BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE

    MDR report key: 7003418 · Received November 6, 2017

    Report

    Report Number
    3009185973-2017-00775
    Event Type
    Malfunction
    Date Received
    November 6, 2017
    Date of Event
    May 9, 2017
    Report Date
    June 28, 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 · 1

    IT HAS BEEN IDENTIFIED DURING INTERNAL REVIEW THAT THE REPORTED EVENT DATE WAS NOT CORRECT. THE EVENT DATE WAS INITIALLY RECORDED AS (B)(6) 2017, HOWEVER THIS DATE SHOULD HAVE BEEN (B)(6) 2017 THIS MEDWATCH REPORT HAS BEEN SUBMITTED TO PROVIDE THE CORRECT EVENT DATE. THIS CORRECTION DOES NOT IMPACT THE TIMELINESS OF THE PREVIOUS REPORTS OR THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION SHOWED THAT THE FIRST COMMUNICATION ERROR WAS TO A SOFTWARE BUG, AR-957. FOR THE SECOND AND THIRD COMMUNICATION ERROR THE ROOT CAUSE CANNOT BE CONFIRMED, BUT MAY BE DUE TO A DEFECTIVE EMERGENCY STOP BUTTON. TO AVOID THE REOCCURRENCE OF SIMILAR INCIDENT, THE EMERGENCY STOP BUTTON WAS REPLACED.

    Additional Manufacturer Narrative · 1

    THE DEVICE ROSA ONE IS NOT FDA CLEARED, BUT IT IS SIMILAR TO THE DEVICE ROSA BRAIN 3.0, CLASSIFIED HAW - K151359. THE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PREVENTIVE MAINTENANCE, WHILE THE FIELD SERVICE ENGINEER WAS PERFORMING AN APPLICATIVE TEST THERE WERE MULTIPLE 'UNRECOVERABLE ERROR' AND SHUTDOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782294 ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SA ROSA ONE 3.1 3.1

    Patients

    Seq Age Sex Outcome Treatment
    1