{ "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": "3009185973-2019-00283", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20190827", "manufacturer_address_2": "", "pma_pmn_number": "K101791", "date_of_event": "20190731", "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": [ "DISTRIBUTOR", "HEALTH PROFESSION" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "CH", "manufacturer_contact_area_code": "", "date_added": "20190827", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "731773", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190827", "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": "ROSA", "catalog_number": "ROSAS00005", "lot_number": "2.5.8.4", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200302", "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", "Computer Software Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "03/02/2020;09/11/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250730", "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": "20190827", "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": "20201009", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8933924", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20190731", "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": "320347629", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "REPORTEDLY, IT WAS NOT POSSIBLE TO CONNECT TO THE ROBOT ARM, EXCEPT IN MAINTENANCE MODE. EVENT SUMMARY, DEVICE HISTORY RECORD REVIEW AND COMPLAINT HISTORY REVIEW DID NOT IDENTIFY ANY CONTRIBUTING FACTORS. THE INITIAL INVESTIGATION INDICATED THAT THE ISSUE WHICH OCCURRED ON THE EVENT DAY WAS DUE TO THE A KNOWN SOFTWARE ISSUE. HOWEVER, THIS SOFTWARE ISSUE IS SUPPOSED TO BE RANDOM AND NOT SYSTEMATIC. EVENTUALLY, THE ROBOT ARM COULD NOT BE CONNECTED ANYMORE, EVEN THROUGH THE MAINTENANCE SESSION. THEREFORE THE ROBOT PC WAS RETURNED FOR ANALYSIS AND THE ISSUE COULD BE INVESTIGATED AND REPRODUCED AT THE MANUFACTURING SITE. THE ANALYSIS LED TO THE FOLLOWING OBSERVATIONS : - THE NETWORK RTX CARD WAS INCORRECTLY INSTALLED (RUNNING UNDER WINDOWS INSTEAD OF RTX). SINCE SOME TROUBLESHOOTING WAS PERFORMED TO TRY TO SOLVE THE ISSUE IN NOVEMBER 2019, IT IS BELIEVED THAT THIS TROUBLESHOOTING MIGHT HAVE UNEXPECTEDLY PROVOKED THIS INSTALLATION ISSUE, LEADING TO THE REPORTED FAILURE TO CONNECT TO THE ROBOT ARM. - THE GRAPHIC CARD FOUND IN THE PC (AMD RADEON R5-430) WAS DIFFERENT FROM THE ORIGINAL ONE PROVIDED (NVIDIA GEFORCE GTS 240) -> THE DISTRIBUTOR OR THE USER VERY PROBABLY REPLACED THE CARD AND DID NOT PROPERLY INSTALL IT. - AFTER THE REINSTALLATION OF THE GRAPHIC CARD, THE ISSUE RELATED TO THE KNOWN SOFTWARE ISSUE COULD BE REPRODUCED SYSTEMATICALLY THROUGH THE USER SESSION. HOWEVER, THE ARM COULD STILL BE CONNECTED SUCCESSFULLY THROUGH THE MAINTENANCE SESSION. THE ROOT CAUSE FOR THE REPORTED FAILURE TO CONNECT TO THE ROBOT ARM THROUGH THE USER SESSION IS ASSUMED TO BE DUE TO THIS UNEXPECTED GRAPHIC CARD INSTALLED, AS THIS GRAPHIC CARD MODEL WAS NOT VALIDATED ON THE SUBJECT DEVICE. A REPLACEMENT PC WILL BE PROVIDED TO THE CUSTOMER IN ORDER TO SOLVE THE ISSUE." }, { "mdr_text_key": "320347630", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ON JULY 31, THE ROBOTIC ARM FAILED TO CONNECT. AFTER INSPECTION, WE CAN'T SOLVE THIS PROBLEM. THE FINAL SITUATION AS BELOW: - WHEN ENTERING THE ROSA APPLICATION INTERFACE, IT IS IMPOSSIBLE TO CONNECT ROBOTIC ARM. - WHEN ENTERING MAINTENANCE INTERFACE, FIRST OPEN ROSARIO SOFTWARE, THEN OPEN ROSANNA SOFTWARE, THE ROBOTIC ARM WORK WELL, OTHERWISE IT CAN'T. IT WAS REPORTED THAT DUE TO THIS EVENT THE SURGERY WAS POSTPONED FOR ONE DAY, WITHOUT REPORTED IMPACT ON THE PATIENT." }, { "mdr_text_key": "155649564", "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": "155649565", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(6) THE ROBOTIC ARM FAILED TO CONNECT. AFTER INSPECTION, WE CAN'T SOLVE THIS PROBLEM. THE FINAL SITUATION AS BELOW: WHEN ENTERING THE ROSA APPLICATION INTERFACE, IT IS IMPOSSIBLE TO CONNECT ROBOTIC ARM. WHEN ENTERING MAINTENANCE INTERFACE, FIRST OPEN ROSARIO SOFTWARE, THEN OPEN ROSANNA SOFTWARE, THE ROBOTIC ARM WORK WELL, OTHERWISE IT CAN'T. IT WAS REPORTED THAT DUE TO THIS EVENT THE SURGERY WAS POSTPONED FOR ONE DAY, WITHOUT REPORTED IMPACT ON THE PATIENT." }, { "mdr_text_key": "317656254", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "CORRECTED DATA: - B4 DATE OF THIS REPORT - 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": "317656255", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ON JULY 31, THE ROBOTIC ARM FAILED TO CONNECT. AFTER INSPECTION, WE CAN'T SOLVE THIS PROBLEM. THE FINAL SITUATION AS BELOW: - WHEN ENTERING THE ROSA APPLICATION INTERFACE, IT IS IMPOSSIBLE TO CONNECT ROBOTIC ARM. - WHEN ENTERING MAINTENANCE INTERFACE, FIRST OPEN ROSARIO SOFTWARE, THEN OPEN ROSANNA SOFTWARE, THE ROBOTIC ARM WORK WELL, OTHERWISE IT CAN'T. IT WAS REPORTED THAT DUE TO THIS EVENT THE SURGERY WAS POSTPONED FOR ONE DAY, WITHOUT REPORTED IMPACT ON THE PATIENT." } ], "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;10/09/2020" } ] }