Events

Rappel de ROSA Brain and ROSA One Surgical Robots

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Surgicom Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2017-RN-00699-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-05-26
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00699-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notes supplémentaires dans les données
  • Cause
    Medtech has identified a potential software issue for certain rosa brain and rosa one devices than can prevent it reaching a planned trajectory. when the robot arm is automatically sent onto a trajectory, cartesian coordinates are converted to joint configuration through a mathematical model, and for a very limited number of positions, the mathematical model is imperfect and may prevent the robot arm from reaching the desired position.For automatic moves, if the robot is sent to an unreachable trajectory, the device will display an error message and shut down. a delay of surgery can occur.For “isocentric micromoves” mode used during brain surgery, a hazardous situation can occur if an automatic micro movement to trajectory is planned and an instrument is inside the patient anatomy. if not detected by the user, this could lead to ineffective treatment, serious injury, or even death of the patient.To date medtech has not recorded any complaints for this issue.
  • Action
    Surgicom is currently working on a software correction for this issue, which is expected to be available in July 2017. Surgicom will contact users to arrange for installation of the software update. In the interim, users are to discontinue use of the micromovement function in isocentric mode during brain surgery. In addition, if the issue occurs for other automatic moves, when the error message "A difference in the expected and the actual robot position has been detected. The device will shut down" is displayed users are advised to follow the directions regarding restart and continuation of use of the device that are included in the customer letter.

Device

ROSA Brain and ROSA One Surgical Robots
  • Modèle / numéro de série
    ROSA Brain and ROSA One Surgical RobotsROSA Brain 3.0.0 Robotic Surgical AssistantSerial Number: BR15002ROSA One 3.1.0 Robotic Surgical AssistantSerial Number: BS16001ARTG Number: 235379 and 278903
  • Manufacturer
    Surgicom Pty Ltd

Manufacturer

Surgicom Pty Ltd
  • Source
    DHTGA