{ "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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(B)(6) CALLED THE FIELD SERVICE ENGINEER ON (B)(6) 2019 TO INFORM THAT THE ROBOT TURNED ON BUT NOTHING DISPLAYED ON THE SCREEN. ANOTHER FSE CALLED AND SUGGEST TO DR. (B)(6) AND HIS TEAM TO CHECK IF THE ELECTRICAL TRANSFORMER OF THE SCREEN WAS WELL PLUGGED. THEY DID IT AND THE SCREEN WORKED AGAIN. IT SEEMS THAT THERE WAS A DISCONNECTION DURING THE TRANSPORTATION OF THE ROBOT. THE SURGEON HAS DECIDED TO POSTPONE THE CASE TO AVOID ANY RISK BEFORE THE TECHNICAL INTERVENTION." }, { "mdr_text_key": "317553206", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "CORRECTED DATA: B4: DATE OF THIS REPORT. G4: DATE RECEIVED BY MANUFACTURER. H2: IF FOLLOW-UP, WHAT TYPE. H3: DEVICE EVALUATED BY MANUFACTURER. H6: EVENT PROBLEM AND EVALUATION CODES. H10: ADDITIONAL NARRATIVES/DATA. ACCORDING TO THE COMPLAINT DESCRIPTION, NOTHING DISPLAYED ON THE SCREEN OF THE ROBOT DESPITE THAT IT WAS TURNED ON. AS MENTIONED BY THE REPORTER, THE SCREEN WORKED AGAIN AFTER A CHECK OF THE ELECTRICAL TRANSFORMER CONNECTION OF THE SCREEN. THE UNPLUGGING OF THE ELECTRICAL TRANSFORMER DURING THE TRANSPORTATION OF THE ROBOT WAS LIKELY CAUSING THE EVENT. NO NEW EVENT RELATED TO THIS ISSUE HAS BEEN REPORTED SINCE THIS EVENT." }, { "mdr_text_key": "182201816", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(B)(4). THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION IS PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED." }, { "mdr_text_key": "182201818", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE SURGEON CALLED THE FIELD CLINICAL ENGINEER ON THE (B)(6) 2019 TO INFORM THAT THE ROBOT TURNED ON BUT NOTHING DISPLAYED ON THE SCREEN. A FIELD TECHNICAL ENGINEER CALLED AND SUGGEST TO THE SURGEON AND HIS TEAM TO CHECK IF THE ELECTRICAL TRANSFORMER OF THE SCREEN WAS WELL PLUGGED. THEY DID IT AND THE SCREEN WORKED AGAIN. IT SEEMS THAT THERE WAS A DISCONNEXION DURING THE TRANSPORTATION OF THE ROBOT. THE SURGEON HAS DECIDED TO POSTPONE THE CASE TO AVOID ANY RISK BEFORE A TECHNICAL INTERVENTION." } ], "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": "04/14/2020" } ] }