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 HARMONIC ACE INSTRUMENT TIP WAS BROKEN. A FRAGMENT FELL INSIDE THE PATIENT AND THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE HARMONIC ACE INSTRUMENT WAS INSPECTED BEFORE USE. THE INSTRUMENT DID NOT COLLIDE WITH OTHER INSTRUMENTS OR TOOLS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL HYSTERECTOMY SURGICAL PROCEDURE, THE USER OBSERVED AN INSTRUMENT RECOGNITION ISSUE WITH THE HARMONIC ACE INSTRUMENT. THE INSTRUMENT WAS REMOVED AND REPLACED WITH A BACKUP. FOLLOWING THIS, THE USER CONTINUED AND COMPLETED THE PROCEDURE. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE REPORTER CONFIRMED THAT A FRAGMENT OF THE TEFLON PAD PIECE WAS FOUND AND RETRIEVED. AN X-RAY TEST WAS PERFORMED TO CHECK FOR REMAINING FRAGMENTS INSIDE THE PATIENT. THERE WAS NO INSTRUMENT COLLISION.

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 VENTRAL HERNIA TRANSABDOMINAL PRE-PERITONEAL (TAPP) SURGICAL PROCEDURE, THE UNIVERSAL SEAL INSUFFLATION PORT BROKE OFF DURING CASE. A FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAD BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: 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 LIVER RESECTION SURGICAL PROCEDURE, THE SYNCHROSEAL INSTRUMENT SLEEVE ON THE JOINT CAME OFF IN THE PATIENT AND WAS RETRIEVED IN THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED.

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 BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY, INSTALLED ON AN MCS INSTRUMENT, FELL OFF INSIDE THE PATIENT. THE MCS TIP COVER ACCESSORY WAS RETRIEVED DURING SAME PROCEDURE AND THE CUSTOMER MOVED ON TO ANOTHER MCS INSTRUMENT TO CONTINUE THE PROCEDURE. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) INQUIRED IF THE MCS TIP COVER ACCESSORY WAS CORRECTLY INSTALLED, BUT THE CUSTOMER WAS NOT ABLE TO VERIFY.

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: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT A REVISION SURGERY WAS NEEDED TO REMOVE AND REPLACE MISPLACED SCREWS THAT WERE PLACED USING THE EXCELSIUS GPS SYSTEM.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A STUDY WHICH COMPARED ROBOT-ASSISTED VERSUS LAPAROSCOPIC LYMPH NODE DISSECTION PROCEDURES IN PATIENTS WITH GYNECOLOGIC MALIGNANCIES, WAS SUMMARIZED IN A LITERATURE ARTICLE. THE ARTICLE COMPARES THE SURGICAL OUTCOMES AND COMPLICATIONS FOR PELVIC LYMPH NODE DISSECTION (PLND) PERFORMED THROUGH CONVENTIONAL LAPAROSCOPIC SURGERY (CLS) VERSUS ROBOT-ASSISTED SURGERY (RAS) IN PATIENTS WITH GYNECOLOGIC MALIGNANCIES OVER A PERIOD OF APPROXIMATELY EIGHT YEARS. THERE WERE 731 PATIENTS WITH GYNECOLOGIC MALIGNANCIES WHO UNDERWENT TRANSPERITONEAL PLND, INCLUDING 460 AND 271 IN THE CLS AND RAS GROUPS, RESPECTIVELY. THE BLOOD LOSS, AND NUMBER OF RESECTED LYMPH NODES WERE 110 +/- 88 ML, AND 45 +/- 17, RESPECTIVELY, IN THE RAS GROUP AND 89 +/- 78 ML, AND 38 +/- 16, RESPECTIVELY, IN THE CLS GROUP. IT WAS CONSIDERED THAT THE DIFFERENCE IN BLOOD LOSS (APPROXIMATELY 20 ML) WAS WITHIN A CLINICALLY ACCEPTABLE RANGE AND RAS RESULTS IN THE RESECTION OF A GREATER NUMBER OF PELVIC LYMPH NODES. THE RATE OF CLAVIEN-DINDO GRADE >/= III COMPLICATIONS WAS 6.3% AND 8.7% IN THE RAS AND CLS GROUPS, RESPECTIVELY. ONE PATIENT IN THE RAS GROUP, COMPARED WITH 4 IN THE CLS GROUP, HAD AN INTRAOPERATIVE VASCULAR COMPLICATIO

