{ "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 DR", "manufacturer_contact_pcity": "91976584", "event_type": "Injury", "report_number": "3007593944-2023-00006", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20230919", "manufacturer_address_2": "", "pma_pmn_number": "K171120", "date_of_event": "20221021", "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": "GM", "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": "2061324", "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": "03/09/2023", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250819", "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": [ "Insufficient Information", "Insufficient Information" ] } ], "distributor_city": "", "date_report": "20231012", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IT", "manufacturer_contact_city": "DURHAM", "mdr_report_key": "17774611", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20230309", "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": "323745053", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE EVENT OCCURRED OUTSIDE THE UNITED STATES. THE EVENT OCCURRED ON (B)(6) 2022, INTERNALLY MADE AWARE ON (B)(6) 2023. THE PATIENT EXPERIENCED SUTURE FAILURE WHICH REQUIRED INTERVENTION FOR TREATMENT (RESOLVED ON (B)(6) 2022). INTERVENTION INCLUDED, RELAPAROSCOPY, COLONOSCOPY, AND ENDOVAC THERAPY. IT WAS REPORTED THAT THE CAUSALITY TO THE SENHANCE SURGICAL SYSTEM WAS POSSIBLE." }, { "mdr_text_key": "338688650", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE COMPLAINT DETAILS ( (B)(4) ), THE PATIENT EXPERIENCED A SUTURE FAILURE WHICH REQUIRED AN INTERVENTION OF TREATMENT WITH A SECOND LAPAROSCOPY, COLONOSCOPY, AND ENDOVAC THERAPY. THIS EVENT DID NOT OCCUR WITHIN THE UNITED STATES. THIS EVENT OCCURRED AT EVANGELISCHES KRANKENHAUS WESEL IN GERMANY. THE EVENT OCCURRED ON 21-OCTOBER-2022, AND ASENSUS SURGICAL WAS MADE AWARE ON 09-MARCH-2023. ACCORDING TO THE INVESTIGATION, FURTHER RESPONSES FROM SURGEON INTERVIEWS INDICATED THAT THE SUTURE FAILURE EVENT THAT OCCURRED WAS NOT RELATED TO THE SENHANCE SURGICAL SYSTEM AND POSSIBLY WITH THE STAPLER-ANASTOMOSIS. FURTHERMORE, NO MALFUNCTION OF THE SENHANCE SYSTEM WAS REPORTED AND NO FAILURES WERE IDENTIFIED. THE RISK POSED BY THIS EVENT WAS EVALUATED THROUGH A HEALTH HAZARD EVALUATION (HHE-001-00035) 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. THEREFORE, ASENSUS SURGICAL IS REPORTING THIS FOLLOWUP FOR COMPLETENESS TO THE INITIAL MDR REPORT SUBMITTED ON 19-SEPTEMBER-2023." }, { "mdr_text_key": "338688651", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE EVENT OCCURRED OUTSIDE THE UNITED STATES. THE EVENT OCCURRED ON 10/21/2022, INTERNALLY MADE AWARE ON 3/9/2023. THE PATIENT EXPERIENCED SUTURE FAILURE WHICH REQUIRED INTERVENTION FOR TREATMENT (RESOLVED ON (B)(6) 2022). INTERVENTION INCLUDED, RELAPAROSCOPY, COLONOSCOPY, AND ENDOVAC THERAPY. IT WAS REPORTED THAT THE CAUSALITY TO THE SENHANCE SURGICAL SYSTEM WAS POSSIBLE." } ], "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" } ] }