{ "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": "7035", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "MR", "manufacturer_contact_state": "NC", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "SUITE 160", "manufacturer_g1_city": "MILAN, LOMBARDY", "manufacturer_contact_address_1": "1 TW ALEXANDER DRIVE", "manufacturer_contact_pcity": "91976584", "event_type": "Injury", "report_number": "3007593944-2023-00005", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20230919", "manufacturer_address_2": "", "pma_pmn_number": "K171120", "date_of_event": "20201016", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "27703", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9197658400", "noe_summarized": "1", "manufacturer_contact_l_name": "HINCKLEY", "source_type": [ "Foreign", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "20126", "manufacturer_g1_state": "", "reporter_country_code": "AU", "manufacturer_contact_area_code": "919", "date_added": "20230919", "manufacturer_contact_f_name": "CASEY", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1447176", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "N", "date_received": "20230919", "brand_name": "SENHANCE", "generic_name": "SENHANCE SURGICAL SYSTEM", "manufacturer_d_name": "ASENSUS SURGICAL, INC.", "manufacturer_d_address_1": "1 TW ALEXANDER DRIVE", "manufacturer_d_address_2": "SUITE 160", "manufacturer_d_city": "DURHAM", "manufacturer_d_state": "NC", "manufacturer_d_zip_code": "27703", "manufacturer_d_zip_code_ext": "7035", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "277037035", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "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": [ "Adverse Event Without Identified Device or Use Problem", "Insufficient Device Problem Information", "Adverse Event Without Identified Device or Use Problem", "Insufficient Device Problem Information" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "09/07/2022", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250806", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9197", "patient": [ { "patient_sequence_number": "1", "date_received": "20230919", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Rupture", "Rupture" ] } ], "distributor_city": "", "date_report": "20231012", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IT", "manufacturer_contact_city": "DURHAM", "mdr_report_key": "17774469", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20220907", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "20126", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ASENSUS SURGICAL ITALIA, S.R.L", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "338749321", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE COMPLAINT DETAILS (B)(4). THERE WAS A REPORT OF AN ADVERSE EVENT TO A PATIENT. THIS EVENT DID NOT OCCUR WITHIN THE UNITED STATES. THIS EVENT OCCURRED AT (B)(6) HOSPITAL IN AUSTRIA. THIS EVENT OCCURRED ON (B)(6) 2020 AND ASENSUS SURGICAL WAS INTERNALLY MADE AWARE ON 07-SEPT-2022. ACCORDING TO THE INVESTIGATION, FURTHER RESPONSES FROM THE SURGEON THAT THE EVENT WAS UNRELATED TO THE SENHANCE SYSTEM BUT RATHER A NORMAL SURGICAL COMPLICATION. FURTHERMORE, NO MALFUNCTION OF THE SENHANCE SYSTEM WAS REPORTED. NO FAILURES WERE IDENTIFIED. THE RISK POSED BY THIS EVENT WAS EVALUATED THOUGH HHE-001-00027 LINKED IN THE RISK PROFILE ASSESSMENT SECTION BELOW AND A CORRECTIVE ACTION PREVENTATIVE ACTION PLAN (CAPA-000048) HAS BEEN OPENED TO MANAGE THE UNSUITABLE TIMELINESS OF THE RECEIPT AND MANAGEMENT OF THIS REPORTED EVENT. THE INVESTIGATION, CONFIRMED BY SURGEON INTERVIEWS, FOUND THERE WAS NO MALFUNCTION OF THE ROBOT AND NO FAILURES IDENTIFIED, THEREFORE ASENSUS REPORTS THIS EVENT FOR COMPLETENESS TO THE INITIAL MDR REPORT SUBMITTED ON 19-SEPTEMBER-2023." }, { "mdr_text_key": "338749322", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE COMPLAINANT, DR. (B)(6), REPORTED A PATIENT BLADDER RUPTURE FOR WHICH SURGICAL INTERVENTION WAS NEEDED. IT WAS REPORTED THAT CAUSALITY TO THE SENHANCE SURGICAL SYSTEM WAS PROBABLE, BUT WITHOUT ANY FURTHER DETAILS PERTAINING TO PATIENT TREATMENT OR RESOLUTION. THIS EVENT DID NOT OCCUR WITHIN THE UNITED STATES. THE EVENT OCCURRED IN FELDKIRCH REGIONAL HOSPITAL IN AUSTRIA. ADDITIONALLY, THIS EVENT OCCURRED ON 16-OCTOBER-2020, AND ASENSUS SURGICAL WAS INTERNALLY MADE AWARE ON 07-SEPTEMBER-2022." }, { "mdr_text_key": "323742567", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE COMPLAINANT, DR. (B)(6), REPORTED A PATIENT BLADDER RUPTURE FOR WHICH SURGICAL INTERVENTION WAS NEEDED. IT WAS REPORTED THAT CAUSALITY TO THE SENHANCE SURGICAL SYSTEM WAS PROBABLE, BUT WITHOUT ANY FURTHER DETAILS PERTAINING TO PATIENT TREATMENT OR RESOLUTION. THIS EVENT DID NOT OCCUR WITHIN THE UNITED STATES. THE EVENT OCCURRED IN (B)(6) HOSPITAL IN AUSTRIA. ADDITIONALLY, THIS EVENT OCCURRED ON (B)(6) 2020, AND ASENSUS SURGICAL WAS INTERNALLY MADE AWARE ON (B)(6) 2022." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "VIALE DELL'INNOVAZIONE 3", "distributor_zip_code": "", "manufacturer_contact_postal_code": "277037035", "manufacturer_contact_exchange": "919", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "10/12/2023" } ] }