BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE

    MDR report key: 9835663 · Received March 16, 2020

    Report

    Report Number
    3009185973-2020-00094
    Event Type
    Malfunction
    Date Received
    March 16, 2020
    Date of Event
    March 5, 2020
    Report Date
    December 10, 2020
    Manufacturer
    MEDTECH SA
    Product Code
    HAW
    PMA / PMN Number
    K182417
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT ON 05-MAR-2020, DURING A PREVENTIVE MAINTENANCE OF THE ROSA ONE DEVICE S/N (B)(6), THE COMPANY REPRESENTATIVE NOTED THAT THE STABILIZATION SYSTEM WAS FAILING TO IMMOBILIZE THE ROBOT STAND. ON THAT DAY, THE COMPANY REPRESENTATIVE FOLLOWED THE WORK INSTRUCTION FOR ADJUSTING THE STABILIZATION SYSTEM BUT THE ISSUE WAS NOT RESOLVED. THE EVENT DESCRIBED IN THE COMPLAINT IS CONFIRMED, THE STABILIZATION SYSTEM CAN NOT BE ADJUSTED AS IT SHOULD NORMALLY, AND IT NEEDS TO BE REPAIRED. BASED ON THE INVESTIGATION PERFORMED, THE TECHNICAL ROOT CAUSE OF THE EVENT WAS DETERMINED TO BE A BROKEN / DAMAGED / FRACTURED STABILIZATION SYSTEM.

    Description of Event or Problem · 0

    DURING A ROUTINE QUARTERLY PM OF ROSA ONE BRAIN APPLICATION SYSTEM (B)(6), IT WAS NOTED THAT THE STABILIZATION SYSTEM WAS FAILING TO IMMOBILIZE THE ROBOT. THE WORK INSTRUCTION FOR ADJUSTING THE STABILIZATION SYSTEM ((B)(6)) WAS FOLLOWED BUT THE ISSUE WAS NOT SUCCESSFULLY RESOLVED AND REQUIRES FURTHER INTERVENTION.

    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. UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 1

    DURING A ROUTINE QUARTERLY PM OF ROSA ONE BRAIN APPLICATION SYSTEM BS18996, IT WAS NOTED THAT THE STABILIZATION SYSTEM WAS FAILING TO IMMOBILIZE THE ROBOT. THE WORK INSTRUCTION FOR ADJUSTING THE STABILIZATION SYSTEM (MPL-HSD-001-WI-040) WAS FOLLOWED BUT THE ISSUE WAS NOT SUCCESSFULLY RESOLVED AND REQUIRES FURTHER INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300598 ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SA ROSA ONE N/A

    Patients

    Seq Age Sex Outcome Treatment
    1