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 THAT DURING A DA VINCI-ASSISTED MEDIASTINAL MASS RESECTION, THE BRACHIOCEPHALIC ARTERY WAS INJURED AND THE PROCEDURE WAS CONVERTED TO OPEN. THE PATIENT EXPIRED ON POST-OPERATIVE DAY ONE. THE SURGEON REPORTED THAT THE ARTERY WAS INJURED WHEN USING THE SYNCHROSEAL INSTRUMENT TO DISSECT LYMPH NODES. THE ARTERY WAS ADHERED TO TISSUE AND TO THE LYMPH NODES, RESULTING IN THE ARTERY NOT BEING VISIBLE TO THE SURGEON. THE ARTERY BEGAN TO BLEED AFTER IT WAS GRASPED WITH THE SYNCHROSEAL INSTRUMENT. THE PROCEDURE WAS CONVERTED TO THORACOTOMY. THERE WAS NO MALFUNCTION OF THE SYNCHROSEAL INSTRUMENT OR ANY OTHER DA VINCI PRODUCTS USED DURING THIS PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

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 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 RECTAL RESECTION AND AMPUTATION PROCEDURE, BLACK DEBRIS WAS FOUND INSIDE THE PATIENT'S BODY. AFTER REMOVAL OF A FORCEPS INSTRUMENT, IT WAS DISCOVERED THAT A PART OF THE UNIVERSAL SEAL WAS DAMAGED. THE CUSTOMER STATED TWO BLACK OBJECTS WERE FOUND IN THE PATIENT'S BODY CAVITY AND WERE RETRIEVED DURING THE SAME SURGICAL PROCEDURE. A BACKUP UNIVERSAL SEAL WAS USED TO PROCEED WITH 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 AFTER A DA VINCI-ASSISTED CHOLECYSTECTOMY PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY FELL INSIDE OF THE PATIENT. A PATIENT HAD UNDERGONE A CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2025. THE PROCEDURE WENT GREAT WITHOUT ANY ISSUES. THE PATIENT WAS RELEASED FROM THE HOSPITAL AFTER THE PROCEDURE. ABOUT A WEEK LATER, THE PATIENT CAME BACK COMPLAINING OF NAUSEA AND VOMITING. MAGNETIC RESONANCE IMAGING (MRI) WAS PERFORMED, AND A MCS TIP COVER ACCESSORY WAS IDENTIFIED. THE SURGEON PERFORMED A LAPAROSCOPIC PROCEDURE AND WAS ABLE TO REMOVE THE TIP COVER. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INITIAL REPORTER HAS SPOKEN WITH THE SURGEON ABOUT THIS TO UNDERSTAND MORE. NO ROBOTIC MSC INSTRUMENT WAS USED DURING THIS CASE AS NONE WERE AVAILABLE ON THAT DATE; HOWEVER, PER THE PREFERENCE CARD THE TEAM OPENED A MSC TIP COVER ACCESSORY EXPECTING TO HAVE AN MCS AVAILABLE. THE ONLY ROBOTIC INSTRUMENTS CAPTURED AS HAVING BEEN USED WERE THE PERMANENT CAUTERY HOOK (PCH), CADIERE FORCEPS, LARGE CLIP APPLIER, ENDOSCOPE, AND A GRASPER. LAPAROSCOPIC SCISSORS WERE USED DURING THE CASE.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: BIRCH, C., WELCH, N., COOK, D., HEDEQUIST, D. (2025). INSTRUMENTATION USING ROBOTICS COUPLED WITH NAVIGATION IN PEDIATRIC SP INE DEFORMITY SURGERY: A TECHNICAL REPORT OF SACROPELVIC INSTRUMENTATION. SPINE DEFORMITY. HTTPS://DOI.ORG/10.1007/S43390-025-01047-6. PURPOSE: THIS TECHNICAL REPORT PRESENTS THE INTRAOPERATIVE EXPERIENCE OF USING ROBOTIC ASSISTED NAVIGATION (RAN) FOR SACRO-PELVIC INSTRUMENTATION IN PEDIATRIC SPINE DEFORMITY SURGERY. METHODS: A RETROSPECTIVE REVIEW OF PATIENTS WHO UNDERWENT SURGERY USING RAN FOR SACROPELVIC INSTRUMENTATION AT A SINGLE INSTITUTION FROM 2019 TO 2022 WAS CONDUCTED. IN CASES WITH SCREW CONFIRMATION IMAGING, SCREWS WERE EVALUATED USING THE GERTZBEIN AND ROBBINS CLASSIFICATION SCALE. RESULTS: 52 CASES WERE INCLUDED. AVERAGE AGE AT SURGERY WAS 14.1 YEARS AND 67.3% OF PATIENTS WERE FEMALE. THE MOST COMMON DIAGNOSIS WAS SPONDYLOLISTHESIS (48.1%). THE AVERAGE MAJOR CURVE IN SCOLIOSIS CASES WAS 77°. A SCHANZ PIN IN THE POSTERIOR SUPERIOR ILIAC SPINE WAS PLACED IN 98.1% OF SURGERIES COMPARED TO 1 CASE WITH A SPINOUS PROCESS CLAMP. INTRAOPERATIVE 3D IMAGING SCANS (SCAN/PLAN) WERE USED FOR 69.2% OF THE ROBOTIC REGISTRATIONS TO THE PATIENT AND INTRAOPERATIV

