BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE

    MDR report key: 14050037 · Received April 8, 2022

    Report

    Report Number
    3009185973-2022-00026
    Event Type
    Malfunction
    Date Received
    April 8, 2022
    Date of Event
    March 9, 2022
    Report Date
    May 17, 2022
    Manufacturer
    MEDTECH SAS
    Product Code
    HAW
    PMA / PMN Number
    K200511
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION IS PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Additional Manufacturer Narrative · 0

    THE REVIEW OF THE PRODUCTION DOCUMENTATION AND COMPLAINT HISTORY DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. A DETAILED ANALYSIS OF THE DATA LOGS AND PATIENT FILE HAS BEEN PERFORMED AND CONCLUDED THAT THE ENTRY POINT OF TRAJECTORY HOS WAS ACCURATE. NO MALFUNCTION OF THE DEVICE WAS FOUND. THE DEVIATION OF THE ELECTRODE INSIDE THE BRAIN DOES NOT DEPEND ON THE ROSA DEVICE, BUT ON OTHER FACTORS SUCH AS THE MATERIAL OF THE ELECTRODE, THE METHOD OF IMPLANTATION OR THE PATIENT ANATOMY.

    Description of Event or Problem · 0

    THE CLINICAL REPRESENTATIVE WAS ONSITE IN (B)(6) TO SUPPORT A SEEG CASE. THE SURGEON DID THE FIRST SCAN WITH FIDUCIALS AND MERGED IT ON ROSA. THE QUALITY OF THE SCAN WAS NOT GOOD, SO ANOTHER SCAN IN HD(O-ARM) WAS TAKEN, MERGED AND USED FOR REGISTRATION (RMS:0,6MM). THE SURGEON PLACED THE FIRST ANCHOR AND INSERTED THE ELECTRODE. AFTER THE PLACEMENT OF THE ELECTRODE ANOTHER SCAN WAS TAKEN TO CONTROL THE PLACEMENT. THE ELECTRODE WAS OFF ABOUT 11 MM AT THE TARGET POINT. THE ENTRY POINT AND THE FIRST 1-2 CM THE ELECTRODE WAS FOLLOWING THE RIGHT/PLANED PATH. THEN THE ELECTRODE TOOK ANOTHER PATH.

    Description of Event or Problem · 0

    THE CLINICAL REPRESENTATIVE WAS ONSITE IN LAUSANNE TO SUPPORT A SEEG CASE. THE SURGEON DID THE FIRST SCAN WITH FIDUCIALS AND MERGED IT ON ROSA. THE QUALITY OF THE SCAN WAS NOT GOOD, SO ANOTHER SCAN IN HD(O-ARM) WAS TAKEN, MERGED AND USED FOR REGISTRATION (RMS: 0, 6MM). THE SURGEON PLACED THE FIRST ANCHOR AND INSERTED THE ELECTRODE. AFTER THE PLACEMENT OF THE ELECTRODE ANOTHER SCAN WAS TAKEN TO CONTROL THE PLACEMENT. THE ELECTRODE WAS OFF ABOUT 11 MM AT THE TARGET POINT. THE ENTRY POINT AND THE FIRST 1-2 CM THE ELECTRODE WAS FOLLOWING THE RIGHT/PLANED PATH. THEN THE ELECTRODE TOOK ANOTHER PATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1727040 ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SAS ROSA ONE 3.1 3.1.5.28

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown