{ "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": "2955842-2025-47187", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20251203", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20251110", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "NURSE", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "KS", "manufacturer_contact_area_code": "408", "date_added": "20251203", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20240508", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1810633", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20251203", "brand_name": "DA VINCI SP", "generic_name": "SURGEON SIDE CONSOLE", "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": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "device_operator": "HEALTH PROFESSIONAL", "model_number": "380940-50", "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": "N", "combination_product_flag": "N", "udi_di": "00886874114735", "udi_public": "(01)00886874114735", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Visual Prompts will not Clear", "Visual Prompts will not Clear" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20251215", "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": "20251203", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Tissue Injury", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20251203", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "23705728", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20251110", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "95051", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "INTUITIVE SURGICAL, INC", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "386631198", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS NOT CONFIRMED. THE FSE WENT ON SITE, AND NO ISSUES WERE IDENTIFIED. THE ERROR WAS NOT REPRODUCED. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT WAS NOT CONFIRMED BASED ON THE FIELD EVALUATION. A SYSTEM LOG REVIEW FOR THE PROCEDURE SHOWED INVALID STATE TRANSITION ERRORS." }, { "mdr_text_key": "386631199", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A SINGLE PORT (SP) DA VINCI-ASSISTED SURGICAL PROCEDURE, THE NURSE ENCOUNTERED AN ERROR. PRIOR TO CALLING, THE USER HAD ALREADY CONVERTED THE PROCEDURE TO LAPAROSCOPIC SURGERY. AT THE TIME OF THE CALL, THERE WAS NO ERROR PRESENT, AND THE SYSTEM HAD RETURNED TO NORMAL OPERATION. THE CUSTOMER WAS ASKED TO REBOOT THE SYSTEM TO CONFIRM ITS STATUS, AND IT POWERED ON NORMALLY. THE ERROR WAS EXPLAINED, AND THE SYSTEM WAS CONFIRMED TO BE READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON, AND THE SYSTEM INITIALLY POWERED ON WITHOUT ANY ERRORS. DURING THE PROCEDURE, TECHNICAL SUPPORT WAS CONTACTED FOR TROUBLESHOOTING; HOWEVER, WHEN THE SUPPORT TEAM WAS ENGAGED, THE SYSTEM APPEARED TO BE FUNCTIONING NORMALLY, AND A TECHNICAL SUPPORT ENGINEER (TSE) CONFIRMED ITS FUNCTIONALITY. DESPITE THE SYSTEM OPERATING AS EXPECTED AT THAT POINT, THE PROCEDURE WAS ULTIMATELY CONVERTED FROM SINGLE PORT TO LAPAROSCOPIC SURGERY. WHEN ASKED IF, DURING THIS CONVERSION TO TRADITIONAL LAPAROSCOPIC SURGERY, THE NUMBER OR SIZE OF PORT INCISIONS WAS INCREASED, IT WAS CONFIRMED THAT NO ADDITIONAL PORTS WERE PLACED AND NO INCISIONS WERE ENLARGED. REGARDING PATIENT OUTCOMES FOLLOWING THE CONVERSION, THE CUSTOMER WAS UNABLE TO PROVIDE INFORMATION ON WHETHER THE PATIENT TOLERATED THE CHANGE; HOWEVER, IT WAS CONFIRMED THAT THERE WAS NO INJURY TO THE PATIENT." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }