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 DURING A ROBOTICALLY ASSISTED BRONCHOSCOPY PROCEDURE, AS THE PHYSICIAN WAS TAKING ANTERIOR/POSTERIOR SCOUT SHOTS USING A 3D C-ARM, THE PATIENT BEGAN TO EXHIBIT IRREGULAR HEART RHYTHMS. THE PHYSICIAN DECIDED TO ABORT THE PROCEDURE. THE PATIENT WENT INTO ATRIAL FIBRILLATION AND CODED. CHEST COMPRESSIONS WERE STARTED IMMEDIATELY. THE CODE CONTINUED FOR 30 - 35 MINUTES, AND THE PATIENT PASSED AWAY. NO BIOPSIES OR NEEDLE ASPIRATIONS WERE PERFORMED DURING THE PROCEDURE. NO ISSUES WERE REPORTED INVOLVING THE DEVICES USED DURING THE PROCEDURE.

ExcelsiusGPS — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AT THE HOSPITAL THEIR ELDERLY PATIENT WITH A THORACIC FRACTURE. THE PATIENT WAS UNWELL AND EVEN HAD AN ISSUE DURING THE SURGERY. EGPS WAS USED WITH E3D AND ALL SCREWS WERE EXECUTED. UNFORTUNATELY THE NEXT DAY THE PATIENT PASSED AWAY. POST OP IMAGING CONFIRMS SCREWS WERE ACCURATE BUT THERE WERE QUESTIONS ABOUT THE ROBOTIC CASE. NO SCREWS WERE FOUND DEVIATED TO HAVE A CLINICAL DEFICIT.

da Vinci Surgical System — Death 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 AIMED TO EVALUATE THE INITIAL EXPERIENCE AND FEASIBILITY OF ROBOTIC-ASSISTED PYLORUS-PRESERVING PANCREATICODUODENECTOMY PROCEDURES (PPPD) USING THE DA VINCI SP SYSTEM VERSUS THE DA VINCI XI SYSTEM. THE STUDY WAS A RETROSPECTIVE CASE SERIES ANALYZING 14 PATIENTS UNDERGOING PPPD FROM DECEMBER 2021 AND SEPTEMBER 2023. ONE PATIENT WITH COMMON BILE DUCT CANCER DIED DURING AT AN UNSPECIFIED TIME POST-PROCEDURE DUE TO THE PROGRESSION OF CANCER. THERE WAS NO REPORT OR INDICATION IN THE ARTICLE OF ANY DA VINCI SP SYSTEM MALFUNCTIONS. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE CORRESPONDING AUTHOR WERE MADE; HOWEVER, NO RESPONSE HAS BEEN RECEIVED.

da Vinci Surgical System — Death 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 PERFORMED THAT EVALUATED OUTCOMES OF ROBOTIC INGUINAL HERNIA REPAIR (RIHR) IN A SINGLE INSTITUTION STUDY COMPARING SURGEONS WITH VARYING ROBOTIC EXPERIENCE. THE STUDY ANALYZED 297 PATIENTS UNDERGOING ROBOTIC INGUINAL HERNIA REPAIR BETWEEN JULY 2016 AND SEPTEMBER 2021. ONE PATIENT DIED WITHIN 30 DAYS POST SURGERY DUE TO ASPIRATION PNEUMONIA LEADING TO CARDIAC ARREST. NO DEVICE MALFUNCTIONS WERE REPORTED, AND THE AUTHORS DID NOT REPORT ANY EVENTS CAUSED BY ANY ISI DEVICE. INTUITIVE SURGICAL INC, (ISI) CONTACTED THE AUTHOR WHO REPORTED THAT THERE WERE NO ISSUES SEEN OR RECORDED WITH THE DA VINCI SYSTEM DURING THE STUDY. THE SYSTEM ITSELF DID NOT CONTRIBUTE TO THE DEATH IN THE STUDY WHICH WAS RELATED TO THE PATIENTS CO MORBIDITY AND NOT THE SURGERY ITSELF.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A REVIEW OF THE CLINICAL ARTICLE WAS CONDUCTED, WHICH SUMMARIZED THE CLINICAL EXPERIENCE AND OUTCOMES OF TRANSORAL ROBOTIC SURGERY (TORS) IN THE TREATMENT OF HYPOPHARYNGEAL CARCINOMA. THE RETROSPECTIVE MULTICENTER STUDY ANALYZED 28 PATIENTS (ALL MALE, AGED 47- 82 YEARS) UNDERGOING TRANSORAL ROBOTIC SURGERY USING THE DA VINCI SI OR XI SURGICAL SYSTEM BETWEEN SEPTEMBER 2017 AND MARCH 2024. THE ARTICLE REPORTED TWO POSTOPERATIVE DEATHS WITHIN ONE MONTH OF SURGERY WITHOUT ANY OTHER DETAILS. NO DEVICE MALFUNCTIONS WERE REPORTED, AND THE AUTHORS DID NOT REPORT ANY EVENTS CAUSED BY THE DA VINCI SURGICAL SYSTEM. REQUESTS FOR ADDITIONAL INFORMATION WERE MADE TO THE CORRESPONDING AUTHOR, BUT NO RESPONSE HAS BEEN RECEIVED.

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.

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 — 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