{ "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": "2955842-2010-00528", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20101206", "manufacturer_address_2": "", "pma_pmn_number": "K011002", "date_of_event": "20100812", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "NURSE", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "Other", "Health Professional", "User facility" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20101206", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20101206", "brand_name": "DA VINCI 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": "IS1200 A4.3P9", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "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": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250815", "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": "20101206", "sequence_number_treatment": [ "DA VINCI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Death" ], "patient_age": "24 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Hemorrhage/Blood Loss/Bleeding", "Unspecified Infection" ] } ], "distributor_city": "", "date_report": "20101111", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "1915208", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20120416", "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": "18181920", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT POST A SUCCESSFUL DA VINCI HYSTERECTOMY PROCEDURE, THE PATIENT DEVELOPED AN INFECTION AND WAS NOT DISCHARGED AS PLANNED. TEN DAYS POST OP, THE PATIENT WAS GIVEN A BLOOD THINNER AND EXPIRED DUE TO AN ARTERIAL BLEED. REPORTEDLY, THE PATIENT'S DEMISE WAS UNRELATED TO THE DA VINCI SURGICAL SYSTEM." }, { "mdr_text_key": "9865742", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(4) 2012, ISI RECEIVED A LEGAL SUMMONS INDICATING THAT THE PATIENT EXPIRED ON (B)(6) 2010, POST OP A DA VINCI SI HYSTERECTOMY WITH BILATERAL SALPINGOO-OOPHORECTOMY AND PELVIC NODE DISSECTION PROCEDURE PERFORMED ON (B)(6) 2010. EMERGENCY SURGICAL PROCEDURES PERFORMED ON THE PATIENT ON (B)(6) 2010, REVEALED THAT THE PATIENT HAD SUSTAINED A BURN TO THE RIGHT EXTERNAL ILIAC ARTERY, PUMPING BLOOD IN THE BODY CAVITY, CAUSING BOWEL ISCHEMIA INCOMPATIBLE WITH LIFE. FOLLOWING THE SURGICAL PROCEDURE, PAIN MEDICATION WAS CONTINUALLY ADMINISTERED TO THE PATIENT WITHOUT GOOD AFFECT DUE TO SIGNIFICANT PAIN EXPERIENCED BY THE PATIENT." }, { "mdr_text_key": "18283605", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON NOVEMBER 30, 2010, AN ISI CLINICAL SALES REPRESENTATIVE SPOKE TO THE SURGEON THAT PERFORMED THE DA VINCI HYSTERECTOMY ON THE PATIENT. THE SURGEON STATED THAT THE PATIENT DID HAVE AN AUTOPSY PERFORMED WHICH FOUND THAT THE PATIENT HAD AN INJURY TO HER LEFT EXTERNAL ILIAC ARTERY. THE SOURCE OF THE INJURY WAS NOT CONFIRMED. BASED ON THE LIMITED INFORMATION PROVIDED, IT IS INDETERMINABLE IF THE DA VINCI SYSTEM, INSTRUMENTS OR ACCESSORIES CONTRIBUTED TO THE PATIENT'S DEMISE. AS OF DECEMBER 3, 2010, NO ADVERSE EVENTS HAVE BEEN EXPERIENCED WITH THE SITE'S SYSTEM." } ], "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": "05/15/2012" } ] }