{ "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": "2955842-2023-14582", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20230525", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20230331", "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", "Study", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20230525", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20220523", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1670115", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230525", "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": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250812", "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": "20230525", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "73 YR", "patient_sex": "Male", "patient_weight": "65 KG", "patient_ethnicity": "Non Hispanic", "patient_race": "Asian", "patient_problems": [ "Pulmonary Dysfunction", "Pulmonary Dysfunction" ] } ], "distributor_city": "", "date_report": "20230502", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "17008090", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20230502", "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": "315999183", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THE PATIENT UNDERWENT DA-VINCI ASSISTED RIGHT UPPER LOBECTOMY PROCEDURE FOR NON-SMALL CELL ADENOCARCINOMA ON (B)(6) 2023 AS PART OF THE SP THORACIC IDE STUDY. THE PATIENT WAS REPORTED AS HAVING AIR LEAKAGE WHICH WAS IDENTIFIED BY THORAGUARD DRAINAGE SYSTEM THAT MEASURES AIR LEAK RATE DIGITALLY. THE PATIENT DID NOT PRESENT WITH ANY SYMPTOMS ASSOCIATED WITH THE AIR LEAKAGE. A CHEST TUBE WAS PLACED IN POST-OPERATIVELY PER STANDARD PROTOCOL, BUT THE DURATION OF INSERTION WAS PROLONGED DUE TO THE AIR LEAK. NO OTHER MEDICAL INTERVENTION WAS PERFORMED. THE PATIENT WAS DISCHARGED HOME WITH CHEST TUBE IN PLACE, AND THE CHEST TUBE WAS REMOVED ON (B)(6) 2023 DURING AN OUTPATIENT VISIT. THERE WAS NO REPORT OF MALFUNCTIONS OF ISI SYSTEMS, INSTRUMENTS OR ACCESSORIES. THE STUDY INVESTIGATOR BELIEVED THE CAUSE OF THE AIR LEAK WAS DUE TO EXTENSIVE INTRA-PLEURA LYSIS OF ADHESIONS, AND NOT RELATED TO THE SINGLE PORT DA VINCI DEVICES." }, { "mdr_text_key": "315999184", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. AS PER THE INVESTIGATOR, THE CAUSE OF THE PROLONGED AIR LEAK WAS DUE TO EXTENSIVE INTRA PLEURAL LYSIS OF ADHESIONS. THERE IS NO INDICATION OR REPORT THAT ANY DA VINCI PRODUCT CAUSED OR CONTRIBUTED TO THE INCIDENTS. THEREFORE, NO PRODUCTS ARE EXPECTED TO BE RETURNED FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP MDR WILL BE SUBMITTED. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS REPORTED THAT AFTER A DA-VINCI ASSISTED RIGHT UPPER LOBECTOMY PROCEDURE, THE PATIENT HAD A PROLONGED AIR LEAK. A CHEST TUBE WAS PLACED FOR A PROLONGED DURATION DUE TO THE AIR LEAK. THERE WAS NO REPORT OF ANY MALFUNCTIONS OF ISI SYSTEMS, INSTRUMENTS OR ACCESSORIES." } ], "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": "" } ] }