{ "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": "2955842-2024-20523", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20241016", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20240326", "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": "CH", "manufacturer_contact_area_code": "408", "date_added": "20241016", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2568343", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20241016", "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": "", "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": "20241016", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "47 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Unspecified Tissue Injury", "Hemorrhage/Blood Loss/Bleeding", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20240920", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "20464628", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20240920", "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": "354364445", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "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 SPECIFIC DA VINCI SYSTEM(S) AND EVENT DATE INFORMATION ARE UNKNOWN. CITATION: GAN, W., YANG, MZ., TAN, ZH. ET AL. ROBOTIC PORTAL RESECTION FOR MEDIASTINAL TUMOURS: A PROSPECTIVE OBSERVATIONAL STUDY. J CARDIOTHORAC SURG 19, 155 (2024). HTTPS://DOI.ORG/10.1186/S13019-024-02660-8. SECTION A: PATIENT INFORMATION - NO SPECIFIC DEMOGRAPHICS WERE PROVIDED FOR EACH OF THE PATIENTS. THE MEDIAN AGE OF THE STUDY PATIENTS WERE 47 YEARS OLD, AND THE MAJORITY OF THE PATIENTS WERE FEMALE. SECTION D - SUSPECT MEDICAL DEVICE: DUE TO THE LACK OF SPECIFIC INFORMATION REGARDING THE DA VINCI SYSTEM ASSOCIATED WITH THE COMPLICATIONS, A GENERAL SYSTEM WAS USED." }, { "mdr_text_key": "354364446", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A REVIEW WAS CONDUCTED OF A CLINICAL ARTICLE THAT ASSESSED THE EFFECTIVENESS AND FEASIBILITY OF ROBOTIC PORTAL RESECTION (RPR) FOR MEDIASTINAL TUMORS AND THE FOLLOWING COMPLICATIONS WERE NOTED: (B)(4) PATIENTS WITH MEDIASTINAL TUMORS BETWEEN (B)(6) 2018 AND (B)(6) 2023 WERE ENROLLED IN THE STUDY. MOST PATIENTS WERE ASYMPTOMATIC ((B)(4)), AND NO MYASTHENIA GRAVIS WAS IDENTIFIED IN THE ENTIRE COHORT. ONE PATIENT EXPERIENCED AN INTRA-OPERATIVE LEFT INNOMINATE VEIN INJURY. THE INJURY WAS SUTURED USING A ROBOTIC PROCEDURE AND WITHOUT THE NEED FOR A CONVERSION TO THORACOTOMY. ALTHOUGH THE BLOOD LOSS DUE TO THE INJURY WAS NOT PROVIDED, IT WAS MENTIONED THAT THE MEDIAN BLOOD LOSS WAS 20 ML WITH THE RANGE OF 5.0¿30.0 ML FOR THE ENTIRE COHORT. (B)(4) PATIENTS UNDERWENT ACTIVE CONVERSION TO STERNOTOMY BECAUSE THE TUMORS WERE FOUND TO INVOLVE THE LEFT INNOMINATE VEIN DURING SURGERY. POSTOPERATIVE COMPLICATIONS WERE DEVELOPED IN (B)(4) PATIENTS, INCLUDING (B)(4) PATIENT WITH CHYLOTHORAX. THE POSTOPERATIVE CHYLOTHORAX WAS TREATED WITH CONSERVATIVE THERAPY (I.E. FASTING AND TOTAL PARENTERAL NUTRITION (TPN)) TO SUPPORT THE PATIENT. THE CHYLOTHORAX WAS RESOLVED AFTER 4 DAYS OF CARE. NO PERIOPERATIVE DEATHS OR SECONDARY OPERATIONS OCCURRED IN THE ENTIRE COHORT. THERE WAS NO MENTION OF ANY DEVICE MALFUNCTIONS OCCURRED DURING THE ROBOTIC ASSISTED SURGERIES." } ], "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": "" } ] }