{ "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": "3009185973-2020-00037", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20200213", "manufacturer_address_2": "", "pma_pmn_number": "K182417", "date_of_event": "20200130", "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": "20200213", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "170419", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200213", "brand_name": "ROSA ONE", "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": "OPTICAL DISTANCE SENSOR", "catalog_number": "ROSAS00316", "lot_number": "ROSA3-277B", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200225", "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": [ "Computer Software Problem", "Optical Problem", "Computer Software Problem", "Optical Problem" ], "reporter_state_code": "OH", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "02/25/2020;11/04/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250820", "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": "20200213", "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": "20201105", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "9705002", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20200130", "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": "318037957", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "CORRECTED DATA: - B4 DATE OF THIS REPORT - D4 CATALOG NUMBER - D10 DEVICE AVAILABILITY - G4 DATE RECEIVED BY MANUFACTURER - H2 IF FOLLOW-UP, WHAT TYPE - H3 DEVICE EVALUATED BY MANUFACTURER - H10 ADDITIONAL NARRATIVES/DATA." }, { "mdr_text_key": "318037958", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "PRIOR TO CONTACTLESS REGISTRATION, WHILE TRYING TO CALIBRATE THE LASER THE SITE RECEIVED THE ERROR 'ERROR WHILE INITIALIZING THE DISTANCE SENSOR. SWITCH OFF AND BACK ON THE DISTANCE SENSOR BEFORE TYING AGAIN'. IT WAS ALSO REPORTED THAT THEIR APPEARED TO BE TWO BEAMS ON THE CALIBRATION PLATE. THE SENSOR WAS SWITCHED OFF AND BACK ON AND THE USER STILL RECEIVED THE ERROR. THE ROBOT WAS THEN TURNED OFF AND REBOOTED AND THE LASER LENS WAS CLEANED. THE ERROR WAS STILL BEING RECEIVED SO THEY USED A DIFFERENT LASER. RESULTED IN ABOUT 45 MINUTE DELAY AS A SECOND LASER HAD TO BE RETRIEVED FROM ANOTHER ROBOT TO CONTINUE. THE CASE RESUMED AS NORMAL." }, { "mdr_text_key": "321663419", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THE OPTICAL DISTANCE SENSOR S/N (B)(6) CAUSED APPEARANCE OF THE FOLLOWING ERROR MESSAGE 'ERROR WHILE INITIALIZING THE DISTANCE SENSOR. SWITCH OFF AND BACK ON THE DISTANCE SENSOR BEFORE TYING AGAIN'. IT WAS ALSO REPORTED THAT THEIR APPEARED TO BE TWO OPTICAL DISTANCE SENSOR BEAMS ON THE ASSOCIATED LASER OFFSET PLATE S/N (B)(6). THE EVENT DESCRIBED IN THE COMPLAINT IS CONFIRMED BASED ON THE LASER BEAM PICTURE PROVIDED BY THE REPORTER. BOTH THE OPTICAL DISTANCE SENSOR AND THE LASER OFFSET PLATE WERE RETURNED AT THE MANUFACTURING SITE FOR EVALUATION. A TESTING WAS PERFORMED BY THE COMPLAINT HANDLER AND A SENIOR COMPLAINT SPECIALIST WITH THE RETURNED PARTS ON AN EQUIVALENT ROSA ONE DEVICE AT THE MANUFACTURING SITE. THE REPORTED ISSUE WAS REPRODUCED SUCCESSFULLY. THEREFORE THE OPTICAL DISTANCE SENSOR MALFUNCTION IS CONFIRMED. IT IS SUSPECTED THAT AN INTERNAL OPTICAL COMPONENT IS DISPLACED WHICH CAUSE A DIFFRACTION ISSUE. D4 UNIQUE IDENTIFIER (UDI) #: (B)(4) CORRECTED DATA: B4 DATE OF THIS REPORT, G4 DATE RECEIVED BY MANUFACTURER, H2 IF FOLLOW-UP, WHAT TYPE, H3 DEVICE EVALUATED BY MANUFACTURER, H4 DEVICE MANUFACTURER DATE, H6 EVENT PROBLEM AND EVALUATION CODES, H10 ADDITIONAL NARRATIVES/DATA AND UDI." }, { "mdr_text_key": "321663420", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "PRIOR TO CONTACTLESS REGISTRATION, WHILE TRYING TO CALIBRATE THE LASER THE SITE RECEIVED THE ERROR 'ERROR WHILE INITIALIZING THE DISTANCE SENSOR. SWITCH OFF AND BACK ON THE DISTANCE SENSOR BEFORE TYING AGAIN'. IT WAS ALSO REPORTED THAT THEIR APPEARED TO BE TWO BEAMS ON THE CALIBRATION PLATE. THE SENSOR WAS SWITCHED OFF AND BACK ON AND THE USER STILL RECEIVED THE ERROR. THE ROBOT WAS THEN TURNED OFF AND REBOOTED AND THE LASER LENS WAS CLEANED. THE ERROR WAS STILL BEING RECEIVED SO THEY USED A DIFFERENT LASER. RESULTED IN ABOUT 45 MINUTE DELAY AS A SECOND LASER HAD TO BE RETRIEVED FROM ANOTHER ROBOT TO CONTINUE. THE CASE RESUMED AS NORMAL." }, { "mdr_text_key": "189881086", "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": "189881087", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "PRIOR TO CONTACTLESS REGISTRATION, WHILE TRYING TO CALIBRATE THE LASER THE SITE RECEIVED THE ERROR 'ERROR WHILE INITIALIZING THE DISTANCE SENSOR. SWITCH OFF AND BACK ON THE DISTANCE SENSOR BEFORE TYING AGAIN'. IT WAS ALSO REPORTED THAT THEIR APPEARED TO BE TWO BEAMS ON THE CALIBRATION PLATE. THE SENSOR WAS SWITCHED OFF AND BACK ON AND THE USER STILL RECEIVED THE ERROR. THE ROBOT WAS THEN TURNED OFF AND REBOOTED AND THE LASER LENS WAS CLEANED. THE ERROR WAS STILL BEING RECEIVED SO THEY USED A DIFFERENT LASER. RESULTED IN ABOUT 45 MINUTE DELAY AS A SECOND LASER HAD TO BE RETRIEVED FROM ANOTHER ROBOT TO CONTINUE. THE CASE RESUMED AS NORMAL." } ], "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": "03/16/2020;11/05/2020" } ] }