BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROSA ONE

    MDR report key: 7604475 · Received June 15, 2018

    Report

    Report Number
    3009185973-2017-00776
    Event Type
    Injury
    Date Received
    June 15, 2018
    Date of Event
    August 24, 2017
    Report Date
    June 15, 2018
    Manufacturer
    MEDTECH SA
    Product Code
    HAW
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ROSA ONE BS16001 IS NOT FDA APPROVED, BUT IT IS SIMILAR TO THE DEVICE ROSA BRAIN 3.0, CLASSIFIED HAW - K151359. (B)(4). BASED ON THE INVESTIGATION PERFORMED ON SUBJECT SURGERY DATA LOG THE TECHNICAL ROOT CAUSE OF THE EVENT WAS DETERMINED TO BE A DESIGN DEFECT ALREADY KNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON WANTED TO PERFORM AN OFF LABEL SURGERY. DURING REGISTRATION IT WAS REPORTED THAT A SAME ERROR OCCURRED TWICE AND FOR THEREFORE THE PATIENT REGISTRATION FAILED TWICE. THE SURGEON DECIDED TO ABORT THE SURGERY AND USE NAVIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448087 ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SA ROSA ONE 3.1 3.1.0.1226

    Patients

    Seq Age Sex Outcome Treatment
    1