BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROSA ONE

    MDR report key: 7008644 · Received November 8, 2017

    Report

    Report Number
    3009185973-2017-00777
    Event Type
    Injury
    Date Received
    November 8, 2017
    Date of Event
    September 11, 2017
    Report Date
    March 22, 2018
    Manufacturer
    MEDTECH SA
    Product Code
    HAW
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OF THE TECHNICAL INVESTIGATION OF LOG FILES INDICATES THAT THE REFERENCE TARGET IS CONSIDERED AS MOVING (BREATH DETECTION FEATURE) DURING PATIENT REGISTRATION. PATIENT IS SUPPOSED TO BE IN APNEA. AFTER ANALYSIS IT SHOWS THAT IT CAN BE CAUSED BY INTERFERENCE OF 3D RAY PATTERN DESCRIBED IN A DESIGN DEFECT. IT IS SECOND OCCURRENCE OF THE ISSUE ON THIS DEVICE.

    Additional Manufacturer Narrative · 1

    THE DEVICE ROSA ONE BS16001 IS NOT FDA APPROVED, BUT IT IS SIMILAR TO THE DEVICE ROSA BRAIN 3.0, CLASSIFIED HAW - K151359. THE DEVICE BS16001 HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION WILL BE PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. NO CODE AVAILABLE WAS SELECTED AS THERE WAS A DELAY GREATER THAN 30 MINUTES ON THE SURGERY DUE TO THIS EVENT. THE SURGERY WAS CONVERTED TO TRADITIONAL SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE POSITIONING OF THE GUIDE WIRES AN UNRECOVERABLE ERROR MESSAGE APPEARED AND THE DEVICE SHUTDOWN. THE DEVICE WAS WAS REBOOTED, BUT AFTER THIS THE PATIENT REFERENCE PIN WAS ACCIDENTALLY MOVED POSSIBLY BY THE ASSISTING SURGEON, LEADING TO ACCURACY LOSS. WIRES WERE ALREADY PLACED AT THIS STAGE AND THE ROSA ONE DEVICE WAS REMOVED. THE SURGERY WAS CONVERTED TO TRADITIONAL SURGERY. NO PATIENT HARM WAS REPORTED BUT A DELAY OF 45 MINUTES IN THE SURGERY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790755 ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SA ROSA ONE 3.1 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1