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A PATIENT WHO WAS ENROLLED IN A STUDY UNDERWENT A DA VINCI-ASSISTED BILATERAL NIPPLE SPARING MASTECTOMY FOLLOWED BY A NON-ROBOTIC IMMEDIATE BREAST RECONSTRUCTION. IT WAS REPORTED THAT THE PATIENT'S LEFT BREAST SHOWED ERYTHEMA AND SWELLING APPROXIMATE THREE MONTHS LATER, AND EXTENDED TO THE ENTIRE BREAST IN A PATCHY PATTERN. THE PATIENT WAS PLACED ON A TRIPLE IV ANTIBIOTIC REGIMEN AND THE LEFT BREAST ERYTHEMA WAS NOTED TO HAVE IMPROVED. THERE WAS NO MENTION OF MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HEPATECTOMY SURGICAL PROCEDURE, THE SLEEVE ON THE JOINT CAME OFF A SYNCHROSEAL INSTRUMENT AND FELL INSIDE THE PATIENT. THE SLEEVE JOINT WAS RETRIEVED INTRAOPERATIVELY DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED USING A BACKUP INSTRUMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO FURTHER DETAILS WERE AVAILABLE REGARDING THE REPORTED EVENT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY W/ LYMPHADENECTOMY SURGICAL PROCEDURE, USING AN DA VINCI SINGLE PORT SYSTEM, APPROXIMATELY 10 MINUTES AFTER INITIALIZATION, THE SYSTEM DISPLAYED RECOVERABLE ERROR CODE 307 ON PATIENT SIDE MANIPULATOR (PSM) 2. TROUBLESHOOTING WAS PERFORMED. THE SYSTEM WAS RESTARTED, AND A DISABLED ARM PROMPT WAS DISPLAYED. FURTHER TROUBLESHOOTING THROUGH A HARD SYSTEM POWER CYCLE CLEARED THE SYSTEM PROMPT; HOWEVER, WITHIN 1 MINUTE, THE ERROR APPEARED AGAIN. THE SURGEON ELECTED TO CONVERT TO FROM DA VINCI SINGLE PORT SYSTEM TO THE MULTI-PORTS SYSTEM. THERE WAS NO REPORTED PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM OPERATED NORMALLY AFTER INITIALIZATION.

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 GENERAL SURGICAL PROCEDURE, SP SYSTEM HAD A UNCOVERABLE FAULT ASSOCIATED WITH THIRD INSTRUMENT DRIVE. THE SURGEON DESCRIBED THE EVENT AS THE INSTRUMENT ¿FREEZING¿. THE SURGEON CONVERTED TO DV XI TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS CONVERTED TO ANOTHER DV SYSTEM WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE WAS IDENTIFIED PRIOR TO START OF PROCEDURE. THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING UP AND IT INITIALLY DID POWER ON WITHOUT ERRORS. THE TROUBLESHOOTING WAS NOT COMPLETED, AND IT WAS A NON-RECOVERABLE FAULT THAT REQUIRED A FIELD TECH TO COME OUT. PATIENT WAS ALREADY UNDER ANESTHESIA, SO THE XI SYSTEM WAS BROUGHT IN TO CONTINUE. THE PROCEDURE WAS ROBOTICALLY COMPLETED WITH THE XI SYSTEM. ADDITIONAL PORTS WERE PLACED TO COMPLETE THE PROCEDURE. THE PATIENT DID TOLERATE THE CHANGE AND NO PATIENT INJURY OCCURRED.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED DURING A MONARCH BRONCHOSCOPY PROCEDURE AN E-STOP ERROR OCCURRED. THE PHYSICIAN WAS UNABLE TO CLEAR THE E-STOP ERROR AND ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT BECAUSE OF THE SYSTEM 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 DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, PHYSICAL DAMAGE WAS OBSERVED ON THE HARMONIC ACE INSTRUMENT. THE INITIAL REPORTER INDICATED THAT THE INSTRUMENT HAD AN "INTERRUPTED TOOTH" AND A FRAGMENT FELL FROM THE INSTRUMENT FELL INSIDE THE PATIENT. THE INITIAL REPORTER ALSO INDICATED THAT THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE WHICH WAS COMPLETED ROBOTICALLY USING A BACKUP HARMONIC ACE INSTRUMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INITIAL REPORT INDICATED THAT NO DEVICE LANDED INSIDE THE PATIENT; HOWEVER, A FRAGMENT WAS REMOVED ENDOSCOPICALLY. THERE WERE NO REPORTED COMPLICATIONS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED BILATERAL NIPPLE SPARING MASTECTOMY (NSM) PROCEDURE FOR THE PATIENT'S RIGHT BREAST CANCER AND LEFT BREAST PROPHYLACTICALLY, THE PATIENT EXPERIENCED POST-OPERATIVE HYPOTENSION PRIOR TO DISCHARGE THAT REQUIRED A BLOOD TRANSFUSION. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITHOUT ANY DEVICE MALFUNCTIONS REPORTED. THE INTRA-OPERATIVE BLOOD LOSS WAS REPORTED AS 170ML BUT WAS NOT AN UNEXPECTED VOLUME FOR THE TYPE OF PROCEDURE. NO MEDICAL OR SURGICAL INTERVENTION WAS RENDERED TO STOP THE BLEEDING. ON THE NIGHT OF THE PROCEDURE, THE PATIENT WAS NOTED TO BE HYPOTENSIVE. ON POST-OPERATIVE DAY #2, LAB RESULTS INDICATED A HEMOGLOBIN LEVEL OF 6.6. ONE UNIT OF PACKED RED BLOOD CELLS (PRBC) WAS TRANSFUSED THE NEXT DAY AND THE HYPOTENSION WAS RESOLVED WITH A HEMOGLOBIN LEVEL OF 8.8. THE PATIENT WAS DISCHARGED ON POST-OPERATIVE DAY #3. THE SURGEON BELIEVED THE CAUSE OF THE HYPOTENSION WAS DUE TO INTRA-OPERATIVE BLOOD LOSS AND HEMODILUTION. THREE MONTHS LATER, THE PATIENT WAS FOUND TO HAVE A RIGHT AXILLARY MASS. AN EXCISION OF THE MASS AND A REVISION OF THE BILATERAL BREAST RECONSTRUCTION WAS PERFORMED ON (B)(6) 2024. THE CAUSE OF THE MASS IS UNKNOWN AT

