{ "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": "2955842-2023-18426", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20230913", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20230725", "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", "Foreign", "Study", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "CH", "manufacturer_contact_area_code": "408", "date_added": "20230913", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "89322", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230913", "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": "20250730", "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": "20230913", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "40 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "Non Hispanic", "patient_race": "Asian", "patient_problems": [ "Hematoma", "Thromboembolism", "Hematoma", "Thromboembolism" ] } ], "distributor_city": "", "date_report": "20230816", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "17740763", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20230816", "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": "323331574", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A PATIENT UNDERWENT A SINGLE PORT DA VINCI-ASSISTED PARTIAL NEPHRECTOMY ON (B)(6) 2023. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DA VINCI SYSTEM, INSTRUMENTS OR ACCESSORIES MALFUNCTION OCCURRED DURING THE SURGERY. THERE WERE ALSO NO INTRA-OPERATIVE COMPLICATIONS REPORTED. ON (B)(6) 2023, THE PATIENT EXPERIENCED BILATERAL DEEP VEIN THROMBOSIS OF THE LEFT LOWER EXTREMITIES. A VASCULAR ULTRASOUND WAS PERFORMED AND CONFIRMED THE DIAGNOSIS. ENOXAPARIN 4000IU WAS GIVEN FOR THE THROMBOSIS. ON (B)(6) 2023, THE PATIENT WAS FOUND WITH A HEMATOMA IN THE LEFT RENAL AREA FROM A ULTRASOUND. NO MEDICAL INTERVENTION WAS PERFORMED FOR THE FINDING. THE PATIENT WAS DISCHARGED ON (B)(6) 2023 WITHOUT REQUIRING PROLONGED HOSPITALIZATION. THE PATIENT HAD MEDICAL HISTORY OF URINARY SYSTEM DISEASE AND SIMPLE RENAL CYST AT LEFT KIDNEY. THE STUDY INVESTIGATOR THOUGHT THE BILATERAL DEEP VEIN THROMBOSIS WAS LIKELY CAUSED BY INTRAOPERATIVE PNEUMOPERITONEUM AND THE CAUSE OF THE RENAL HEMATOMA WAS DUE TO ANTICOAGULATIVE MEDICATION. IT WAS CONFIRMED THAT THERE WAS NO UNEXPECTED BLEEDING THAT COULD HAVE LED TO THE RENAL HEMATOMA." }, { "mdr_text_key": "323331575", "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 WAS NOT PERFORMED SINCE THERE IS INSUFFICIENT OR UNCONFIRMED PRODUCT/EVENT INFORMATION." } ], "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": "" } ] }