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 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 HARMONIC ACE INSTRUMENT FRACTURED AND A FRAGMENT FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. AT THE TIME THE EVENT OCCURRED, THE SURGEON WAS PERFORMING SEPARATION. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT AND NO POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRASOUND WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH A BACKUP HARMONIC ACE INSTRUMENT. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL 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: REFER TO 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 INSTRUMENT ON THE UNIVERSAL SURGICAL MANIPULATOR (USM) 3 WAS NOT RECOGNIZED. THE CUSTOMER INFORMED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) THAT USM 3 HAD A CAUTERY SPATULA THAT WAS IN USE WHEN THE USM ERRORED WITH THE MESSAGE "INSTRUMENT NOT RECOGNIZED". THE CUSTOMER MADE MULTIPLE ATTEMPTS TO RESEAT THE INSTRUMENT WITH NO CHANGE. THE STAFF THEN SWAPPED THE INSTRUMENT WITH A SPARE SPATULA, BUT THE ISSUES REMAINED. THE CUSTOMER STATED THAT THE ROBOTIC PROCEDURE WAS ALMOST COMPLETE BUT OPTED TO CONVERT TO OPEN TO COMPLETE THE CASE. THE TSE REVIEWED MULTIPLE ERRORS ON USM 3 AND ASKED IF THE STAFF RESEATED THE STERILE ADAPTER. THE CUSTOMER WAS NOT SURE ABOUT THE COMPLETE TROUBLESHOOTING STEPS TAKEN AND REQUESTED A FOLLOW-UP FROM THE FIELD SERVICE ENGINEER (FSE). THE CUSTOMER CONTINUED WITH AN OPEN 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: INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA MEDWATCH REPORT (MDR) WITH MDR REPORT #MW5165586 STATING: ROBOTIC HARMONIC INSTRUMENT BROKE INSIDE THE PATIENT'S ABDOMEN DURING PROCEDURE. THE PIECE THAT BROKE OFF WAS LOCATED AND REMOVED FROM THE PATIENT. THERE WERE NO NOTED INJURIES. ROBOTIC HARMONIC WAS REPLACED.

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 ENCOUNTERED SYSTEM FAULT MESSAGES AND ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

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.

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 PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, A SMALL GREY PIECE OF MATERIAL WAS NOTICED IN THE PATIENT. THE FRAGMENT WAS REMOVED DURING THE SAME PROCEDURE. AFTER UNDOCKING THE ROBOT, ALL UNIVERSAL SEALS WERE INSPECTED. ONE UNIVERSAL SEAL WAS MISSING A PIECE THAT MATCHED THE MATERIAL THAT WAS RETRIEVED. ALL OTHER SEALS WERE INTACT. NO HARM WAS DONE TO THE PATIENT. THE PROCEDURE WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE. THE PIECE OF MATERIAL WAS NOTICED INSIDE OF THE PATIENT. THE FRAGMENT WAS REMOVED IMMEDIATELY WITH A GRASPER INSTRUMENT THROUGH THE ASSISTANT PORT. THE UNIVERSAL SEAL WAS USED FOR ABOUT 30 MINUTES TO AN HOUR WHEN THE ISSUE OCCURRED. THERE WERE NO FUNCTIONAL ISSUES WITH THE SEAL. THERE WAS NO COLLUSION WITH ANY OTHER INSTRUMENTS OR HARD MATERIALS. INSTRUMENTS WERE EXCHANGED A FEW TIMES THROUGH THE UNIVERSAL SEAL DURING THE PROCEDURE. THE INSTRUMENTS' WRISTS WERE ALWAYS STRAIGHTENED AND NO RESISTANCE FELT. UPON FINAL REMOVAL OF THE INSTRUMENT, THE WRIST WAS STRAIGHTENED. THERE WAS N

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: NO NEW 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 FROM A SOCIAL MEDIA POST THAT DURING AT LEAST THREE DA VINCI-ASSISTED SURGICAL PROCEDURES, A FRAGMENT FROM A UNIVERSAL CANNULA SEAL FELL INSIDE THE PATIENT. IT IS UNKNOWN IF THE FRAGMENT WAS ALL RETRIEVED.

