{ "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": "2955842-2023-12335", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20230502", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20230403", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "NURSE", "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": "20230502", "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": "160063", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230502", "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": "Follow-Up", "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": "20230502", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "" ], "patient_age": "76 YR", "patient_sex": "Male", "patient_weight": "47 KG", "patient_ethnicity": "Non Hispanic", "patient_race": "White", "patient_problems": [ "Pneumothorax", "Pneumothorax" ] } ], "distributor_city": "", "date_report": "20230411", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "16856329", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20230411", "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": "314441236", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THE PATIENT UNDERWENT DA VINCI-ASSISTED PULMONARY LOBECTOMY WITH MEDIASTINAL LYMPHADENECTOMY FOR AN ADENOCARCINOMA OF THE PERIPHERAL UPPER LOBE OF LEFT LUNG (STAGED CLINICALLY T2A, N0, M0) ON (B)(6) 2023 AS PART OF THE SP THORACIC IDE STUDY. POST-OPERATIVELY, THE PATIENT WAS FOUND WITH INCREASED LEFT APICAL PNEUMOTHORAX. FLEXIBLE BRONCHOSCOPY WITH BALLOON OCCLUSION AND INSERTION OF BRONCHIAL VALVE WERE PERFORMED ON (B)(6) 2023. THE PATIENT WAS DISCHARGED ON (B)(6) 2023 WITH MINI ATRIUM ON. ADDITIONAL INFORMATION WAS OBTAINED FROM THE OPERATIVE NOTES, AND IT INDICATED A 5CM INCISION WAS MADE IN THE LEFT SUBCOSTAL REGION WITH THE POSTERIOR END OF THE INCISION AT APPROXIMATELY THE EIGHTH RIB. THE FLEXIBLE CAMERA WAS FIRST PLACED FOLLOWED BY A MARYLAND BIPOLAR FORCEPS INSTRUMENT AND A FENESTRATED BIPOLAR FORCEPS AND A ROUND TOOTH RETRACTOR INSTRUMENT. THE MASS WAS IN THE APICOPOSTERIOR SEGMENT AND THIS AREA WAS ADHERENT TO THE APICAL PARIETAL PLEURA. DISSECTION BEGAN BY RETRACTING THE LUNG POSTERIORLY AND ISOLATING THE SUPERIOR PULMONARY VEINS. THESE WERE DIVIDED WITH SERIAL APPLICATIONS OF A LINEAR STAPLER (NON- INTUITIVE SURGICAL, INC. (ISI) STAPLER INSTRUMENT) USING VASCULAR RELOAD. NODES FROM THE STATION 11L REGION WERE RESECTED. THE FISSURE WAS DIVIDED BY CREATING A TUNNEL ON TOP OF THE PULMONARY ARTERY AND USING SERIAL APPLICATIONS OF A LINEAR STAPLER (NON-ISI STAPLER INSTRUMENT) USING TAN LOAD CARTRIDGE. 11 ADDITIONAL LYMPH NODES WERE REMOVED. NODES FROM STATION 10L AND 12L WERE REMOVED DURING THE DISSECTION. THE APEX OF THE LUNG WAS ATTACHED TO THE PARIETAL PLEURA AND THEREFORE AN EXTRAPLEURAL PLANE WAS CREATED AND THE PARIETAL PLEURA RESECTED EN BLOC WITH THE LEFT UPPER LOBE. STATION 7 LYMPH NODES WERE RESECTED FROM AN ANTERIOR APPROACH. STATION 9 LYMPH NODES WERE ALSO REMOVED AND THE INFERIOR PULMONARY WAS DIVIDED. CHEST WAS IRRIGATED WITH NORMAL SALINE AND THE LUNG INSUFFLATED WITH AIR TO A PRESSURE OF 20MMHG. THERE WAS NO AIR LEAK FROM THE BRONCHUS IDENTIFIED INTRA-OPERATIVELY. THE CHEST CAVITY IS THEN IRRIGATED WITH A LITER OF SALINE AND THE HEMOSTASIS AND PNEUMOSTASIS WERE CONFIRMED. A 24F CHEST TUBE WAS PLACED IN THE CHEST CAVITY. VICRYL #1SUTURES WAS USED FOR THE MUSCULAR LAYER, VICRYL 2-0 SUTURES WERE USED FOR THE SUBCUTANEOUS LAYER, AND MONOCRYL 4-0 SUTURES FOR THE SKIN AND STERISTRIPS. A DRY DRESSING WAS APPLIED TO THE WOUND. THE PATIENT WAS SENT TO THE POST ANESTHESIA CARE UNIT (PACU) IN A STABLE CONDITION. ACCORDING TO THE STUDY INVESTIGATOR, THE REPORTED AIR LEAKAGE WAS RELATED TO THE DA-VINCI ASSISTED PROCEDURE, BUT THE PATIENT'S PRE-EXISTING CONDITION OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) CONTRIBUTED TO THE PROLONGED AIR LEAK. THE SURGEON DID NOT THINK THE EVENT WAS RELATED TO THE DV SYSTEMS, INSTRUMENTS OR ACCESSORIES. THERE WAS NO MALFUNCTIONS OF DA VINCI DEVICES REPORTED DURING THE PROCEDURE." }, { "mdr_text_key": "314441237", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE AIR LEAKAGE 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 SYSTEM LOG 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. A REVIEW OF THE INSTRUMENT LOG CONFIRMED THERE WERE NO DA VINCI STAPLER INSTRUMENT OR RELOADS USED DURING THE PROCEDURE. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS REPORTED THAT THE PATIENT UNDERWENT DA VINCI-ASSISTED PULMONARY LOBECTOMY ON (B)(6) 2023 AS PART OF THE SP THORACIC IDE STUDY. THE PATIENT WAS REPORTED AS HAVING A PROLONGED AIR LEAKAGE. FLEXIBLE BRONCHOSCOPY WITH BALLOON OCCLUSION AND INSERTION OF BRONCHIAL VALVE WERE PERFORMED AS MEDICAL INTERVENTION. THE PATIENT`S HOSPITALIZATION WAS ALSO PROLONGED AS A RESULT OF THE AIR LEAK." }, { "mdr_text_key": "338983367", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "338983368", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION WAS OBTAINED AS THE FOLLOWING: ON POST-OPERATIVE DAY 1 (POD 1), THE CHEST TUBE WAS NOTED TO HAVE SEROSANGUINOUS OUTPUT WITH 1-2 COLUMN AIR LEAK WITH RESPIRATION ON (B)(6) 2023. CHEST X-RAY PERFORMED ON THE SAME DAY NOTED THAT THE LEFT CHEST TUBE WAS UNCHANGED, BUT THAT THERE WAS AN INCREASE IN MODERATE LEFT APICAL PNEUMOTHORAX. ON (B)(6) 2023 (POD 2), THE CHEST TUBE OUTPUT WAS 1 COLUMN AIR LEAK WITH RESPIRATION, ON -10 MMHG EMERSON PUMP SUCTION. ON (B)(6) 2023 (POD 3) AN AIR LEAK OF APPROXIMATELY 1800 WAS NOTED IN THE CHEST TUBE WITH -15 MMHG THOPAZ. ON THE SAME DAY, DUE TO THE PERSISTENCE OF AIR LEAK AND PNEUMOTHORAX, A BRONCHOSCOPY WITH BALLOON OCCLUSION WAS PERFORMED. DUE TO THE PERSISTENCE OF THE AIR LEAK, ENDOBRONCHIAL VALVES WERE PLACED IN THE SUPERIOR SEGMENT OF THE LEFT LOWER LOBE (LLL) AND LATERAL BASILAR SEGMENT OF THE LLL. THE PATIENT WAS THEN TRANSFERRED TO THE BRONCHOSCOPY RECOVERY AREA IN STABLE CONDITION. THE AIR LEAK WAS APPROXIMATELY 1100 ON POD 6 ((B)(6) 2023). SHE WAS SUBSEQUENTLY DISCHARGED TO HOME ON (B)(6) 2023 (POD 7) WITH A CHEST TUBE IN PLACE, CONNECTED TO AN AMBULATORY DRAINAGE SYSTEM. DURING A 14-DAY FOLLOW UP PHONE CALL ((B)(6) 2023), THE SUBJECT REPORTED 100-200 ML OF DRAINAGE FROM THE CHEST TUBE EVERY DAY FOLLOWING DISCHARGE. SHE WAS SUBSEQUENTLY SEEN IN CLINIC ON (B)(6) 2023 WHERE A CHEST X-RAY DEMONSTRATED GOOD EXPANSION OF THE LEFT LUNG WITH A SMALL LEFT-SIDED PNEUMOTHORAX. ON EXAM, A SMALL LEAK THROUGH THE CHEST DRAIN WAS NOTED, THE CHEST TUBE WAS WITHDRAWN BY 5 CM WITH PLANS FOR CONTINUED FOLLOW UP. DURING THE 30-DAY FOLLOW UP VISIT ((B)(6) 2023), A CT SCAN OF THE CHEST SHOWED SMALL LEFT HYDROPNEUMOTHORAX WITH TWO LEFT LOWER LOBE ENDOBRONCHIAL VALVES IN THE SEGMENTAL BRONCHI. THE EVENT WAS CONSIDERED AS RESOLVED ON (B)(6) 2023 AS ENDOBRONCHIAL VALVES WERE REMOVED." } ], "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" } ] }