{ "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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A DHR REVIEW AND COMPLAINT HISTORY REVIEW DID NOT IDENTIFY ANY CONTRIBUTING FACTORS. AN ANALYSIS OF THE DATA LOGS FROM THE SUBJECT EVENT HAS BEEN PERFORMED. THIS ANALYSIS CONCLUDED THAT THE CLEARANCE PROCEDURE COULD NOT BE PROCEEDED, AFTER THAT THE ROBOT ARM MOVEMENT WAS INTERRUPTED BETWEEN PARKING TO HOME POSITION, DUE TO THE CALIBRATION OF THE FORCE SENSOR WHICH WAS NOT YET DONE. THIS ISSUE IS A KNOWN ANOMALY. FURTHERMORE, ANALYSIS SHOWS THAT THE ROBOT ARM MOVEMENT WAS INTERRUPTED BY A VIGILANCE DEVICE FAILURE WHICH WAS PROVOKED EITHER BY A MOMENTARY BREAKDOWN OR AN INCORRECT CONNECTION OF THE FOOT PEDAL. ON THIS OCCASION IT IS NOT POSSIBLE TO DETERMINE WHICH WAS THE ROOT CAUSE FOR THE ISSUE. (B)(4)." }, { "mdr_text_key": "171626580", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE SURGEON CALL THE COMPANY FIELD SERVICE ENGINEER ON 15-NOV-2019. SHE TOLD, THAT THE ROBOT HAD AN UNDISCOVERABLE ERROR. SHE TOLD THEY TRIED SEVERAL TIMES TO RESTART, BUT THE ROBOT DIDN´T START AGAIN. FINALLY THE SURGERY WAS CANCELLED. THE SURGEON ASKED FOR A CHECK, WHAT HAPPENED." } ], "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": "" } ] }