{ "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": "2955842-2023-17052", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20230713", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20210326", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20230714", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "699387", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230713", "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": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "380601-34", "catalog_number": "380601", "lot_number": "UNKNOWN", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "R", "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": [ "Insufficient Device Problem Information", "Insufficient Device Problem Information" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250731", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "4085", "patient": [ { "patient_sequence_number": "1", "date_received": "20230713", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Liver Damage/Dysfunction", "Hemorrhage/Blood Loss/Bleeding", "Liver Damage/Dysfunction" ] } ], "distributor_city": "", "date_report": "20230615", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "17322316", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20230615", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "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": "319103010", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE FOLLOWING INVESTIGATIONS COULD NOT BE PERFORMED DUE TO INSUFFICIENT INFORMATION PROVIDED (I.E. EVENT DATE, SYSTEM SERIAL NUMBER, SURGEON NAME): SITE HISTORY, EVENT VERIFICATION, SYSTEM/INSTRUMENT LOG REVIEW. FRANCAVILLA S, ABERN MR, DOBBS RW, VIGNESWARAN HT, TALAMINI S, ANTONELLI A, SIMEONE C, CRIVELLARO S. SINGLE-PORT ROBOT ASSISTED PARTIAL NEPHRECTOMY: INITIAL EXPERIENCE AND TECHNIQUE WITH THE DA VINCI SINGLE-PORT PLATFORM (IDEAL PHASE 1). MINERVA UROL NEPHROL. 2022 (B)(6) ;74(2):216-224. DOI: 10.23736/S2724-6051.21.03919-9. EPUB 2021 MAR 26. PMID: 33769009." }, { "mdr_text_key": "319103011", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "DURING REVIEW OF A LITERATURE ARTICLE INVOLVING DA VINCI ASSISTED ROBOTIC PROCEDURES TITLED, ¿SINGLE-PORT ROBOT ASSISTED PARTIAL NEPHRECTOMY: INITIAL EXPERIENCE AND TECHNIQUE WITH THE DA VINCI SINGLE-PORT PLATFORM (IDEAL PHASE 1)¿ THE FOLLOWING EVENTS WERE REPORTED. ONE PATIENT EXPERIENCED AN INTRA-OPERATIVE \"MILD LIVER CAPSULE INJURY.\" DESPITE THIS EVENT, THE ARTICLE STATES THAT NO INTRA-OPERATIVE COMPLICATIONS OCCURRED, AND THERE WERE NO PROCEDURE CONVERSIONS. ADDITIONALLY, TWO PATIENTS EXPERIENCED POST-OPERATIVE RETROPERITONEAL HEMATOMAS WHICH WERE TREATED WITH SELECTIVE EMBOLIZATION." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }