{ "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": "2955842-2025-00850", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20250128", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20250106", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "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": "20250129", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20221107", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2566303", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250128", "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": "380941-45", "catalog_number": "N/A", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20250121", "device_report_product_code": "NAY", "device_age_text": "DA", "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": "TX", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "01/22/2025;02/25/2025", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20250825", "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": "20250128", "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", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20250106", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "21260953", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250106", "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": "366164352", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "FURTHER INVESTIGATION WAS PERFORMED, AND NO ADDITIONAL FINDINGS WERE NOTED. THE INVESTIGATION HAS BEEN COMPLETED." }, { "mdr_text_key": "362381702", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. 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, INSPECTED THE SYSTEM, AND WAS ABLE TO REPRODUCE THE CUSTOMER REPORTED ISSUE. THE FSE FOUND A LOOSE CONNECTOR FOR THE CABLE CONNECTING THE EMBEDDED SERIALIZER MANIPULATOR (ESM) TO THE CORE. THE ISI FSE REPLACED THE CABLE, ESM, AND INTEGRATED ELECTROSURGICAL UNIT (IESU). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE EVENT INVESTIGATION IS IN PROGRESS." }, { "mdr_text_key": "362381703", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIMPLE PROSTATECTOMY PROCEDURE, THE CUSTOMER EXPERIENCED AN ISSUE WITH NOT HAVING MONOPOLAR ENERGY. THE OPERATING ROOM (OR) STAFF CALLED IN TO REPORT THAT MONOPOLAR WAS NOT WORKING AND THERE WERE YELLOW LEDS ON THE ENERGY SHIELD. THE STAFF DID NOT WANT TO TROUBLESHOOT THE SYSTEM AT THE TIME. THE CUSTOMER HAD OPTED TO PROCEED WITH BIPOLAR ENERGY, AND USE THE MONOPOLAR INSTRUMENT(S) MECHANICALLY BUT WITH NO ENERGY. HOWEVER, DUE TO THE CUSTOMER REPORTED ISSUE, THE CUSTOMER SUBSEQUENTLY ELECTED TO CONVERT THE CASE TO OPEN SURGERY. THE CUSTOMER PERFORMED A HARD POWER CYCLE ON THE EMBEDDED SERIALIZER MANIPULATOR (ESM) AND THE VISION SIDE CART (VSC) AND THE SYSTEM POWERED BACK ON NORMALLY INDICATING THE ESM WAS READY FOR USE; HOWEVER, THE CUSTOMER HAD ALREADY CONVERTED TO OPEN SURGERY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM WAS INSPECTED PRIOR TO USE AND NO ISSUES WERE NOTED. THE PROCEDURE WAS IN PROGRESS FOR 30 MINUTES WHEN THE ISSUE WAS IDENTIFIED. NO PATIENT INFORMATION IS AVAILABLE." }, { "mdr_text_key": "363522440", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "363522441", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) RECEIVED DA VINCI PRODUCTS INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE EMBEDDED SERIALIZER MANIPULATOR (ESM) WAS ANALYZED AND FOUND TO HAVE A FAILURE. THE ESM WAS INSTALLED AND TESTED INTO A GOLDEN SYSTEM WHERE THE COMPONENT FUNCTIONED AS EXPECTED. THE CORE LED TURN AMBER, SHOULD BE BLUE WHEN CABLE CONNECTED FROM THE ESM TO THE ERBE. COULD NOT CUT/SEAL. UPON VISUAL INSPECTION, IT WAS FOUND THAT THE PIN OF THE NEUTRAL CABLE WAS PUSHING IN AND CAUSED LOOSE CONTACT BETWEEN THE ERBE AND ESM. THE INTEGRATED ELECTROSURGICAL UNIT (IESU) WAS ANALYZED AND FOUND TO HAVE NO FAILURE. THE REPORTED PROBLEM WAS CONFIRMED IN THE FIELD VIA LOGS: ERBE ERROR: M-B1 - NEUTRAL ELECTRODE (GROUND PAD) CURRENT WARNING (INSERT THE CONNECTOR OF THE NEUTRAL ELECTRODE CABLE INTO THE RECEPTACLE AS FAR AS IT WILL GO. ENSURE GROUNDING PAD IS ORIENTED CORRECTLY). THE ERBE WAS TESTED; THE UNIT ENERGIZED, CAUTERIZED, AND RECOGNIZED INSTRUMENTS WITH NO ISSUES. UPON VISUAL INSPECTION, THERE WERE NO ISSUES FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. 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": "02/12/2025;03/19/2025" } ] }