{ "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": "2955842-2024-18111", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20240815", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20240116", "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", "Literature", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "SZ", "manufacturer_contact_area_code": "408", "date_added": "20240815", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1619606", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240815", "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", "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": "20250821", "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": "20240815", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Unspecified Blood or Lymphatic problem", "Unspecified Kidney or Urinary Problem", "Hemorrhage/Blood Loss/Bleeding", "Unspecified Blood or Lymphatic problem", "Unspecified Kidney or Urinary Problem" ] } ], "distributor_city": "", "date_report": "20240717", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "19990410", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20240717", "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": "349349210", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT REFLECTS ADVERSE EVENT ONLY DATA FROM A LITERATURE ARTICLE. THERE WAS NO REPORT OF, OR INDICATION OF, ANY DA VINCI PRODUCT ISSUES. ADDITIONALLY, THERE IS NO INDICATION THAT ANY DA VINCI PRODUCTS CONTRIBUTED TO THE REPORTED COMPLICATIONS. THE DESIGNATE AUTHOR WAS CONTACTED FOR ADDITIONAL INFORMATION WITH NO RESPONSE RECEIVED. CITATION: OUTCOMES OF ROBOT ASSISTED LAPAROSCOPIC EXTENDED PELVIC LYMPH NODE DISSECTION FOR PROSTATE CANCER. HTTPS://DOI.ORG/10.1186/S12894-024-01409-8." }, { "mdr_text_key": "349349211", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IN REVIEWING THE LITERATURE ARTICLE, A RETROSPECTIVE STUDY WAS CONDUCTED BASED ON COLLECTED CLINICOPATHOLOGICAL DATA OF A CONSECUTIVE SERIES OF MEN WITH LOCALIZED PROSTATE CANCER WHO UNDERWENT ROBOTIC-ASSISTED RADICAL PROSTATECTOMY (RARP) AT A SINGLE CENTER BETWEEN APRIL 2004 AND SEPTEMBER 2017. THE PRIMARY AIM OF THE STUDY WAS TO ASSESS LYMPH NODE (LN) YIELD, STRATIFIED BY SIDE AND ANATOMICAL REGION. THE SECONDARY OBJECTIVES WERE TO EXAMINE METASTATIC PATTERNS, COMPLICATION RATES, AND THE POTENTIAL THERAPEUTIC BENEFIT OF REMOVING REGIONAL METASTATIC LNS IN INDIVIDUALS WITH NODE-POSITIVE DISEASE. THE STUDY FOUND THAT AMONG PATIENTS WHO UNDERWENT EXTENDED PELVIC LYMPH NODE DISSECTION (EPLND) USING THE DA VINCI ROBOT ASSISTED APPROACH, SYMPTOMATIC LYMPHOCELES OCCURRED IN 2.1% OF CASES, WITH NONE OBSERVED IN MEN WHO DID NOT UNDERGO EPLND. THE STUDY ALSO REPORTED THAT CLAVIEN-DINDO GRADE IIIA AND GRADE IIIB COMPLICATIONS WERE 1.6% AND 3.3%, RESPECTIVELY, COMPARED TO 0.3% AND 1.1% IN PATIENTS WITHOUT PLND. FURTHERMORE, THE OVERALL COMPLICATION RATES (GREATER THAN OR EQUAL TO CLAVIEN-DINDO GRADE IIIA) INCREASED OVER TIME AMONG EPLND PATIENTS, WITH A TOTAL RATE OF 4.8%. NOTABLY, SIGNIFICANT BLEEDING REQUIRING TRANSFUSIONS WAS LESS FREQUENT IN EPLND PATIENTS (2.1%) COMPARED TO THOSE WHO DID NOT UNDERGO THE PROCEDURE. IMPORTANTLY, NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS WERE REPORTED IN THE ARTICLE. THE STUDY DOCUMENTED SEVERAL LIMITATIONS. AS A SINGLE CENTER RETROSPECTIVE STUDY, THE RESULTS MAY BE INFLUENCED BY SITE SPECIFIC SURGICAL TECHNIQUES AND PATHOLOGICAL WORKUPS, POTENTIALLY AFFECTING THE REPORTED LN NUMBERS. THE DECISION TO PERFORM PLND WAS NOT BASED ON AN ESTABLISHED NOMOGRAM SUCH AS BRIGANTI BUT RATHER ON THE COUNSELING OF THE TREATING UROLOGIST. A MORE STRINGENT SELECTION OF PATIENTS MIGHT HAVE RESULTED IN A MORE FAVORABLE COST-BENEFIT RATIO FOR EPLND, POTENTIALLY REDUCING THE NUMBER OF PROCEDURES AND SPARING PATIENTS FROM ANDROGEN DEPRIVATION THERAPY (ADT) AND/OR EXTERNAL BEAM RADIATION THERAPY (EBRT). ADDITIONALLY, THE STUDY RECORDED ONLY SYMPTOMATIC LYMPHOCELES, REOPERATIONS, AND TRANSFUSION RATES DURING FOLLOW-UP, WITH NO DATA ON OTHER COMPLICATIONS, METASTASIS-FREE SURVIVAL, RECURRENCE LOCATION, OR TIME TO CASTRATION RESISTANCE. MOREOVER, ADJUVANT TREATMENT WAS NOT STANDARDIZED, AND DATA ON THE DOSE AND FIELD FOR POSTOPERATIVE RADIATION THERAPY WERE UNAVAILABLE. THERE WERE NO DA VINCI DEVICE ISSUES REPORTED IN THE ARTICLE. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, THE AUTHOR RESPONDED INDICATING THAT NO FURTHER INFORMATION WOULD BE PROVIDED." } ], "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": "" } ] }