{ "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": "2955842-2026-35123", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260812", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20250829", "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", "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": "638928", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260812", "brand_name": "Da Vinci Surgical System", "generic_name": "Da Vinci Surgical System", "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": "PA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "", "manufacturer_contact_country": "US", "date_changed": "20260814", "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": [ "Required Intervention" ], "patient_age": "27 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20260722", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "Santa Clara", "mdr_report_key": "50223512", "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": "15976487969", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "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: Herrick-Reynolds, K. M., Ceuppens, S., Yip, L., & Paniccia, A. (2025). Robot-assisted resection of retrocaval paraganglioma: technical considerations and approach. Updates in Surgery. https://doi.org/10.1007/s13304-025-02393-w." }, { "mdr_text_key": "15476487968", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "During dissection along the superior border of the left renal vein, a minor arterial bleed was encountered. Initial maneuvers with monopolar and bipolar energy were attempted but unsuccessful. Direct pressure was easily able to achieve hemostasis while a suture was prepared. Post procedure, the patient recovered uneventfully. The robotic-assisted procedure led to complete resection with an uncomplicated hospital course, and discharge home on postoperative day one.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": "" } ] }