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER A SUCCESSFUL DIAGNOSTIC PROCEDURE USING THE MONARCH BRONCHOSCOPY SYSTEM, THE PATIENT DEVELOPED A PNEUMOTHORAX AND LATER PASSED AWAY. THERE WAS NO REPORTED DEVICE MALFUNCTION ASSOCIATED WITH THE ADVERSE EVENT. PER THE ACCOUNT MANAGER, HOSPITAL ENDO MANAGEMENT DOES NOT ATTRIBUTE THE PNEUMOTHORAX OR THE SUBSEQUENT DEATH TO ANY DEFICIENCY OF THE MONARCH SYSTEM.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS INFORMED THAT ONE CASE OF L1-L4 MIS FIXATION WITH INTRAOP (O-ARM)WORKFLOW WAS BEING DONE AND THE PLANNING WAS DONE AFTER REGISTRATION. SURGEON HAD ALREADY PLACED L1 LEFT, L2 LEFT & L3 LEFT SCREWS. AFTER DRILLING IN L4 LEFT PEDICLE, SURGEON HAS CHECKED WITH BALL TIP PROBE AND OBSERVED THAT SOMETHING WAS WRONG, AND HE STOPPED THE PROCEDURE. AFTER CHECKING WITH C-ARM SHOT IT WAS FOUND THAT ALL THREE PLACED SCREWS ARE NOT AS PER THE PLAN AND ALL THE SCREWS WERE SHIFTED MEDIALLY AND CAUDALLY. AFTER THAT SURGEON HAS STOPPED USING ROBOT AND REPOSITIONED ALL THE SCREWS MANUALLY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT BROKE. THE CUSTOMER USED THE SAME INSTRUMENT TO COMPLETE THE PROCEDURE. FRAGMENTS WERE REPORTED TO FALL INSIDE THE PATIENT AND WERE RETRIEVED FROM THE BODY DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED.

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 AFTER ROSA SURGERY FOR LASER REMOVAL OF LESION ON RIGHT HIPPOCAMPUS TAIL, PATIENT WAS HAVING STROKE LIKE SYMPTOMS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED AND SCREWS WERE THEN PLACED BY HAND. THIS EVENT OCCURRED IN GERMANY.

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 SOCIAL MEDIA POSTING THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE INNER SILICONE PORTION OF A UNIVERSAL SEAL (5-12MM) BROKE OFF. THE INITIAL REPORTER INDICATED THAT IT SEEMS THAT WHEN CERTAIN INSTRUMENTS ARE INSERTED, A PIECE WOULD RIP OFF AND END UP INSIDE THE PATIENT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY THAT WAS INSTALLED ON AN MCS INSTRUMENT WAS LEFT INSIDE THE PATIENT. ACCORDING TO THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) WHO WAS PRESENT DURING THE CASE, THE CUSTOMER HABITUALLY INCLUDES THE TIP COVER ACCESSORY IN THE INTRAOPERATIVE COUNTS, BUT DID NOT REALIZE THE COUNT WAS INCORRECT UNTIL AFTER THE PATIENT WAS CLOSED. THE PATIENT REMAINED IN THE OPERATING ROOM AND UNDER ANESTHESIA THROUGHOUT THE EVENT. THE STAFF SPENT ROUGHLY 20 MINUTES SEARCHING THE OR FOR THE MISSING TIP COVER ACCESSORY BEFORE THE SURGEON REOPENED THE PATIENT. A 12MM AND TWO 5MM PORTS WERE USED DURING REENTRY, AND THE TIP COVER ACCESSORY WAS FOUND WITHIN A COUPLE OF MINUTES OF MANIPULATING THE BOWEL. ONCE RETRIEVED, THE CSR INSPECTED THE TIP COVER ACCESSORY AND THERE WAS NO DAMAGE NOTED. ADDITIONALLY, THERE WERE NO ISSUES WITH THE INSTALLATION OF THE TIP COVER ACCESSORY AND NO LUBRICATION WAS USED. DURING THE PROCEDURE, THE CUSTOMER DID NOT EXPERIENCE ANY ISSUES WITH THE INSTRUMENT. THERE WAS NO BULGING OF THE TIP COVER ACCESSORY OBSERVED ON THE MCS INSTRUMENT

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THIS WAS AN INTRAOP ADOLESCENT SCOLI CASE T4-L5 WITH A SIEMENS CIOS SPIN. WE DIVIDED THE CASE INTO THREE SEGMENTS (L2-L5, T9-T11 AND T4-T6) AND REIMAGED THE PATIENT. APPARENTLY, THE TECHNICIAN CANNOT ISOLATE THE SINGLE SCAN, SO ALL SCANS WERE TRANSFERRED WITH THE LAST ONE. DURING THE NAVIGATION ON THE LAST SEGMENT, THE IMAGE OF THE SCAN WAS KIND OF TORN AND THE SAGITTAL AND AXIAL PLANE LOOKED ALIKE. RESET SOFTWARE, HARD DID NOT HELP, DID A HARD SHUTDOWN AND RESTART. THE ISSUE WITH THE SCAN WAS STILL THERE AND COULD NOT BE SOLVED. THE LAST THREE TRAJECTORIES WERE DRILLED WITH THE ROBOT, BUT SCREWS WERE INSERTED FREEHANDED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A PATIENT WHO WAS ENROLLED IN A STUDY UNDERWENT A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE. APPROXIMATELY NINE MONTHS LATER, THE PATIENT UNDERWENT A SURGERY FOR INTESTINAL ADHESIONS. ON POST-OPERATIVE DAY THREE, A SMALL AMOUNT OF RED AND WHITE PUS DISCHARGED FROM THE UMBILICAL WOUND WHEN CLEANING WITH SALINE. THE DRESSING WAS SWITCHED TO A WET SALINE DRESSING. ON POST-OPERATIVE DAY SEVEN, THE PATIENT UNDERWENT STOMA SURGERY, WITH A STOMA PLACED IN THE LOWER RIGHT ABDOMEN, A NASOGASTRIC TUBE FOR CONTINUOUS DRAINAGE, AND A RECTAL TUBE FOR CONTINUOUS DRAINAGE OF MODERATE AMOUNTS OF DARK GREENISH-BROWN LIQUID STOOL. ON POST-OPERATIVE DAY EIGHT, A SMALL AMOUNT OF BROWNISH EXUDATE WAS FOUND FROM THE UMBILICAL WOUND. ON THE FOLLOWING DAY, A SAMPLE OF THE BROWNISH EXUDATE FROM THE UMBILICAL WOUND WAS TAKEN FOR CULTURE, AND ANTIBIOTICS WERE ADMINISTERED. ON POST-OPERATIVE DAY 10, THE RECTAL AND NASOGASTRIC TUBES REMOVED. THE ABDOMINAL DISTENSION IMPROVED SIGNIFICANTLY, AND THE DISCOMFORT WAS REDUCED. THE CLEAR LIQUID DIET WAS WELL-TOLERATED. ON POST-OPERATIVE DAY 11, THE UMBILICAL WOUND HAD BROWNISH EXUDATE. THE SUTURES WERE REMOVED, AND POVIDONE-IODINE WAS USED TO PACK T

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 PANCREATODUODENECTOMY SURGICAL PROCEDURE, THE TIP FELL OFF FROM THE SINGLE PORT (SP) MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A BACKUP INSTRUMENT OF SAME KIND. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SP MCS INSTRUMENT AND THE SP MCS TIP ACCESSORY WERE INSPECTED PRIOR TO USE WITH NO DAMAGE NOTED. DURING THE PROCEDURE, THE PLASTIC PART OF THE SP MCS INSTRUMENT WAS BROKEN WHILE DISSECTING THE TISSUE. THIS PLASTIC PART AND THE SP MCS TIP ACCESSORY FELL INSIDE THE PATIENT AND WERE RETRIEVED DURING SAME PROCEDURE. POST-OPERATIVE TESTS WERE NOT PERFORMED AS RETRIEVAL OF THE BROKEN PIECES WAS CONFIRMED WITH VISUAL INSPECTION. IN ADDITION, THE SP MCS INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS AND THE SP MCS TIP ACCESSORY APPEARED TO BE PROPERLY INSTALLED DURING USE. THERE WAS NO DIFFICULTY IN REMOVING THE INSTRUMENT AND SP MCS TIP ACCESSORY AND THE INSTRUMENT WRIST WAS STRAIGHTENED UPON REMOVAL. THE CUSTOMER INDICATED THAT NO DAMAGE, TEARS OR HOLE FOUND ON THE SP MCS TI

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: GPS UNIT IS HAVING HARD DRIVE ISSUES. IT WILL ONLY DISPLAY A BLACK SCREEN WHEN BOOTING UP STATING "REBOOT AND SELECT PROPER BOOT DEVICE OR INSERT BOOT MEDIA IN SELECTED BOOT DEVICE AND PRESS A KEY."

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ACCORDING TO A NEWSPAPER ARTICLE, A PATIENT WHO UNDERWENT A DA VINCI ASSISTED COMPONENT SEPARATION PROCEDURE DEVELOPED A SERIOUS COMPLICATION THAT NECESSITATED AN ADDITIONAL SURGERY. ACCORDING TO THE SURGEON, IT WAS HIS FIRST DA VINCI ASSISTED COMPONENT SEPARATION PROCEDURE THAT HE HAD PERFORMED. THERE WERE NO MALFUNCTIONS OF DA VINCI SYSTEMS, INSTRUMENTS OR ACCESSORIES REPORTED IN THE ARTICLE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ACCORDING TO A NEWSPAPER ARTICLE, THERE WAS A DA VINCI-ASSISTED COMPONENT SEPARATION SURGERY THAT HAD POST-OPERATIVE COMPLICATION WHICH REQUIRED AN ADDITIONAL SURGERY. IT WAS REPORTED THAT THE PATIENT DEVELOPED A "MICKEY MOUSE HERNIA", WHERE THE PATIENT'S INTESTINES WERE BULGING OUT OF HER SIDES. THE SURGEON THAT PERFORMED THE REPAIR BELIEVED THE PROCEDURE WAS DONE INCORRECTLY AND THAT THAT THE ORIGINAL SURGEON HAD CUT INTO THE WRONG MUSCLE PLANE. THERE WERE NO MALFUNCTIONS OF DA VINCI SYSTEMS, INSTRUMENTS OR ACCESSORIES REPORTED IN ANY OF THE PROCEDURES IN THE ARTICLE.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.

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.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: FARIVAR, D., KIM, T. T., SY, C. A., BARON, E. M., NOMOTO, E. K., WALKER, C. T., & AMP; SKAGGS, D. L. (2023). COMPLICATIONS HAVE NOT IMPROVED WITH NEWER GENERATION ROBOTS. GLOBAL SPINE JOURNAL. HTTPS://DOI.ORG/10.1177/21925682231216081 OBJECTIVE: THE PURPOSE OF THIS STUDY WAS TO SEE WHETHER UPGRADES IN NEWER GENERATION ROBOTS IMPROVE SAFETY AND CLINICAL OUTCOMES FOLLOWING SPINE SURGERY. METHODS: ALL PATIENTS UNDERGOING ROBOTIC-ASSISTED SPINE SURGERY WITH THE MAZOR X STEALTH EDITIONTM (MEDTRONIC, MINNEAPOLIS, MN) FROM 2019 TO 2022 AT A COMBINED ORTHOPEDIC AND NEUROSURGICAL SPINE SERVICE WERE RETROSPECTIVELY REVIEWED. ROBOT RELATED COMPLICATIONS WERE RECORDED. RESULTS: 264 CONSECUTIVE PATIENTS (54.1% FEMALE; AGE AT TIME OF SURGERY 63.5 ± 15.3 YEARS) OPERATED ON BY 14 SURGEONS WERE ANALYZED. THE AVERAGE NUMBER OF INSTRUMENTED LEVELS WITH ROBOTICS WAS 4.2 ± 2.7, WHILE THE AVERAGE NUMBER OF INSTRUMENTED SCREWS WITH ROBOTICS WAS 8.3 ± 5.3. THERE WAS A NEARLY 50/50 SPLIT BETWEEN AN OPEN AND MINIMALLY INVASIVE APPROACH. SIX PATIENTS (2.2%) HAD ROBOT RELATED COMPLICATIONS. THREE PATIENTS HAD TEMPORARY NERVE ROOT INJURIES FROM MISPLACED SCREWS THAT REQUIRED REOPERATION, ONE PATIENT HAD A PERM

