Events

Alerte De Sécurité sur ROSA Brain 3.0.0 Robotic Surgical Assistant

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Medtech SA.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2017-03-28
  • Date de publication de l'événement
    2017-03-28
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170328.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: rosa brain 3.0.0 robotic surgical assistant the therapeutic goods administration (tga) of australia has posted a medical device safety alert concerning rosa brain 3.0.0 robotic surgical assistant [serial number: br15002], manufactured by medtech sa. according to the manufacturer, 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. for details, please refer to the tga website: http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2017-rn-00404-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 28 march 2017.

Device

ROSA Brain 3.0.0 Robotic Surgical Assistant
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: ROSA Brain 3.0.0 Robotic Surgical Assistant
  • Manufacturer
    Medtech SA

Manufacturer

Medtech SA
  • Société-mère du fabricant (2017)
    Zimmer Biomet Holdings
  • Commentaire du fabricant
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    DH