{ "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": "2955842-2023-12296", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20230501", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20230329", "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": "20230501", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20190522", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "832844", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230501", "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": "380601-34", "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": "NC", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250728", "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": "20230501", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "64 YR", "patient_sex": "Female", "patient_weight": "107 KG", "patient_ethnicity": "Non Hispanic", "patient_race": "White", "patient_problems": [ "Pulmonary Dysfunction", "Pulmonary Dysfunction" ] } ], "distributor_city": "", "date_report": "20230403", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "16846250", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20230403", "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": "314311385", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE ATELECTASIS 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. A REVIEW OF THE SYSTEM LOG REVEALED NO RELATED SYSTEM ERRORS OCCURRING DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: AFTER UNDERGOING A DA-VINCI ASSISTED PULMONARY LOBECTOMY, THE PATIENT EXPERIENCED ATELECTASIS AND HOSPITALIZATION WAS PROLONGED. BEDSIDE BRONCHOSCOPY WAS PERFORMED, AND THE PATIENT WAS PLACED ON NASAL CANNULA FOR OXYGEN. ADDITIONALLY, A 14 FRENCH PIGTAIL CHEST TUBE WAS INSERTED AND CONNECTED TO THE DRAINAGE SYSTEM." }, { "mdr_text_key": "314311406", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "AS PART OF A CLINICAL STUDY, IT WAS REPORTED THAT A PATIENT UNDERWENT DA-VINCI ASSISTED PULMONARY LOBECTOMY ON (B)(6) 2023 AND THE PATIENT PRESENTED WITH RAPID WORSENING SHORTNESS OF BREATH WITH ESCALATING OXYGEN REQUIREMENTS ON (B)(6) 2023 WITH PROLONGED HOSPITALIZATION REQUIRED. A CHEST X-RAY SHOWED COLLAPSE OF THE REMAINING RIGHT LUNG WITH CONCERN FOR MUCOUS PLUGGING POST RIGHT UPPER LOBECTOMY WITH PARTIAL CHEST WALL RESECTION. A BEDSIDE BRONCHOSCOPY REVEALED TENACIOUS SECRETIONS IN BRONCHI WITH MUCOUS PLUGGING WHICH WAS CLEARED WITH LAVAGE. THERE WAS NO IMMEDIATE COMPLICATIONS AND THE PATIENT WAS PLACED BACK ON NASAL CANULA OXYGEN, WHICH WAS RAPIDLY TITRATED DOWN. A COMPUTERIZED TOMOGRAPHY (CT) SCAN ON (B)(6) 2023 REVEALED A MODERATE TO LARGE RIGHT PLEURAL EFFUSION WITH COMPRESSIVE ATELECTASIS OF THE RIGHT LUNG. WHEN THE PLEURAL SPACE WAS ENTERED, A GUSH OF AIR AND SEROUS FLUID WERE OBSERVED. A 14 FRENCH PIGTAIL CHEST TUBE AS INSERTED AND CONNECTED TO A CHEST DRAINAGE SYSTEM WHICH IMMEDIATELY DRAINED APPROXIMATELY 600ML OF SEROSANGUINOUS FLUID. THE PATIENT REPORTED BREATHING WAS IMPROVING, BUT STILL WITH SHORTNESS OF BREATH WITH OXYGEN SUPPLEMENT REQUIRED. THE PATIENT WAS REPORTEDLY DISCHARGED WITH SYMPTOM RESOLVED ON (B)(6) 2023. THE STUDY INVESTIGATOR DETERMINED THE EVENT TO BE RELATED TO THE DA VINCI-ASSISTED SURGERY, AND RELATED TO THE PATIENT'S UNDERLINE DISEASE, BUT NOT RELATED TO THE USE OF THE DA VINCI SYSTEM, INSTRUMENTS OR ACCESSORIES. THERE WAS NO REPORT OF A MALFUNCTION OF ANY DA VINCI SYSTEMS INSTRUMENTS OR ACCESSORIES DURING THE PROCEDURE." } ], "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": "" } ] }