{ "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": "3007593944-2023-00014", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20230919", "manufacturer_address_2": "", "pma_pmn_number": "K171120", "date_of_event": "20220817", "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": [ "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": "1938444", "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": [ "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": "06/29/2022", "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": [ "Bowel Burn", "Bowel Burn" ] } ], "distributor_city": "", "date_report": "20231013", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IT", "manufacturer_contact_city": "DURHAM", "mdr_report_key": "17774580", "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": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "323744547", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE COMPLAINANT, PROF. (B)(6), REPORTED A TRANSABDOMINAL PREPERITONEAL REPAIR (RTAPP) WAS PERFORMED ON (B)(6) 2022, AND NEXT DAY THE PATIENT WAS DISCHARGED WITHOUT PROBLEMS. ON (B)(6) 2022 THE PATIENT HAD ABDOMINAL PAIN AND INFLAMMATION FOR WHICH AN ORGAN LESION WAS SUSPECTED AND THE PATIENT WAS RE-OPERATED. THE RE-SURGERY FOUND A THERMIC LESION OF THE SMALL BOWEL (3CM) WITH ABSCESS FOR WHICH AN OPEN RESECTION AND ILEOASCENDOSTOMY WERE PERFORMED. THE PATIENT FOLLOW-UP WAS UNEVENTFUL NOTING 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) IN GERMANY. ADDITIONALLY, THIS EVENT OCCURRED ON (B)(6) 2022, AND ASENSUS SURGICAL WAS INTERNALLY MADE AWARE ON 25-SEPTEMBER-2022." }, { "mdr_text_key": "338692940", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE COMPLAINANT, PROF. LUDGER STAIB, REPORTED A TRANSABDOMINAL PREPERITONEAL REPAIR (RTAPP) WAS PERFORMED ON (B)(6) 2022, AND NEXT DAY THE PATIENT WAS DISCHARGED WITHOUT PROBLEMS. ON (B)(6) 2022, THE PATIENT HAD ABDOMINAL PAIN AND INFLAMMATION FOR WHICH AN ORGAN LESION WAS SUSPECTED AND THE PATIENT WAS RE-OPERATED. THE RE-SURGERY FOUND A THERMIC LESION OF THE SMALL BOWEL (3CM) WITH ABSCESS FOR WHICH AN OPEN RESECTION AND ILEOASCENDOSTOMY WERE PERFORMED. THE PATIENT FOLLOW-UP WAS UNEVENTFUL NOTING 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 KLINIKUM ESSLINGEN IN GERMANY. ADDITIONALLY, THIS EVENT OCCURRED ON 17-AUGUST-2022, AND ASENSUS SURGICAL WAS INTERNALLY MADE AWARE ON 25-SEPTEMBER-2022." }, { "mdr_text_key": "338692961", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE COMPLAINT DETAILS (PCR-001564), THE PATIENT WAS READMITTED IN THE HOSPITAL AFTER AN RTAPP DUE TO ABDOMINAL PAIN AND INFLAMMATION. AN OPEN RESECTION AND ILEOASCENDOSTOMY WAS PERFORMED DUE TO A THERMIC LESION DETECTED ON THE SMALL BOWEL WITH ABSCESS. THE PATIENT RECOVERED FOR A (B)(6) 2022 DATE OF RESOLUTION. THIS EVENT DID NOT OCCUR WITHIN THE UNITED STATES. THIS EVENT OCCURRED AT KLINIKUM ESSLINGEN IN GERMANY. THE EVENT OCCURRED ON 17-AUG-2022, AND ASENSUS SURGICAL WAS MADE AWARE ON 25-SEPT-2022. ACCORDING TO THE INVESTIGATION, FURTHER RESPONSES FROM SURGEON INTERVIEWS INDICATED THAT THE SEVERE ADVERSE EVENT WAS NOT RELATED TO THE SENHANCE SURGICAL SYSTEM, BUT RATHER CONSIDERED TO BE A NORMAL SURGICAL COMPLICATION UNRELATED TO THE ROBOT. 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-001-00033) 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." } ], "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" } ] }