{ "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": "2955842-2015-01371", "type_of_report": [ "Initial submission" ], "product_problem_flag": "", "date_received": "20151105", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20151009", "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": [ "HEALTH PROFESSIONAL" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20151105", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "736199", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20151105", "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 A6.0P8", "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": "KS", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250814", "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": "20151105", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death", " L" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20151015", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "5205661", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20151015", "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": "30569328", "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 ALLEGED INTRA-OPERATIVE COMPLICATION EXPERIENCED BY THE PATIENT AND THE PATIENT'S SUBSEQUENT DEMISE. THE DATE OF THE PATIENT'S DEATH IS UNKNOWN. THERE IS NO ALLEGATION FROM THE SITE THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE DA VINCI SURGICAL PROCEDURE. ON (B)(6) 2015, ISI CONTACTED THE ISI TECHNICAL FIELD SPECIALIST (TFS). THE TFS VISITED THE SITE ON (B)(6) 2015, INSPECTED THE DV SURGICAL SYSTEM INVOLVED WITH THIS COMPLAINT, AND DID NOT FIND ANY ISSUES. THE TFS CONFIRMED WITH VARIOUS NURSES AT THE SITE THAT THE PATIENT HAD PASSED AWAY. HOWEVER, THE TFS DID NOT HAVE ANY ADDITIONAL INFORMATION TO PROVIDE REGARDING THE REPORTED EVENT. ISI HAS ATTEMPTED TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2015 REVEALED THAT NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE PATIENT'S ALLEGED INTRA-OPERATIVE INJURY. THREE OF THE FOUR DA VINCI INSTRUMENTS USED DURING THE SURGICAL PROCEDURE INVOLVED WITH THIS COMPLAINT HAVE BEEN USED IN SUBSEQUENT SURGICAL PROCEDURES. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO REPORTED COMPLAINTS REGARDING THE INSTRUMENTS USED DURING THE DA VINCI SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI NEPHRECTOMY PROCEDURE, THE SURGEON ALLEGEDLY TORE A VESSEL AND THE CASE WAS CONVERTED TO OPEN SURGERY DUE TO A LARGE AMOUNT OF BLEEDING. THE PATIENT SUBSEQUENTLY PASSED AWAY. HOWEVER, AT THIS TIME, THE CAUSES OF THE ALLEGED INTRA-OPERATIVE INJURY AND THE PATIENT'S DEMISE ARE UNKNOWN." }, { "mdr_text_key": "30569329", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED NEPHRECTOMY PROCEDURE, THE SURGEON ENCOUNTERED A LARGE AMOUNT OF BLEEDING AND THE SURGICAL PROCEDURE WAS CONVERTED TO OPEN SURGERY. ACCORDING TO THE INITIAL REPORTER, IT IS UNCLEAR IF THE SURGEON TORE THE RENAL ARTERY OR ACTUALLY GOT INTO THE AORTA. ON (B)(6) 2015, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. ACCORDING TO THE CSR, HE WAS INFORMED BY MULTIPLE SOURCES AT THE SITE THAT THE PATIENT HAD PASSED AWAY AFTER BEING MOVED TO THE HOSPITAL FLOOR." } ], "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": "" } ] }