{ "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": "2955842-2023-10229", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20230120", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20221213", "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", "Distributor" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "HU", "manufacturer_contact_area_code": "408", "date_added": "20230120", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2104283", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230120", "brand_name": "DA VINCI X/XI", "generic_name": "PATIENT SIDE CART, 4-ARM", "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": "380652-51", "catalog_number": "N/A", "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": "00886874110720", "udi_public": "(01)00886874110720", "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": "20250725", "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": "20230120", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "70 YR", "patient_sex": "Male", "patient_weight": "104 KG", "patient_ethnicity": "", "patient_race": "White", "patient_problems": [ "Rupture", "Rupture" ] } ], "distributor_city": "", "date_report": "20221221", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "16218803", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20221221", "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": "307837580", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CURRENT PROVIDED INFORMATION, THE PROBABLE ROOT CAUSE OF THE REPORTED INTRA-OPERATIVE COMPLICATION EVENT THAT A TUMOR WAS RUPTURED LEADING TO THE SURGEON¿S DECISION TO CONVERT TO AN OPEN SURGERY IS ATTRIBUTED TO PATIENT¿S TISSUE BEING TOO DELICATE AND FRAGILE AND HAS BEEN DEEMED TO BE PATIENT¿S ANATOMY/CONDITION RELATED. THERE IS NO ALLEGATION OR EVIDENCE THAT AN INTUITIVE SURGICAL, INC. (ISI) DA VINCI SYSTEM, INSTRUMENTATION OR ACCESSORIES CAUSED OR CONTRIBUTED TO THIS REPORTED ADVERSE EVENT. THEREFORE, THERE IS NO ISI PRODUCT EXPECTED TO RETURN FOR FAILURE ANALYSIS EVALUATION. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE SURGEON UNEXPECTEDLY CONVERTED TO OPEN SURGERY AFTER THE START OF DA VINCI ASSISTED SURGICAL PROCEDURE." }, { "mdr_text_key": "307837581", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI ASSISTED LIVER RESECTION SURGICAL PROCEDURE, THE SURGEON EXPERIENCED A TUMOR RUPTURE DUE TO THE PATIENT¿S TISSUE BEING TOO DELICATE AND THAT THEY COULDN¿T MANIPULATE IT WITH THE INSTRUMENTS PROPERLY. THE SURGEON THEN DECIDED TO CONVERT TO AN OPEN PROCEDURE. AS REPORTED, THE PATIENT¿S VITAL PARAMETERS WERE FINE, THERE WERE NO INSTRUMENT FAILURE OR LIFE-THREATENING SITUATION. NO REPORT OF PATIENT HARM, ADVERSE OUTCOME OR INJURY AND NO DELAYS. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED-UP WITH THE REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS EVENT: THE TUMOR RUPTURED DUE TO TISSUE BEING TOO DELICATE AND FRAGILE. THERE WAS NO MALFUNCTION OF THE DA VINCI SYSTEM OR ANY INSTRUMENTS. THE REPORTER CONFIRMED THE PATIENT WAS STABLE AND HAD SINCE LEFT THE HOSPITAL WITH NO OTHER ISSUES REPORTED." } ], "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": "" } ] }