{ "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": "3009185973-2018-00254", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20181004", "manufacturer_address_2": "", "pma_pmn_number": "PK101791", "date_of_event": "20180924", "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": "20181004", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "775303", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20181004", "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": "ROSAS00013", "catalog_number": "FORCE SENSOR INTERFACE", "lot_number": "N/A", "other_id_number": "", "device_availability": "No", "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": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "11/29/2018", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250818", "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": "20181004", "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 Code Available", "No Known Impact Or Consequence To Patient", "No Code Available" ] } ], "distributor_city": "", "date_report": "20181203", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "7933501", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20180924", "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": "122629097", "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": "122629098", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE ROBOT WAS PUT IN AXIAL SLOW, THEN FREE AND FAST TO CLEAR THE ARM AWAY FROM THE PATIENT. THE SURGEON STARTED MANEUVERING THE ARM AND SPINNING IT. AS THE SURGEON WAS MOVING IT, THE FORCE SENSOR CABLE GOT CAUGHT IN THE JOINT CAUSING IT TO RIP OUT OF THE FORCE SENSOR BLOCK. IN THE PROCESS, IT BENT A COUPLE OF PINS. THE PINS WERE STRAIGHTENED AND THE CABLE PLACED BACK, BUT EVERY TIME THE ARM WAS SET TO AUTOMATIC MODE, IT DETECTED A COLLISION. THE PATIENT WAS ASLEEP AND INCISION HAD ALREADY BEEN MADE. THREE OUT OF 10 ELECTRODES WERE PLACED BEFORE THE SURGERY HAD TO BE ABORTED." }, { "mdr_text_key": "292986094", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT PINS OF THE FORCE SENSOR CONNECTOR WERE DAMAGED. A DHR REVIEW AND A COMPLAINT HISTORY REVIEW WERE PERFORMED AND DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. THE DAMAGED PART WAS NOT AVAILABLE FOR INVESTIGATION THEREFORE THE FIELD SERVICE ENGINEER SENT PICTURES OF THE FORCE SENSOR CONNECTOR. PICTURES CONFIRMED THE DAMAGE. ACCORDING TO THE COMPLAINT DESCRIPTION THE CAUSE OF THIS ISSUE IF THE TRACTION APPLIED WHILE THE FORCE SENSOR CABLE WAS PINCHED IN THE ARM JOINT. THE CABLE LENGTH IS WITHIN THE SPECIFICATIONS. THE IFU DOES NOT PROVIDE ANY SPECIFIC INSTRUCTION TO AVOID PINCHING OF THE CABLE IN THE ROBOT ARM JOINTS. USER VIGILANCE IS REQUIRED TO ENSURE THAT THE CABLE IS NOT PINCHED IN THE JOINTS OF THE ROBOT ARM. HOWEVER AS THE STERILE DRAPES COULD POTENTIALLY OBSCURE VISIBILITY OF THE CABLE, THE USER MAY NOT NOTICE THE ISSUE UNTIL AFTER IT HAS OCCURRED. THEREFORE THE ROOT CAUSE OF THE ISSUE CAN BE CONSIDERED AS A DESIGN ISSUE. CORRECTED DATA: DATE OF THIS REPORT, DATE RECEIVED BY MANUFACTURER, IF FOLLOW-UP, WHAT TYPE, DEVICE EVALUATED BY MANUFACTURER, EVALUATION CODE." }, { "mdr_text_key": "292986095", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE ROBOT WAS PUT IN AXIAL SLOW, THEN FREE AND FAST TO CLEAR THE ARM AWAY FROM THE PATIENT. THE SURGEON STARTED MANEUVERING THE ARM AND SPINNING IT. AS THE SURGEON WAS MOVING IT, THE FORCE SENSOR CABLE GOT CAUGHT IN THE JOINT CAUSING IT TO RIP OUT OF THE FORCE SENSOR BLOCK. IN THE PROCESS, IT BENT A COUPLE OF PINS. THE PINS WERE STRAIGHTENED AND THE CABLE PLACED BACK, BUT EVERY TIME THE ARM WAS SET TO AUTOMATIC MODE, IT DETECTED A COLLISION. THE PATIENT WAS ASLEEP AND INCISION HAD ALREADY BEEN MADE. THREE OUT OF 10 ELECTRODES WERE PLACED BEFORE THE SURGERY HAD TO BE ABORTED." } ], "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": "12/04/2018" } ] }