{ "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": "2955842-2026-34683", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260811", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20250707", "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": "20260812", "manufacturer_contact_f_name": "Izabel", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "275399", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260811", "brand_name": "da Vinci SP", "generic_name": "PATIENT SIDE CART", "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": "380601", "catalog_number": "N/A", "lot_number": "N/A", "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": "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": "20260811", "sequence_number_treatment": [ "da Vinci Instruments and Accessories." ], "sequence_number_outcome": [ "Required Intervention", " H" ], "patient_age": "66 YR", "patient_sex": "Male", "patient_weight": "112 LB", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Ventricular Fibrillation" ] } ], "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": "50209347", "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": "15976544463", "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.Due to the lack of specific information regarding the event date associated with the adverse event, the publication date has been used as the event date. Verification of the event details cannot be performed at this time due to insufficient event date information. The procedures described in the article were performed using an unspecified da Vinci Surgical System device. Therefore, a generic material number has been used as the primary product. A System Logs Review cannot be performed at this time due to insufficient event date information.Citation: Kim, J.-M., & Jun, M. R. (2025). Coronary artery spasm following mannitol administration during partial nephrectomy: A case report. Medicine, 104(31), e43527. https://doi.org/10.1097/MD.0000000000043527." }, { "mdr_text_key": "15476544462", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A review of the article reported that a patient developed ventricular premature contractions followed by ventricular fibrillation approximately 40 minutes after receiving a high-dose mannitol infusion during Da Vinci robotic-assisted partial nephrectomy. Cardiopulmonary resuscitation and 3 rounds of defibrillation were performed along with arterial line placement and large-bore venous access. The patient was admitted to the intensive care unit for further evaluation and management. The diagnosis was variant angina due to significant coronary artery spasm. The patient recovered without neurologic sequelae and appropriate medication was initiated." } ], "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": "" } ] }