJECTORY ENTRY AND TARGET). THE SURGEON DID NOT EXPRESS NEED FOR A REVISION AND DID NOT ADJUST PLACEMENT OF ANY ELECTRODES. HOWEVER, THE SURGEON COMMENTED THEIR COULD BE A MERGE ISSUE, ALTHOUGH HE DID NOT PERSONALLY RECOGNIZE ONE, WHEN AT THE STEP THAT ASKED TO VERIFY THE 3D MERGE. THE FIELD SERVICE ENGINEER, ONCE THE PATIENT WAS DISCONNECTED LOOKED AT THE MERGE BETWEEN THE PRE-OP O ARM SPIN USED FOR REGISTRATION AND THE POST-OP SCAN TO SEE IF THERE WAS AN ISSUE THAT COULD BE IDENTIFIED WITH THE MERGE. WHEN COMPARING THE FIDUCIALS FROM PRE-OP TO POST

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 THE PATIENT'S LEFT KNEE WAS REVISED DUE TO LOOSENING OF THE FEMORAL COMPONENT. SURGEON REPORTED THAT THE DISTAL FEMUR METAPHYSIS LOOKED "DISINTEGRATED." PATIENT'S KNEE CONSTRUCT WAS REVISED TO A HINGED DISTAL FEMUR CONSTRUCT. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED TIBIAL BASEPLATE OR INSERT. REP PROVIDED PRIMARY AND REVISION USAGE SHEETS, PRE- AND POST-REVISION X-RAYS, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED.

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 (B)(6) 2020, INTUITIVE BECAME AWARE OF A ¿JOURNAL OF GASTROINTESTINAL ONCOLOGY¿ ARTICLE TITLED, ¿RARE POSTOPERATIVE HEMORRHAGE AFTER ROBOTIC-ASSISTED PANCREATODUODENECTOMY FOR PANCREATIC HEAD CANCER: A CASE REPORT¿ (ZHOU, J.J., CHEN, W., ET AL., 2020). WITHIN THE JOURNAL ARTICLE, AN OPERATIVE COMPLICATION INVOLVING A DA VINCI SURGICAL PROCEDURE WAS NOTED. ON POST OPERATIVE DAY 6 PATIENT UNDERWENT AN EMERGENCY OPERATION DUE TO BLOOD IN VOMIT. PATIENT WAS FOUND TO HAVE AN OUTPUT JEJUNAL LOOP INTUSSUSCEPTION IN THE STOMACH. PATIENT WAS DISCHARGED ON POST OPERATIVE DAY 10 AND WAS REPORTED TO BE DOING WELL. 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.

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.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TOTAL BENIGN HYSTERECTOMY SURGICAL PROCEDURE, A SMALL GRAY COVER ON THE END OF THE SYNCHROSEAL INSTRUMENT FELL INTO THE PATIENT. THE PIECE WAS RETRIEVED DURING THE SAME PROCEDURE. THE SURGEON USED A VESSEL SEALER INSTRUMENT TO CONTINUE AND THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT HARM, INJURY OR ADVERSE OUTCOME. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE INSTRUMENT WAS IN USE FOR 15 MINUTES PRIOR TO THE ISSUE. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGE WAS NOTED. PRIOR TO INSTRUMENT USAGE, THE SCRUB TECH WAS ATTEMPTING TO PEEL OFF THE YELLOW PROTECTIVE COVER ON TOP OF THE JAW COVER AND MIGHT HAVE LOOSE THE JAW COVER DURING THE PROCESS. THE SURGEON WAS DISSECTING A TISSUE WHEN A FRAGMENT FROM THE SYNCHROSEAL INSTRUMENT FELL INTO THE PATIENT. THE FRAGMENT WAS RETRIEVED WITH A GRASPER INSTRUMENT. THERE WAS NO INSTRUMENT COLLISION DURING THE PROCEDURE.

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.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2020, IT WAS REPORTED THAT AFTER A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE, THE PATIENT WAS OBSERVED TO HAVE A PNEUMOTHORAX DURING POST-OP CHECK-UP. THE CUSTOMER DOES NOT FEEL THE PNEUMOTHORAX WAS CAUSED BY THE MONARCH PLATFORM. DURING THE CASE, NO AURIS INSTRUMENTS WERE USED. THE INSTRUMENT USED WAS A MEDTRONIC NEEDLE TIPPED CYTOLOGY BRUSH. A CHEST TUBE WAS PLACED TO TREAT THE PNEUMOTHORAX, AND THE PATIENT WAS HOSPITALIZED FOR 2 DAYS. THE PATIENT HAS SINCE RECOVERED AND WAS RELEASED FROM HOSPITAL.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE FOLLOWING EVENT OCCURRED DURING A DBS CASE ON (B)(6) 2020: FOLLOWING THE IMPLANTATION OF TWO LEADS, UTILIZING THE FHC STARDRIVE FOR A DBS CASE, A POST-OP SCAN WAS TAKEN WHILE THE PATIENT WAS STILL UNDER ANESTHESIA, ALTHOUGH DISCONNECTED FROM THE ROBOT, USING THE BODYTOM. THE SCAN WAS TRANSFERRED AND MERGED TO THE MRI ON THE ROSA ROBOT IN ORDER TO CONFIRM PLACEMENT OF THE LEADS. AFTER CHECKING THAT THE MERGER WAS ACCURATE, IT WAS FOUND THAT WHEN LOOKING AT THE PLANNED TRAJECTORIES, THAT THE RIGHT LEAD WAS 8MM SHALLOW THAN THE PLANNED TARGET (THE ENTRY POINT OF THE RIGHT LEAD WAS COMPLETELY ACCURATE). THERE WAS ALSO NO ACCURACY ISSUES WITH THE LEFT LEAD. AT THIS POINT, THE SURGEON DETERMINED THAT THE RIGHT LEAD WOULD NEED TO BE ADVANCED THE 8 MM ON THE RIGHT SIDE, WHICH WOULD ULTIMATELY REQUIRE THE LEAD TO BE REMOVED AND REPLACED. SURGEON AND THE RESIDENTS THAT WERE PRESENT BELIEVED THAT THE LEAD HAD BEEN RETRACTED SLIGHTLY WHEN THE WATCHFACE HAD BEEN PLACED ON TOP TO SECURE THE LEAD, THUS THAT THE ERROR HAD NOT BEEN DUE TO THE ROBOT, BUT RATHER USER ERROR. THE PLAN WAS NOT ALTERED AND THE PATIENT WAS THEN RECONNECTED TO THE ROSA ROBOT AGAIN USING THE LEKSELL HEADFRAME ADAPTOR. R

