{ "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": "3009185973-2018-00099", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20180322", "manufacturer_address_2": "", "pma_pmn_number": "PK101791", "date_of_event": "20180319", "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": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20180322", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "204578", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20180322", "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": "TOUCHSCREEN", "catalog_number": "N/A", "lot_number": "N/A", "other_id_number": "N/A", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20180404", "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": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "10/24/2018", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250725", "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": "20180322", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Code Available", "No Code Available" ] } ], "distributor_city": "", "date_report": "20181025", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "7360988", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20180319", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Replace" ], "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": "103136540", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION WILL BE PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED." }, { "mdr_text_key": "103136541", "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." }, { "mdr_text_key": "310461583", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "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." }, { "mdr_text_key": "310461584", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE TOUCHSCREEN WAS RETURNED TO MANUFACTURING SITE ON 04-APR-2018. VISUAL INSPECTION OF THE RETURNED PART SHOWED THAT NO DAMAGE IS VISIBLE ON THE TOUCHSCREEN. A FUNCTIONAL TEST WAS PERFORMED AT MANUFACTURING SITE: THE TOUCHSCREEN WAS PLUGGED ON A FUNCTIONAL ROBOT STAND. THE TESTED TOUCHSCREEN DID NOT SWITCH ON. THE ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED AS THE TOUCHSCREEN IS PROVIDED BY A SUPPLIER AND NO REWORK IS PLANNED FOR THIS PART. THE TOUCHSCREEN WAS REPLACED ON 25-MAR-2018. CORRECTED DATA: DATE OF THIS REPORT. MANUFACTURER. ADDITIONAL DEVICE INFORMATION. DEVICE AVAILABILITY. OFFICE CONTACT - MANUFACTURING SITE. DATE RECEIVED BY MANUFACTURER. IF FOLLOW-UP, WHAT TYPE. DEVICE EVALUATED BY MANUFACTURER. EVALUATION CODE. REMEDIAL ACTION." } ], "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": "10/26/2018" } ] }