{ "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": "3009185973-2018-00225", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20180817", "manufacturer_address_2": "", "pma_pmn_number": "PK101791", "date_of_event": "20180810", "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": "20180817", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "634075", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20180817", "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": "N/A", "lot_number": "2.5.8.4", "other_id_number": "", "device_availability": "Yes", "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": [ "Break", "Entrapment of Device", "Mechanical Jam", "Break", "Entrapment of Device", "Mechanical Jam" ], "reporter_state_code": "MI", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "01/24/2019", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250819", "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": "20180817", "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": "20190130", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "7792640", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20180810", "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": "117432625", "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": "117432626", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AT THE END OF THE CASE WHEN THE SURGEON WAS TRYING TO MOVE THE ARM CLEAR IN FREE/ FAST MODE, THE FORCE SENSOR CABLE GOT STUCK AND BENT. A COMMUNICATION ERROR THEN OCCURRED AND THE ROBOT SHUT DOWN. SINCE THIS WAS THE END OF THE CASE AND THE ROBOT WAS NOT ATTACHED TO THE PATIENT (PATIENT¿S HEAD HOLDER WAS ONLY ATTACHED TO THE BED), THE LASERS WERE PLACED BEFORE RESTARTING THE ROBOT AND ROLLING IT AWAY FROM THE PATIENT. A MEDTECH REPRESENTATIVE WAS PRESENT AT THE TIME OF THE EVENT AND ATTEMPTED TO RESOLVE THE ISSUE, HOWEVER THE DAMAGE SUSTAINED BY THE CABLE CAUSED FURTHER COLLISION ERRORS. AS THIS ISSUE OCCURRED AFTER THE ROSA PORTION OF THE SURGERY WAS FINISHED, THERE WAS NO DELAY AND THE PATIENT WAS NOT AFFECTED. HOWEVER, DUE TO THE DAMAGE, THE NEXT SCHEDULED SURGERY WITH ROSA WAS CANCELLED. THE SURGEON HAD ANOTHER NAVIGATION SYSTEM THAT HE USED INSTEAD." }, { "mdr_text_key": "312102634", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THE THE FORCE SENSOR CABLE GOT STUCK AND BENT DURING A ROBOT ARM MOVEMENT, CAUSING A COMMUNICATION ERROR. THE CONNECTOR ALSO GOT DAMAGED. EVENT SUMMARY, DEVICE HISTORY RECORD REVIEW AND COMPLAINT HISTORY REVIEW DID NOT IDENTIFY CONTRIBUTING FACTORS. A PREVIOUS COMPLAINT WAS RECEIVED FOR THIS DEVICE DUE TO A DISCONNECTION OF THE POWER CABLE. THE TECHNICAL INVESTIGATION CONFIRMED THAT TWO COMMUNICATION ERRORS OCCURRED DUE TO THE PART BEING DAMAGED. USER VIGILANCE IS REQUIRED TO ENSURE THAT THE CABLE IS NOT PINCHED, HOWEVER THE CABLE IS NOT ALWAYS VISIBLE ESPECIALY WHEN THE DEVICE IS DRAPED. THE ROOT CAUSE IDENTIFIED IS A DESIGN ISSUE. PATIENT CODE(S): 3191 - NO CODE AVAILABLE: THE CASE THAT WAS PLANNED LATER ON THE DAY WAS CONVERTED, THE ROSA DEVICE WAS NOT USED TO PERFORM IT." }, { "mdr_text_key": "312102635", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "AT THE END OF THE CASE WHEN THE SURGEON WAS TRYING TO MOVE THE ARM CLEAR IN FREE/ FAST MODE, THE FORCE SENSOR CABLE GOT STUCK AND BENT. A COMMUNICATION ERROR THEN OCCURRED AND THE ROBOT SHUT DOWN. SINCE THIS WAS THE END OF THE CASE AND THE ROBOT WAS NOT ATTACHED TO THE PATIENT (PATIENT¿S HEAD HOLDER WAS ONLY ATTACHED TO THE BED), THE LASERS WERE PLACED BEFORE RESTARTING THE ROBOT AND ROLLING IT AWAY FROM THE PATIENT. A MEDTECH REPRESENTATIVE WAS PRESENT AT THE TIME OF THE EVENT AND ATTEMPTED TO RESOLVE THE ISSUE, HOWEVER THE DAMAGE SUSTAINED BY THE CABLE CAUSED FURTHER COLLISION ERRORS. AS THIS ISSUE OCCURRED AFTER THE ROSA PORTION OF THE SURGERY WAS FINISHED, THERE WAS NO DELAY AND THE PATIENT WAS NOT AFFECTED. HOWEVER, DUE TO THE DAMAGE, THE NEXT SCHEDULED SURGERY WITH ROSA WAS CANCELLED. THE SURGEON HAD ANOTHER NAVIGATION SYSTEM THAT HE USED INSTEAD." } ], "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": "01/31/2019" } ] }