{ "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": "2955842-2026-25827", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260520", "manufacturer_address_2": "", "pma_pmn_number": "K191736", "date_of_event": "20250121", "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": "JA", "manufacturer_contact_area_code": "", "date_added": "20260520", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20240202", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1295814", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260520", "brand_name": "DA VINCI", "generic_name": "ENDOSCOPE PLUS", "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": "470057-11", "catalog_number": "470057", "lot_number": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "GCJ", "device_age_text": "", "device_evaluated_by_manufacturer": "N", "combination_product_flag": "N", "udi_di": "00886874116555", "udi_public": "(01)00886874116555", "openfda": { "device_name": "Laparoscope, General & Plastic Surgery", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Insufficient Device Problem Information" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "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": "20260520", "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": [ "Superficial (First Degree) Burn", "Partial thickness (Second Degree) Burn" ] } ], "distributor_city": "", "date_report": "20260520", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "25233836", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250121", "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": "401831117", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROCTECTOMY PROCEDURE, THE 30 DEGREE ENDOSCOPE PLUS WAS LEFT ON THE PATIENT WITH THE LIGHT TURNED ON, CAUSING A 2CM DIAMETER CIRCULAR BURN ON THE PATIENT'S THIGH. THE ENDOSCOPE REMAINED ON THE PATIENT FOR APPROXIMATELY 15-20 MINUTES WHILE NOT IN USE, CAUSING THE DRAPE COVERING THE PATIENT TO MELT AND INFLICTING A 1ST TO 2ND DEGREE BURN. THE BURN WAS NOTED WITHOUT CHARRING, BRUISING, OR BLEEDING. THE ONLY MEDICAL TREATMENT ADMINISTERED WAS THE APPLICATION OF BURN OINTMENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT DID NOT EXPERIENCE ANY POST-OPERATIVE COMPLICATIONS." }, { "mdr_text_key": "401831118", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. THE CUSTOMER INDICATED THAT THE ENDOSCOPE LIGHT WAS LEFT ON AND BURNED THE PATIENT AFTER BEING ON THE PATIENTS THIGH FOR 15-20 MINUTES. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED. A REVIEW OF THE SITE¿S SYSTEM LOGS SHOWED NO RELATED ERRORS." } ], "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": "" } ] }