{ "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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AFTER LOGS AND ROBOT CHECKS THE FSE NOTICED THAT THE OPTICAL DISTANCE SENSOR CONNECTOR WAS LOOSE. HE SCREWED THE CONNECTOR AND IT WAS POSSIBLE TO PERFORM THE CONTACTLESS REGISTRATION (E.G. THE MEASUREMENT WAS NOT INTERRUPTED ANYMORE)." }, { "mdr_text_key": "312109270", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THE CONTACTLESS REGISTRATION COULD NOT BE COMPLETED. DEVICE HISTORY RECORD REVIEW AND COMPLAINT HISTORY REVIEW DID NOT IDENTIFY CONTRIBUTING FACTORS. THE SUBJECT PARTS, THE OPTICAL DISTANCE SENSOR AND ITS ASSOCIATED LASER OFFSET PLATE WERE RETURNED TO THE MANUFACTURING SITE FOR INVESTIGATION. A VISUAL INSPECTION OF THE PART DID NOT REVEAL ANY NOTICEABLE DAMAGE. A FUNCTIONAL TEST HAS BEEN PERFORMED WITH THE RETURNED PARTS, SHOWING THEY ARE FULLY FUNCTIONAL. THE FIELD SERVICE ENGINEER HAD INDICATED THAT THE OPTICAL DISTANCE SENSOR CONNECTOR WAS LOOSE (NOTE: THE CONNECTOR THAT LINKS TO THE ROBOT ARM). HE SCREWED IT BACK WHICH RESOLVED THE ISSUE. IT IS THEREFORE NORMAL THAT THE ISSUE COULD NOT BE REPRODUCED AT THE MANUFACTURING SITE. ON THIS OCCASION, THE CAUSE FOR THE LOOSENING IS NOT KNOWN." }, { "mdr_text_key": "162428777", "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": "162428778", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "DURING A SURGERY WHERE THE FIELD SERVICE ENGINEER (FSE) WAS PRESENT THE SURGEON TOLD HIM THAT ON TUESDAY(B)(6) 2019 THE CONTACTLESS REGISTRATION COULD NOT BE COMPLETED, DESPITE HAVING BEEN TRIED SEVERAL TIMES (7 ATTEMPTS MADE), AND THAT THEREFORE THE SURGERY WAS CANCELLED. AFTER LOGS AND ROBOT CHECKS THE FSE NOTICED THAT THE OPTICAL DISTANCE SENSOR CONNECTOR WAS LOOSE. HE SCREWED THE CONNECTOR AND IT WAS POSSIBLE TO PERFORM THE CONTACTLESS REGISTRATION (E.G. THE MEASUREMENT WAS NOT INTERRUPTED ANYMORE)." } ], "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": "11/21/2019" } ] }