{ "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 IS PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. UNIQUE IDENTIFIER (UDI) #: (B)(4)." }, { "mdr_text_key": "217325499", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "WHEN REGISTERING, THE ROBOT STARTED TO MOVE ON ITS OWN IN DIFFERENT DIRECTIONS. THE CLINICAL REPRESENTATIVE (CR) SHUT DOWN THE ROBOT AND RECALIBRATED THE POINTER PROBE TO REGISTER. THE ARM STOPPED DRIFTING ON ITS OWN, BUT WAS STILL DIFFICULT TO WORK WITH. THE CR AND THE SURGEON DECIDED TO CONTINUE ON WITH THE SURGERY SINCE THEY GOT A 0.7 RMS AND THE VERIFICATION LOOKED GOOD. WHEN THEY MERGED THE INTER-OPERATIVE SCAN, THE BIOPSY NEEDLE WAS ABOUT 9MM LATERAL FROM THE PLANNED TRAJECTORY. A CONVERTED SURGERY HAD TO BE DONE: THE SURGEON HAD TO USE THE STEALTH TO COMPLETE THE PROCEDURE. THERE WAS NO INJURY TO THE PATIENT BUT A DELAY > 30 MINUTES WAS OBSERVED." }, { "mdr_text_key": "323803776", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A FULL ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED AND CONCLUDED THAT: FOR THE FIRST EVENT: THE ARM DRIFT ISSUE WAS CONFIRMED BY ADDITIONAL TESTS PERFORMED ON THE DEVICE ON (B)(6) 2020. THE TESTS PERMITTED TO FIND THAT THE FORCE SENSOR BECAME DEFECTIVE. IT WAS REPLACED ON (B)(6) 2020 WHICH SOLVED THE ISSUE. FOR THE SECOND EVENT: THE APPARENT INACCURACY WAS DUE TO AN INACCURATE FUSION. ANALYSIS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. THE FUSION OF THE POST-OPERATIVE EXAM WAS PERFORMED AGAIN ON MANUFACTURING SITE, AND IT CONCLUDED THAT THE ENTRY POINT OF THE TRAJECTORY WAS ACCURATE. CORRECTED DATA: B4: DATE OF THIS REPORT. G3: DATE RECEIVED BY MANUFACTURER. H2: IF FOLLOW-UP, WHAT TYPE. H3: DEVICE EVALUATED BY MANUFACTURER. H6: ADVERSE EVENT PROBLEM. H10: ADDITIONAL NARRATIVES/DATA." }, { "mdr_text_key": "323803777", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "WHEN REGISTERING, THE ROBOT STARTED TO MOVE ON ITS OWN IN DIFFERENT DIRECTIONS. THE CLINICAL REPRESENTATIVE (CR) SHUT DOWN THE ROBOT AND RECALIBRATED THE POINTER PROBE TO REGISTER. THE ARM STOPPED DRIFTING ON ITS OWN, BUT WAS STILL DIFFICULT TO WORK WITH. THE CR AND THE SURGEON DECIDED TO CONTINUE ON WITH THE SURGERY SINCE THEY GOT A 0.7 RMS AND THE VERIFICATION LOOKED GOOD. WHEN THEY MERGED THE INTER-OPERATIVE SCAN, THE BIOPSY NEEDLE WAS ABOUT 9MM LATERAL FROM THE PLANNED TRAJECTORY. A CONVERTED SURGERY HAD TO BE DONE: THE SURGEON HAD TO USE THE STEALTH TO COMPLETE THE PROCEDURE. THERE WAS NO INJURY TO THE PATIENT BUT A DELAY > 30 MINUTES WAS OBSERVED." } ], "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": "04/23/2021" } ] }