{ "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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ONCE THE EVALUATION WILL BE PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. NO CODE AVAILABLE' WAS SELECTED AS THERE WAS A DELAY GREATER THAN 30 MINUTES ON THE SURGERY DUE TO THIS EVENT AND BECAUSE THE SURGERY WAS ABORTED." }, { "mdr_text_key": "101689486", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A REGISTRATION PHASE THE ROBOT ARM LOST COMMUNICATION WITH CONTROLLER AND THE SURGEON DECIDED TO ABORT THE SURGERY." }, { "mdr_text_key": "310459973", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "IT WAS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE INCIDENT. THE ATTEMPTS TO RESTORE THE COMMUNICATION WITH THE ROBOT ARM DURING THE SURGERY HAD DELETED PART OF THE SURGERY DATA LOG. FIELDS UPDATED: DATE OF THIS REPORT. IF FOLLOW-UP, WHAT TYPE. DEVICE EVALUATED BY MANUFACTURER. EVALUATION CODE. DATE RECEIVED BY MANUFACTURER." }, { "mdr_text_key": "130550199", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "IT HAS BEEN IDENTIFIED DURING INTERNAL REVIEW THAT THE REPORTED EVENT DATE WAS NOT CORRECT. THE EVENT DATE WAS INITIALLY RECORDED AS (B)(6) 2018, HOWEVER THIS DATE SHOULD HAVE BEEN (B)(6) 2018. THIS MEDWATCH REPORT HAS BEEN SUBMITTED TO PROVIDE THE CORRECT EVENT DATE. THIS CORRECTION DOES NOT IMPACT THE TIMELINESS OF THE PREVIOUS REPORTS OR THE INVESTIGATION CONCLUSIONS." } ], "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": "04/20/2018;06/29/2018" } ] }