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 PROCTECTOMY PROCEDURE, THE 30 DEGREE ENDOSCOPE PLUS WAS LEFT ON THE PATIENT WITH THE LIGHT TURNED ON, CAUSING A 2CM DIAMETER CIRCULAR BURN ON THE PATIENT'S THIGH. THE ENDOSCOPE REMAINED ON THE PATIENT FOR APPROXIMATELY 15-20 MINUTES WHILE NOT IN USE, CAUSING THE DRAPE COVERING THE PATIENT TO MELT AND INFLICTING A 1ST TO 2ND DEGREE BURN. THE BURN WAS NOTED WITHOUT CHARRING, BRUISING, OR BLEEDING. THE ONLY MEDICAL TREATMENT ADMINISTERED WAS THE APPLICATION OF BURN OINTMENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT DID NOT EXPERIENCE ANY POST-OPERATIVE COMPLICATIONS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED FROM A SOCIAL MEDIA POST THAT DURING TWO DA VINCI-ASSISTED SURGICAL PROCEDURES, THE UNIVERSAL CANNULA SEAL BROKE. IT IS UNCLEAR IF FRAGMENTS FELL INSIDE THE PATIENTS, AND IF SO, WERE THE FRAGMENTS RETRIEVED. NO OTHER DETAILS WERE PROVIDED.

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 FROM A SOCIAL MEDIA POST THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE RUBBER SEALANT PART OF A UNIVERSAL CANNULA SEAL BROKE OFF AND FELL INSIDE THE PATIENT. IT IS UNKNOWN IF THE FRAGMENT WAS RETRIEVED.

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 KNIFE HEAD FRACTURED ON THE HARMONIC ACE INSTRUMENT. THE FRAGMENT FELL INTO THE PATIENT AND WAS RETRIEVED DURING 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HIATAL HERNIA PROCEDURE, THE TIP OF THE HARMONIC ACE INSTRUMENT BROKE OFF INSIDE THE PATIENT'S THORACIC CAVITY MID-PROCEDURE. DISSECTING WAS BEING PERFORMED WHEN THE FRAGMENT FELL. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE USING A LAP GRASPER. VISUAL INSPECTION CONFIRMED THAT ALL FRAGMENTS WERE RETRIEVED. THE PROCEDURE WAS COMPLETED ROBOTICALLY USING A BACKUP HARMONIC ACE INSTRUMENT. NO X-RAY OR OTHER IMAGING WAS PERFORMED, AND NO ADDITIONAL PROCEDURE WAS REQUIRED. THE PATIENT HAD NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL 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 DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT TIP COVER FELL OFF TWICE DURING INTRAOPERATIVE USE. THE PROCEDURE WAS COMPLETED. 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.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WE RECENTLY HAD A SURGEON REACH OUT ABOUT AN OUTCOME OF A TKA 2.0 CASE THAT HAPPENED (B)(6) 2025. THE PATIENT STARTED WITH A NATIVE 8 DEGREE VARUS DEFORMITY. WE PLANNED 4 DEGREES TOTAL OF VARUS. 3 DEGREES OF VARUS ON THE TIBIA AND 1 DEGREE OF VARUS ON THE FEMUR. WE ALSO HAD 1 DEGREE OF EXTERNAL ROTATION. THE SURGEON HAS REACHED AND HAS SAID THE PATIENT IS NOW IN 20 DEGREE OF VALGUS AND IS QUESTIONING WHETHER SOMETHING HAPPENED DURING THE CASE THAT CAUSED THE DRASTIC CHANGE. HE IS CONCERNED THE CUTS WEREN'T ACCURATE WHICH HAS LED TO THE IMBALANCE HE IS SEEING NOW. WE ARE SUBMITTING THE COMPLAINT TO SEE IF ANYTHING SHOWS UP THAT MIGHT HAVE CAUSED THIS ISSUE. CASE TYPE / APPLICATION: TKA 2.0. MPS: "THIS SURGEON HAS DONE A MANUAL REVISION ALREADY TO TAKE CARE OF 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: REFER TO 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 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.

