{ "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": "2026-10-13", "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": "+1(408)5", "event_type": "Injury", "report_number": "2955842-2026-34404", "type_of_report": [ "Initial submission" ], "product_problem_flag": "", "date_received": "20260812", "manufacturer_address_2": "", "pma_pmn_number": "K131861", "date_of_event": "20260720", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "+1(408)523-2100", "noe_summarized": "1", "manufacturer_contact_l_name": "Nielson", "source_type": [ "Other", "Foreign" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "GM", "manufacturer_contact_area_code": "", "date_added": "20260813", "manufacturer_contact_f_name": "Izabel", "device_date_of_manufacturer": "20210317", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2316231", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260812", "brand_name": "da Vinci Xi", "generic_name": "VISION SIDE SYSTEM, RECONDITIONED", "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": "380721-10", "catalog_number": "380721", "lot_number": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "00886874115343", "udi_public": "(01)00886874115343", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Output Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "", "manufacturer_contact_country": "US", "date_changed": "20260826", "health_professional": "N", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20260812", "sequence_number_treatment": [ "da Vinci Instruments and Accessories" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20260812", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "Santa Clara", "mdr_report_key": "50228451", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260720", "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": "", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "15964435254", "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. The ERBE generator was replaced to correct the reported problem. The system was tested and verified as ready for use. ISI did not receive a da Vinci product involved with this complaint to perform failure analysis." }, { "mdr_text_key": "15464435253", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "It was reported that during a da Vinci-assisted transvesical prostatectomy procedure, an error on the ERBE generator occurred during coagulation. Prior to calling an Intuitive Surgical, Inc. (ISI) Technical Support Engineer (TSE), the customer rebooted the ERBE generator, disconnected and reconnected the energy cables. The TSE inquired about the monopolar energy settings. The customer stated the monopolar energy was at level 3 with swift mode. The TSE asked what error codes were observed as the system was offline. The customer identified a possible error. The TSE asked the customer to switch to Classic mode, but the error persisted. The TSE advised the customer to shut down and unplug the ERBE generator, and wait 10 to 15 seconds before restarting the unit. After rebooting, two possibly related errors were observed. The TSE advised the customer to use a backup generator or another da Vinci system; however, the customer said there was no available backup. The customer elected to abort the procedure after ports had already been placed. The procedure was rescheduled and completed the next day. The patient is reported to be doing well." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 Central Expressway", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }