{ "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": "3009185973-2019-00048", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20190219", "manufacturer_address_2": "", "pma_pmn_number": "K101791", "date_of_event": "20190122", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "GM", "manufacturer_contact_area_code": "", "date_added": "20190219", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "142193", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190219", "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": "0", "model_number": "ROBOT ARM CONTROLLER", "catalog_number": "N/A", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20190205", "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": [ "Failure to Power Up", "Failure to Power Up" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "10/21/2019", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250727", "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": "20190219", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Code Available", "No Code Available" ] } ], "distributor_city": "", "date_report": "20191030", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8349821", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20190122", "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": "136478496", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION IS PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. (B)(4)." }, { "mdr_text_key": "136478497", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IN PREPARATION OF THE SURGERY THE ROBOT WAS TURNED ON, AND IT WAS NOT POSSIBLE TO CONNECT TO THE ROBOT ARM DESPITE SEVERAL ATTEMPTS. THE PATIENT WAS ALREADY IN THE OR AND PREPARED FOR SURGERY. MULTIPLE RESOLUTIONS WERE ATTEMPTED UNSUCCESSFULLY. THE SURGERY WAS ABORTED AND POSTPONED TO ANOTHER DAY." }, { "mdr_text_key": "312109039", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A REVIEW OF DHR FOR THE SUBJECT DEVICE WITHIN SIX MONTHS HAS DETERMINED THAT THERE ARE NOT ANY RECORDED ISSUES OR INTERVENTIONS WHICH MAY BE RELATED TO OR IMPACTING ON THE USER REPORTED EVENT. A REVIEW OF THE COMPLAINTS THAT OCCURRED IN THE PAST 12 MONTHS AND OF THE TWO LAST COMPLAINTS RECEIVED FOR THIS DEVICE HAS BEEN COMPLETED AND THIS DETERMINED THAT THERE WAS NO COMPLAINT DIRECTLY LINKED WITH THE REPORTED EVENT. THE DEFECTIVE CONTROLLER CPU WAS REPLACED BY THE SUPPLIER AND IT WAS RE-INSTALLED ON THE DEVICE RO15066 ON 01-FEB-2019 BY A FIELD SERVICE ENGINEER. FOLLOWING THIS REPLACEMENT THE DEVICE WORKED AS INTENDED. THE CAUSE FOR THE CONTROLLER CPU FAILURE IS NOT DETERMINED ON THIS OCCASION. IT IS NOTED THAT THIS PART WAS INSTALLED ON THE CUSTOMER SITE AT THE SAME DATE THAN THE CORE DEVICE. THEREFORE THIS PART HAS BEEN IN USE FOR TWO YEARS AND A HALF BEFORE THE ALLEGED EVENT OCCURRED." }, { "mdr_text_key": "312109040", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IN PREPARATION OF THE SURGERY THE ROBOT WAS TURNED ON, AND IT WAS NOT POSSIBLE TO CONNECT TO THE ROBOT ARM DESPITE SEVERAL ATTEMPTS. THE PATIENT WAS ALREADY IN THE OR AND PREPARED FOR SURGERY. MULTIPLE RESOLUTIONS WERE ATTEMPTED UNSUCCESSFULLY. THE SURGERY WAS ABORTED AND POSTPONED TO ANOTHER DAY." } ], "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": "10/30/2019" } ] }