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 THE LEFT L4 SCREW WAS NOT PLACED ACCORDING TO THE SURGICAL PLAN. THE SCREW WAS REMOVED AND REPOSITIONED INTRA-OPERATIVELY.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS REPORTED: "PT BROUGHT TO EMERGENCY DEPARTMENT DUE TO LEG SWELLING AFTER A FALL AT HOME. OBVIOUS SHORTENING OF LEG NOTED IN EMERGENCY DEPARTMENT, XRAY SHOWED HIP DISLOCATION AND PT ADMITTED. PT RETURN TO OR (B)(6) 2020 FOR HIP REVISION. PT DISCHARGED TO...REHAB."

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2020, A PATIENT EXPERIENCED A PNEUMOTHORAX THAT WAS DISCOVERED THREE HOURS AFTER THE PROCEDURE DURING THE POST-OP CHECKS. THE PNEUMOTHORAX WAS LOCATED IN THE LEFT UPPER LUNG WHERE THE TARGET WAS LOCATED. DURING THE CASE, NO AURIS INSTRUMENTS WERE USED. THE INSTRUMENTS USED DURING THE CASE WERE AN OLYMPUS PERIVIEW 21 GAUGE NEEDLE, AND AN OLYMPUS FORCEPS. THE PATIENT WAS HELD OVERNIGHT FOR OBSERVATION, NO OTHER INTERVENTION WAS REQUIRED. THE PNEUMOTHORAX WAS RESOLVED, AND THE PATIENT WAS RELEASED ON THE FOLLOWING DAY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE 6MM CANNULA BECAME STUCK INSIDE THE DRILL ADAPTER, WHICH THE SURGEON USED A MALLET TO PASS THE CANNULA THROUGH THE DRILL ADAPTER. THIS RESULTED IN A "SKIVED" TRAJECTORY.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AFTER COMPLETION OF REGISTRATION AND INTRAOPERATIVE IMAGE ACQUISITION FOR THE ROSA SPINE ROBOT, THE SURGEON PLANNED HIS SCREW TRAJECTORIES. ONCE PLANNING WAS COMPLETED, THE CLINICAL REPRESENTATIVE (CR) DROVE TO THE FIRST SCREW. THE SURGEON WAS LOOKING AWAY FROM THE ROBOT WHILE ON THE PEDAL. THE CR WAS TRYING TO WATCH THE ARM MOVEMENT AS WELL SO THAT IT DID NOT RUN INTO THE PATIENT REFERENCE, BUT THE INSTRUMENT HOLDER ENDED UP COLLIDING WITH THE PATIENT REFERENCE. DUE TO THE COLLISION, THE PATIENT REFERENCE DID LOOSEN FROM THE PSIS PIN. BECAUSE OF THIS THE CR INFORMED THE SURGEON THAT ANOTHER INTRAOPERATIVE SCAN WOULD HAVE TO BE PERFORMED. THE SURGEON DECIDED TO ABORT THE CASE USING ROSA AND DECIDED TO PLACE THE PEDICLE SCREWS IN THE TRADITIONAL TECHNIQUE. THE PATIENT WAS NOT INJURED OR EFFECTED DUE TO THE COLLISION.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING AN SEEG PROCEDURE THE MAYFIELD HEAD HOLDER ADAPTOR SLOWLY LOOSENED AND THEN EVENTUALLY SLIPPED FROM IT'S POSITION. THIS MOVEMENT CAUSED A SIGNIFICANT HEAD SHIFT AND CAUSED THE SURGERY TO BE DELAYED BY 40+ MINUTES. THIS DELAY WAS BECAUSE THE PATIENT HAD TO BE REPOSITIONED AND RE-REGISTERED FOR SURGERY. AT THE TIME OF THE SHIFT, 5 ELECTRODES HAD BEEN PLACED AND A TOTAL OF 8 WERE GOING TO BE PLACED FOR THE SURGERY. TWO OF THE ELECTRODES WERE REMOVED AFTER THE SHIFT (DUE TO THE MAYFIELD ADAPTOR SLOWLY SHIFTING WHICH WAS NOT REALIZED UNTIL THE ACCURACY OF THE ENTRY SITES OF EACH TRAJECTORY WAS CHECKED). AFTER THE SECOND REGISTRATION, THE PROCEDURE CONTINUED AS PLANNED AND ALL TRAJECTORIES WERE FINISHED TO COMPLETION, INCLUDING THE TWO ELECTRODES THAT HAD PREVIOUSLY REMOVED.