{ "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": "2955842-2024-21964", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20241115", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20240427", "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": "JA", "manufacturer_contact_area_code": "408", "date_added": "20241115", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2187757", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20241115", "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": "UNKNOWN", "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": "20250819", "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": "20241115", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20241023", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "20693926", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20241023", "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": "356725629", "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. THERE WAS NO REPORT OF, OR INDICATION OF, ANY DA VINCI PRODUCT ISSUES. THERE IS NO INDICATION THAT ANY DA VINCI PRODUCTS CONTRIBUTED TO THE REPORTED COMPLICATIONS. CITATION: UCHIDA S, MATSUNAGA T, TOMITA H, FUKUI M, HATTORI A, TAKAMOCHI K ET AL. USEFULNESS OF FINAL TRANSECTION OF THE PROXIMAL PULMONARY ARTERY IN ROBOTIC LEFT UPPER LOBECTOMY. INTERDISCIP CARDIOVASC THORAC SURG 2024; DOI:10.1093/ICVTS/IVAE054. SECTION A: PATIENT INFORMATION - NO SPECIFIC PATIENT DEMOGRAPHICS WERE PROVIDED FOR THE PATIENTS. THE MEDIAN AGE OF THE WHOLE COHORT IS NOT PROVIDED. THE MEDIAN AGE OF THE PATIENTS WAS 69.5 YEARS IN THE BRONCHUS PRIOR TRANSECTION GROUP (BT GROUP) AND 74 YEARS IN THE ARTERY PRIOR TRANSECTION GROUP (AT GROUP). THE MAJORITY OF THE WHOLE COHORT IS FEMALE (30 FEMALES OUT OF 49 PATIENTS). SECTION B3: DUE TO THE LACK OF SPECIFIC INFORMATION REGARDING THE EVENT DATE ASSOCIATED WITH THE ADVERSE EVENT, AN ALTERNATE DATE, PUBLISHED DATE HAS BEEN USED. SECTION D - SUSPECT MEDICAL DEVICE: DUE TO THE LACK OF SPECIFIC INFORMATION REGARDING THE DA VINCI SYSTEM ASSOCIATED WITH THE ADVERSE EVENT, A GENERIC SYSTEM WAS USED." }, { "mdr_text_key": "356725630", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A LITERATURE ARTICLE DESCRIBED A RETROSPECTIVE SINGLE-INSTITUTION STUDY, AN EVALUATION OF PATIENTS WHO HAD UNDERGONE ROBOTIC LUNG RESECTION FOR LUNG ADENOCARCINOMA WAS PERFORMED. THE AIM OF THE STUDY WAS TO EXAMINE THE USEFULNESS OF FINAL TRANSECTION OF THE PROXIMAL PULMONARY ARTERY IN ROBOTIC LEFT UPPER LOBECTOMY AND ITS IMPACT ON PERIOPERATIVE OUTCOMES. THE STUDY TOOK PLACE BETWEEN JANUARY 2017 AND NOVEMBER 2022, DURING WHICH 49 PATIENTS UNDERWENT ROBOTIC LEFT UPPER LOBECTOMY. THE MEDIAN AGE OF THE PATIENTS WAS 69.5 YEARS IN THE BRONCHUS PRIOR TRANSECTION GROUP (BT GROUP) AND 74 YEARS IN THE ARTERY PRIOR TRANSECTION GROUP (AT GROUP). THE GROUPS DID NOT DIFFER SIGNIFICANTLY IN PREOPERATIVE FACTORS, INCLUDING AGE, SEX, SMOKING STATUS, BASELINE FUNCTION, CLINICAL TUMOR SIZE OR NODAL STATUS. TWO PATIENTS IN THE AT GROUP EXPERIENCED INTRAOPERATIVE BLEEDING. ONE PATIENT'S MOST PROXIMAL BRANCH OF THE PULMONARY ARTERY WAS INJURED WHEN THE ARTERY WAS BEING TRANSECTED WITH A STAPLER BY AN ASSISTANT SURGEON. A CONVERSION TO THORACOTOMY WAS PERFORMED, AND THE LEFT MAIN PULMONARY ARTERY WAS CLAMPED. THE INJURY WAS SUTURED USING 6-0 PROLENE. THE PATIENT LOST 2460 ML OF BLOOD AND REQUIRED A BLOOD TRANSFUSION. THE PATIENT RECOVERED AND WAS DISCHARGED ON POSTOPERATIVE DAY 11 WITHOUT COMPLICATIONS. ANOTHER PATIENT EXPERIENCED BLEEDING FROM THE PULMONARY ARTERY ON REAR SIDE DURING LEFT UPPER BRONCHUS EXFOLIATION. THE BLEEDING WAS SUTURED USING 6-0 PROLENE WITH A BLOOD LOSS OF 100ML. A MIX OF ROBOTIC SYSTEMS WAS USED IN THE PROCEDURES, WITH A DA VINCI SI/XI RATIO OF 10:1, THOUGH IT WAS NOT SPECIFIED WHICH STAPLER WAS USED FOR THIS PATIENT, AS THIRD-PARTY STAPLERS, ENDOWRIST OR SUREFORM STAPLERS COULD BE USED AMONG THESE PROCEDURES, ACCORDING TO THE ARTICLE. THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS REPORTED IN THE ARTICLE. THE THIRTY-DAY MORTALITY WAS 0% IN THE WHOLE COHORT OF PATIENTS. FOLLOW-UP ATTEMPTS MADE TO THE AUTHORS, AND THE AUTHOR COMMENTED THAT THE INTRA-OPERATIVE BLEEDING WERE CAUSED BY ECHELON 7 WHITE RELOAD, AND NOT CAUSED BY DA VINCI DEVICES." } ], "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": "" } ] }