{ "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": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "3009185973-2017-00759", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20171104", "manufacturer_address_2": "", "pma_pmn_number": "PK101791", "date_of_event": "20171010", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "HEALTH PROFESSIONAL", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20171104", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "781248", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20171104", "brand_name": "ROSA SURGICAL DEVICE", "generic_name": "COMPUTER-ASSISTED SURGICAL DEVICE", "manufacturer_d_name": "MEDTECH SA", "manufacturer_d_address_1": "ZAC EUREKA", "manufacturer_d_address_2": "900 RUE DU MAS DE VERCHANT", "manufacturer_d_city": "MONTPELLIER, LANGUEDOC-ROUSSILLON", "manufacturer_d_state": "", "manufacturer_d_zip_code": "34000", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "FR", "manufacturer_d_postal_code": "34000", "device_operator": "HEALTH PROFESSIONAL", "model_number": "ROSA 2.5.8", "catalog_number": "N/A", "lot_number": "2.5.8.10", "other_id_number": "N/A", "device_availability": "Yes", "device_report_product_code": "HAW", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Neurological Stereotaxic Instrument", "medical_specialty_description": "Neurology", "regulation_number": "882.4560", "device_class": "2" } } ], "product_problems": [ "Imprecision", "Imprecision" ], "reporter_state_code": "WA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "04/20/2018", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250827", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20171104", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Code Available", "No Code Available" ] } ], "distributor_city": "", "date_report": "20180424", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "7001983", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20171010", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Inspection" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "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": "91056117", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DEVICE (B)(4) HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION WILL BE PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. (B)(4) - NO CODE AVAILABLE\" BECAUSE A DELAY OF 30 MINUTES WAS OBSERVED IN THE SURGERY, FURTHERMORE, PATIENT HAD TO BE BROUGHT BACK TO THE RADIOLOGY DEPARTMENT TO OBTAIN A SECOND CT EXAM." }, { "mdr_text_key": "91056118", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A SURGERY THE SURGEON NOTICED THAT THE TIP OF THE OPTICAL DISTANCE SENSOR DEFLECTED. THE SURGEON HAD TO PLAN A SECOND TRAJECTORY TO REACH THE TARGET POINT, AND A NEW CT EXAM WAS ACQUIRED. THE SURGEON WAS ABLE TO SUCCESSFULLY ABLATE THE TUMOR USING THE SECOND TRAJECTORY. THE EVENT CAUSED A DELAY OF 30 MINUTES IN THE PROCEDURE." }, { "mdr_text_key": "250774155", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "INVESTIGATION OF THE REPORTED EVENT INDICATED THAT THE ENTRY POINT ACCURACY OF THE LASER CATHETER WAS WITHIN SPECIFICATION AND DID NOT APPEAR TO CONTRIBUTE TO THE DEFLECTION OF THE LASER CATHETER. NO FAILURE OF THE DEVICE WAS DETECTED. ADDITIONALLY, THE CATHETER ITSELF APPEARS TO HAVE A MILD CURVATURE INDICATING THAT THE DEVIATION AT THE TARGET POINT MAY HAVE BEEN CAUSED BY DEFLECTION OF THE LASER CATHETER WITHIN THE BRAIN DUE TO THE PRESENCE OF ANATOMICAL VARIATIONS. THIS STATEMENT IS SUPPORTED BY THE SURGEON WHICH STATED THAT THE DEVIATION WAS DUE TO DEFLECTION OF THE LASER CATHETER DUE TO THE PATIENT¿S ANATOMY." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "04/24/2018" } ] }