{ "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": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "Santa Clara", "manufacturer_contact_address_1": "3410 Central Expressway", "manufacturer_contact_pcity": "+1(408)5", "event_type": "Injury", "report_number": "2955842-2026-35101", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260812", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20250701", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "+1(408)523-2100", "noe_summarized": "1", "manufacturer_contact_l_name": "Nielson", "source_type": [ "Other", "Foreign", "Literature" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20260813", "manufacturer_contact_f_name": "Izabel", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "131519", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260812", "brand_name": "Da Vinci Surgical System", "generic_name": "Da Vinci", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "3410 Central Expressway", "manufacturer_d_address_2": "", "manufacturer_d_city": "Santa Clara", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "device_operator": "HEALTH PROFESSIONAL", "model_number": "N/A", "catalog_number": "N/A", "lot_number": "Unknown", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "N", "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": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "", "manufacturer_contact_country": "US", "date_changed": "20260826", "health_professional": "Y", "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": "20260812", "sequence_number_treatment": [ "da Vinci Instruments and Accessories" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "50 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Low Blood Pressure/ Hypotension" ] } ], "distributor_city": "", "date_report": "20260722", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "Santa Clara", "mdr_report_key": "50222868", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260722", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "95051", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "INTUITIVE SURGICAL, INC", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "15964431810", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "There is insufficient information to determine the specific system that was used during the procedures with complications; thus, the product is reported as Not Applicable.No investigation could be performed as the article did not provide any specific information regarding the procedure date or da Vinci System identifiers. No image(s) and/or video clip(s) associated with this reported event were reviewed.Citation: Baheti, S., Sakhavalkar, P., Jain, R., Kedia, U., & Sharan, M. (2025). Successful management of unexpected massive blood loss during robot-assisted partial nephrectomy: A case report. Journal of Clinical and Diagnostic Research, 19(7), UD1 1UD13. https://doi.org/10.7860/JCDR/2025/76891.21230." }, { "mdr_text_key": "15464431809", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "During a Robot-assisted Partial Nephrectomy (RAPN) surgery, the patient experienced an accidental massive hemorrhage and hypotension due to sudden iatrogenic rupture of the IVC. The procedure was converted to open nephrectomy. The patient was transferred to the Intensive Care Unit on Synchronized Intermittent Mandatory Ventilation (SIMV) ventilator mode.The patient remained hemodynamically stable and was extubated and subsequently discharged from the hospital on postoperative day 7.Intuitive Surgical Inc. (ISI) has made multiple attempts to obtain additional information; however, as of the date of this report, no new information has been obtained." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 Central Expressway", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }