{ "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": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2955842-2019-10062", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20190125", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20190109", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20190125", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "71582", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190125", "brand_name": "DA VINCI", "generic_name": "TIP COVER ACCESSORY", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "950 KIFER RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "SUNNYVALE", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "94086", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "94086", "device_operator": "HEALTH PROFESSIONAL", "model_number": "400180", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "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", "Arcing" ], "reporter_state_code": "GA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250825", "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": "20190125", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Burn(s)", "Injury", "Burn(s)", "Injury" ] } ], "distributor_city": "", "date_report": "20190109", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8278196", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20190109", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "134115817", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, ISI HAS NOT RECEIVED THE MCS TIP COVER ACCESSORY OR MCS INSTRUMENT INVOLVED WITH THE REPORTED EVENT. THEREFORE, AT THIS TIME, THE ROOT CAUSES OF THE CUSTOMER REPORTED FAILURE MODE AND THE PATIENT¿S OPERATIVE COMPLICATION ARE UNKNOWN. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. ISI HAS REVIEWED THE SITE¿S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2019. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED RADICAL HYSTERECTOMY PROCEDURE, IT WAS ALLEGED THAT THE PATIENT SUSTAINED A VESSEL INJURY AFTER ELECTRICAL ENERGY ARCED THROUGH A MCS TIP COVER ACCESSORY. THE VESSEL INJURY WAS REPAIRED VIA OPEN SURGERY. HOWEVER, THE ROOT CAUSES OF THE CUSTOMER REPORTED FAILURE MODE AND THE PATIENT¿S OPERATIVE COMPLICATION ARE UNKNOWN." }, { "mdr_text_key": "134115818", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL HYSTERECTOMY PROCEDURE, ELECTRICAL ENERGY BURNED THROUGH A MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY THAT WAS INSTALLED ON A MCS INSTRUMENT. AS A RESULT, THE PATIENT SUSTAINED AN INJURY THROUGH THE ILIAC ARTERY. THE CASE WAS REPORTEDLY CONVERTED TO OPEN SURGERY. ON (B)(4) 2019, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES ASSOCIATE (CSA) AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE CSA WAS NOT PRESENT DURING THE SURGICAL PROCEDURE. THE SITE¿S ROBOTICS COORDINATOR CLAIMED THAT ELECTRICAL ENERGY ¿ESCAPED¿ THROUGH THE MCS TIP COVER ACCESSORY. THE SURGICAL STAFF INITIALLY ATTEMPTED TO REPAIR THE VESSEL INJURY USING THE DA VINCI SURGICAL SYSTEM. HOWEVER, THE CASE WAS REPORTEDLY CONVERTED TO OPEN SURGERY TO REPAIR THE VESSEL. AFTER THE VESSEL WAS REPAIRED, THE HYSTERECTOMY WAS COMPLETED VIA OPEN SURGERY. NO POST-OPERATIVE COMPLICATIONS HAVE BEEN REPORTED. THE CSA INDICATED THAT THE LAST TIME HE HAD SPOKEN TO THE CUSTOMER, THE SITE¿S RISK MANAGEMENT DEPARTMENT HAD THE MCS INSTRUMENT AND/OR MCS TIP COVER ACCESSORY." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }