{ "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": "N", "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": "3009185973-2017-00006", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20170202", "manufacturer_address_2": "", "pma_pmn_number": "K101791", "date_of_event": "20161212", "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": "GM", "manufacturer_contact_area_code": "", "date_added": "20170202", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "81413", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20170202", "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": "MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE", "model_number": "ROSA 2.5.8", "catalog_number": "", "lot_number": "", "other_id_number": "", "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": [ "Unintended Collision", "Unintended Collision" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "01/10/2017;01/10/2017", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250810", "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": "20170202", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient", "No Code Available", "No Consequences Or Impact To Patient", "No Code Available" ] } ], "distributor_city": "", "date_report": "20171026", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "6295960", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20170110", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "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": "117737257", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE COMPLAINT RECEIVED FROM THE USER DETAILED FOUR SEPARATE EVENTS DURING THE ONE SURGICAL PROCEDURE. THESE FOUR SEPARATE EVENTS WERE LOGGED AS FOUR COMPLAINTS TO FACILITATE THE INVESTIGATIONS OF THE FOUR EVENTS. THE FOUR EVENTS IN THE SURGICAL PROCEDURE RESULTED IN THE DELAY OF 40-60 MINUTES, WHICH CONSTITUTES A SERIOUS INJURY. THE FOUR EVENTS HAVE BEEN CONSOLIDATED IN THIS MDR SUBMISSION FOR THE ONE COMPLAINT. THE FOUR EVENTS ARE DETAILED AS BELOW: DOUBLE LASER REGISTRATION: 25-30 MINUTE DELAY; ROBOT ALMOST COLLIDING WITH PATIENT'S HEAD: 5 MINUTE DELAY; COMMUNICATION ERROR AFTER COLLISION: 5 MINUTE DELAY; SOFTWARE FREEZE/ARM STOPPING: 1 MINUTE DELAY. CORRECTED DATA: ADVERSE EVENT; SERIOUS INJURY; PATIENT CODE." }, { "mdr_text_key": "66336248", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "DURING SURGERY DEVICE ROBOT ARM WAS GOING TO A PLANNED TRAJECTORY. THE OPERATOR NOTICED THAT THE ROBOT ARM WOULD HAVE COLLIDED WITH THE PATIENT'S HEAD DURING THIS MOVEMENT, SO HE RELEASED THE VIGILANCE DEVICE WHICH PREVENTED THE COLLISION." }, { "mdr_text_key": "130719622", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ANALYSIS OF THE ROSANNA LOG CONFIRMS THAT THE USER SENT THE ROBOT ON THE DIFFERENT TRAJECTORIES EQUIPPED WITH THE DISTANCE SENSOR, TO MARK THE ENTRY POINT. ON THIS OCCASION THE TOOL USED FOR THE PROCEDURE WAS THE DISTANCE SENSOR. THE DEFAULT TOOL LENGTH THAT IS NORMALLY USED IS 20CM. THIS LENGTH CORRESPONDS TO THE DISTANCE FROM THE TOOL TO THE TARGET POINT WHEN THE ROBOT IS IN POSITION. FOR THIS PARTICULAR CASE THE TOOL LENGTH USED WAS 19 CM. IT IS NOT NOTED WHY THE SURGEON DID NOT SELECT A STANDARD 20CM INSTRUMENT. USER ERROR -INAPPROPRIATE TOOL LENGTH SELECTION IN THE TRAJECTORY PARAMETERS- USER ADJUSTED TO LENGTH TO 19 CM WHILE THE DEFAULT VALUE IS 20 CM." } ], "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": "10/24/2017;10/26/2017" } ] }