{ "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": "2955842-2022-16041", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20221219", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20221121", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign", "Study", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "TW", "manufacturer_contact_area_code": "408", "date_added": "20221219", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2543615", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20221219", "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", "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": "", "udi_public": "", "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": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250731", "health_professional": "", "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": "20221219", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "54 YR", "patient_sex": "Male", "patient_weight": "75 KG", "patient_ethnicity": "Non Hispanic", "patient_race": "Asian", "patient_problems": [ "Bacterial Infection", "Fluid Discharge", "Bacterial Infection", "Fluid Discharge" ] } ], "distributor_city": "", "date_report": "20221121", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "16010732", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20221121", "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": "305784912", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE POST-OPERATIVE COMPLICATION CANNOT BE DETERMINED ALTHOUGH TWO PHYSICIANS INDICATED THAT THE POTENTIAL CAUSE WAS THE PATIENT NOT FOLLOWING AGREED THORACIC EXPANSION EXERCISES. THERE IS NO REPORT OR ALLEGATION OF A MALFUNCTION OF AN ISI DEVICE OR SYSTEM. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. A REVIEW OF THE SYSTEM LOGS DO NOT EXIST A THIS TIME. IMAGE(S) AND/OR VIDEO CLIP(S) ASSOCIATED WITH THIS REPORTED EVENT WERE NOT SUBMITTED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER UNDERGOING A DA VINCI-ASSISTED RIGHT LOWER LOBECTOMY PROCEDURE, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH ABNORMAL SECRETION AND FLUID COMING OUT FROM THE CLOSURE WOUND. THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS AND EXPERIENCED ADDITIONAL HOSPITALIZATION. THE CAUSE OF THE POST-OPERATIVE COMPLICATION IS UNKNOWN." }, { "mdr_text_key": "305784913", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED AS PART OF A CLINICAL STUDY THAT AFTER UNDERGOING A DA VINCI-ASSISTED RIGHT LOWER LOBECTOMY PROCEDURE, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT ON POST-OPERATIVE DAY (POD) #4 WITH ABNORMAL SECRETION AND FLUID COMING OUT FROM THE CLOSURE WOUND. THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS AND HOSPITALIZATION. THE FOLLOWING DAY THE PATIENT WAS DIRECTED TO OUTPATIENT CARE. THE INTENSITY OF SECRETION WAS REDUCED ON POD #5 AND WAS ABSORBED WITHOUT A CHEST DRAIN. PER EVALUATION BY TWO PHYSICIANS, THE POSSIBLE CAUSE OF THE COMPLICATION WAS DUE TO THE PATIENT NOT FOLLOWING AGREED THORACIC EXPANSION EXERCISES. THE PLAN WAS TO ENCOURAGE THE PATIENT TO STICK TO REHABILITATION MEASURES, RE-EVALUATE THE DRAINAGE POSITION AND CONDUCT AN-PATIENT ULTRASOUND CHECK-UP BEFORE REMOVING THE CHEST DRAIN. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, FURTHER DETAILS HAVE YET TO BE RECEIVED AS OF THE DATE OF THIS REPORT." } ], "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": "" } ] }