BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE

    MDR report key: 7012501 · Received November 9, 2017

    Report

    Report Number
    3009185973-2017-00778
    Event Type
    Malfunction
    Date Received
    November 9, 2017
    Date of Event
    June 6, 2017
    Report Date
    January 9, 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
    BE
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 OPTICAL DISTANCE SENSOR OF 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

    A FIELD SERVICE ENGINEER WAS PRESENT AT THE TIME OF THE IDENTIFICATION OF THE OPTICAL DISTANCE SENSOR DYSFUNCTION. VISUAL INSPECTION CONFIRMED THAT THERE WAS NO VISUAL DAMAGE TO THE PACKAGING BUT THAT THE WAY IN WHICH THE PART HAD BEEN INSERTED IN THE PACKAGING LED TO A BEND OF THE BLACK PLASTIC PART NEAR THE CONNECTOR AND THE LASER HAD DISCONNECTED. INVESTIGATION INDICATED THAT AT THE TIME WHEN EVENT OCCURRED, THERE WAS NO PACKAGING INSTRUCTIONS FOR THE OPTICAL DISTANCE SENSOR WHICH LED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TRAINING SESSION, AN OPTICAL DISTANCE SENSOR CONNECTOR DAMAGE WAS NOTICED BY THE FIELD SERVICE ENGINEER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794588 ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SA ROSA ONE 3.1 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1