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.

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 LITERATURE ARTICLE WAS REVIEWED THAT DESCRIBED A RETROSPECTIVE ANALYSIS THE SAFETY AND PERFORMANCE OF THE DA VINCI SINGLE-PORT SYSTEM IN NIPPLE SPARING MASTECTOMY (NSM) WITH IMMEDIATE RECONSTRUCTION BETWEEN OCTOBER 2020 AND AUGUST 2021 IN ONE SINGLE INSTITUTION. A TOTAL OF 60 PATIENTS DIAGNOSED WITH BREAST CANCER WERE INCLUDED; 53.3% OF THE PATIENTS HAD INVASIVE DUCTAL CARCINOMA. ALL PROCEDURES WERE COMPLETED WITH NO CONVERSION TO MULTIPORT OR OPEN SURGERY REQUIRED. THE ARTICLE DOCUMENTS THAT NO INTRAOPERATIVE ADVERSE EVENTS WERE REPORTED. AMONG THE SIXTY PATIENTS, ONE PATIENT EXPERIENCED HYPOTENSION AND WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) POSTOPERATIVELY FOR ONE DAY DUE TO A BLOOD PRESSURE DROP FROM INTRAOPERATIVE BLEEDING. TWELVE PATIENTS EXPERIENCED POST-OPERATIVE COMPLICATIONS: FIVE DEVELOPED NIPPLE-AREOLAR COMPLEX (NAC) NECROSIS, SIX DEVELOPED HEMATOMAS AND ONE DEVELOPED A PNEUMOTHORAX. AMONG THE PATIENTS THAT EXPERIENCED POST-OPERATIVE COMPLICATIONS, THREE REQUIRED RE-OPERATION WITHIN A MONTH AFTER SURGERY: TWO WERE FOR SURGICAL SITE HEMATOMAS, AND ONE REQUIRED OPEN SURGERY FOR WOUND DEBRIDEMENT. NO DA VINCI DEVICE MALFUNCTIONS WERE REPORTED, AND THE AUTHORS DI

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, HARMONIC ACE BROKE AFTER USE. A FRAGMENT FELL INSIDE OF 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 SINGLE PORT DA VINCI-ASSISTED RETZIUS SPARING PROSTATECTOMY SURGICAL PROCEDURE, THE CUSTOMER CONTACTED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT PRESENTATION OF AN "ACTIVATION HAS BEEN HALTED" MESSAGE. THE CUSTOMER STATED THEY WERE ALSO RECEIVING A C-34 ERROR ON THE INTEGRATED ELECTROSURGICAL UNIT (IESU). THE INSTRUMENT, CORD, AND NEUTRAL PAD HAD BEEN REPLACED WITH NO CHANGE. THE TSE INSTRUCTED THE CUSTOMER TO REBOOT THE IESU AND THE ISSUE RESOLVED. THE CUSTOMER LATER CALLED BACK TO REPORT THAT BIPOLAR ENERGY STOPPED WORKING DURING THE PROCEDURE. THE CUSTOMER MENTIONED THEY'D CALLED EARLIER WHEN MONOPOLAR ENERGY STOPPED WORKING. THE CUSTOMER HAD POWER CYCLED THE SYSTEM, TRIED TWO DIFFERENT INSTRUMENTS, AND DIFFERENT BLUE INSTRUMENT CORDS PRIOR TO CALLING. THE TSE VIEWED THE SYSTEM LOGS AND DID NOT IDENTIFY ANY ENERGY RELATED MESSAGES. THE CUSTOMER REQUESTED THE ERBE BIPOLAR AND MONOPOLAR BE EVALUATED. THE CUSTOMER CALLED BACK AGAIN TO REPORT THAT THE ERBE ISSUE RETURNED WITH PERSISTENT C-34 AND C-00 ERRORS THAT WERE NOT ABLE TO BE CLEARED. THE EXTERNAL FOOT PEDALS WERE REMOVED, AND THE UNIT WAS RESTARTED, HOWEVER, THE

