{ "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": "2955842-2023-16261", "type_of_report": [ "Initial submission", "Followup", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20230614", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20230424", "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": "20230614", "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": "945613", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230614", "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": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/29/2023;09/19/2023;11/15/2023", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "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": "20230614", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "" ], "patient_age": "51 YR", "patient_sex": "Female", "patient_weight": "57 KG", "patient_ethnicity": "Non Hispanic", "patient_race": "White", "patient_problems": [ "Pneumothorax", "Pneumothorax" ] } ], "distributor_city": "", "date_report": "20230516", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "17124600", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20230516", "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": "336088912", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION WAS OBTAINED AND IT WAS REPORTED THAT THE PATIENT UNDERWENT DA VINCI-ASSISTED RIGHT LOWER LOBECTOMY ON (B)(6) 2023. THE PATIENT WAS OBSERVED WITH AIR LEAKAGE AND A PNEUMOTHORAX VIA X-RAY POST-OPERATIVELY, BUT NO MEDICAL INTERVENTION OR ACTION WAS REQUIRED. THERE WERE NO INTRA-OPERATIVE COMPLICATIONS NOR MALFUNCTIONS OF DA VINCI SYSTEMS, INSTRUMENTS OR ACCESSORIES REPORTED." }, { "mdr_text_key": "338983062", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION WAS OBTAINED AS THE FOLLOWING: ON (B)(6) 2023, THE PATIENT WAS DIAGNOSED WITH RIGHT PNEUMOTHORAX, AND REQUIRED READMISSION WITH 14 FRENCH PIGTAIL DRAINAGE. ON POST-OPERATIVE DAY (POD) 9 CHEST X RAY SHOWED DECREASED SMALL RIGHT HYDROPNEUMOTHORAX WITH SMALL PLEURAL EFFUSION AND TRACE PNEUMOTHORAX, PLEURAL PIGTAIL CATHETER IN SITU. CHEST TUBE WAS SUBSEQUENTLY CLAMPED FOR 24 HOURS. ON (B)(6) 2023 (POD 10), CHEST X RAY SHOWED INCREASED PNEUMOTHORAX, CHEST TUBE WAS SET TO SUCTION. THE CHEST X RAY ON (B)(6) 2023 (POD 11) SHOWED UNCHANGED PNEUMOTHORAX AND SUCTION WAS CONTINUED. ON (B)(6) 2023 (POD 12), THE PATIENT WAS NOTED TO HAVE CONTINUED AIR LEAK. THE NEXT DAY (POD 13, (B)(6) 2023), THE CHEST TUBE WAS SWITCHED TO WATER SEAL FROM SUCTION AND A POSITIVE INTERMITTENT AIR LEAK WAS STILL NOTED. AFTER TWO CLAMP TRIALS ON (B)(6) 2023 AND (B)(6) 2023, THE CHEST TUBE WAS FINALLY REMOVED ON (B)(6)2023 (POD 17). SHE WAS DISCHARGED HOME ON THE SAME DATE WITH ALL DRAINAGE REMOVED." }, { "mdr_text_key": "338983063", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "337009945", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION WAS OBTAINED AND IT WAS REPORTED THAT THE PATIENT UNDERWENT DA VINCI-ASSISTED RIGHT LOWER LOBECTOMY ON (B)(6) 2023. THE PATIENT WAS OBSERVED WITH AIR LEAKAGE ON X-RAY POST-OPERATIVELY, BUT REQUIRED PROLONGED HOSPITALIZATION. THERE WERE NO INTRA-OPERATIVE COMPLICATIONS NOR MALFUNCTIONS OF DA VINCI SYSTEMS, INSTRUMENTS OR ACCESSORIES REPORTED. THE PATIENT WAS DISCHARGED ON (B)(6) 2023 WITH ALL DRAINAGE SYSTEM REMOVED ON (B)(6) 2023. THE PATIENT STARTING HAVING WORSENING COUGH, AND MILD SHORTNESS OF BREATH SINCE DISCHARGED. ON (B)(6) 2023, THE PATIENT WAS DIAGNOSED WITH RIGHT PNEUMOTHORAX, AND REQUIRED READMISSION WITH PIGTAIL DRAINAGE. THE PATIENT WAS HOSPITALIZED FOR 9 DAYS AND DISCHARGED ON (B)(6) 2023." }, { "mdr_text_key": "337009946", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "317123669", "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 INCIDENT. THEREFORE, NO PRODUCTS ARE EXPECTED TO BE RETURNED FOR EVALUATION AND THE ROOT CAUSE OF THE CUSTOMER REPORTED POSTOPERATIVE INCIDENT CANNOT BE DETERMINED. 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." }, { "mdr_text_key": "317123670", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THE PATIENT UNDERWENT DA VINCI-ASSISTED RIGHT LOWER LOBECTOMY FOR NON-SMALL CELL ADENOCARCINOMA ON (B)(6) 2023 AS PART OF THE SP THORACIC IDE STUDY. IT WAS REPORTED THE PATIENT HAD BEEN HAVING WORSENING COUGH, AND MILD SHORTNESS OF BREATH SINCE DISCHARGED. ON (B)(6) 2023, THE PATIENT WAS DIAGNOSED WITH RIGHT PNEUMOTHORAX, AND REQUIRED READMISSION WITH PIGTAIL DRAINAGE. THE PATIENT WAS HOSPITALIZED FOR 9 DAYS AND DISCHARGED ON (B)(6) 2023 WITH ALL DRAINAGE REMOVED. DURING THE DA VINCI ASSISTED PROCEDURE, IT WAS FOUND THE TUMOR WAS LOCATED 1CM TO THE LOBAR BRONCHUS AND THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO CONVERSIONS REQUIRED. NO BLOOD TRANSFUSIONS WERE REQUIRED. THERE WERE NO INTRA-OPERATIVE COMPLICATIONS NOR MALFUNCTIONS OF ISI SYSTEMS, INSTRUMENTS OR ACCESSORIES REPORTED. A 28 FRENCH CHEST TUBE WAS PLACED IN AFTER THE PROCEDURE AS STANDARD CARE. THE PATIENT WAS DISCHARGED ON (B)(6) 2023 WITH ALL DRAINAGE SYSTEM REMOVED. THERE WAS NO POST-OPERATIVE COMPLICATIONS REPORTED UPON DISCHARGE. THE STUDY INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO ISI DEVICES, DEFINITELY RELATED TO THE PROCEDURE, AND POSSIBLY RELATED TO PATIENT¿S DISEASE." } ], "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": "07/27/2023;09/20/2023;12/08/2023" } ] }