{ "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": "3009185973-2018-00285", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20181026", "manufacturer_address_2": "", "pma_pmn_number": "K101791", "date_of_event": "20180319", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER HEALTH CARE 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": "US", "manufacturer_contact_area_code": "", "date_added": "20181026", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "848908", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20181026", "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": "CONTROLLER", "catalog_number": "N/A", "lot_number": "CR1D-721-S15", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "HAW", "device_age_text": "", "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": [ "Device Alarm System", "Device Alarm System" ], "reporter_state_code": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "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": "20181026", "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": "20181026", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8008510", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20181024", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Repair" ], "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": "125095402", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ACCORDING TO THE COMPLAINT DESCRIPTION, THE EMERGENCY BUTTON WAS DEPRESSED MULTIPLE TIMES AND THE DEVICE WAS TURNED OFF AND UNPLUGGED BEFORE TO BE RESTARTED. THE LOG ANALYSIS CLEARLY SHOWS THAT IT DID NOT CHANGE ANYTHING TO THE ISSUE ALTHOUGH THE MANIPULATION WAS ATTEMPTED FIVE TIMES. IT IS ALSO NOTED THAT DR. (B)(6) SAID THAT THE ROBOT HAS NOT BEEN USED FOR A FEW WEEKS. THIS COULD HAVE AN IMPACT ON THE BATTERIES¿ CONDITION. THE CONTROLLER WAS BEEPING BECAUSE IT DETECTED ERRORS RELATED TO THE BATTERIES¿ CONDITION. ACCORDING TO THE CONTROLLER TROUBLE SHOOTING, THE ROBOT ARM BATTERY AND THE CONTROLLER BATTERY HAVE LOST THEIR CHARGE AND CANNOT BE CHARGED ANYMORE. THEREFORE THEY NEED TO BE REPLACED. THE BATTERIES WERE REPLACED ON THE DATE OF THE EVENT ((B)(6) 2018)." }, { "mdr_text_key": "125095403", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "WHILE TURNING THE ROBOT ON FOR A LASER ABLATION SURGERY, THE ROBOT WAS MAKING A BEEPING NOISE. THEY PUSH DOWN AND RELEASE THE EMERGENCY STOP BUTTON AND THEN POWER THE ROBOT DOWN, TURN THE ROBOT OFF, UNPLUG THE DEVICE, WAIT, AND THEN TURN THE ROBOT BACK ON. AFTER THE ROBOT WAS TURNED BACK ON, THE CONTROLLER BEGAN TO BEEP AGAIN AND THEN THE MONITOR WOULD NOT TURN ON. THE SURGEON TRIED TO PRESS THE PC RESET BUTTON A FEW TIMES AND ROBOT WAS STILL BEEPING, THE SCREEN STILL DID NOT TURN ON, AND THE DVD DRIVE OPENED AND CLOSED, MEANING THAT THE PC WAS ON." } ], "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": "" } ] }