{ "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": "2955842-2026-25983", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260528", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20250618", "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": "IT", "manufacturer_contact_area_code": "", "date_added": "20260528", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1374930", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260528", "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": "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": "", "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": "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": "20260528", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "62 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Hemorrhage/Blood Loss/Bleeding", "Post Operative Wound Infection" ] } ], "distributor_city": "", "date_report": "20260504", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "25322546", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260504", "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": "402695206", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A REVIEW OF AN ARTICLE THAT EVALUATED THE SAFETY AND PERIOPERATIVE OUTCOMES OF ROBOTIC-ASSISTED SINGLE-PORT VERSUS MULTI-PORT SURGICAL STAGING FOR APPARENT EARLY-STAGE ENDOMETRIAL CANCER WAS PERFORMED. THE RETROSPECTIVE, PROPENSITY-MATCHED STUDY ANALYZED 100 PATIENTS UNDERGOING ROBOTIC-ASSISTED HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY AND NODAL STAGING USING THE DA VINCI SURGICAL SYSTEM BETWEEN JANUARY 2021 AND DECEMBER 2024. A TOTAL OF 3 PATIENTS IN THE SINGLE-PORT GROUP EXPERIENCED POSTOPERATIVE COMPLICATIONS WITHIN 30 DAYS, INCLUDING SURGICAL SITE INFECTION AND ABDOMINAL PAIN REQUIRING READMISSION, AND HEMOPERITONEUM REQUIRING SURGICAL RE-INTERVENTION. NO DEVICE MALFUNCTIONS WERE REPORTED, AND THE AUTHORS DID NOT REPORT ANY EVENTS CAUSED BY ANY INTUITIVE SURGICAL, INC. (ISI) DEVICE. MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE AUTHOR. NO RESPONSE HAS BEEN RECEIVED." }, { "mdr_text_key": "402695207", "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. IMAGES ASSOCIATED WITH THIS REPORTED EVENT WERE INCLUDED IN THE ARTICLE. CITATION: GIANNINI A, VIZZA E, BRUNO V, ET AL. ROBOTIC-ASSISTED SINGLE-PORT AND MULTI-PORT SURGICAL STAGING IN EARLY-STAGE ENDOMETRIAL CANCER: A PROPENSITY-MATCHED COMPARISON. EUR J SURG ONCOL. 2025;51(9):110269. DOI:10.1016/J.EJSO.2025.06.697 SECTION A2: PATIENT INFORMATION AGE - REFLECTS THE STUDY MEAN AGE OF THE PATIENTS IN THE ROBOTIC GROUP. SECTION A3A: PATIENT GENDER REPRESENTS THE MAJORITY OF 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 FIRST AUTHOR'S ASSOCIATED HOSPITAL. WHILE THE EXACT SITE IS UNKNOWN, THIS DESIGNATION IS CONSIDERED AN APPROPRIATE SUBSTITUTION. SECTION E: SINCE THIS ARTICLE WAS IDENTIFIED DURING A LITERATURE REVIEW BY INTUITIVE SURGICAL, INC. (ISI) RATHER THAN REPORTED BY THE SITE, THE CORRESPONDING AUTHOR IS DESIGNATED AS THE INITIAL REPORTER OF THE EVENT." } ], "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": "" } ] }