{ "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": "+1(408)5", "event_type": "Injury", "report_number": "2955842-2026-34202", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260811", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20250620", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "PHARMACIST", "manufacturer_contact_plocal": "+1(408)523-2100", "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": "US", "manufacturer_contact_area_code": "", "date_added": "20260812", "manufacturer_contact_f_name": "Izabel", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "620869", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260811", "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": "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" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "", "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": "20260811", "sequence_number_treatment": [ "da Vinci Instruments and Accessories." ], "sequence_number_outcome": [ "Other" ], "patient_age": "62 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Blood or Lymphatic problem" ] } ], "distributor_city": "", "date_report": "20260722", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "Santa Clara", "mdr_report_key": "50210876", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260722", "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": "15963584422", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A system logs review cannot be performed at this time due to insufficient information provided. The event date and da Vinci System identifiers are unknown. Citation: Brassetti, A., Bove, A. M., Proietti, F., Anceschi, U., Bologna, E., Cartolano, S., Chiacchio, G., D'Annunzio, S., Ferriero, M., Flammia, S. R., Guaglianone, S., Leonardo, C., Licari, L. C., Mastroianni, R., Misuraca, L., Tuderti, G., & Simone, G. (2025). Single-port antegrade robotic lymphadenectomy: A novel minimally invasive approach to treat lymph nodes in men with penile cancer. European Urology, 88, 381-387. https://doi.org/10.1016/j.eururo.2025.06.016. NOTE: 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. The patient demographics provided represent the demographics of the majority population described in the article. 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." }, { "mdr_text_key": "15463584421", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A review of an article was performed that presented a retrospective review of experiences with robotic lymphadenectomy procedures. The article noted four patients developed clinically evident lymphoceles, with one case requiring temporary percutaneous drainage under local anesthesia due to the risk of cutaneous ulceration.Intuitive Surgical, Inc. (ISI) followed up with the initial reporter and obtained the following additional information: The reported postoperative lymphoceles were not caused by, nor attributed to, any Intuitive Surgical device. They represent well-recognized complications following inguinal lymph node dissection. No da Vinci system or instrument malfunctions occurred during any of the procedures reported in the manuscript. Consequently, no corrective actions or interventions related to device malfunction were required. The patients were adult males undergoing robotic inguinal lymphadenectomy for penile cancer. No additional patient-specific information can be provided due to privacy regulations." } ], "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": "" } ] }