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE CASE WAS AN L4-S1 ALIF 360 USING HEDRON IA AND CREO ONE HARDWARE. THERE WAS NO PRIOR HARDWARE IN THE PATIENT. THE EGPS WORKFLOW WAS INTRA-OP CT. THE EGPS IS RUNNING SOFTWARE VERSION 1_1R3. THE PATIENT WAS POSITIONED PRONE FOR THE POSTERIOR PORTION AND THE CAMERA WAS POSITIONED AT THE FOOT OF THE BED. AN O-ARM WAS USED FOR IMAGING AND REGISTRATION. DR. (B)(6) PLACED THE DRB AT RIGHT PSIS WITH THE LOW-PROFILE QUATTRO SPIKE AND SURVEILLANCE MARKER AT LEFT PSIS. SURVEILLANCE WAS REGISTERED PRIOR TO THE ICT BEING POSITIONED ON THE QUATTRO SPIKE. THE ICT WAS POSITIONED, THE BED WAS RAISED, AND THE SURGICAL SNAPSHOT WAS TAKEN. THE O-ARM SPIN WAS ACQUIRED AND TRANSFERRED SUCCESSFULLY TO EGPS VIA ETHERNET. ALL 7 FIDUCIALS WERE CAPTURED SUCCESSFULLY, AND THE REGISTRATION FIT WAS DOWN ON GREEN. DR. (B)(6) PERFORMED LANDMARK CHECKS ON THE ICT FIDUCIALS AS WELL AS DOWN THE LOW-PROFILE QUATTRO SPIKE. NAVIGATION APPEARED TO EVERYONE IN THE ROOM TO BE ACCEPTABLE AND OF HIGH QUALITY. FOLLOWING PERCUTANEOUS PLACEMENT OF ALL SCREWS THROUGH BILATERAL WILTSY INCISIONS, A POST-OP REGISTRATION O-ARM SPIN WAS ACQUIRED. DR. (B)(6) DECIDED TO DO THIS PRIOR TO LOCKING THE CONSTRUCT DOWN AS HE QUESTIONED

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 THE REVIEW OF A LITERATURE ARTICLE WHICH DESCRIBED A RETROSPECTIVE COHORT STUDY, A SINGLE-PORT TRANSVESICAL (TV) ROBOT-ASSISTED SIMPLE PROSTATECTOMY (RASP) WAS PERFORMED. THE ARTICLE NOTED THAT DURING THESE SURGERIES, THERE WERE TWO SUSPECTED VENOUS AIR EMBOLI IN THE COHORT. THE AUTHORS ATTRIBUTED THIS EFFECT TO PNEUMOVESICUM PRESSURES (>12 MMHG). ONE OF THE PATIENTS HAD A SPONTANEOUS RESOLUTION IN THE OPERATING ROOM WITH HIGH-FLOW OXYGEN AND REPOSITIONING TO LEFT LATERAL DECUBITUS. THE SECOND PATIENT REQUIRED MANAGEMENT IN THE INTENSIVE CARE UNIT FOR 3 DAYS; HE WAS ALSO THE ONLY PATIENT THAT REQUIRED CONTINUOUS BLADDER IRRIGATION (CBI) POST OPERATIVELY. THE AUTHORS ALSO NOTED THAT PNEUMOVESICUM PRESSURE WAS SET AT 10 MMHG USING AN AIRSEAL (CONMED, UTICA, NY, USA) SYSTEM. THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS REPORTED, NOR DID THE AUTHORS ALLEGE THAT INTUITIVE PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENT. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP 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: THE SURGEONS COMPLAINT WAS THE FACT THAT WHILE ATTEMPTING TO MERGE THE L2 VERTEBRAL BODY, HE WAS UNABLE TO GET A BETTER MERGE BECAUSE OF THE LORDOTIC SHIFTING.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WE WERE INSTRUMENTING PEDICLE SCREWS AT T12 & L2 , SKIPPING THE FRACTURE LEVEL. THE E3D SPIN WENT FINE, AND INITIAL NAV INTEGRITY CHECKS SEEMED FINE AS WELL. WE PLACED ALL 4 SCREWS AT T12 / L2. WE BATTLED A LITTLE BIT OF SAVING BUT NOTHING SIGNIFICANT. WE TOOK AP SHOT AFTER SCREWS WERE PLACED, AND ALL FOUR SCREWS WERE COMPLETELY OUT OF THE PEDICLE. THE LEFT SIDE WAS LATERAL, AND RIGHT SIDE WAS MEDIAL.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY SURGICAL PROCEDURE, THE DISTAL SHAFT OFFSET ITSELF AND CAUSED PARTS OF AN INSTRUMENT TO FALL INTO THE PATIENT'S ABDOMEN. THE PARTS WERE RETRIEVED. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND NO FURTHER INFORMATION WAS AVAILABLE.

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.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ALL OUR SCREWS WERE ON, WE USED PRE OP CT WORKFLOW WITH G-ARM. THEN WE TOOK AN X-RAY OF OUR LATERAL TRIAL, AND THE NAVIGATION WAS ON. WHEN PLACING THE IMPLANT, WE WERE 4/5MM OFF POSTERIOR. WE HAD TO GO BACK IN, OPEN THE PATIENT, RETRIEVE THE CAGE AND RE DO EVERYTHING, NAVIGATION APPEARED TO BE ON UP UNTIL THE CAGE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A REVIEW OF A LITERATURE ARTICLE TRANSORAL ROBOTIC SURGERY IN OROPHARYNGEAL SQUAMOUS CELL CARCINOMA: A COMPARATIVE STUDY BETWEEN DA VINCI SINGLE-PORT AND DA VINCI XI SYSTEMS WAS PERFORMED. THE STUDY'S AIM WAS TO COMPARE THE INTRA- AND POST-OPERATIVE OUTCOMES, TECHNICAL ADVANTAGES, AND SHORTCOMINGS OF TRANSORAL RESECTIONS PERFORMED WITH THE DA VINCI SINGLE PORT (SP) AND THE DA VINCI XI SYSTEMS USING A LARGE-VOLUME ACADEMIC CENTER USING TRANSORAL ROBOTIC SURGERY (TORS) TO TREAT OROPHARYNGEAL SQUAMOUS CELL CARCINOMA (OPSCC). PATIENTS DIAGNOSED WITH AN OPSCC WHO UNDERWENT TORS BY THE SENIOR AUTHOR¿S (SHK) TEAM BETWEEN JANUARY 2015 AND JANUARY 2023 WERE INCLUDED. THE ARTICLE NOTED THAT THAT DURING THESE DV SURGERIES, A TOTAL OF 6 PATIENTS HAD MAJOR POST-OPERATIVE BLEEDING THAT REQUIRED HEMOSTASIS AND 4 PATIENTS WERE DEPENDENT ON TRACHEOTOMY AND FEEDING TUBE 6 MONTHS AFTER SURGERY IN THE SP GROUP. THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS REPORTED, NOR DID THE AUTHOR ALLEGED THAT ISI PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENT.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: APOLOGIES, ORIGINAL REPORT DID NOT PROCESS. LOGS HAVE BEEN UPLOADED TO INR PORTAL. THERE WAS A SUSPECTED ISSUE WITH THE PREOP REGISTRATION/MERGE. T12 FRACTURE, SCREWS PLACED AT T10-11, L1-2. NAMELY, T11-L WAS PLACED LATERAL TO THE ORIGINAL PLACE. ADDITIONALLY, T10 SCREWS PLACED PROUD. AFTER DISCUSSION, SUSPECTED MISSTEP MAY HAVE BEEN PROPER PLACEMENT OF FLUORO FIXTURE BUT NO YET CAUSE DETERMINED. SCREWS WERE REPOSITIONED VIA TRADITIONAL MIS JAMSHID TECHNIQUE.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY PROCEDURE THE PHYSICIAN WAS ADJUSTING THE SCOPE TOWARDS TARGET OF NODULE AND THE PATIENTS HEART RATE (HR) BEGAN TO DECLINE AND THE PHYSICIAN ABORTED THE CASE. THE PATIENT THEN WENT INTO ASYSTOLE AND REQUIRED EMERGENT CONVERSION AND CHEST COMPRESSIONS. ONCE THE PATIENT REGAINED A PULSE THE WERE TRANSPORTED THE INTENSIVE CARE UNIT (ICU) WHERE THE PATIENT CODED AGAIN AND WAS BEING SENT TO THE CARDIAC CATH LAB. THE PHYSICIAN STATED THAT THE ADVERSE EVENTS ARE NOT ATTRIBUTED TO THE MONARCH SYSTEM.