{ "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": "2955842-2026-17159", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20260323", "manufacturer_address_2": "", "pma_pmn_number": "K231212", "date_of_event": "20260224", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "FR", "manufacturer_contact_area_code": "", "date_added": "20260323", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "721814", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260323", "brand_name": "DA VINCI", "generic_name": "GENERATOR E200", "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": "374897-41", "catalog_number": "374897", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "device_report_product_code": "GEI", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "00886874120873", "udi_public": "(01)00886874120873", "openfda": { "device_name": "Electrosurgical, Cutting & Coagulation & Accessories", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4400", "device_class": "2" } } ], "product_problems": [ "No Device Output" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "04/30/2026", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20260702", "health_professional": "", "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": "20260323", "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" ] } ], "distributor_city": "", "date_report": "20260507", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "24662155", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260224", "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": "401014109", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) RECEIVED A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE ERROR LOGS SHOWED ERROR: ELECTROSURGICAL UNIT (ESU) GENERIC NON-RECOVERABLE ERROR, POST TEST PROMETHEUS GENERATOR CORE (PGC) ENERGY TEST. DURING AN IN-HOUSE FAILURE ANALYSIS (FA), UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT COULD BE RELATED TO THE REPORTED EVENT. THE UNIT WAS INTEGRATED INTO A KNOWN-GOLDEN PRINTED CIRCUIT ASSEMBLY (PCA) SYSTEM. IT POWERED ON AND ALL THE PORT LED LIGHTS WERE RED. LOCALHOST WAS USED TO CHECK DIAGNOSTICS WHERE ERROR LOGS SHOWED ERROR CODES INDICATING (ERROR_ESU_POST_TEST_FAILURE). THIS WAS LOGGED WHEN THE ESU POST TEST FAILS OR FAILS TO COMPLETE WITHIN THE TIMEOUT PERIOD. ERROR (ERROR_ESU_PGC_HARDWARE_FAILURE). THE ENERGY CONTROLLER ON THE ESU CALLED PROMETHEUS GENERATOR CORE (PGC) HAS FOUND A HARDWARE FAILURE AND CANNOT CONTINUE. THE UNIT ALSO COMPLETED FIXTURE TESTING, WHERE IT FAILED BOTH FUNCTIONAL STATION 2 AND FUNCTIONAL STATION 3 TESTS. DURING FUNCTIONAL STATION 3 TESTING, IT WAS ALSO NOTICED THAT PORTS LED LIGHTS WERE ALL RED. AS A RESULT OF THESE FINDINGS, FAILURE ANALYSIS WAS ABLE TO CONCLUDE THAT THE RELAY DRIVER SUPPLY ON THE PROMETHEUS GENERATOR CORE (PGC) BOARD COULD BE ATTRIBUTED TO THE REPORTED ISSUE." }, { "mdr_text_key": "401014110", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "396246025", "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 FSE REPLACED THE E-200 GENERATOR TO RESOLVE THE ISSUE WITH A NON-RECOVERABLE FAULT AT STARTUP. 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. A SYSTEM LOG REVIEW INDICATED A NON-RECOVERABLE FAULT ON THE GENERATOR." }, { "mdr_text_key": "396246026", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UNILATERAL INGUINAL HERNIA ENHANCED-VIEW TOTALLY EXTRAPERITONEAL (ETEP) SURGICAL PROCEDURE, AN INTUITIVE SURGICAL (IS) CLINICAL SALES REPRESENTATIVE (CSR) CALLED AN ISI TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT THAT THE E200 GENERATOR TURNED RED AND BECAME IMPOSSIBLE TO USE. THE CUSTOMER STATED THAT A POWER CYCLE WAS ATTEMPTED, BOTH WITH AND WITHOUT THE CAUTERY CABLES CONNECTED, BUT THE ISSUE PERSISTED. THE TSE REVIEWED THE SYSTEM LOGS AND IDENTIFIED TWO ERRORS, BOTH INDICATING THAT THE E200 GENERATOR NEEDED TO BE REPLACED. THE CUSTOMER CONFIRMED THAT NO ALTERNATIVE EQUIPMENT, SUCH AS A FORCETRIAD OR ANOTHER TOWER, WAS AVAILABLE ON-SITE. INTUITIVE SURGICAL (IS) CONTACTED THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS EVENT: THE SURGEON HAD TO CONVERT TO OPEN SURGERY AND CANCEL THE SECOND PROCEDURE." } ], "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": "05/07/2026" } ] }