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 DISTAL GASTRECTOMY SURGICAL PROCEDURE, THE HARMONIC ACE HAD A BROKEN TIP. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE TIP WAS DETACHED FROM THE INSTRUMENT. THE ISSUE WAS IDENTIFIED DURING THE PROCEDURE. A FRAGMENT FELL INTO THE PATIENT AND THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED ROBOTICALLY. THERE ARE NO PHOTOS AND/OR VIDEOS OF THIS EVENT AVAILABLE FOR ISI REVIEW.

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 SUBTOTAL GASTRECTOMY SUBTOTAL SURGICAL PROCEDURE, THE TIP OF THE HARMONIC ACE INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE AND THE CUSTOMER PROCEEDED WITH THE CASE USING A BACKUP HARMONIC ACE INSTRUMENT. THE PROCEDURE WAS COMPLETED ROBOTICALLY. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR TOOL DURING THE PROCEDURE. THERE ARE NO PHOTOGRAPHIC IMAGES OF THE DEVICE(S) OR A VIDEO RECORDING OF THE PROCEDURE AVAILABLE FOR INTUITIVE SURGICAL, INC. (ISI) TO REVIEW. PATIENT DEMOGRAPHICS WERE REQUESTED BUT WERE UNABLE TO BE PROVIDED.

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 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 HYSTERECTOMY PROCEDURE, THE MONOPOLAR ENERGY INSTRUMENT WAS ACTIVATED INSTEAD OF THE INTENDED BIPOLAR INSTRUMENT. BOTH THE MONOPOLAR AND BIPOLAR ENERGY SETTINGS WERE SET TO 4. WHILE DISSECTING THE URETER, THE SURGEON HAD THE FORCE BIPOLAR INSTRUMENT IN THE LEFT HAND AND THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT IN THE RIGHT. WHILE ATTEMPTING TO CAUTERIZE WITH THE BIPOLAR ENERGY USING THE FORCE BIPOLAR INSTRUMENT, THE MCS INSTRUMENT HAD INADVERTENTLY FIRED CAUSING AN INJURY TO THE URETER. UPON THE INCORRECT ACTIVATION OF THE MCS INSTRUMENT, THE SURGEON CHECKED THE FOOT PEDALS TO ENSURE THEY WERE PRESSING THE CORRECT ONES, WHICH WAS CONFIRMED TO BE CORRECT. THE FORCE BIPOLAR INSTRUMENT WAS THEN TESTED SEPARATELY AND INITIALLY DID NOT ADMINISTER BIPOLAR ENERGY, BUT THE PROBLEM RESOLVED ITSELF SHORTLY AFTER. A UROLOGIST WAS CONSULTED, RESULTING IN A 15-MINUTE DELAY IN THE PROCEDURE, AND IT WAS DETERMINED THAT NO FURTHER INTERVENTION WAS REQUIRED. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITHOUT FURTHER COMPLICATIONS. POSTOPERATIVELY, THE PATIENT WAS HOSPITALIZED FOR TWO ADDITIONAL DAYS TO ENSURE THERE WERE NO FURTHER COMPLICATIONS TO

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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE TIP OF THE HARMONIC ACE INSTRUMENT BROKE. A FRAGMENT FELL INSIDE THE PATIENT BUT WAS RETRIEVED DURING THE SAME PROCEDURE WHICH WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGE WAS NOTED. THE SURGEON WAS RETRACTING TISSUE AT THE TIME OF THE INSTRUMENT BREAKAGE. THE INSTRUMENT WAS IN USE FOR ABOUT AN HOUR BEFORE THE EVENT OCCURRED. THERE WAS NO ISSUE WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR HARD MATERIAL DURING THE SURGICAL PROCEDURE. A FRAGMENT BROKE OFF THE INSTRUMENT DURING AN INSTRUMENT TIP COLLISION. UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA, THERE WAS NO RESISTANCE. THERE WAS NO DAMAGE TO THE CANNULA AFTER THE EVENT OCCURRED. THE FRAGMENT WAS RETRIEVED BY THE FIRST ASSISTANT. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT. NO POSTOPERATIVE TESTS LIKE AN X-RAY OR ULTRASOUND WERE PERFORMED TO CHECK FOR FRAGMENTS. ALSO, NO ADDITIONAL SURG

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 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 HYSTERECTOMY PROCEDURE, DURING NORMAL USE OF THE MONOPOLAR CURVED SCISSORS INSTRUMENT, THE TIP COVER ACCESSORY FELL OFF OF THE TIP/ORANGE PART OF SCISSORS INTO THE PATIENT. THE ROBOTICS COORDINATOR STATED THAT THE SURGEON WAS UNAWARE OF WHY THE TIP COVER HAD COME OFF SO EASILY. THE SITE DOES USE ELECTROLUBE FOR THEIR CASES. AS SOON AS THE TIP COVER FELL OFF INTO THE PATIENT, IT WAS IMMEDIATELY RETRIEVED WITH A LAPAROSCOPIC GRASPER. THE PROCEDURE WAS COMPLETED ROBOTICALLY AS PLANNED WITH NO FURTHER COMPLICATIONS.