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 THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY FELL OFF INSIDE THE PATIENT. THE FRAGMENT(S) WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE. THE SURGEON WAS ABLE TO USE A BACKUP MCS TIP COVER ACCESSORY TO COMPLETE THE PROCEDURE ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE MCS TIP COVER ACCESSORY WAS PROPERLY INSTALLED DURING THE SURGICAL PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE CLEAR AREA OF THE MCS TIP COVER ACCESSORY WAS SEPARATED FROM THE GRAY AREA. NO ARCING WAS OBSERVED.

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 PROCEDURE, ONE OF THE TIPS OF THE HARMONIC ACE INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT. THE SURGEON COMPLETED THE PROCEDURE USING A BACKUP HARMONIC ACE INSTRUMENT. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGE WAS NOTED. THE INSTRUMENT WAS IN USE FOR THREE HOURS PRIOR TO THE INSTRUMENT BREAKAGE. THE SURGEON DID NOT NOTICE ANY ISSUE WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE PROCEDURE UNTIL THE FRAGMENT FELL OFF. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIALS DURING THE SURGICAL PROCEDURE. UPON REMOVAL OF THE HARMONIC ACE INSTRUMENT THROUGH THE CANNULA, THE INSTRUMENT'S WRIST WAS STRAIGHTENED AND THE STAFF DID NOT FEEL ANY RESISTANCE. THERE WAS NO DAMAGE IDENTIFIED ON THE CANNULA AFTER THE EVENT OCCURRED. THE FRAGMENT WAS REMOVED BY AN ASSISTANT. ALL FRAGMENTS WERE RETRIEVED. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT. THE PATIENT DID NOT RETURN TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS. THERE ARE NO IMAGES OF THE DEVICE OR VIDEO RECORDING AVAILABLE FOR 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 INCISIONAL HERNIA SURGICAL PROCEDURE, A PIECE OF THE UNIVERSAL SEAL FELL OFF INTO THE TUBE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER STATED THAT THEY ARE WATCHING FOR ANY FURTHER ISSUES. THE UNIVERSAL SEAL WAS DISCARDED.

