{ "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": "2955842-2025-18856", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20250509", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20250409", "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": "KS", "manufacturer_contact_area_code": "408", "date_added": "20250509", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20200210", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2233461", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250509", "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": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "N", "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": [ "Adverse Event Without Identified Device or Use Problem", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "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": "20250509", "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": [ "Necrosis", "Necrosis" ] } ], "distributor_city": "", "date_report": "20250409", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "21997515", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250409", "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": "369955256", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A SITE VISIT WAS MADE BY THE INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) AND THE SYSTEM WAS TESTED, BUT NO ISSUE WAS FOUND. THE SYSTEM WAS TESTED AND VERIFIED FOR USE. THE MONOPOLAR CURVED SCISSORS (MCS) USED WAS RETURNED FOR FAILURE ANALYSIS (FA). THE INSTRUMENT WAS INSTALLED ON AN IN-HOUSE SYSTEM AND PASSED THE RECOGNITION AND ENGAGEMENT TEST, MOVED INTUITIVELY WITH FULL RANGE OF MOTION, AND THE INSTRUMENT TIPS OPENED AND CLOSED PROPERLY. THE INSTRUMENT WAS CONNECTED TO AN IN-HOUSE ERBE ENERGY GENERATOR AND THE INSTRUMENT WAS RECOGNIZED WITH NO ISSUES AND PASSED THE ENERGY DELIVERY TEST. A SYSTEM LOG REVIEW FOR THE ASSOCIATED PROCEDURE WAS PERFORMED AND CONFIRMED THE OCCURRENCE OF THE CUSTOMER REPORTED ERROR, HOWEVER, NO HARDWARE ISSUE COULD BE IDENTIFIED." }, { "mdr_text_key": "369955257", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NIPPLE-SPARING MASTECTOMY, THE CUSTOMER RECEIVED A \"REPLACE INSTRUMENT SHEATH\" MESSAGE WHEN USING MONOPOLAR ENERGY. THE SHEATH, TIP, CAUTERY CABLE AND GROUND PAD WERE REPLACED, AND THE ISSUE WAS RESOLVED TEMPORARILY, HOWEVER, THE ERROR OCCURRED SEVERAL TIMES. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO PATIENT ISSUE REPORTED. HOWEVER, ON THE SURGERY DATE, NECROSIS OF THE BREAST TISSUE WAS NOTED. THE SURGEON DOES NOT THINK AN INTUITIVE SURGICAL, INC. (ISI) PRODUCT CAUSED OR CONTRIBUTED TO THE NECROSIS, BUT DOES THINK THAT THE CAUSE OF THE SHEATH MESSAGING WAS A SYSTEM/INSTRUMENT ISSUE. INSTEAD, THE SURGEON THINKS THE CAUSE OF THE NECROSIS WAS A \"SURGICAL ISSUE.\" ONLY THE MONOPOLAR ENERGY INSTRUMENT EXPERIENCED ISSUES. THERE WAS NO REPORT OF ARCING." } ], "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": "" } ] }