{ "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": "3007593944-2023-00007", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20230919", "manufacturer_address_2": "", "pma_pmn_number": "K171120", "date_of_event": "20220528", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "27703", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "9197658400", "noe_summarized": "1", "manufacturer_contact_l_name": "HINCKLEY", "source_type": [ "Health Professional", "User facility" ], "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": "1817939", "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 DR", "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": [ "Insufficient Device Problem Information", "Insufficient Device Problem Information" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/29/2022", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250807", "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": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Vomiting", "Stenosis of the esophagus", "No Clinical Signs, Symptoms or Conditions", "Vomiting", "Stenosis of the esophagus", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20231012", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IT", "manufacturer_contact_city": "DURHAM", "mdr_report_key": "17774532", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20220629", "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": "323743534", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE COMPLAINANT, (B)(6), REPORTED THAT A PATIENT EXPERIENCED NARROW STENOSIS IN THE GASTRO-ESOPHAGEAL AREA AND VOMITING FOR WHICH TREATMENT WITH ANTIEMETICS WAS ADMINISTRATED (DOMPERIDONE-50,00 MG TOTAL DOSAGE); ADDITIONALLY, AN OGD + DILATATION WAS PERFORMED FOR A (B)(6) 2022 DATE OF RESOLUTION. IT WAS REPORTED THAT CAUSALITY TO THE SENHANCE SURGICAL SYSTEM WAS POSSIBLE. THIS EVENT DID NOT OCCUR WITHIN THE UNITED STATES. THE EVENT OCCURRED IN (B)(6). ADDITIONALLY, THIS EVENT OCCURRED ON (B)(6) 2022, AND ASENSUS SURGICAL WAS INTERNALLY MADE AWARE ON 29-JUNE-2022." }, { "mdr_text_key": "338689816", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE COMPLAINT DETAILS ((B)(4)), THE PATIENT EXPERIENCED NARROW STENOSIS IN THE GASTRO-ESOPHAGEAL AREA AND ASSOCIATED VOMITING FOR WHICH PATIENT WAS TREATED WITH ANTIEMETICS (DOMPERIDONE; TOTAL DOSAGE ADMINISTRATED: 50,00 MG) AND PERFORMED AN OGD (OESOPHAGOGASTRODUODENOSCOPY) WITH DILATATION FOR (B)(6) 2022 DATE OF RESOLUTION. THIS EVENT DID NOT OCCUR WITHIN THE UNITED STATES. THIS EVENT OCCURRED AT (B)(6) IN GERMANY. THE EVENT OCCURRED ON 28-MAY-2022, AND ASENSUS SURGICAL WAS MADE AWARE ON 29-JUNE-2022. ACCORDING TO THE INVESTIGATION, FURTHER INTERVIEW QUESTIONS POSED TO THE SURGEON CONFIRM THAT PATIENT ID (B)(6) BELONGED TO A MALE PATIENT WITH AN INGUINAL HERNIA, WITHOUT SURGICAL PROBLEMS. THE CORRECTED PATIENT CREDENTIALS FOR THIS PARTICULAR EVENT IS A FEMALE PATIENT WITH ID (B)(6) AND WAS FOUND TO ALREADY BE HANDLED IN A SEPARATE (B)(4) FOR THE SERIOUS ADVERSE EVENT ASSOCIATED WITH VERIFIED FEMALE PATIENT ID (B)(6). THEREFORE, AS NO SERIOUS ADVERSE EVENT OCCURRED ON THE MALE PATIENT ID (B)(6), THIS COMPLAINT IS DEEMED ERRONEOUS. ASENSUS SURGICAL IS REPORTING THIS FOLLOWUP WITH THE CORRECTED PATIENT DATA TO UPDATE THE INITIAL MDR REPORT SUBMITTED ON 19-SEPTEMBER-2023." }, { "mdr_text_key": "338689817", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE COMPLAINANT, BETTINA PFEIFFER, REPORTED THAT A PATIENT EXPERIENCED NARROW STENOSIS IN THE GASTRO-ESOPHAGEAL AREA AND AND VOMITING FOR WHICH TREATMENT WITH ANTIEMETICS WAS ADMINISTRATED (DOMPERIDONE-50,00 MG TOTAL DOSAGE); ADDITIONALLY, AN OGD + DILATATION WAS PERFORMED FOR (B)(6) 2022 DATE OF RESOLUTION. IT WAS REPORTED THAT CAUSALITY TO THE SENHANCE SURGICAL SYSTEM WAS POSSIBLE. THIS EVENT DID NOT OCCUR WITHIN THE UNITED STATES. THE EVENT OCCURRED IN (B)(6) IN GERMANY. ADDITIONALLY, THIS EVENT OCCURRED ON 28-MAY-2022, AND ASENSUS SURGICAL WAS INTERNALLY MADE AWARE ON 29-JUNE-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": "10/13/2023" } ] }