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 UNABLE TO QUERY PACS (PICTURE ARCHIVING AND COMMUNICATION SYSTEM) AND ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO 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: REFER TO 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: A PATIENT WHO WAS ENROLLED IN A STUDY UNDERWENT A DA VINCI-ASSISTED LEFT BREAST NIPPLE SPARING MASTECTOMY (NSM) SURGICAL PROCEDURE. DURING THE SURGICAL PROCEDURE A 1.0CM FULL THICKNESS BURN WAS NOTED ON THE ANTERIOR FLAP MEDIAL TO THE NIPPLE AT THE CONCLUSION OF THE CASE; THIS WAS EXCISED BY THE PLASTICS SERVICE. THE PHYSICIAN INDICATED THAT THE SKIN FLAP WAS VIABLE. THE PATIENT WAS DISCHARGED THE NEXT DAY. TWO WEEKS AFTER THE ORIGINAL SURGERY, THE PATIENT HAD A PRE-OP ASSESSMENT FOR RECONSTRUCTION TO BE PERFORMED ON THE SAME DAY AND IT WAS REPORTED THAT THE PATIENT WAS IN GOOD CONDITION. THE STUDY INVESTIGATOR REPORTED THAT THE EVENT WAS PROBABLY RELATED TO THE DA VINCI SP SYSTEM AND PROBABLY RELATED TO THE SP NSM PROCEDURE.

Monarch Platform — Death 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 CODED DURING PROCEDURE, THE PHYSICIAN HAD CONDUCTED 4-BIOPSIES AND ON THE 5TH BIOPSY AN ABNORMAL AMOUNT OF BLOOD WAS COMING THROUGH THE ET TUBE. THE SCOPE AND THE PATIENT INTRODUCER WERE REMOVED AND THEY WERE ABLE TO STABILIZE THE PATIENT IN THE ROOM. THE PATIENT WAS MOVED TO ICU WHERE THEY LATER CODED AND PASSED AWAY. THE PHYSICIAN STATED THAT THE MONARCH DID NOT CAUSE OR CONTRIBUTE TO THE DEATH.

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 FRAGMENT FROM A HARMONIC ACE INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT. IT IS UNKNOWN IF THE FRAGMENT WAS RETRIEVED. THE INSTRUMENT HAD REPORTEDLY BEEN IN USE FOR LESS THAN A MINUTE. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO REPORTED INJURY.

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 THERE WAS A CONCERNING INCREASE IN SPINE SURGICAL SITE INFECTIONS (SSIS) ASSOCIATED WITH THE GUIDANCE SYSTEM ROBOT. THE INFECTION RATE HAD TRIPLED COMPARED TO FISCAL YEAR 2024, WITH SEVEN FUSION INFECTIONS REPORTED IN FY2025, FIVE OF WHICH INVOLVED PROCEDURES UTILIZING THE GUIDANCE SYSTEM ROBOT. IT WAS NOTED THAT THE INSTRUMENT WAS NOT PROPERLY CLEANED AFTER STERILIZATION, AS OBSERVED USING A BORESCOPE DOWN THE CANNULA INSERTER. IN RESPONSE TO THESE FINDINGS, THE USE OF THE GUIDANCE SYSTEM ROBOT FOR SPINE SURGERIES WAS TEMPORARILY SUSPENDED EFFECTIVE (B)(6) 2025, WHILE FURTHER INVESTIGATION AND MITIGATION EFFORTS WERE UNDERTAKEN. THE PROCEDURE BEING PERFORMED WAS AN EXPLORATION OF OCCIPUT TO C5 FUSION, REMOVAL OF HARDWARE, OCCIPUT TO C5, REVISION POSTERIOR FUSION C2-5, POSTERIOR SPINAL FUSION C6-7, T1-3, SEGMENTAL INSTRUMENTATION C3-T3, AND APPLICATION OF ALLOGRAFT BONE ON (B)(6) 2024. THE PATIENT EXPERIENCED COMPLICATIONS ON (B)(6) 2025. THE PATIENT STATED THEY EXPERIENCED WORSENING PAIN AND HARDWARE PROTRUSION 4-5 DAYS PRIOR. IT WAS NOTED THAT THE PATIENT WAS RECE

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 "ROBOTIC SURGERY OF THE UROTHELIAL CARCINOMA OF THE UPPER URINARY TRACT SINGLE SURGEON INITIAL EXPERIENCE, 66 CONSECUTIVE CASES" WAS PERFORMED. THE STUDY INVESTIGATED THE ADVANTAGES AND BURDEN OF ROBOT-ASSISTED SURGICAL TREATMENT OF THE UROTHELIAL CARCINOMA OF THE UPPER URINARY TRACT. THE STUDY INCLUDED 66 PROSPECTIVELY ENROLLED PATIENTS WHO WERE SURGICALLY TREATED BY A SINGLE, ROBOTICALLY SPECIALIZED SURGEON BETWEEN JULY 2019 AND DECEMBER 2023. THE PATIENTS¿ MEAN AGE WAS 71 YEARS. THE PATIENTS WERE DIVIDED INTO THREE GROUPS. GROUP 1: 50 PATIENTS UNDERWENT ROBOT-ASSISTED RADICAL NEPHROURETERECTOMY (RANU) WITH BLADDER CUFF EXCISION, GROUP 2: 11 PATIENTS UNDERWENT RANU SIMULTANEOUSLY WITH ROBOT-ASSISTED RADICAL CYSTECTOMY (RARC), AND GROUP 3: 5 PATIENTS UNDERWENT ROBOT-ASSISTED SEGMENTAL URETERECTOMY (RASU). COMPLICATIONS OBSERVED INCLUDED 4 INCISIONAL HERNIAS ON THE MINI-LAPAROTOMY SITE THAT WAS USED TO EXTRACT THE SPECIMEN, EMBOLUS, HEMORRHAGE, SURGERY, AND WOUND INFECTION. ONE FEMALE PATIENT DEVELOPED AN EMBOLUS OF THE ARTERIA ILIACA EXTERNA AND HAD TO UNDERGO AN EMERGENCY EMBOLECTOMY. ONE (B)(6)-YEAR-OLD MALE PATIENT EXPERIENCED BLEEDING ON THE FI

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DRS. (B)(6), PLEASE NOTE, MS. (B)(6), WHO DIED WITHIN ONE YEAR FOLLOWING ROBOTIC MASTECTOMY FOR STAGE 2 BREAST CANCER: PLEASE NOTE - MS. (B)(6) CASE WAS ADVERTISED AS THE FIRST ROBOTIC MASTECTOMY OPERATION PERFORMED IN THE U.S. FOR TREATMENT OF BREAST CANCER: PLEASE NOTE, 5-YR SURVIVAL RATES FOR STAGE 2 BREAST CANCER USING THE CONVENTIONAL APPROACH TO MASTECTOMY IS OVER 80%. MS. (B)(6) DIED WITHIN ONE YEAR OF HER ROBOTIC MASTECTOMY SURGERY. PLEASE ENSURE THAT INTUITIVE SURGICAL HAS FORMALLY REPORTED THIS PATIENT MORTALITY FOLLOWING HER ROBOTIC MASTECTOMY TO THE FDA. ON JAN 5, 2025, AT 11:37 PM, (B)(6) WROTE: DRS. (B)(6), I AM WRITING THIS LETTER OF SAFETY AND ETHICS CONCERN/WARNING TO YOU BASED ON THE TWO RECENT HUMAN SUBJECT RESEARCH PUBLICATIONS FROM SOUTH KOREA, WHICH WERE SUPPORTED BY INTUITIVE SURGICAL: HTTPS://JAMANETWORK.COM/JOURNALS/JAMASURGERY/FULLARTICLE/2822315, HTTPS://WWW.NATURE.COM/ARTICLES/S41598-024-84807-0. THESE STUDIES INVOLVE THE USE OF THE DA VINCI ROBOTIC SYSTEM TO PERFORM MASTECTOMIES ON PATIENTS WITH BREAST CANCER, WHICH AS YOU KNOW WELL, IS CONSIDERED A NON-STANDARD AND OFF-LABEL APPROACH IN THE US AND WESTERN EUROPE. ADDITIONALLY, THESE EXPERIMENTAL SURGER

