BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE

    MDR report key: 7177723 · Received January 10, 2018

    Report

    Report Number
    3009185973-2018-00003
    Event Type
    Malfunction
    Date Received
    January 10, 2018
    Date of Event
    December 13, 2017
    Report Date
    October 2, 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
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE NAVIGATION PROBE (B)(4) WAS BENT. A REQUEST FOR PRODUCT RETURN HAS BEEN COMPLETED HOWEVER THE FSE CONFIRMED BY MAIL THAT THE PART WAS NOT FOUND AT THE CUSTOMER SITE. IN ADDITION, NO PRODUCT RETURN HAS BEEN RECORDED FOR THIS PART AT THE MANUFACTURER SITE. THEREFORE THE NAVIGATION PROBE (B)(4) IS NOT AVAILABLE FOR INVESTIGATION PURPOSE. THE ROOT CAUSE OF THE ISSUE CANNOT BE DETERMINED PRECISELY HOWEVER THE MOST PROBABLE ROOT CAUSE IS DAMAGE DURING USE. UNIQUE IDENTIFIER (UDI) # : (B)(4). CORRECTED DATA: DATE OF THIS REPORT, MANUFACTURER EMAIL, ADDITIONAL DEVICE INFORMATION, DEVICE AVAILABILITY, OFFICE CONTACT MANUFACTURING SITE, DATE RECEIVED BY MANUFACTURER, IF FOLLOW-UP, WHAT TYPE, DEVICE EVALUATED BY MANUFACTURER, EVALUATION CODE.

    Additional Manufacturer Narrative · 1

    THE POINTER PROBE FROM 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. THE DEVICE MODEL ROSA ONE IS NOT FDA CLEARED BUT IS SIMILAR TO THE DEVICE ROSA BRAIN 3.0, CLASSIFIED HAW AND CLEARED UNDER K151359.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE POINTER PROBE IS BENT AND NEED TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22711 ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SA ROSAS00132 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1