{ "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. 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HE TOLD THAT THE LED NEEDS TO BE FIXED. IN THE SAME TIME, THE DISPLAY OF THE ROBOT SEEMS TO BE NOT THE MAIN DISPLAY. THE CAMERA DISPLAY SHOWS MORE INFORMATION ON THE START UP (BIOS MESSAGE). THIS SHOULD BE CHANGED TO HAVE TO ROBOT DISPLAY SHOWING THIS. THIS WILL ALSO HELP ON THE ISSUE WITH THE LED." }, { "mdr_text_key": "315959072", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DEVICE HISTORY RECORD REVIEW AND COMPLAINT HISTORY REVIEW DID NOT IDENTIFY CONTRIBUTING FACTORS. AN INSPECTION OF THE ACTUAL SUSPECTED DEVICE HAS BEEN PERFORMED. THIS ANALYSIS CONCLUDED THAT THE LED ISSUE ON THE CENTRAL UNIT RESTART BUTTON WAS DUE TO A FALSE CONTACT IN THE ELECTRIC PANEL. THE ISSUE DID NOT IMPACT THE ROBOT FUNCTIONING AND IS NOT RELATED TO THE CASE ABORTION. THE STARTUP MESSAGE PROVIDED BY THE BIOS IS SUPPOSED TO BE ON THE CAMERA STAND SCREEN AS IT WAS DESIGN TO BE THE MAIN SCREEN. IT DOES NOT IMPACT THE USE OF THE ROBOT AND ONCE THE SOFTWARE MAIN MENU IS DISPLAYED, THE SCREENS ARE DUPLICATED AS EXPECTED. THIS IS A NORMAL BEHAVIOR OF THE DEVICE." }, { "mdr_text_key": "317750161", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DEVICE HISTORY RECORD REVIEW AND COMPLAINT HISTORY REVIEW DID NOT IDENTIFY CONTRIBUTING FACTORS. AN INSPECTION OF THE ACTUAL SUSPECTED DEVICE HAS BEEN PERFORMED. THIS ANALYSIS CONCLUDED THAT THE LED ISSUE ON THE CENTRAL UNIT RESTART BUTTON WAS DUE TO A FALSE CONTACT IN THE ELECTRIC PANEL. THE ISSUE DID NOT IMPACT THE ROBOT FUNCTIONING AND IS NOT RELATED TO THE CASE ABORTION." }, { "mdr_text_key": "317750162", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE FIELD SERVICE ENGINEER RECEIVED A CALL FROM THE SURGEON. HE TOLD THAT THE LED NEEDS TO BE FIXED. IN THE SAME TIME, THE DISPLAY OF THE ROBOT SEEMS TO BE NOT THE MAIN DISPLAY. THE CAMERA DISPLAY SHOWS MORE INFORMATION ON THE START UP (BIOS MESSAGE). THIS SHOULD BE CHANGED TO HAVE TO ROBOT DISPLAY SHOWING THIS. THIS WILL ALSO HELP ON THE ISSUE WITH THE LED." }, { "mdr_text_key": "173679099", "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": "173679100", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE FIELD SERVICE ENGINEER RECEIVED A CALL FROM THE SURGEON. HE TOLD THAT THE LED NEEDS TO BE FIXED. IN THE SAME TIME, THE DISPLAY OF THE ROBOT SEEMS TO BE NOT THE MAIN DISPLAY. THE CAMERA DISPLAY SHOWS MORE INFORMATION ON THE START UP (BIOS MESSAGE). THIS SHOULD BE CHANGED TO HAVE TO ROBOT DISPLAY SHOWING THIS. THIS WILL ALSO HELP ON THE ISSUE WITH THE LED." } ], "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": "05/27/2020;06/09/2020" } ] }