{ "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": "2955842-2026-04750", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20260218", "manufacturer_address_2": "", "pma_pmn_number": "K131861", "date_of_event": "20260123", "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": "MN", "manufacturer_contact_area_code": "", "date_added": "20260218", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20200908", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "438284", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260218", "brand_name": "DA VINCI X", "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": "380721-09", "catalog_number": "N/A", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "device_report_product_code": "NAY", "device_age_text": "DA", "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": [ "Visual Prompts will not Clear" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/04/2026", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260720", "health_professional": "Y", "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": "20260218", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20260527", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "24376869", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260123", "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": "403359936", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATED SECTIONS: D9, G3, G6, H2, H3, H6, H11. DEVICE EVALUATION: INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE REDUNDANT POWER TRAY ASSEMBLY FOR FAILURE ANALYSIS EVALUATION. A VISUAL INSPECTION FOUND NO ISSUES RELATED TO THE CUSTOMER REPORTED ISSUE. THE UNIT WAS INSTALLED ON AN IN-HOUSE SYSTEM. THE SYSTEM WAS POWER CYCLED 10 TIMES AND SET TO IDLE FOR ONE HOUR. THE ERROR CONFIRMED IN THE LOGS DID NOT RETURN." }, { "mdr_text_key": "403359937", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "393268117", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL SALVAGE PROSTATECTOMY PROCEDURE, A PERSISTENT NON-RECOVERABLE SYSTEM ERROR OCCURRED PRIOR TO DOCKING THE PATIENT SIDE CART (PSC), RESULTING IN ABORTION OF THE SURGERY. THE ISSUE OCCURRED AFTER PORT PLACEMENT, WHILE PREPARING TO DOCK THE PSC, WHEN THE SYSTEM DISPLAYED A NON-RECOVERABLE ERROR. AFTER INITIAL TROUBLESHOOTING OF THE FIBERS BY THE CUSTOMER, INTUITIVE SURGICAL INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WAS CONSULTED. THE TSE REVIEWED THE SYSTEM LOGS AND CONFIRMED THE RECURRENCE OF THE ERROR, WHICH WAS ATTRIBUTED TO AN INTUITIVE SURGICAL CORE POWER DISTRIBUTION (IPD) ERROR. THE TSE DIRECTED THE CUSTOMER TO PERFORM A HARD POWER CYCLE; HOWEVER, THE ERROR REAPPEARED IMMEDIATELY UPON RESTART. WHEN ASKED ABOUT THE AVAILABILITY OF A BACKUP SYSTEM, THE CUSTOMER INDICATED THAT THEIR OTHER SYSTEM WAS ALREADY IN USE. DUE TO THE PERSISTENT ISSUE AND INABILITY TO DOCK THE PSC, THE SURGEON DECIDED TO ABORT THE PROCEDURE AND RESCHEDULE." }, { "mdr_text_key": "393268118", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) PERFORMED A SITE VISIT, VERIFIED THE ERROR, AND REPLACED THE CORE REDUNDANT POWER TRAY ASSEMBLY TO RESOLVE THE ERROR. ISI HAS NOT RECEIVED THE COMPONENT TO PERFORM FAILURE ANALYSIS. A REVIEW OF THE SITE'S SYSTEM LOGS WAS PERFORMED, AND REVEALED THE FOLLOWING POSSIBLE RELATED ERRORS: - POWER DISTRIBUTION BOARD ANALOG TO DIGITAL CONVERTER (ADC) FAULT - THE MASTERY SUPERVISORY CONTROLLER (MSC) SAW AN ACD VOLTAGE OUT-OF-RANGE ON CHANNEL 9, 12.0V - POWER DISTRIBUTION BOARD ADC FAULT - THE MSC SAW AN ACD VOLTAGE OUT-OF-RANGE ON CHANNEL 9, 12.0V." } ], "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": "05/27/2026" } ] }