{ "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": "2955842-2025-17074", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20250425", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20241107", "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", "Literature", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "JA", "manufacturer_contact_area_code": "408", "date_added": "20250514", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2615172", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250425", "brand_name": "DA VINCI SURGICAL SYSTEM", "generic_name": "DA VINCI SURGICAL SYSTEM", "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", "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": "20250825", "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": "20250425", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Urinary Tract Infection", "Unspecified Vascular Problem", "Unspecified Gastrointestinal Problem", "Urinary Tract Infection", "Unspecified Vascular Problem", "Unspecified Gastrointestinal Problem" ] } ], "distributor_city": "", "date_report": "20250328", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "21911734", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250328", "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": "370280101", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THERE IS NO INDICATION THAT ANY DA VINCI PRODUCTS CONTRIBUTED TO THE REPORTED COMPLICATIONS. A SYSTEM LOG REVIEW WAS NOT PERFORMED SINCE THERE IS INSUFFICIENT OR UNCONFIRMED EVENT INFORMATION. CITATION: ITO, H., ET AL. INTERIM ANALYSIS OF ROBOT-ASSISTED RADICAL HYSTERECTOMY IN JAPAN: A MULTICENTER, PROSPECTIVE INTERVENTIONAL SINGLE-ARM CLINICAL TRIAL. BIOMED CENTRAL (2024) 24:1360. DOI.ORG/10.1186/S12885-024-13090-Z. THE MISSING PATIENT/DEVICE INFORMATION IN SECTIONS A, B, AND D WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE MEAN AGE AND BODY MASS INDEX OF THE PATIENTS WERE 47 YEARS AND 22 KG/M2." }, { "mdr_text_key": "370280106", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A REVIEW OF A LITERATURE ARTICLE \"INTERIM ANALYSIS OF ROBOT-ASSISTED RADICAL HYSTERECTOMY IN JAPAN: A MULTICENTER, PROSPECTIVE INTERVENTIONAL SINGLE-ARM CLINICAL TRIAL\" WAS PERFORMED. THE PURPOSE OF THIS STUDY WAS TO ASSESS THE EFFICACY AND SAFETY OF ROBOT-ASSISTED RADICAL HYSTERECTOMY (RARH) USING THE DA VINCI SURGICAL SYSTEM (DVSS) COMPARED TO CONVENTIONAL RADICAL HYSTERECTOMY (RH). A PROSPECTIVE OBSERVATIONAL STUDY WAS CONDUCTED, PERFORMING 292 RASS BETWEEN MARCH 2009 AND DECEMBER 2015. THE SURGERIES WERE PERFORMED USING THE DVSS S, SI, OR XI MODELS. THE MEAN AGE AND BODY MASS INDEX OF THE PATIENTS WERE 47 YEARS AND 22 KG/M2, RESPECTIVELY. THE ARTICLE NOTED THAT DURING THESE DV SURGERIES, SEVERAL SERIOUS ADVERSE EVENTS WERE NOTED. THE SERIOUS PERIOPERATIVE AND POSTOPERATIVE ADVERSE EVENTS OBSERVED INCLUDED URINARY TRACT, VASCULAR, INTESTINAL AND NERVE INJURIES; AND PELVIC INFLAMMATORY DISEASE (PID), URINARY TRACT INFECTION, ILEUS, VAGINAL CUFF DEHISCENCE, AND PULMONARY EMBOLISM. NO CASES WERE CONVERTED TO OPEN SURGERY AND NO DEATHS WERE REPORTED 1 YEAR POSTOPERATIVELY. THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS REPORTED FOR THESE EVENTS, NOR DID THE AUTHOR ALLEGE THAT OTHER INTUITIVE SURGICAL, INC. (ISI) PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE 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": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }