{ "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": "2955842-2025-00613", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20250123", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20241227", "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", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20250123", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20200115", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1422406", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250123", "brand_name": "DA VINCI SP", "generic_name": "VISION SYSTEM 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": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "device_operator": "HEALTH PROFESSIONAL", "model_number": "380941-40", "catalog_number": "N/A", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20250103", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "00886874114742", "udi_public": "(01)00886874114742", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Output Problem", "Output Problem" ], "reporter_state_code": "NC", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250822", "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": "20250123", "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": "20241227", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "21217561", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20241227", "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": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "361948964", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A SINGLE PORT DA VINCI-ASSISTED RETZIUS SPARING PROSTATECTOMY SURGICAL PROCEDURE, THE CUSTOMER CONTACTED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT PRESENTATION OF AN \"ACTIVATION HAS BEEN HALTED\" MESSAGE. THE CUSTOMER STATED THEY WERE ALSO RECEIVING A C-34 ERROR ON THE INTEGRATED ELECTROSURGICAL UNIT (IESU). THE INSTRUMENT, CORD, AND NEUTRAL PAD HAD BEEN REPLACED WITH NO CHANGE. THE TSE INSTRUCTED THE CUSTOMER TO REBOOT THE IESU AND THE ISSUE RESOLVED. THE CUSTOMER LATER CALLED BACK TO REPORT THAT BIPOLAR ENERGY STOPPED WORKING DURING THE PROCEDURE. THE CUSTOMER MENTIONED THEY'D CALLED EARLIER WHEN MONOPOLAR ENERGY STOPPED WORKING. THE CUSTOMER HAD POWER CYCLED THE SYSTEM, TRIED TWO DIFFERENT INSTRUMENTS, AND DIFFERENT BLUE INSTRUMENT CORDS PRIOR TO CALLING. THE TSE VIEWED THE SYSTEM LOGS AND DID NOT IDENTIFY ANY ENERGY RELATED MESSAGES. THE CUSTOMER REQUESTED THE ERBE BIPOLAR AND MONOPOLAR BE EVALUATED. THE CUSTOMER CALLED BACK AGAIN TO REPORT THAT THE ERBE ISSUE RETURNED WITH PERSISTENT C-34 AND C-00 ERRORS THAT WERE NOT ABLE TO BE CLEARED. THE EXTERNAL FOOT PEDALS WERE REMOVED, AND THE UNIT WAS RESTARTED, HOWEVER, THE ISSUE PERSISTED. THE CUSTOMER HAD SWITCHED OUT INSTRUMENTS AND CABLES WITH NO CHANGE. THE INSTRUMENT CORD, SHEATH, AND PAD WERE ALL GOOD AND CONFIRMED VIA THE SYSTEM LOGS. THE ERBE UNIT WOULD ERROR WITH ALL INSTRUMENT CABLES DISCONNECTED. THE SURGEON STATED THE SOUND WAS AUDIBLE, BUT THERE WAS NO EFFECT NOTICED FROM THE BIPOLAR ENERGY. THE SURGEON WAS NOT ABLE TO CONTINUE WITH THE PROCEDURE WITHOUT BIPOLAR ENERGY, AND AS A RESULT, OPTED TO CONVERT TO A MULTIPORT SYSTEM THAT WAS NOT IN USE. THE PROCEDURE WAS CONVERTED TO DA VINCI MULTI-PORT." }, { "mdr_text_key": "361948965", "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 ISI FSE WENT ON SITE AND REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) DUE TO ERRORS C-34 AND C-00 DURING GENERATOR START UP. ISI RECEIVED THE IESU, AND THE ERRORS DURING STARTUP AND MONOPOLAR ACTIVATION WERE REPRODUCED. THE EVENT INVESTIGATION IS IN PROGRESS." } ], "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": "" } ] }