BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE

    MDR report key: 11093661 · Received December 30, 2020

    Report

    Report Number
    3009185973-2020-00334
    Event Type
    Malfunction
    Date Received
    December 30, 2020
    Date of Event
    December 2, 2020
    Report Date
    February 19, 2021
    Manufacturer
    MEDTECH SA
    Product Code
    HAW
    PMA / PMN Number
    K200511
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS CONCLUDED THAT THE EXAM DISAPPEARANCE FROM THE USB LIST WAS PROBABLY DUE TO THE FACT THAT WINDOWS DETECTED AN ISSUE WITH THE USB, TRIED TO REPAIR IT AUTOMATICALLY AND MODIFIED THE FILE. THE FILE DID NOT APPEAR ANYMORE IN THE ROSA LIST BECAUSE IT HAD BEEN MODIFIED. IT COULD BE LOADED THROUGH IQVIEW WITHOUT ANY ISSUE AFTER REPAIR.

    Description of Event or Problem · 0

    WHEN LOADING IN THE OARM CT SCAN TO MERGE WITH THE MRI FOR BONE FID REG, THE SCAN SHOWED UP ON USB THEN CLICKING ON IT TO SEE THE SERIES DESCRIPTION AND THE EXAM DISAPPEARED. USER WAS ABLE TO GO INTO THE IQVIEW APPLICATION AND PULL IT OVER FROM FILESYSTEM OFF USER USB SO THERE WAS NO DELAY IN SURGERY.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION IS PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. (UDI) #: (B)(4).

    Description of Event or Problem · 1

    WHEN LOADING IN THE OARM CT SCAN TO MERGE WITH THE MRI FOR BONE FID REG, THE SCAN SHOWED UP ON USB THEN CLICKING ON IT TO SEE THE SERIES DESCRIPTION AND THE EXAM DISAPPEARED. USER WAS ABLE TO GO INTO THE IQVIEW APPLICATION AND PULL IT OVER FROM FILESYSTEM OFF USER USB SO THERE WAS NO DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1561679 ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SA ROSA ONE 3.1.4.1650

    Patients

    Seq Age Sex Outcome Treatment
    1