{ "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": "217645184", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "DURING BRAIN BIOPSY CASE WITH THE SURGEON, SIGNIFICANT INACCURACY WAS EXPERIENCED. PRIOR TO THE START OF THE CASE, THERE WERE ISSUES MERGING THE PRE-OP O-ARM CT SCAN TO EXISTING MRI SCAN (THIS MERGE ISSUE HAS BEEN ADDRESSED IN ANOTHER COMPLAINT). IMPROVED SUCCESS WAS SEEN WHEN MERGING WITH EXISTING CT SCAN. INTRAOPERATIVELY, THE BIOPSY NEEDLE WAS PLACED ALONG THE TRAJECTORY AND UPON ATTEMPT TO ASPIRATE THE ABSCESS, NO FLUID WAS DRAWN, WHICH WAS NOT EXPECTED. AT THIS TIME, THE SAMPLE WAS BROUGHT TO THE LAB AND DETERMINED NOT TO BE DESIRED TISSUE. AT THIS TIME, IT WAS NECESSARY TO OBTAIN AN ADDITIONAL INTRA-OPERATIVE O-ARM CT SCAN TO ENSURE THE LOCATION OF THE NEEDLE. THERE WERE ISSUES WITH THIS O-ARM SCAN AS WELL, HOWEVER EXTENSIVE EFFORT WAS MADE TO MANUALLY MERGE THIS SCAN. IT WAS DETERMINED THAT THE NEEDLE WAS OFF THE TARGET BY APPROXIMATELY 6MM. A NEW TRAJECTORY WAS PLANNED USING THIS INFORMATION TO CORRECT FOR THE ERROR. UPON ASPIRATION OF THE BIOPSY NEEDLE AT THE NEW TRAJECTORY, FLUID WAS DRAWN AS INITIALLY EXPECTED AND THE DESIRED TISSUE WAS OBTAINED. THE DELAY DUE TO THIS ISSUE TOOK APPROXIMATELY 45 MINUTES ADDITIONAL ANESTHESIA TO THE PATIENT WAS NEEDED DUE TO THIS DELAY." }, { "mdr_text_key": "322651941", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "DURING BRAIN BIOPSY CASE WITH THE SURGEON, SIGNIFICANT INACCURACY WAS EXPERIENCED. PRIOR TO THE START OF THE CASE, THERE WERE ISSUES MERGING THE PRE-OP O-ARM CT SCAN TO EXISTING MRI SCAN (THIS MERGE ISSUE HAS BEEN ADDRESSED IN ANOTHER COMPLAINT). IMPROVED SUCCESS WAS SEEN WHEN MERGING WITH EXISTING CT SCAN. INTRAOPERATIVELY, THE BIOPSY NEEDLE WAS PLACED ALONG THE TRAJECTORY AND UPON ATTEMPT TO ASPIRATE THE ABSCESS, NO FLUID WAS DRAWN WHICH WAS NOT EXPECTED. AT THIS TIME, THE SAMPLE WAS BROUGHT TO THE LAB AND DETERMINED NOT TO BE DESIRED TISSUE. AT THIS TIME, IT WAS NECESSARY TO OBTAIN AN ADDITIONAL INTRA-OPERATIVE O-ARM CT SCAN TO ENSURE THE LOCATION OF THE NEEDLE. THERE WERE ISSUES WITH THIS O-ARM SCAN AS WELL, HOWEVER EXTENSIVE EFFORT WAS MADE TO MANUALLY MERGE THIS SCAN. IT WAS DETERMINED THAT THE NEEDLE WAS OFF THE TARGET BY APPROXIMATELY 6MM. A NEW TRAJECTORY WAS PLANNED USING THIS INFORMATION TO CORRECT FOR THE ERROR. UPON ASPIRATION OF THE BIOPSY NEEDLE AT THE NEW TRAJECTORY, FLUID WAS DRAWN AS INITIALLY EXPECTED AND THE DESIRED TISSUE WAS OBTAINED. THE DELAY DUE TO THIS ISSUE TOOK APPROXIMATELY 45 MINUTES ADDITIONAL ANESTHESIA TO THE PATIENT WAS NEEDED DUE TO THIS DELAY." }, { "mdr_text_key": "322651942", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A FULL ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED AND CONCLUDED THAT NO FAILURE OF THE ROSA DEVICE WAS FOUND AS THERE WAS NO INACCURACY AT THE ENTRY POINT OF THE TRAJECTORY. THE INACCURACY AT THE TARGET POINT IS NOT RELATED TO ROSA DEVICE PERFORMANCE." } ], "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": "01/29/2021" } ] }