Events

Rappel de 8 mm Fenestrated Bipolar Forceps used with da Vinci Standard System (IS1200)

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-2013-RN-00539-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-05-29
  • 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-2013-RN-00539-1
  • 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 manufacturer has received customer complaints regarding dislodged cautery plug inserts which prevents a bipolar cautery cable from being properly connected to the instrument, resulting in loss of cautery function of the bipolar instrument. the dislodged cautery plug insert most commonlyoccurs prior to the commencement of a procedure, but may be noticed when connecting or disconnecting the bipolar cautery cable during the procedure.
  • Action
    Customers are asked quarantine any affected stock and return them.

Device

8 mm Fenestrated Bipolar Forceps used with da Vinci Standard System (IS1200)
  • Modèle / numéro de série
    8 mm Fenestrated Bipolar Forceps used with da Vinci Standard System (IS1200) Product code: INS-400172Lot numbers: M10120815, M10120817, M10120831, M10120913, M10120918, M10121008, M10121024, M10121120, M10121123, M10121203, M10121210, M10121215, M10130220, M10130222, M10130311, M10130315, M10130411ARTG Number: 132451
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd