BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE

    MDR report key: 7356970 · Received March 21, 2018

    Report

    Report Number
    3009185973-2018-00089
    Event Type
    Malfunction
    Date Received
    March 21, 2018
    Date of Event
    March 14, 2018
    Report Date
    June 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
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 0

    THE POINTER PROBE MT-02-157 S16046 WAS RETURNED TO THE MANUFACTURING SITE FOR INVESTIGATION PURPOSE. IT WAS FOUND OUT OF CALIBRATION BUT THE ROOT CAUSE CANNOT BE DETERMINED. THE POINTER PROBE HAS BEEN RE-CALIBRATED AND RE-INSTALLED INTO THE CUSTOMER SITE.

    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. THE POINTER PROBE FROM DEVICE BS16001 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 DURING SCHEDULED MAINTENANCE THE POINTER PROBE FAILED THREE TIMES THE ACCURACY TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203398 ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SA POINTER PROBE N/A

    Patients

    Seq Age Sex Outcome Treatment
    1