Events

Rappel de 5mm and 8mm Harmonic ACE Instruments IFU (for use with 5mm Harmonic ACE instruments (PNs 400274 and 400275) 8mm Harmonic ACE instruments (PNs 420274 and 420275) and Harmonic ACE Curved Shears Disposable Insert (PN 400272) used with the da Vinci Standard, S, and Si Surgical Systems.

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Device Technologies 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-00114-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2015-02-17
  • 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-00114-1
  • 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
    Device technologies australia is informing the customers: intuitive surgical has found that the harmonic ace ifu used with the da vinci standard, s, and si surgical systems, contains incorrect instructions in regard to the proper use of the ininstrument release kit (irk) (or “emergency grip release allen wrench”). the harmonic ace ifu instructs the user to turn the irk counterclockwise. the correct instruction is to turn the irk clockwise.
  • Action
    Device Technologies Australia (DTA) is requesting the users to discard the currentHarmonic ACE IFUs and to follow the instructions from the Instrument and Accessories User Manual, section 9.1. Introduction, paragraph General Precautions and Warnings; that is attached to the system.

Device

5mm and 8mm Harmonic ACE Instruments IFU (for use with 5mm Harmonic ACE instruments (PNs 400274 a...
  • Modèle / numéro de série
    5mm and 8mm Harmonic ACE Instruments IFU (for use with 5mm Harmonic ACE instruments (PNs 400274 and 400275) 8mm Harmonic ACE instruments (PNs 420274 and 420275) and Harmonic ACE Curved Shears Disposable Insert (PN 400272) used with the da Vinci Standard, S, and Si Surgical Systems. Model Numbers: 550635-01; 550635-02; 550635-03; 550635-04
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd