{ "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": "2955842-2025-48904", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20251218", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20250409", "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" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "NL", "manufacturer_contact_area_code": "408", "date_added": "20251218", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "588346", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20251218", "brand_name": "DA VINCI SURGICAL 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": "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": [ "Insufficient Device Problem Information", "Insufficient Device Problem Information" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260112", "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": "20251218", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Required Intervention", " H" ], "patient_age": "67 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Unspecified Infection", "Unspecified Tissue Injury", "Hemorrhage/Blood Loss/Bleeding", "Unspecified Infection", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20251218", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "23839765", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20251124", "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": "388002245", "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 INCLUDED IN THE ARTICLE. CITATION: GEITENBEEK, R.T.J.; ET AL. AN INTERNATIONAL MULTICENTRE RETROSPECTIVE COHORT STUDY EVALUATING ROBOT-ASSISTED TOTAL MESORECTAL EXCISION IN EXPERIENCED DUTCH, FRENCH, AND UNITED KINGDOM CENTRES¿THE EUREKA COLLABORATIVE. CANCERS 2025, 17, 1268. HTTPS://DOI.ORG/10.3390/CANCERS17081268. SECTION A2 - PATIENT INFORMATION AGE: REFLECTS THE STUDY'S MEAN YEARS PATIENT AGE. THE PATIENT'S GENDER IS SELECTED AS MALE, AS 65% OF THE PATIENT POPULATION IS MALE. SECTION D4 - THE PROCEDURES IN THE ARTICLE WERE PERFORMED ON EITHER DA VINCI SI/X/XI SYSTEMS. THERE WAS NO DIFFERENTIATION PROVIDED REGARDING WHICH SYSTEM WAS USED PER PROCEDURE." }, { "mdr_text_key": "388002246", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A REVIEW OF THE ARTICLE WAS CONDUCTED WHICH AIMED TO EVALUATE THE SHORT-TERM CLINICAL AND LONG-TERM ONCOLOGICAL OUTCOMES OF ROBOT-ASSISTED TOTAL MESORECTAL EXCISION (R-TME) IN HIGH-VOLUME EUROPEAN CENTRES. THE STUDY, DESIGNED AS AN INTERNATIONAL MULTICENTRE RETROSPECTIVE COHORT ANALYSIS, EVALUATED 1390 PATIENTS UNDERGOING ROBOT-ASSISTED TOTAL MESORECTAL EXCISION BETWEEN JANUARY 2013 AND JANUARY 2022. THE ARTICLE NOTED THAT DURING THESE DV SURGERIES, INTRAOPERATIVE COMPLICATIONS WERE REPORTED IN 67 PATIENTS, WITH CONVERSION TO OPEN OR LAPAROSCOPIC SURGERY REQUIRED IN 52 CASES. TYPES OF INTRA-OPERATIVE COMPLICATIONS WERE BLEEDING IN 3 PATIENTS, PERFORATION IN 20 PATIENTS. POST OP COMPLICATIONS WITHIN 31 DAYS REPORTED IN 322 PATIENTS WHICH INCLUDED ILEUS REPORTED IN 132 PATIENTS, WOUND INFECTION IN 67 PATIENTS, BLEEDING IN 25 PATIENTS. READMISSION WITHIN 30 DAYS OCCURRED IN 189 PATIENTS, RE-INTERVENTION WITHIN 31 DAYS OCCURRED IN 144 PATIENTS. ANASTOMOTIC LEAKAGE OCCURRED IN 115 PATIENTS. THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS REPORTED, AND NO INDICATION THAT ISI PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENT. ISI HAS REACHED OUT TO THE AUTHOR; NO INFORMATION IS AVAILABLE AS OF NOW." } ], "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": "" } ] }