{ "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": "MS", "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": "3015488559-2026-00135", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20260714", "manufacturer_address_2": "", "pma_pmn_number": "K252111", "date_of_event": "20260619", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "CB24", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "GALLAGHER", "source_type": [ "Foreign", "Health Professional", "Distributor" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "CB24 9NG", "manufacturer_g1_state": "", "reporter_country_code": "IT", "manufacturer_contact_area_code": "", "date_added": "20260714", "manufacturer_contact_f_name": "DEBBIE", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "647888", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "N", "date_received": "20260714", "brand_name": "VERSIUS SURGICAL SYSTEM", "generic_name": "BIPOLAR MARYLAND GRASPER", "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": "10200", "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": "", "udi_public": "", "openfda": { "device_name": "Modular Electromechanical Surgical System", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4964", "device_class": "2" } } ], "product_problems": [ "Difficult to Open or Close" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "UK", "date_changed": "20260814", "health_professional": "Y", "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": "20260714", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20260714", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "UK", "manufacturer_contact_city": "CAMBRIDGE,", "mdr_report_key": "25810676", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20260619", "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": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "407368734", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "CMR SURGICAL LIMITED IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REGULATION 803. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE DEVICE HAS BEEN RETURNED AND INSPECTED. CMR SURGICAL LIMITED 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." }, { "mdr_text_key": "407368735", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE REPORTER ALLEGED THAT DURING A LEFT INFERIOR LOBECTOMY PROCEDURE ON (B)(6) 2026, WHILST USING A BIPOLAR MARYLAND GRASPER PART OF THE LUNG'S TISSUE GOT STUCK IN THE JOINT AND WAS UNABLE TO REMOVE THE TISSUE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. 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 INJURIES." } ], "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": "" } ] }