{ "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": "2955842-2023-11938", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20230413", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20230220", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign", "Study", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "TW", "manufacturer_contact_area_code": "408", "date_added": "20230413", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20211012", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1027556", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230413", "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": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "380601-45", "catalog_number": "380601", "lot_number": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "00886874114605", "udi_public": "(01)00886874114605", "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": "", "date_changed": "20250801", "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": "20230413", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "60 YR", "patient_sex": "Female", "patient_weight": "53 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Blood or Lymphatic problem", "Unspecified Blood or Lymphatic problem" ] } ], "distributor_city": "", "date_report": "20230320", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "16736159", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20230320", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "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": "313251756", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THE PATIENT UNDERWENT DA-VINCI ASSISTED LOBECTOMY ON (B)(6) 2023 AS PART OF THE CGMH SP CLINICAL STUDY. ON (B)(6) 2023, THE PATIENT DEVELOPED CHYLOTHORAX WITH HIGH TRIGLYCERIDES (TG) AND REQUIRED PROLONGED HOSPITALIZATION. DIET CONTROL WAS IMPLEMENTED INCLUDING KABIVEN (TOTAL PARENTERAL NUTRITION) ADMINISTERED ON (B)(6) 2023 FOR TWO DAYS. THE PATIENT WAS STARTED CLEAR LIQUID DIET ON (B)(6) 2023 AND STARTED NON-FAT DIET ON (B)(6) 2023. THE PATIENT`S CHEST TUBE WAS REMOVED ON (B)(6) 2023. THE STUDY INVESTIGATOR ASSESSED THE REPORTED EVENT AS TO NOT RELATED TO THE DV SYSTEM, INSTRUMENTS OR ACCESSORIES, NOT RELATED TO THE DV ASSISTED SURGERY. INTUITIVE SURGICAL, INC, (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO ADDITIONAL INFORMATION. HOWEVER, AT THE TIME OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED." }, { "mdr_text_key": "313251757", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE CHYLOTHORAX CANNOT BE DETERMINED. THERE WAS NO CLAIM AGAINST THE PRODUCT AND NO INDICATION OF A PRODUCT ISSUE, AND THUS THERE IS NO INDICATION THAT THE DEVICE DIRECTLY CAUSED THE REPORTED EVENT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS REPORTED THAT THE PATIENT UNDERWENT DA-VINCI ASSISTED LOBECTOMY ON (B)(6) 2023 AS PART OF THE CGMH SP CLINICAL STUDY. ON POST-OPERATIVE DAY 2, THE PATIENT DEVELOPED CHYLOTHORAX WITH HIGH TRIGLYCERIDES (TG) AND REQUIRED PROLONGED HOSPITALIZATION. DIET CONTROL WAS IMPLEMENTED INCLUDING KABIVEN (TOTAL PARENTERAL NUTRITION) ADMINISTERED ON (B)(6) 2023 FOR TWO DAYS, STARTED CLEAR LIQUID DIET ON (B)(6) 2023 AND STARTED NON-FAT DIET ON (B)(6) 2023. CHEST TUBE WAS REMOVED ON (B)(6) 2023. THE STUDY INVESTIGATOR ASSESSED THE REPORTED EVENT AS TO NOT RELATED TO THE DV SYSTEM, INSTRUMENTS OR ACCESSORIES, NOT RELATED TO THE DV ASSISTED SURGERY." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }