{ "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": "2955842-2013-04053", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131004", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20130813", "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": "20131007", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "502669", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131004", "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": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "FL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250810", "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": "20131004", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Death" ], "patient_age": "51 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Exsanguination", "Hemorrhage/Blood Loss/Bleeding", "Tissue Damage" ] } ], "distributor_city": "", "date_report": "20130906", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3388878", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130906", "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": "15017093", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON 09/06/2013, INTUITIVE SURGICAL, INC. (ISI) RECEIVED A LETTER FROM AN ATTORNEY SEEKING INFORMATION RELATED TO A DA VINCI SYSTEM. IT WAS REPORTED IN THE LETTER THAT A PATIENT HAD DIED FOLLOWING VASCULAR DAMAGE THAT WAS INCURRED AT THE TIME OF INITIATING A DA VINCI ROBOTIC HYSTERECTOMY PROCEDURE ON (B)(6) 2013. ON (B)(4) 2013, ISI SPOKE WITH THE ATTORNEY REPRESENTING THE HOSPITAL. SHE CONFIRMED THAT THE DA VINCI SYSTEM WAS NEVER USED DURING THE PROCEDURE. SHE COULD NOT PROVIDE THE CAUSE OF DEATH AS THE RESULTS OF THE AUTOPSY ARE STILL PENDING. THE PATIENT'S INJURY WAS NOTICED UPON INSERTION OF THE CAMERA SCOPE INTO THE FIRST NON-ISI TROCAR THAT WAS INSERTED. THE PATIENT'S HYSTERECTOMY PROCEDURE WAS PLANNED TO BE A ROBOTIC ASSISTED LAPAROSCOPIC HYSTERECTOMY; HOWEVER, THE PATIENT'S HYSTERECTOMY WAS NOT PERFORMED AS THE BLEED WAS NOTICED BEFORE THE SURGERY. THE DA VINCI SYSTEM WAS NOT USED. THE ATTORNEY ALSO STATED THAT THE SURGEON DOES NOT FEEL THAT THE PATIENT'S DEATH DID INVOLVE ANY TYPE OF MALFUNCTION OF ANY DEVICE." }, { "mdr_text_key": "15334298", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE OF THE PATIENT'S DEATH. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. ALTHOUGH THE DA VINCI SYSTEM WAS NOT USED DURING THE PATIENT'S PLANNED HYSTERECTOMY PROCEDURE, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY EXPIRED AFTER PREPARATION OF A PLANNED DA VINCI SI HYSTERECTOMY SURGERY." } ], "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": "" } ] }