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 TOTAL HYSTERECTOMY PROCEDURE, THE TIP OF THE HARMONIC ACE INSTRUMENT BROKE OFF WHILE THE SURGEON WAS DISSECTING THE CERVIX. A FRAGMENT FELL INSIDE THE PATIENT BUT WAS RETRIEVED DURING THE SAME PROCEDURE WITH A LAPAROSCOPIC GRASPER INSTRUMENT. THE INSTRUMENT DID NOT COLLIDE WITH OTHER INSTRUMENTS OR HARD MATERIALS DURING THE PROCEDURE. NO X-RAYS OR ADDITIONAL PROCEDURES WERE REQUIRED. AN UNSPECIFIED SCISSOR INSTRUMENT WAS USED AS A BACK-UP TO COMPLETE THE PROCEDURE. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL 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: REFER TO 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 TIP OF THE HARMONIC ACE INSTRUMENT BROKE. THE SURGICAL NURSE REPORTED THAT THERE WAS NO SIGN OF THE INSTRUMENTS COLLIDING WITH EACH OTHER DURING THE OPERATION. THE BROKEN END OF THE INSTRUMENT WAS REMOVED FROM THE PATIENT'S BODY. HOWEVER, IT WAS LOST DURING THE HANDOVER FROM THE OPERATING ROOM STAFF. 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, A PIECE OF NON-ORGANIC MATERIAL WAS FOUND INSIDE THE PATIENT. THE PIECE WAS REMOVED AND IDENTIFIED AS A FRAGMENT FROM A UNIVERSAL SEAL FOR A CANNULA. AFTER COMPLETION OF THE PROCEDURE, THE CUSTOMER VERIFIED THAT THE REMOVED FRAGMENT WAS FROM ONE OF THE UNIVERSAL SEALS. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE UNIVERSAL SEAL WAS INSPECTED PRIOR TO USE AND NO ISSUES WERE NOTED. THE FOREIGN BODY WAS NOTICED WHILE TISSUE WAS BEING RETRACTED BY THE CUSTOMER. THE INSTRUMENTATION WORKED FINE DURING THE CASE. NO DEVICE COLLISIONS WERE NOTED DURING THE CASE. THE STAFF DID NOT NOTICE ANY DAMAGE TO THE CANNULA OR THE INSTRUMENT AFTER THE EVENT OCCURRED. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT. NO POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRASOUND WERE PERFORMED. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO INJURY REPORTED. THE PATIENT DID NOT RETURN TO THE HOSPITAL DUE TO RETAINING A FOREIGN OBJECT. THE FRAGMENT WAS SENT FOR FAILURE ANALYSIS. THERE ARE NO IMAGES/VIDEO RECORDS AVAILABLE FOR REVIE

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 RADICAL NEPHROURETERECTOMY AND BLADDER CUFF RESECTION SURGICAL PROCEDURE. THE NEXT DAY, THE PATIENT EXPERIENCED DIFFICULTY BREATHING. UPON PHYSICAL EXAMINATION, NO WHEEZING, NO SOFT ABDOMEN, AND THE PATIENT WAS BREATHING RAPIDLY, REQUIRING THE USE OF A NON-REBREATHER MASK (NRM). IT WAS OBSERVED THAT THE PATIENT WAS USING ACCESSORY MUSCLES AND CONTINUED TO BREATHE RAPIDLY. ARTERIAL BLOOD GAS ANALYSIS SHOWED CARBON DIOXIDE RETENTION AND REDUCED PARTIAL PRESSURE OF OXYGEN (PO2). DUE TO DIFFICULTIES IN INTUBATION, AN ANESTHESIOLOGIST WAS CONSULTED TO PERFORM INTUBATION. A CT SCAN OF THE CHEST, ABDOMEN, AND PELVIS WITH AND WITHOUT CONTRAST WAS CONDUCTED. A SMALL PULMONARY EMBOLISM COULD NOT BE RULED OUT, AND THE PATIENT DEVELOPED A FEVER OF 38.8 DEGREES CELSIUS. THE PATIENT WAS TRANSFERRED TO THE ICU FOR FURTHER CARE. UPON VERBAL CONVERSATION WITH STUDY TEAM, ALL SYMPTOMS WERE RELIEVED, AND THE PATIENT WAS DISCHARGED WITH NO FURTHER COMPLICATION. THERE WAS NO REPORT OF A DA VINCI DEVICE MALFUNCTION DURING THE PROCEDURE. THE STUDY INVESTIGATOR REPORTED THAT THE EVENT WAS UNLIKELY TO BE RELATED TO THE DA VINCI SP DEVICE A

