{ "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": "2026-10-13", "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": "+1(408)5", "event_type": "Injury", "report_number": "2955842-2026-36946", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "", "date_received": "20260826", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20260731", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "+1(408)523-2100", "noe_summarized": "1", "manufacturer_contact_l_name": "Nielson", "source_type": [ "Other", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20260826", "manufacturer_contact_f_name": "Izabel", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "126620", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260826", "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", "catalog_number": "400180", "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": "", "udi_public": "", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Arcing" ], "reporter_state_code": "CT", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/28/2026", "mfr_report_type": "", "manufacturer_contact_country": "US", "date_changed": "20260918", "health_professional": "N", "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": "20260826", "sequence_number_treatment": [ "da Vinci Instruments and Accessories." ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Burn(s)" ] } ], "distributor_city": "", "date_report": "20260918", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "Santa Clara", "mdr_report_key": "50459633", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260731", "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": "", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "15580824503", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "It was reported that during a da Vinci-assisted benign hysterectomy with colpotomy procedure, the Monopolar Curved Scissors (MCS) Tip Cover Accessory, installed on an MCS instrument, was damaged. As a result, arcing occurred and the patient sustained a burn. During the colpotomy portion of the procedure, the surgeon saw a spark in the abdomen near the uterus specimen as the cervix was nearly detached from the vagina. The surgeon believes the arcing primarily came in contact with the uterus specimen but could not definitively exclude contact with other tissue. Upon inspecting the MCS instrument, a crack/scratch was observed on the MCS Tip Cover Accessory. The surgeon speculates the arcing must have coupled with the trocar and travelled upward because at the port site, the patient's skin was blackened. The blackened burn site was excised and then reapproximated. The procedure was completed; however, the surgeon expressed a concern for delayed thermal injury to the bowel or the ureter, primarily the bowel because the location during the colpotomy was mainly posterior." }, { "mdr_text_key": "16080824504", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "The MCS instrument nor the MCS Tip Cover Accessory used during this event were received for failure analysis investigations." } ], "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": "09/18/2026" } ] }