{ "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": "2955842-2026-24661", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260512", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20250530", "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", "Literature", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "CH", "manufacturer_contact_area_code": "", "date_added": "20260512", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1207157", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260512", "brand_name": "DA VINCI", "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": "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": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260707", "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": "20260512", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "57 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Thrombosis/Thrombus" ] } ], "distributor_city": "", "date_report": "20260416", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "25147960", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260416", "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": "400966181", "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. CITATION: ZHOU, MINSHU MDA; QI, HAIOU MDA,*. EVALUATION OF CONTINUOUS IMPROVEMENT EFFECT OF PERIOPERATIVE NURSING QUALITY IN DA VINCI ROBOT-ASSISTED LAPAROSCOPIC RADICAL PROSTATECTOMY. MEDICINE 104(24):P E42896, JUNE 13, 2025. / DOI: 10.1097/MD.0000000000042896. SECTION A2: PATIENT AGE: REFLECTS THE STUDY MEAN OF 57 +/- 6.7 YRS. SECTION A3A- PATIENT GENDER REPRESENTS THE MAJORITY OF THE PATIENTS IN THE ROBOTIC GROUP. SECTION A6 - PATIENT RACE REPRESENTS THE PATIENTS IN THE ROBOTIC GROUP. SECTION B7: MEDICAL HISTORY REFLECTS THE STUDY POPULATION CO-MORBIDITIES, NOT THE SPECIFIC PATIENT. SECTION D: GENERIC DA VINCI XI SYSTEM PRODUCT INFORMATION NUMBER IS PROVIDED. SECTION E - THE EVENT SITE IS RECORDED BASED ON THE LOCATION OF THE CORRESPONDING AUTHOR'S ASSOCIATED HOSPITAL. SECTION E: SINCE THIS ARTICLE WAS IDENTIFIED DURING A LITERATURE REVIEW BY ISI, RATHER THAN REPORTED BY THE SITE, THE CORRESPONDING AUTHOR IS DESIGNATED AS THE INITIAL REPORTER OF THE EVENT." }, { "mdr_text_key": "400961715", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A REVIEW OF AN ARTICLE THAT EVALUATED THE CLINICAL EFFECT OF CONTINUOUS IMPROVEMENT OF PERIOPERATIVE NURSING QUALITY IN PATIENTS WITH DA VINCI ROBOT-ASSISTED LAPAROSCOPIC RADICAL PROSTATECTOMY. A TOTAL OF SEVEN PATIENTS EXPERIENCED COMPLICATIONS, INCLUDING DEEP VEIN THROMBOSIS. NO DEVICE MALFUNCTIONS WERE REPORTED, AND THE AUTHORS DID NOT REPORT ANY EVENTS CAUSED BY ANY ISI DEVICE. MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE CORRESPONDING AUTHOR; HOWEVER, NO RESPONSE HAS BEEN RECEIVED." } ], "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": "" } ] }