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 TIP OF THE HARMONIC ACE INSTRUMENT BROKE OFF. THE INTACT FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO DAMAGE NOTED. THE SURGEON WAS DISSECTING WHEN THE ISSUE WAS NOTED. IT IS UNKNOWN WHAT THE SURGEON BELIEVES WAS THE CAUSE OF THE INSTRUMENT BREAKAGE. THE INSTRUMENT WAS IN USE FOR 60+ MIN AND NO ISSUE WITH THE FUNCTIONALITY OF THE INSTRUMENT WAS NOTED. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIALS DURING THE PROCEDURE. THE FRAGMENT DID NOT FALL INSIDE THE PATIENT DURING AN INSTRUMENT TIP OR ACCESSORY COLLISION. THE INSTRUMENT WAS REMOVED PRIOR TO THE INSTRUMENT BREAKAGE WITH THE WRIST STRAIGHTENED. THE STAFF DID NOT FEEL ANY RESISTANCE TO THE REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. UPON FINAL REMOVAL OF THE INSTRUMENT, THE WRIST WAS STRAIGHTENED. THE STAFF DID NOT FEEL ANY RESISTANCE UPON THE FINAL REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA, NOR 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 PANCREATODUODENECTOMY PROCEDURE, THE HARMONIC ACE INSTRUMENT BROKE AND A PIECE FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. A BACK-UP HARMONIC ACE INSTRUMENT WAS THEN USED BUT THE SAME ISSUE OCCURRED. ANOTHER BROKEN PIECE WAS RETRIEVED. A THIRD BACK-UP HARMONIC ACE INSTRUMENT WAS USED TO COMPLETE 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 PANCREATODUODENECTOMY PROCEDURE, THE HARMONIC ACE INSTRUMENT BROKE WITHIN LESS THAN AN HOUR OF OPERATION. THE BROKEN PIECE FELL INTO THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. A BACK-UP HARMONIC ACE INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. THE BACK-UP HARMONIC ACE EXPERIENCED THE SAME ISSUE AS THE FIRST ONE. THE BROKEN PIECE WAS RETRIEVED. A THIRD BACK-UP HARMONIC ACE WAS USED TO COMPLETE 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 VENTRAL HERNIA REPAIR PROCEDURE, THE WRIST OF THE MONOPOLAR CURVED SCISSOR (MCS) INSTRUMENT PROTRUDED THROUGH A CRACK IN THE MCS TIP COVER ACCESSORY, RESULTING IN A BURN INJURY AND SMALL HOLE TO ABDOMINAL WALL MUSCLE TISSUE. SUTURES WERE APPLIED TO RESOLVE THE DEFECT. THERE WAS NO BLEEDING ASSOCIATED WITH THIS EVENT. THE GRAY PORTION OF THE MCS TIP COVER ACCESSORY WAS NOTED TO BE TORN. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO ISSUES WERE IDENTIFIED AT THE TIME. MONOPOLAR ENERGY SETTINGS WERE 40CUT, 40 COAGULATION. THE DAMAGED MCS TIP COVER ACCESSORY WAS REMOVED FROM THE MCS INSTRUMENT AND REPLACED WITH A NEW ONE. THE PROCEDURE THEN CONTINUED AND WAS COMPLETED AS PLANNED. THE PATIENT IS RECOVERING WELL.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT 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 WHICH WAS COMPLETED ROBOTICALLY.

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, FRAGMENTS FELL INTO THE PATIENT FROM THE HARMONIC ACE INSTRUMENT. THE FRAGMENTS WERE RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO DAMAGE NOTED. THE SURGEON WAS DISSECTING WHEN THE FRAGMENT FELL INTO THE PATIENT. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT PRIOR TO THE BREAKAGE. THERE WAS NO INSTRUMENT COLLISION. ALL FRAGMENT(S) WERE RETRIEVED DURING THE SAME PROCEDURE, WHICH WAS CONFIRMED BY VISUAL INSPECTION. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED. NO POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRASOUND WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE PROCEDURE WAS COMPLETED ROBOTICALLY. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATION RELATED TO RETAINING A FOREIGN OBJECT. THE INSTRUMENT AND FRAGMENT(S) WERE AVAILABLE FOR RETURN. NO PHOTOS OR VIDEO WERE 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: IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED TRANSORAL ROBOTIC SURGERY (TORS) PROCEDURE, AN UNSPECIFIED NUMBER OF PATIENTS EXPERIENCED POSTOPERATIVE BLEEDING EVENTS OVER A THREE-MONTH PERIOD, AND SOME REQUIRED UNSPECIFIED, ADDITIONAL INTERVENTION. THE EVENT DATES OF THESE PATIENTS WERE UNAVAILABLE/UNKNOWN. THE PATIENTS WOULD EXPERIENCE A SUCCESSFUL PROCEDURE, NO INTRAOPERATIVE COMPLICATIONS OCCURRED. THE ERBE SETTINGS ARE SET TO 3 CUT 4 COAGULATION. THE SURGEON NOTES THE MONOPOLAR AND BIPOLAR ENERGY WERE EFFECTIVE INTRAOPERATIVELY, AND APPROPRIATELY CAUTERIZED BLEEDING TISSUE AS INTENDED. HOWEVER, SOME WOULD EXPERIENCE A POSTOPERATIVE BLEEDING EVENT FROM A RANGE OF 5 DAYS TO 3 WEEKS. SOME REQUIRED SUBSEQUENT PROCEDURES TO SUCCESSFULLY ADDRESS THE BLEEDING.