BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE

    MDR report key: 7016858 · Received November 10, 2017

    Report

    Report Number
    3009185973-2017-00780
    Event Type
    Malfunction
    Date Received
    November 10, 2017
    Date of Event
    September 11, 2017
    Report Date
    March 22, 2018
    Manufacturer
    MEDTECH SA
    Product Code
    HAW
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ROSA ONE (B)(4) IS NOT FDA APPROVED, BUT IT IS SIMILAR TO THE DEVICE ROSA BRAIN 3.0, CLASSIFIED HAW - K151359. THE DEVICE (B)(4) HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION WILL BE PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION PERFORMED ON THE SURGERY DATA LOG FILE POINTED OUT THAT THE ISSUE OCCURRED IS DUE TO A DESIGN DEFECT ALREADY KNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNRECOVERABLE ERROR OCCURRED SEVERAL TIMES DURING A SURGERY. THE SURGEON WAS ABLE TO OVERCOME THE ISSUE AND THE SURGERY WAS COMPLETED AS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801007 ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SA ROSA ONE 3.1 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1