{ "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": "2955842-2023-18177", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20230904", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20230412", "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": "20230904", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20220627", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1397259", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230904", "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": "DA", "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": "TX", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "11/15/2023", "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": "20230904", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "57 YR", "patient_sex": "Female", "patient_weight": "50 KG", "patient_ethnicity": "Non Hispanic", "patient_race": "Asian", "patient_problems": [ "Dyspnea", "Pneumothorax", "Cough", "Dyspnea", "Pneumothorax", "Cough" ] } ], "distributor_city": "", "date_report": "20230809", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "17675228", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20230809", "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": "338245539", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "338245540", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION OBTAINED AS THE FOLLOWING: A CHEST X RAY ON (B)(6) 2023 (POST-OPERATIVE DAY (POD) 10) DEMONSTRATED INTERVAL INCREASE IN THE MODERATE SIZED RIGHT HYDROPNEUMOTHORAX WITH DEVELOPMENT OF AIR FLUID LEVELS. PNEUMOPERITONEUM WAS ALSO NOTED. DURING A FOLLOW-UP ON (B)(6) 2023 (POD 12), THE PATIENT WAS NOTED BE RECOVERING WELL WITH MILD SHORTNESS OF BREATH THAT WAS LIKELY RELATED TO THE LOSS OF LUNG VOLUME AND NOT THE PNEUMOTHORAX. THE HYDROPNEUMOTHORAX WAS NOTED TO HAVE DECREASED ON (B)(6) 2023 (POD 16). CT CHEST PERFORMED ON (B)(6) 2023 DEMONSTRATED TRACE RIGHT PLEURAL FLUID CONSISTENT WITH POSTOPERATIVE FLUID, AND THE EVENT WAS CONSIDERED AS RESOLVED ON THIS DATE. FIELD B7 (PATIENT MEDICAL HISTORY) IS UPDATED WITH ADDITIONAL INFORMATION." }, { "mdr_text_key": "322620720", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THE PATIENT UNDERWENT DA VINCI ASSISTED RIGHT LOBECTOMY ON (B)(6) 2023 AS PART OF A CLINICAL STUDY. POST-OPERATIVELY, THE PATIENT'S SERIES OF CHEST X-RAYS SHOWED SIGNS OF AIR LEAKAGE AND CHEST TUBE HAD TO BE REMAINED IN PLACE LONGER THAN USUAL. PATIENT WAS REPORTED HAVING COUGHING AND DYSPNEA ON EXERTION POST-OPERATIVELY. THE PATIENT WAS THEN DISCHARGED HOME ON (B)(6) 2023 WITH CHEST TUBE STILL IN PLACED. ON POST-OPERATIVE DAY NINE, THE PATIENT REPORTED PAIN AND DYSPNEA ASSOCIATED WITH THE CHEST TUBE INSERTION AND THE SYMPTOMS WERE RESOLVED AFTER THE CHEST TUBE WAS REMOVED ON (B)(6) 2023. ON THE SAME DAY, THE PATIENT WAS STILL OBSERVED WITH RIGHT SIDE SMALL PNEUMOTHORAX ON CHEST X-RAY, BUT NO INTERVENTION WAS REQUIRED, AND NO OTHER SYMPTOMS WERE ASSOCIATED WITH IT. THE DA VINCI ASSISTED PROCEDURE WAS COMPLETED ROBOTICALLY, WITH NO INTRA-OPERATIVE COMPLICATIONS. A 24 FR CHEST TUBE WAS INSERTED INTRA-OPERATIVELY. THERE WAS NO REPORT OF ANY MALFUNCTIONS OF DV SYSTEMS, INSTRUMENTS OR ACCESSORIES." }, { "mdr_text_key": "322620721", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE INFORMATION GATHERED, THERE IS NO INDICATION OR REPORT THAT DAVINCI PRODUCT CAUSED OR CONTRIBUTED TO THE INCIDENTS. THEREFORE, NO PRODUCTS ARE EXPECTED TO BE RETURNED FOR EVALUATION AND THE ROOT CAUSE OF THE CUSTOMER REPORTED POSTOPERATIVE INCIDENT CANNOT BE DETERMINED. A SYSTEM LOG REVIEW SHOWED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT." } ], "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": "12/08/2023" } ] }