BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE

    MDR report key: 8238887 · Received January 11, 2019

    Report

    Report Number
    3009185973-2019-00013
    Event Type
    Malfunction
    Date Received
    January 11, 2019
    Report Date
    April 12, 2019
    Manufacturer
    MEDTECH SA
    Product Code
    NAY
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE NAVIGATED POINTER WAS BROKEN. A DHR REVIEW AND A COMPLAINT HISTORY REVIEW WERE PERFORMED AND DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. A VISUAL INSPECTION CONFIRMED THAT THE PART RECEIVED WAS DAMAGED. HOWEVER THE CAUSE OF THE DAMAGE CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    FIELD SERVICE ENGINEER WAS INFORMED ON WED. DEC. 11TH THAT THE NAVIGATION PROBE WAS BROKEN.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION IS 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 SPINE 1.0.2, CLASSIFIED OLO AND CLEARED UNDER K151511.

    Description of Event or Problem · 1

    FIELD SERVICE ENGINEER WAS INFORMED ON WED. (B)(6) THAT THE NAVIGATION PROBE WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35073 ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE NAY MEDTECH SA ROSAS00132 MALI-170

    Patients

    Seq Age Sex Outcome Treatment
    1