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY PROCEDURE THE PHYSICIAN WAS ADJUSTING THE SCOPE TOWARDS TARGET OF NODULE AND THE PATIENTS HEART RATE (HR) BEGAN TO DECLINE AND THE PHYSICIAN ABORTED THE CASE. THE PATIENT THEN WENT INTO ASYSTOLE AND REQUIRED EMERGENT CONVERSION AND CHEST COMPRESSIONS. ONCE THE PATIENT REGAINED A PULSE THE WERE TRANSPORTED THE INTENSIVE CARE UNIT (ICU) WHERE THE PATIENT CODED AGAIN AND WAS BEING SENT TO THE CARDIAC CATH LAB. THE PHYSICIAN STATED THAT THE ADVERSE EVENTS ARE NOT ATTRIBUTED TO THE MONARCH SYSTEM.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE PLANNED SURGERY ON THE DORSAL CERVICAL SPINE INCLUDED A SCREW FIXATION C1/C3/C4. WHEN CHECKING THE SCREW POSITION IN THE 3D SCAN AFTER SCREW PLACEMENT, THE SURGEONS WERE NOT SATISFIED WITH THE SCREW POSITION OF A C1 SCREW. A NEW 3D SCAN WAS PERFORMED AND A NEW C1 SCREW WAS PLANNED INTRAOPERATIVELY. WHEN APPROACHING THE TRAJECTORY, THE ROBOTIC ARM STOPPED FAR AWAY FROM THE FINAL POSITION AND ONLY SHOWED A YELLOW FRAME. THE END EFFECTOR WAS SO FAR AWAY THAT THE INSTRUMENTS DID NOT REACH THE BONE. RESETTING THE SOFTWARE AND MOVING THE ROBOT ARM MANUALLY DID NOT CHANGE ANYTHING. BECAUSE THE ROBOT ARM WAS TOO FAR AWAY, THE C1 SCREW HAD TO BE INSERTED MANUALLY (WITH NAVIGATION OF THE ROBOT), BUT NOT BY THE END EFFECTOR.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT REPEATED SYSTEM FAULTS OCCURRED DURING A MONARCH BRONCHOSCOPY. THE PHYSICIAN TRIED MULTIPLE BRONCHOSCOPES, BUT THE SYSTEM CONTINUED TO FAULT. THE PHYSICIAN ELECTED TO ABORT THE DIAGNOSTIC PROCEDURE. NO CLINICAL CONSEQUENCES TO THE PATIENT WERE REPORTED DUE TO THIS EVENT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT BLADE SUDDENLY BROKE. THE CUSTOMER USED A SPARE INSTRUMENT TO PROCEED. THE PROCEDURE WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE HARMONIC ACE INSTRUMENT WAS INSPECTED PRIOR TO USE AND THERE WAS NO ISSUE OBSERVED AT THE TIME. THE REPORTED ISSUE OCCURRED WHILE PERFORMING A TISSUE-DISSOLVING PLANE. THE SURGEON BELIEVED WHAT CAUSED THE ISSUE WAS A QUALITY PROBLEM. THE HARMONIC ACE INSTRUMENT ISSUE OCCURRED AT THE START OF THE PROCEDURE. THE SURGEON NOTICED FUNCTIONALITY ISSUES DURING THE SURGICAL PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR HARD MATERIAL. THE INSTRUMENT WAS REMOVED BEFORE THE BREAKAGE OCCURRED AND THE INSTRUMENT'S WRIST WAS EXTENDED OR STRAIGHTENED PRIOR TO REMOVAL. THE STAFF DID NOT FEEL RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. ALL FRAGMENTS WERE RETRIEVED. THE PROCEDURE WAS COMPLETED WITH A SPARE INSTRUMENT OF THE SAME KIND. NO ADDITIONAL MEDICAL PROCEDURES SUCH AS X-RAYS WERE PERFORMED POST-PROCEDURALLY. THERE WAS NO PA

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT A SCREW USING THE EXCELSIUS GPS SYSTEM WAS MISPLACED INTRA-OPERATIVELY CAUSING A SCREW TO BREACH THE PATIENT'S SPINAL CANAL.