{ "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": "2026-10-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "N", "manufacturer_contact_t_name": "Ms.", "manufacturer_contact_state": "IN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "Mauguio, Languedoc-Roussillon", "manufacturer_contact_address_1": "56 E. Bell Drive", "manufacturer_contact_pcity": "+1(574)5", "event_type": "Injury", "report_number": "3009185973-2026-00011", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260818", "manufacturer_address_2": "", "pma_pmn_number": "K231103", "date_of_event": "20260731", "reprocessed_and_reused_flag": "", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "46582", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "+1(574)526-0384", "noe_summarized": "1", "manufacturer_contact_l_name": "Rapsavage", "source_type": [ "Health Professional", "User facility", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "34130", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20260818", "manufacturer_contact_f_name": "Jennifer", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "147155", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "N", "date_received": "20260818", "brand_name": "ROSA ONE BRAIN", "generic_name": "Neurological Stereotaxic Instrument", "manufacturer_d_name": "Medtech SAS", "manufacturer_d_address_1": "432 Rue du Rajol", "manufacturer_d_address_2": "", "manufacturer_d_city": "Mauguio, Languedoc-Roussillon", "manufacturer_d_state": "", "manufacturer_d_zip_code": "34130", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "FR", "manufacturer_d_postal_code": "34130", "device_operator": "", "model_number": "", "catalog_number": "ROSAS00203", "lot_number": "3.7.1", "other_id_number": "", "device_availability": "No", "device_report_product_code": "HAW", "device_age_text": "", "device_evaluated_by_manufacturer": "N", "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": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20260904", "health_professional": "Y", "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": "20260818", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Intracranial Hemorrhage" ] } ], "distributor_city": "", "date_report": "20260818", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "FR", "manufacturer_contact_city": "Warsaw", "mdr_report_key": "50309513", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20260731", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "34130", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "Medtech SAS", "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": "15512567867", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "It was reported that during a pediatric stereoelectroencephalography electrode implantation using a robotic guidance system, multiple electrodes deviated from the surgical plan, several were positioned within vessels, and the patient sustained an intracranial hemorrhage.This was the second of two procedures performed with the system that day; the first was completed without reported issue. The system was operated by a clinical support representative under supervision. On review of a post-procedure intraoperative 3D scan, multiple electrodes were advanced deeper than planned, with the largest over-insertion measuring approximately 2 cm. Several implanted electrodes did not follow a straight trajectory and exhibited multiple curves, with some approximating an S-shaped configuration; it was not known whether curvature of the first electrode was present at placement or developed prior to the post-procedure scan. Actual entry points deviated from planned entry points in an anterior/inferior direction, with a non-linear trend of increasing deviation during the case; the final entry point deviated by more than approximately 2 mm. Post-procedure accuracy and applicative testing of the system was performed and showed results within specification. A review of the case materials, including image merges and frame pin placement, was conducted and a root cause was not established. Users at the facility declined further use of the system pending resolution.Attempts have been made and no further information has been provided." }, { "mdr_text_key": "16012567868", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental MedWatch 3500A will be submitted." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "432 Rue du Rajol", "distributor_zip_code": "", "manufacturer_contact_postal_code": "46582", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }