{ "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": "3009185973-2017-00702", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20170818", "manufacturer_address_2": "", "pma_pmn_number": "PK101791", "date_of_event": "20170710", "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": [ "HEALTH PROFESSIONAL" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "SP", "manufacturer_contact_area_code": "", "date_added": "20170818", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "585152", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20170818", "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": "N/A", "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": [ "Adverse Event Without Identified Device or Use Problem", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "10/11/2017;11/15/2017", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250818", "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": "20170818", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hematoma", "Memory Loss/Impairment", "Paresis", "Coma", "Hematoma", "Memory Loss/Impairment", "Paresis", "Coma" ] } ], "distributor_city": "", "date_report": "20171122", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "6803336", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20170714", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Repair", "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": "117872959", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DEVICE (B)(4) HAS BEEN INSPECTED FOR INVESTIGATION PURPOSE. BASED ON THE AVAILABLE INFORMATION THE INCIDENT WAS IDENTIFIED TO BE DUE TO THE FOLLOWING PROBABLE ROOT CAUSES: INCORRECT CHECKING OF THE REGISTRATION RESULT BY THE OPERATING SURGEON, UNDETECTED PATIENT HEAD MOTION DURING THE SURGERY, TWO ELECTRODES MAY HAVE PASSED THROUGH A VESSEL DUE TO ROBOT ARM INACCURATE POSITION DURING THE CASE, THIS INACCURACY MOST PROBABLY BEING DUE TO THE UNDETECTED PATIENT HEAD MOTION. CORRECTED DATA: DATE OF THIS REPORT; DATE RECEIVED BY MANUFACTURER; EVALUATION CODE." }, { "mdr_text_key": "120450371", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "AS PER ADDITIONAL INFORMATION RECEIVED FROM THE HOSPITAL THE PATIENT IS DOING IT A BIT BETTER AND CAN SPEAK NORMALLY WITHOUT PROBLEM. THE NASOGASTRIC PROBE HAS BEEN REMOVED AND PATIENT CAN EAT ALSO WITHOUT PROBLEMS. PATIENT STILL HAS SOME AMNESIA AND SOME RIGHT HEMIPARESIA BUT OVERALL CAN STAND UP AND WALK WITHOUT HELP." }, { "mdr_text_key": "83002695", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE OPERATING SURGEON INDICATED THAT THERE WERE NO APPARENT ISSUES NOTED INTRA-OPERATIVELY AND THAT THE ROSA DEVICE RO12020 HAD NOT MALFUNCTIONED DURING THE SUBJECT SURGERY. THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. A MEDTECH REPRESENTATIVE WILL GO ON CUSTOMER SITE TO INSPECT THE DEVICE AND DETERMINE THE ROOT CAUSE OF EVENT. ONCE THE EVALUATION WILL BE PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED." }, { "mdr_text_key": "83002696", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE SURGEON REPORTED THAT THE PATIENT UNDERWENT A SEEG PROCEDURE TO IMPLANT ELECTRODES. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM. IT WAS STATED THAT WHILST IN THE RECOVERY ROOM THAT THE PATIENT SUFFERED AN ACUTE SUBDURAL HEMATOMA, LOST CONSCIOUSNESS AND WAS TRANSFERRED TO THE OPERATING ROOM FOR SUBDURAL HAEMATOMA EVACUATION. ADDITIONAL INFORMATION PROVIDED LATER BY THE OPERATING SURGEON INDICATES THAT THERE WERE NO APPARENT ISSUES NOTED INTRA-OPERATIVELY AND THAT THE ROSA DEVICE HAD NOT MALFUNCTIONED." } ], "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": "10/18/2017;11/22/2017" } ] }