Events

Rappel de ROSA Brain 3.0.0 Robotic Surgical Assistant

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-00404-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-03-24
  • 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-00404-1
  • 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
    Investigation revealed that a computer file parameter that is linked to the robot arm calibration has been modified by the robot arm supplier without notification to the manufacturer. as a result, once the robot arm is on a trajectory, if the system reboots or shuts down (voluntarily or due to an error) without the robot arm returning to a parking position, the device’s applicative accuracy may decrease to a level below the applicable specification. in the event that the inaccurate tool positioning of the instruments by the rosa devices is not detected by the user, it could ultimately lead to ineffective treatment, serious injury or death of the patient. to date, no complaint reports, which could be linked to the above issue in normal conditions of use, have been recorded.
  • Action
    As an interim measure, Surgicom is requesting users to follow the instructions as detailed in the recall notification letter. This action has been closed-out on 15/03/2018.

Device

ROSA Brain 3.0.0 Robotic Surgical Assistant
  • Modèle / numéro de série
    ROSA Brain 3.0.0 Robotic Surgical AssistantSerial Number: BR15002ARTG Number: 235379
  • Manufacturer
    Surgicom Pty Ltd

Manufacturer

Surgicom Pty Ltd
  • Source
    DHTGA