BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE

    MDR report key: 7420762 · Received April 11, 2018

    Report

    Report Number
    3009185973-2018-00115
    Event Type
    Malfunction
    Date Received
    April 11, 2018
    Date of Event
    April 4, 2018
    Report Date
    August 6, 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
    HU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE ROSA ONE BS18024 IS NOT FDA APPROVED, BUT IT IS SIMILAR TO THE DEVICE ROSA BRAIN 3.0, CLASSIFIED HAW - K151359. UNIQUE IDENTIFIER (UDI) # : (B)(4). IT WAS REPORTED THAT THE ROBOT AFTER SENDING THE TRAJECTORY DEFINED WITH 189 MM LENGTH DIDN'T REACH THE TARGET AND POSITIONED THE TOOL AT 188,41 MM. A DHR REVIEW AND A COMPLAINT HISTORY REVIEW WERE PERFORMED AND DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. A FULL ANALYSIS OF DATA LOG HAS BEEN PERFORMED AND DETERMINED THAT AFTER AN AUTOMATIC MOVEMENT TO REACH A PREDEFINED TRAJECTORY DURING LEKSELL FRAME REGISTRATION, A DISTANCE ERROR WAS FOUND BETWEEN THE TOOL POSITION AND THE ACTUAL PLANNED TRAJECTORY LENGTH. THE DESIGN DEFECT IS KNOWN. HOWEVER IT WAS DETERMINED THAT THE DISCREPANCY WAS 0.41MM BETWEEN THE DEFINED AND ACTUAL TOOL POSITIONING. THIS DISCREPANCY IS WITHIN THE SPECIFIED ACCURACY LEVEL OF THE DEVICE, I.E <2 MM. CORRECTED DATA: DATE OF THIS REPORT, MANUFACTURER EMAIL, ADDITIONAL DEVICE INFORMATION, OPERATOR OF DEVICE, OCCUPATION, OFFICE CONTACT, DATE RECEIVED BY MANUFACTURER, IF FOLLOW-UP, WHAT TYPE, DEVICE EVALUATED BY MANUFACTURER, DEVICE MANUFACTURE DATE, EVALUATION CODE.

    Additional Manufacturer Narrative · 1

    THE DEVICE ROSA ONE BS18024 IS NOT FDA APPROVED, BUT IT IS SIMILAR TO THE DEVICE ROSA BRAIN 3.0, CLASSIFIED HAW - K151359. THE DEVICE 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 A TRAINING THE ROBOT ARM DID NOT REACH THE REQUESTED TARGET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263137 ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SA ROSA ONE 3.1.0.1276

    Patients

    Seq Age Sex Outcome Treatment
    1