{ "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": "2955842-2026-14643", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20260302", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20260203", "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", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20260302", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20231012", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "552382", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260302", "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": "380941-48", "catalog_number": "380941", "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": "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": [ "No Device Output" ], "reporter_state_code": "LA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "03/27/2026", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260504", "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": "20260302", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Other" ], "patient_age": "63 YR", "patient_sex": "Male", "patient_weight": "110 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20260417", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "24490047", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260203", "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": "398737157", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATED FIELDS: D9, G6, H2, H3, H6, H11. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE ENERGY SHIELD MONITOR (ESM) ASSOCIATED WITH THIS COMPLAINT FOR FAILURE ANALYSIS EVALUATION. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND. THE UNIT WAS INSTALLED ONTO A GOLDEN SYSTEM WHERE THE GREEN MONOPOLAR CABLE WAS SHOWING INTERMITTENT CONNECTION ISSUES. ANYTIME THE CABLE WAS MOVED, THE CORD LIGHT WOULD FLASH AMBER. THE COMPLAINT WAS CONFIRMED BASED ON FAILURE ANALYSIS." }, { "mdr_text_key": "394431842", "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 ARRIVED ON-SITE AND REPLACED THE ENERGY SHIELD MONITOR (ESM). THE SYSTEM WAS TESTED AND VERIFIED READY FOR USE. THE ESM REPORTED IN THIS EVENT HAS NOT YET BEEN RECEIVED FOR FAILURE ANALYSIS INVESTIGATION." }, { "mdr_text_key": "394431843", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RIGHT COLECTOMY PROCEDURE, THERE WAS INADEQUATE ENERGY TO STOP BLEEDING. THE FOLLOWING INFORMATION IS UNKNOWN: THE SOURCE AND CAUSE OF THE BLEEDING, THE ESTIMATED BLOOD LOSS ASSOCIATED WITH THE COMPLICATION, AND WHAT SURGICAL/MEDICAL INTERVENTION WAS RENDERED DUE TO THE BLEEDING. ADDITIONALLY, IT WAS REPORTED THAT AN UNSPECIFIED INSTRUMENT WAS EXPERIENCING ISSUES CONNECTING TO THE ENERGY SHIELD MONITOR (ESM) VIA THE GREEN MONOPOLAR CORD. THE CUSTOMER WAS REPORTEDLY LOSING CONNECTION VIA THE MONOPOLAR CORD AND GETTING A \"BAD CORD\" MESSAGE. FURTHERMORE, ENERGY WOULD START AND THEN STOP. MULTIPLE CORDS AND INSTRUMENTS WERE TRIED WITHOUT SUCCESSFULLY RESOLVING THE ISSUE. THE PROCEDURE WAS COMPLETED USING THE SAME GENERATOR." } ], "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": "04/17/2026" } ] }