{ "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": "3009185973-2018-00255", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20181003", "manufacturer_address_2": "", "pma_pmn_number": "PK172444", "date_of_event": "20180925", "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": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20181003", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "772876", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20181003", "brand_name": "ROSA BRAIN", "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": "ROSAS00316", "catalog_number": "OPTICAL SENSOR", "lot_number": "ROSA3-277B", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20180928", "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": [ "Mechanical Problem", "Mechanical Problem" ], "reporter_state_code": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/27/2019", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250803", "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": "20181003", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Known Impact Or Consequence To Patient", "No Known Impact Or Consequence To Patient" ] } ], "distributor_city": "", "date_report": "20190529", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "7929352", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20180925", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "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": "122453630", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE EVENT IS CONSIDERED AS REPORTABLE REGARDING THE PATIENT IMPACT. INDEED, THE SURGERY WAS DELAYED OF MORE THAN 30 MINUTES WHICH IS CONSIDERED AS SERIOUS INJURY. THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION WILL BE PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. (B)(4)." }, { "mdr_text_key": "122453631", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS THE LASER WAS BEING MOVED FROM THE MEDIAL CANTHUS TO THE NOSE DURING REGISTRATION, THE LASER LIGHT TURNED OFF WITHOUT PRESSING ANY SWITCH OR DISCONNECTING THE CABLE. AFTER MOVING THE ARM AND DISTANCE SENSOR WIRE AROUND, THE LIGHT CAME BACK ON. HOWEVER, WHEN TRYING TO RECORD A POINT AFTER THE LIGHT WENT OFF AND CAME BACK ON, THERE WAS A DISTANCE CALIBRATION ERROR. THE LASER HAS BEEN COLLECTED FORM THE HOSPITAL AND WILL BE SHIPPED BACK. A NEW LASER IS BEING ORDERED FOR THE HOSPITAL. THE PATIENT WAS ASLEEP AND UNDER ANESTHESIA." }, { "mdr_text_key": "312104117", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "AS THE LASER WAS BEING MOVED FROM THE MEDIAL CANTHUS TO THE NOSE DURING REGISTRATION, THE LASER LIGHT TURNED OFF WITHOUT PRESSING ANY SWITCH OR DISCONNECTING THE CABLE. AFTER MOVING THE ARM AND DISTANCE SENSOR WIRE AROUND, THE LIGHT CAME BACK ON. HOWEVER, WHEN TRYING TO RECORD A POINT AFTER THE LIGHT WENT OFF AND CAME BACK ON, THERE WAS A DISTANCE CALIBRATION ERROR. THE LASER HAS BEEN COLLECTED FORM THE HOSPITAL AND WILL BE SHIPPED BACK. A NEW LASER IS BEING ORDERED FOR THE HOSPITAL. THE PATIENT WAS ASLEEP AND UNDER ANESTHESIA." }, { "mdr_text_key": "312104118", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT A FALSE CONTACT BETWEEN DISTANCE SENSOR AND ROBOT APPEARED LEADING THE DISTANCE SENSOR LIGHT TURN ON AND OFF. A DHR REVIEW AND A COMPLAINT HISTORY REVIEW WERE PERFORMED AND DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. FUNCTIONAL TEST WAS PERFORMED AT THE MANUFACTURING SITE AND CONFIRMED THE ISSUE HOWEVER INVESTIGATION DID NOT ALLOW TO DETERMINE THE CAUSE OF THE ISSUE." } ], "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": "05/29/2019" } ] }