Events

Rappel de Base array component of the MAKO RIO Robotic Arm

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Stryker Australia 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-2015-RN-00873-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-09-08
  • 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-2015-RN-00873-1
  • 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
    The base array and the base array connector is a two piece component on the rio that is used by the rio camera to determine location of the rio relative to the patient. the pin which olds the base array in position and prevents movement has been visually confirmed to have been damaged during assembly.Incidences have been reported where the locking pin on the rio base array may be damaged during assembly onto the rio base array connector.The incidence of this issue is uncommon (only 0.15% of cases over the past 36 months) and, of the reported cases, all were successfully completed with no reported injury to the patient or operating room staff.
  • Action
    Users are requested to complete and return the notification response. A Stryker Representative will be in contact and a new RIO Base Array Connector and Base Array will be installed on the RIO system during regularly scheduled product maintenance. A workaround is also provided for interim use of the system.

Device

Base array component of the MAKO RIO Robotic Arm
  • Modèle / numéro de série
    Base array component of the MAKO RIO Robotic ArmCatalogue Numbers:207300 (207956) MAKO RIO Robotic Arm112220 RIO Base Array205143 RIO Base Array ConnectorLot/Serial Numbers: AllARTG Number: 223105
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    DHTGA