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 RESECTION OF ESOPHAGEAL SURGICAL PROCEDURE, THE HARMONIC ACE CURVED SHEARS INSTRUMENT BROKE WHILE THE SURGEON WAS DISSOCIATING THE GREATER CURVATURE OF THE STOMACH. A FRAGMENT FELL INSIDE THE PATIENT BUT WAS RETRIEVED DURING THE SAME PROCEDURE WHICH WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE HARMONIC ACE CURVED SHEARS INSTRUMENT WAS INSPECTED PRIOR TO USE AND WAS IN USE FOR ABOUT AN HOUR BEFORE THE EVENT OCCURRED. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIALS DURING THE SURGICAL PROCEDURE. A FRAGMENT FELL INSIDE OF THE PATIENT DURING AN INSTRUMENT TIP COLLISION. THE INSTRUMENT WAS NOT REMOVED DURING THE PROCEDURE PRIOR TO THE BREAKAGE. THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. THERE WAS NO DAMAGE NOTED TO THE CANNULA AFTER THE EVENT OCCURRED. THE CUSTOMER USED A LAPAROSCOPIC INSTRUMENT TO RETRIEVE THE FRAGMENT. ALL FRAGMENTS WERE REMOVED. THERE WERE N

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIMPLE PROSTATECTOMY PROCEDURE, THE CUSTOMER EXPERIENCED AN ISSUE WITH NOT HAVING MONOPOLAR ENERGY. THE OPERATING ROOM (OR) STAFF CALLED IN TO REPORT THAT MONOPOLAR WAS NOT WORKING AND THERE WERE YELLOW LEDS ON THE ENERGY SHIELD. THE STAFF DID NOT WANT TO TROUBLESHOOT THE SYSTEM AT THE TIME. THE CUSTOMER HAD OPTED TO PROCEED WITH BIPOLAR ENERGY, AND USE THE MONOPOLAR INSTRUMENT(S) MECHANICALLY BUT WITH NO ENERGY. HOWEVER, DUE TO THE CUSTOMER REPORTED ISSUE, THE CUSTOMER SUBSEQUENTLY ELECTED TO CONVERT THE CASE TO OPEN SURGERY. THE CUSTOMER PERFORMED A HARD POWER CYCLE ON THE EMBEDDED SERIALIZER MANIPULATOR (ESM) AND THE VISION SIDE CART (VSC) AND THE SYSTEM POWERED BACK ON NORMALLY INDICATING THE ESM WAS READY FOR USE; HOWEVER, THE CUSTOMER HAD ALREADY CONVERTED TO OPEN SURGERY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM WAS INSPECTED PRIOR TO USE AND NO ISSUES WERE NOTED. THE PROCEDURE WAS IN PROGRESS FOR 30 MINUTES WHEN THE ISSUE WAS IDENTIFIED. NO PATIENT INFORMATION IS 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: A REVIEW OF AN ARTICLE WAS CONDUCTED WHICH PROVIDED UPDATED OUTCOMES ON PREVIOUSLY REPORTED ROBOTIC REPAIRS OF PARASTOMAL HERNIAS USING A NOVEL TECHNIQUE. THE STUDY REVIEWED 26 PATIENTS WHO HAD PREVIOUSLY UNDERGONE ROBOTIC ASSISTED "SUGARBAKER" PARASTOMAL HERNIA REPAIR (PHR) USING MESH BETWEEN 2018 AND 2024. THE PATIENTS INCLUDED 9 FEMALES AND 17 MALES WITH A MEAN AGE OF 61.5 YEARS (58.0-67.0 YEARS) AND A MEAN BMI OF 29.5 KG/M2 (25.7-32.6 KG/M2). A TOTAL OF 3 PATIENTS EXPERIENCED COMPLICATIONS REQUIRING RE-OPERATION, INCLUDING ONE WHO DEVELOPED AN OBSTRUCTION AT THE STOMA SITE AND A CECAL PERFORATION AND REQUIRED MESH EXCISION. ANOTHER PATIENT REPORTEDLY DEVELOPED A FISTULA BETWEEN THE COLOSTOMY AND THE MESH REQUIRING MESH EXCISION AND A THIRD WHO DEVELOPED A STRICTURE AT THE PERITONEAL CLOSURE AND WAS REVISED WITHOUT FURTHER COMPLICATIONS. NO DEVICE MALFUNCTIONS WERE REPORTED, AND THE AUTHORS DID NOT ATTRIBUTE ANY EVENTS TO A DA VINCI DEVICE, SYSTEM OR PRODUCT. THE STUDY CONCLUDED THAT THIS NOVEL TECHNIQUE FOR MINIMALLY INVASIVE PARASTOMAL HERNIA REPAIR IS EFFECTIVE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CORRESPONDENCE AUTHOR. THE CORRESPONDENCE AUTHOR INDICATED: "THIS WAS

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 H11 FOR FOLLOW-UP INFORMATION.