{ "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": "2955842-2025-47816", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20251209", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20250918", "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": "NO", "manufacturer_contact_area_code": "408", "date_added": "20251209", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20250206", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2760349", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20251209", "brand_name": "DA VINCI", "generic_name": "TIP COVER ACCESSORY", "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": "400180-14", "catalog_number": "400180", "lot_number": "K10250206", "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": "10886874111045", "udi_public": "(01)10886874111045(17)270228(10)K10250206", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Material Split, Cut or Torn", "Material Split, Cut or Torn" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260128", "health_professional": "", "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": "20251209", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "40 YR", "patient_sex": "Female", "patient_weight": "81 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Bowel Burn", "Bowel Burn" ] } ], "distributor_city": "", "date_report": "20251209", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "23761080", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20251111", "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": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "387239421", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. CONCOMITANT PRODUCT: MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WITH (PART #470179-23)." }, { "mdr_text_key": "387239422", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY SURGERY, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY DEVELOPED A HOLE, WHICH LED TO THERMAL INJURY OF THE SMALL INTESTINE. THE INCIDENT OCCURRED WHILE THE SURGEON WAS DISSECTING THE UTERUS ON THE LEFT SIDE. AS THE TIP OF THE MCS INSTRUMENT WAS POSITIONED AGAINST THE UTERUS, A PORTION OF THE SMALL INTESTINE CAME INTO CONTACT WITH THE INSTRUMENT'S SHAFT, WHICH IS NORMALLY INSULATED BY THE MCS TIP COVER ACCESSORY. DUE TO THE HOLE NEAR THE ORANGE MARKER ON THE MCS TIP COVER ACCESSORY, A BURN APPROXIMATELY 1 CM IN DIAMETER OCCURRED ON THE INTESTINE. THE SURGEON PROMPTLY SUTURED THE AFFECTED AREA TO PREVENT RUPTURE, AND A GASTROINTESTINAL SURGEON WAS CONSULTED TO EVALUATE THE INJURY. THE ASSESSMENT CONFIRMED THAT THE INTERVENTION WAS SUFFICIENT. THE AFFECTED MCS INSTRUMENT WAS REMOVED AND THE MCS TIP COVER ACCESSORY WAS REPLACED. NO ELECTRICAL ARCING WAS OBSERVED AT THE TIME OF THE EVENT, AND THE PROCEDURE WAS COMPLETED ROBOTICALLY. THE SURGEON ASSESSED THE IMPACT ON THE PATIENT'S OUTCOME AS MINIMAL, AND NO POST-OPERATIVE COMPLICATIONS WERE REPORTED." } ], "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": "" } ] }