{ "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": "40852321", "event_type": "Injury", "report_number": "2955842-2026-25853", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260521", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20260218", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign", "Study", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "GM", "manufacturer_contact_area_code": "", "date_added": "20260521", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20240513", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1303843", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260521", "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": "380601-50", "catalog_number": "380601", "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": "00886874114605", "udi_public": "(01)00886874114605", "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": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260601", "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": "20260521", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "69 YR", "patient_sex": "Female", "patient_weight": "57 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "High Blood Pressure/ Hypertension" ] } ], "distributor_city": "", "date_report": "20260521", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "25243422", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260427", "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": "401923388", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THERE WAS NO REPORT THAT A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY MALFUNCTIONED DURING THE PROCEDURE. ADDITIONAL PATIENT INFORMATION: HEIGHT 158 CM., BODY MASS INDEX (BMI) 22.8 KG/M2." }, { "mdr_text_key": "401923389", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A PATIENT IN A STUDY UNDERWENT A DA VINCI ASSISTED SACROCOLPOPEXY AND COLPORRHAPHY SURGICAL PROCEDURE. ON POST-OPERATIVE DAY TWO, PRIOR TO DISCHARGE, THE PATIENT EXPERIENCED A HYPERTENSIVE CRISIS. THERE WAS A CARDIOLOGY CONSULT AND THE PATIENT'S HYPERTENSION MEDICATION WAS ADJUSTED TO HIGHER DOSES OF ENALAPRIL. THE INDEX PROCEDURE WAS COMPLETED WITHOUT ANY INTRA-OPERATIVE COMPLICATIONS; IT WAS REPORTED THERE WERE NO DA VINCI DEVICE MALFUNCTIONS. THE EVENT WAS REPORTED AS RESOLVED THREE DAYS LATER; DISCHARGE TO HOME OCCURRED THE SAME DAY. THE STUDY INVESTIGATOR REPORTED THE EVENT AS MODERATE SEVERITY, NOT A SERIOUS ADVERSE EVENT, A CLAVIEN-DINDO GRADE II, NOT RELATED TO THE STUDY PROCEDURE, NOT RELATED TO THE PATIENT'S UNDERLYING DISEASE STATUS, NOT RELATED TO THE DA VINCI INVESTIGATIONAL DEVICE AND NOT RELATED TO A THIRD-PARTY DEVICE. THE PATIENT'S PRIOR HEALTH CONDITION OF KNOWN HYPERTONIA MAY BE RELEVANT TO THIS INCIDENT." } ], "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": "" } ] }