{ "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": "", "event_location": "", "report_to_fda": "N", "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": "3015488559-2026-00067", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20260605", "manufacturer_address_2": "", "pma_pmn_number": "K252111", "date_of_event": "20260413", "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_zip_code_ext": "", "manufacturer_g1_postal_code": "CB6 3NX", "manufacturer_g1_state": "", "reporter_country_code": "BE", "manufacturer_contact_area_code": "", "date_added": "20260605", "manufacturer_contact_f_name": "Debbie", "device_date_of_manufacturer": "20240102", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "572484", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "N", "date_received": "20260605", "brand_name": "Versius Surgical System", "generic_name": "Versius Cadiere 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": "11000", "lot_number": "216084", "other_id_number": "", "device_availability": "No", "device_report_product_code": "SCV", "device_age_text": "", "device_evaluated_by_manufacturer": "Y", "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", "Insufficient Device Problem Information" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/13/2026", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "UK", "date_changed": "20260814", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "NX", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20260605", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Laceration(s)", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20260729", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "UK", "manufacturer_contact_city": "Cambridge,", "mdr_report_key": "25407015", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20260513", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "CB6 3", "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": "403418758", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "CMR SURGICAL IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REGULATION 803 L. CMR SURGICAL WILL SUBMIT A SUPPLEMENTAL REPORT ONCE THE INSTRUMENT IS RETURNED AND FURTHER RELEVANT INFORMATION BECOMES AVAILABLE." }, { "mdr_text_key": "403418759", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE REPORTER ALLEGED THAT DURING A SACROCOLPOPEXY PROCEDURE ON (B)(6) 2026 THE SURGEON OBSERVED THAT THERE WAS A PIECE OF COLON TISSUE STUCK IN THE CADIERE GRASPER. IT WAS NOT POSSIBLE TO PULL IT OUT AND THE TISSUE HAD TO BE CUT LOOSE. BESIDE THIS CUTTING THERE WAS NO HARM TO THE PATIENT AND THE ISSUE DID NOT OCCUR AGAIN. THE PATIENT HAS RECOVERED WELL FROM SURGERY AND HAS BEEN DISCHARGED FROM HOSPITAL WITH NO COMPLICATIONS. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED. 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