BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROSA ONE

    MDR report key: 7016837 · Received November 10, 2017

    Report

    Report Number
    3009185973-2017-00784
    Event Type
    Injury
    Date Received
    November 10, 2017
    Date of Event
    October 19, 2016
    Report Date
    November 8, 2017
    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
    HEALTH 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. INVESTIGATION INDICATED THAT THE DEVICE COMPUTER CONFIGURATION WAS MODIFIED BUT NOT SET BACK TO THE CORRECT CONFIGURATION BEFORE DEVICE SHIPMENT TO CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGERY, THE ROBOT ARM COLLIDED WITH THE ROBOT STAND REFERENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800698 ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SA ROSA ONE N/A

    Patients

    Seq Age Sex Outcome Treatment
    1