{ "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": "2955842-2026-30026", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260701", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20250618", "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": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign", "Study", "Literature" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20260701", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "460740", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260701", "brand_name": "DA VINCI SYSTEM", "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": "UNKNOWN", "catalog_number": "UNKNOWN", "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": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "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": "20260701", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Fistula", "Urinary Tract Infection" ] } ], "distributor_city": "", "date_report": "20260605", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "25684630", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260605", "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": "406236914", "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. 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. A DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE PERFORMED BECAUSE THERE IS INSUFFICIENT INFORMATION REGARDING THE DEVICE/SYSTEM AND THE EVENT DATE. THE PATIENT DEMOGRAPHICS PROVIDED REPRESENT THE DEMOGRAPHICS OF THE MAJORITY POPULATION DESCRIBED IN THE ARTICLE. CITATION: VIZZA, E., GIANNINI, A., BRUNO, V., BAIOCCO, E., MANCINI, E., VIZZA, R., UCCELLA, S., RASPAGLIESI, F., & BOGANI, G. (2025). ROBOTIC-ASSISTED SINGLE-PORT AND MULTI-PORT SURGICAL STAGING IN EARLY-STAGE ENDOMETRIAL CANCER: A PROPENSITY MATCHED COMPARISON. EUROPEAN JOURNAL OF SURGICAL ONCOLOGY, 51(9), 110269. HTTPS://DOI.ORG/10.1016/J.EJSO.2025.110269." }, { "mdr_text_key": "406236915", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A REVIEW OF THE ARTICLE REPORTED THE FOLLOWING ADVERSE EVENT. IN THE DA VINCI SP GROUP REASONS FOR READMISSION WERE: SURGICAL SITE INFECTION AND ABDOMINAL PAIN AND 1 PATIENT REQUIRED A BLOOD TRANSFUSIONS. IN THE DA VINCI XI GROUP REASONS FOR READMISSION WERE URETERAL FISTULA, URINARY TRACT INFECTION, AND ABDOMINAL PAIN. SEVERE COMPLICATIONS (GRADE 3 OR MORE) IN THE DA VINCI SP GROUP INCLUDED HEMOPERITONEUM REQUIRING SURGERY (N 1); WHILE IN THE DA VINCI XI GROUP INCLUDED HEMOPERITONEUM REQUIRING SURGERY (N = 1) AND URETERAL FISTULA (N = 1). ALL SEVERE COMPLICATIONS OCCURRED WITHIN 30 DAYS." } ], "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": "" } ] }