{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "HOSPITAL", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Death", "report_number": "2955842-2015-01348", "type_of_report": [ "Initial submission" ], "product_problem_flag": "", "date_received": "20151030", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "OTHER" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20151030", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "723286", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20151030", "brand_name": "DA VINCI SI SURGICAL SYSTEM", "generic_name": "ENDOSCOPIC INSTRUMENT CONTROL SYSTEM", "manufacturer_d_name": "INTUITIVE SURGICAL,INC.", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "SUNNYVALE", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "IS3000", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Insufficient Device Problem Information" ], "reporter_state_code": "FL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250805", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20151030", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Hemorrhage/Blood Loss/Bleeding", "Unspecified Infection", "Laceration(s)", "Sepsis" ] } ], "distributor_city": "", "date_report": "20151001", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "5192204", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20151001", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "29984305", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE PATIENT DEATH INVOLVED WITH THIS COMPLAINT. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE DA VINCI SURGICAL PROCEDURE. THE SITE WAS UNABLE TO CONFIRM THAT THE REPORTED PATIENT DEATH HAD OCCURRED. THE DATE THE PATIENT UNDERWENT THE DA VINCI SURGICAL PROCEDURE, THE DATE OF THE PATIENT'S DEATH, AND THE CAUSE OF THE PATIENT'S DEATH ARE UNKNOWN. ISI HAS CONTACTED THE SITE'S RISK MANAGEMENT DEPARTMENT. HOWEVER, THE SITE'S RISK MANAGER WAS UNWILLING TO PROVIDE ANY INFORMATION REGARDING THE REPORTED EVENT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: A PATIENT ALLEGEDLY PASSED AWAY AFTER UNDERGOING A DA VINCI MITRAL VALVE REPAIR PROCEDURE. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S DEATH IS UNKNOWN." }, { "mdr_text_key": "29984306", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON 10/01/2015, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA VOLUNTARY REPORT MW5056296 WITH THE FOLLOWING EVENT DESCRIPTION: THIS IS A LATE REPORT AS WE WERE UNAWARE WE COULD HAVE REPORTED EARLIER TO FDA. MY MOTHER, (B)(6), AT TIME OF DEATH, WAS UNDERGOING A MITRAL VALUE [SIC] REPAIR WITH THE SURGEON, DR. (B)(6) , USING THE DAVINCI ROBOT. THIS OCCURRED AT (B)(6) ON (B)(6) 2006. ACCORDING TO THE PHYSICIAN, THE ROBOT NICKED HER HEART WHICH RESULTED IN BLEEDING OUT AND EMERGENCY OPEN HEART SURGERY. SHE NEVER RECOVERED AND DEVELOPED SEPSIS INFECTION 4 DAYS LATER. WE WERE INFORMED LATER THAT OUR MOM WAS THE ONLY THE 3RD PATIENT FOR HEART VALVE SURGERY ON THIS ROBOT. WE ALSO ARE AWARE THAT ANOTHER WOMAN DIED SUBSEQUENTLY BY THE SAME ROBOT AND PHYSICIAN. THE DOCTOR LEFT TOWN AFTER THIS. (WE NEVER FILED A LAWSUIT DUE TO (B)(6) LAWS ON DAMAGES.) I AM WRITING THIS TO INFORM THE FDA AND TO NOTIFY YOU OF AN ADVERSE EVENT FOR YOUR STATS OF THIS DAVINCI ROBOT. MY HOPE IS THAT NO ONE WILL HAVE TO DIE FROM THIS ROBOT IN THE FUTURE IN THE CARDIAC REALM OF USE FOR DAVINCI. THANK YOU. (B)(6). THIS MDR ADDRESSES THE SECOND PATIENT DEATH NOTED IN THE EVENT DESCRIPTION. REFER TO THE MDR REPORT WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION REGARDING THE FIRST PATIENT DEATH NOTED IN THE EVENT DESCRIPTION. ON 10/02/2015 AND 10/13/2015, ISI CONTACTED THE INITIAL REPORTER OF THE FDA VOLUNTARY REPORT. SHE PROVIDED WHAT SHE BELIEVED WAS THE NAME OF THE PATIENT WHO APPARENTLY PASSED AWAY AFTER UNDERGOING A DA VINCI MITRAL VALVE REPAIR PROCEDURE. THE INITIAL REPORTER DID NOT KNOW THE DATE THAT THE PATIENT UNDERWENT THE DA VINCI MITRAL VALVE REPAIR PROCEDURE OR THE CAUSE OF THE PATIENT'S DEATH. ON 10/13/2015, ISI CONTACTED THE SITE'S RISK MANAGEMENT DEPARTMENT. THE RISK MANAGER WAS UNABLE TO FIND ANY RECORDS IN THE SITE'S PATIENT DATABASE WITH THE NAME GIVEN BY THE INITIAL REPORTER. THE RISK MANAGER WAS UNABLE TO CONFIRM THAT A SECOND PATIENT PASSED AWAY AFTER UNDERGOING A DA VINCI MITRAL VALVE REPAIR PROCEDURE AT THE SITE. THE RISK MANAGER WAS ALSO UNWILLING TO FURTHER INVESTIGATE THE REPORTED PATIENT DEATH DUE TO PATIENT CONFIDENTIALITY ISSUES." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }