{ "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": "210005096", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE 25-SEP-2020, THE NEUROSURGEON ASKED TO HAVE A COMPANY CLINICAL REPRESENTATIVE PRESENT TO SUPPORT A CASE AND CHECK IF THERE ARE NO PROBLEM WITH THE SCREEN. THE CASE WAS SUPPORTED BY PHONE: THE NEUROSURGEON CALLED BECAUSE ROBOT BOOTING FOR 2 SECONDS AND THEN SHUTDOWN (START BUTTON IS BECOMING RED AFTER 2 SECONDS). NO SOLUTION FOUND, SURGERY WAS ABORTED." }, { "mdr_text_key": "322525721", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "NO DATA WERE AVAILABLE FOR ANALYSIS. THE DESCRIBED ISSUE WAS THAT A MESSAGE WAS DISPLAYED AT THE START OF THE COMPUTER, INDICATING 'BOOT GUARD VERIFIED FAILED, SYSTEM WILL SHUT DOWN'. TWO WEEKS LATER, WHEN STARTED, THE COMPUTER BOOTED FOR TWO SECONDS, THEN THE START BUTTON LIT ON, AND THE COMPUTER SHUT DOWN. AFTER SEVERAL ATTEMPTS, IT COULD NOT BE STARTED. THE BIOS WAS UPGRADED TO THE LAST VERSION RELEASED 'PRECISION_TOWER_3620_2.15.0, AND IT CORRECTED THE ISSUE. BASED ON THE INVESTIGATION PERFORMED, THE TECHNICAL ROOT CAUSE OF THE EVENT WAS DETERMINED TO BE A BIOS VERSION ISSUE." }, { "mdr_text_key": "322525722", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE (B)(6) 2020, THE NEUROSURGEON ASKED TO HAVE A COMPANY CLINICAL REPRESENTATIVE PRESENT TO SUPPORT A CASE AND CHECK IF THERE ARE NO PROBLEM WITH THE SCREEN. THE CASE WAS SUPPORTED BY PHONE: THE NEUROSURGEON CALLED BECAUSE ROBOT BOOTING FOR 2 SECONDS AND THEN SHUTDOWN (START BUTTON IS BECOMING RED AFTER 2 SECONDS). NO SOLUTION FOUND, SURGERY WAS ABORTED." } ], "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": "01/14/2021" } ] }