{ "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": "9NG", "manufacturer_g1_address_2": "MILTON ROAD", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "MILTON ROAD", "manufacturer_g1_city": "CAMBRIDGE,", "manufacturer_contact_address_1": "1 EVOLUTION BUSINESS PARK", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "3015488559-2026-00018", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20260506", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20260407", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "CB24", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "NOWACKA-PERRIN", "source_type": [ "Foreign", "Distributor" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "CB24 9NG", "manufacturer_g1_state": "", "reporter_country_code": "BU", "manufacturer_contact_area_code": "", "date_added": "20260506", "manufacturer_contact_f_name": "AGNIESZKA", "device_date_of_manufacturer": "20231101", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1165494", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "Y", "date_received": "20260506", "brand_name": "VERSIUS SURGICAL SYSTEM", "generic_name": "VERSIUS SURGEON CONSOLE", "manufacturer_d_name": "CMR SURGICAL LIMITED", "manufacturer_d_address_1": "1 EVOLUTION BUSINESS PARK", "manufacturer_d_address_2": "MILTON ROAD", "manufacturer_d_city": "CAMBRIDGE,", "manufacturer_d_state": "", "manufacturer_d_zip_code": "CB24", "manufacturer_d_zip_code_ext": "9NG", "manufacturer_d_country": "UK", "manufacturer_d_postal_code": "CB24 9NG", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "V-SS-1000", "lot_number": "", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "SCV", "device_age_text": "", "device_evaluated_by_manufacturer": "N", "combination_product_flag": "N", "udi_di": "05060548210045", "udi_public": "(01)05060548210045", "openfda": { "device_name": "Modular Electromechanical Surgical System", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4964", "device_class": "2" } } ], "product_problems": [ "Material Frayed" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "UK", "date_changed": "20260518", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "9NG", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20260506", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20260506", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "UK", "manufacturer_contact_city": "CAMBRIDGE,", "mdr_report_key": "25090983", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20260407", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "CB24", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "CMR SURGICAL LIMITED", "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": "400398757", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "CMR SURGICAL LIMITED IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REGULATION 803. THE DEVICE WAS INSPECTED BY THE DISTIBUTOR. CMR SURGICAL LTD DOES NOT CONSIDER THIS REPORT AND CONTENT TO BE AN ADMISSION THAT ITS PRODUCT IS DEFECTIVE OR THAT IT HAS CAUSED A DEATH OR SERIOUS INJURY. THE USE OF VERSIUS SURGICAL SYSTEM IS NOT INDICATED FOR PATIENTS WITH MORBID OBESITY." }, { "mdr_text_key": "400398758", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS ALLEGED THAT THE SURGEON CONSOLE WENT INTO A MEDIUM PRIORITY ALARM DURING SURGERY AND THE RIGHT HAND CONTROLLER ARM BECAME STILL. THE SURGEON CONSOLE COULD NOT BE RECOVERED AND THE PROCEDURE WAS CONVERTED. IT IS ALLEGED BY THE REPORTER (DISTRIBUTOR) THAT THE PROCEDURE WAS CONVERTED TO OPEN APPROACH DUE TO THE FOLLOWING PATIENT CONDITIONS: HIGH BLOOD PRESSURE AND BMI OF OVER 30 WITH A LOT OF ABDOMINAL FAT. A DELAY OF APPROXIMATELY 20 MINUTES WAS ALLEGED IN RELATION TO THIS EVENT. NO PATIENT HARM WAS REPORTED IN RELATION TO THIS EVENT. PHOTOS WERE PROVIDED BY THE REPORTER (DISTRIBUTOR) TO SHOW THE MALFUNCTIONING PART. THE MALFUNCTIONING PART WAS REPLACED BY THE DISTRIBUTOR. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "1 EVOLUTION BUSINESS PARK", "distributor_zip_code": "", "manufacturer_contact_postal_code": "CB24 9NG", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }