BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE

    MDR report key: 7036286 · Received November 16, 2017

    Report

    Report Number
    3009185973-2017-00794
    Event Type
    Malfunction
    Date Received
    November 16, 2017
    Date of Event
    October 30, 2017
    Report Date
    April 20, 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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THERE WERE 5 COMMUNICATION ERRORS DURING A SURGERY. INVESTIGATION CONFIRMED 4 OF THE COMMUNICATIONS ERRORS. THE ROOT CAUSE OF THE FIRST THREE COMMUNICATION ERROR IS A DEIGN DEFECT ALREADY KNOWN. THE ROOT CAUSE OF THE FOURTH COMMUNICATION IS ANOTHER DESIGN DEFECT. THE FIFTH COMMUNICATION ERROR WAS NOT CONFIRMED BY THE INVESTIGATION.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FIVE UNCOVERABLE ERRORS OCCURRED UPON DEVICE START UP. AFTER THE LSAT ONE, THE SYSTEM REMAINED ON AND THE CASE WAS COMPLETED WITHOUT ANY OTHER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817370 ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SA ROSA ONE 3.1 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1