{ "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": "MILANO, LOMBARDY", "manufacturer_contact_address_1": "1 TW ALEXANDER DR", "manufacturer_contact_pcity": "91976584", "event_type": "Injury", "report_number": "3007593944-2023-00010", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20230919", "manufacturer_address_2": "", "pma_pmn_number": "K171120", "date_of_event": "20220210", "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": "1817936", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "N", "date_received": "20230919", "brand_name": "SENHANCE", "generic_name": "SENHANCE SUGICAL 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": [ "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": "12/01/2022", "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": [ "Required Intervention" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Dysphagia/ Odynophagia", "Dysphagia/ Odynophagia" ] } ], "distributor_city": "", "date_report": "20231013", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IT", "manufacturer_contact_city": "DURHAM", "mdr_report_key": "17774529", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20221201", "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": "323743213", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE COMPLAINANT, DR. (B)(6) , REPORTED PATIENT HAD HYPOTENSIVE ESOPHAGEAL MOTILITY WITH RESIDUAL PRESSURE AT 37MMHG AND NICOTINE ABUSE, AND PATIENT COMPLAINS OF DYSPHAGIA POST-OP. STANDARD TREATMENT WITH PREDNISOLONE 100MG FOR 3 DAYS WAS GIVEN, AFTER WHICH THE PATIENT WAS SYMPTOM-FREE. IT WAS REPORTED THAT CAUSALITY TO THE SENHANCE SURGICAL SYSTEM WAS PROBABLE. ON (B)(6) 2022, PATIENT AGAIN COMPLAINS OF DYSPHAGIA, NICOTINE ABSTINENCE WAS RECOMMENDED. IN (B)(6) 2022, GASTROSCOPY WAS PERFORMED WITH FUNCTIONAL SPASM, ACHALASIA AND EXCLUSION OF RECURRENT HERNIA WITH BALLOON DILATATION. ON (B)(6) 2022, PATIENT WAS RE-OPERATED VIA LAPAROSCOPY WITH ADHESIOLYSIS AND REPOSITIONING OF THE STOMACH IN THE ABDOMEN FOR RESOLUTION. THIS EVENT DID NOT OCCUR WITHIN THE UNITED STATES. THE EVENT OCCURRED AT (B)(6) IN GERMANY. ADDITIONALLY, THIS EVENT OCCURRED ON (B)(6) 2022, AND ASENSUS SURGICAL WAS INTERNALLY MADE AWARE ON (B)(6) 2022." }, { "mdr_text_key": "339222480", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE COMPLAINT DETAILS ((B)(4)), THE PATIENT EXPERIENCED DYSPHAGIA AND WAS TREATED WITH A BALLOON DILATATION PROCEDURE. THE PATIENT WAS RE-OPERATED WITH LAPAROSCOPY RESOLVING THE ADVERSE EVENT ON (B)(6) 2022. THIS EVENT DID NOT OCCUR WITHIN THE UNITED STATES. THIS EVENT OCCURRED AT (B)(6) GERMANY. THE EVENT OCCURRED ON (B)(6) 2022, AND ASENSUS SURGICAL WAS MADE AWARE ON 01-DECEMBER-2022. ACCORDING TO THE INVESTIGATION, FURTHER RESPONSES FROM SURGEON INTERVIEWS INDICATED THAT THE DYSPHAGIA EVENT WAS NOT RELATED TO THE SENHANCE SURGICAL SYSTEM, BUT RATHER CONSIDERED TO BE A NORMAL SURGICAL COMPLICATION, UNRELATED TO THE ROBOT. ADDITIONALLY, THE SURGEON CONFIRMED THE INITIAL PATIENT ID WAS ERRONEOUSLY REPORTED IN THE PATIENT ID DATABASE AND THE CORRECT PATIENT ID IS (B)(6). 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 ((B)(4)) AND A CORRECTIVE ACTION PREVENTATIVE ACTION PLAN ((B)(4)) 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": "339222501", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE COMPLAINANT, DR. (B)(6) , REPORTED PATIENT HAD HYPOTENSIVE ESOPHAGEAL MOTILITY WITH RESIDUAL PRESSURE AT 37MMHG AND NICOTINE ABUSE, AND PATIENT COMPLAINS OF DYSPHAGIA POST-OP. STANDARD TREATMENT WITH PREDNISOLONE 100MG FOR 3 DAYS WAS GIVEN, AFTER WHICH THE PATIENT WAS SYMPTOM-FREE. IT WAS REPORTED THAT CAUSALITY TO THE SENHANCE SURGICAL SYSTEM WAS PROBABLE. ON (B)(6) 2022, PATIENT AGAIN COMPLAINS OF DYSPHAGIA, NICOTINE ABSTINENCE WAS RECOMMENDED. IN (B)(6) 2022, GASTROSCOPY WAS PERFORMED WITH FUNCTIONAL SPASM, ACHALASIA AND EXCLUSION OF RECURRENT HERNIA WITH BALLOON DILATATION. ON (B)(6) 2022, PATIENT WAS RE-OPERATED VIA LAPAROSCOPY WITH ADHESIOLYSIS AND REPOSITIONING OF THE STOMACH IN THE ABDOMEN FOR RESOLUTION. THIS EVENT DID NOT OCCUR WITHIN THE UNITED STATES. THE EVENT OCCURRED AT (B)(6) IN GERMANY. ADDITIONALLY, THIS EVENT OCCURRED ON (B)(6) 2022, AND ASENSUS SURGICAL WAS INTERNALLY MADE AWARE ON 01-DECEMBER-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" } ] }