{ "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": "2955842-2016-00898", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20161215", "manufacturer_address_2": "", "pma_pmn_number": "K063221", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "HEALTH PROFESSIONAL" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20161215", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "829836", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20161215", "brand_name": "DA VINCI XI SURGICAL SYSTEM", "generic_name": "ENDOSCOPIC INSTRUMENT CONTROL SYSTEM", "manufacturer_d_name": "INTUITIVE SURGICAL,INC.", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "SUNNYVALE", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "IS4000", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "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": [ "Insufficient Device Problem Information", "Insufficient Device Problem Information" ], "reporter_state_code": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250725", "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": "20161215", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemothorax", "Blood Loss", "Hemothorax", "Blood Loss" ] } ], "distributor_city": "", "date_report": "20161116", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "6179497", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20161117", "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": "64143187", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE INITIAL MDR WAS SUBMITTED ON 08/09/2016 WITH AN INCORRECT DATE RECEIVED BY MFR VALUE OF 11/17/2016. THIS FOLLOW-UP MDR IS BEING SUBMITTED WITH A CORRECTED VALUE OF 11/16/2016." }, { "mdr_text_key": "62525656", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE POST-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP MDR WILL BE SUBMITTED TO THE FDA. AFTER UNDERGOING A DA VINCI ASSISTED THORACOTOMY PROCEDURE, THE PATIENT WAS FOUND TO HAVE BLEEDING FROM THE IMA ON POST-OPERATIVE DAY 1 WHICH REQUIRED REPAIR WITH SUTURES. HOWEVER, THE ROOT CAUSE OF THE BLEEDING IS UNKNOWN." }, { "mdr_text_key": "62525657", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI-ASSISTED THORACOTOMY PROCEDURE PERFORMED ON AN UNSPECIFIED DATE IN (B)(6) 2016, THE PATIENT WAS IDENTIFIED TO HAVE A HEMOTHORAX ON POST-OPERATIVE DAY 1. THE SURGEON INDICATED THAT THE INTERNAL MAMMARY ARTERY (IMA), WHICH WAS HARVESTED DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE, WAS FOUND TO BE BLEEDING. THE SURGEON HAD TO PLACE SUTURES ON THE IMA IN ORDER TO CONTROL THE BLEEDING. THE SURGEON COULD NOT CONFIRM A ROOT CAUSE FOR THE POST-OPERATIVE COMPLICATION. HOWEVER, THE SURGEON INITIALLY ATTRIBUTED THE POST-OPERATIVE COMPLICATION TO POSSIBLE SURGEON-ERROR. ACCORDING TO THE SURGEON, THE PATIENT HAS BEEN DOING VERY WELL SINCE THEN. THE SURGEON STATED THAT A POSSIBLE CAUSE OF THE POST-OPERATIVE COMPLICATION WAS DUE TO A SETTING ON THE ERBE GENERATOR WHICH IS INTEGRATED WITH THE DA VINCI XI SURGICAL SYSTEM. THE SURGEON EXPLAINED THAT THE INTEGRATED ERBE GENERATOR DOES NOT GIVE THE OPTION OF INCREASING THE SETTINGS IN SMALLER INCREMENTS WHICH WOULD HELP WITH PURE COAGULATION. DURING THE SURGICAL PROCEDURE, THE SURGEON STATED THAT HE HAD SET THE ERBE GENERATOR AT 2 BUT WOULD HAVE PREFERRED TO SET IT AT 1.5 WHICH IS NOT AN AVAILABLE SETTING ON THE GENERATOR. THE SURGEON INDICATED THAT HE DOES NOT BELIEVE A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED OR CAUSED/CONTRIBUTED TO THE PATIENT'S BLEEDING. MOVING FORWARD, THE SURGEON STATED THAT HE WILL USE A FORCETRIAD GENERATOR INSTEAD OF AN ERBE GENERATOR SINCE THERE IS A WIDER RANGE OF SETTINGS. THE SURGEON STATED THAT HE HAS PERFORMED HIS LAST FEW SIMILAR DA VINCI-ASSISTED SURGICAL PROCEDURES WITH A FORCETRIAD GENERATOR AND HAS NOT HAD ANY ISSUES SINCE THEN." } ], "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": "01/05/2017" } ] }