Events

Rappel de microTargeting Depth Stop Adapter; microTargeting STar Drive System (Manual); microTargeting STar Drive System (Motorised); microTargeting Drive System; microTargeting STar Drive System (Manual)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Emergo Asia Pacific Pty Ltd T/a Emergo Australia.

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-2018-RN-00663-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-06-07
  • 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-2018-RN-00663-1
  • 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
    During a dbs lead implant procedure, the fhc depth stop adapter is placed onto the lead to set the desired distance to target. the depth stop adapter then mounts in the lead measurement fixture to ensure that the lead is not inserted beyond the targeted depth. the fhc depth stop adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. this damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, and has resulted in the need to remove and replace the implanted lead intraoperatively or in a follow-up procedure. recent reports of lead short circuit events have led to an improvement of the depth stop design and a recall the previous version of this product. to date, there have been no reports of patient death related to this problem.
  • Action
    Emergo is advising FHC and Medtronic Field Representatives will review user's inventory and replace affected Depth Stop Adapters on hand with an improved design. In the interim, Emergo advise that users do not over-tighten the Depth Stop Adapter screw. If low impedances or a short circuit is found, physicians should replace the lead prior to use and report the issue to FHC, Emergo Australia, or their local field rep.

Device

microTargeting Depth Stop Adapter; microTargeting STar Drive System (Manual); microTargeting STar...
  • Modèle / numéro de série
    microTargeting Depth Stop AdapterProduct Model Number: 66-AC-DS(1.8)microTargeting STar Drive System (Manual)Product Numbers: ST-DS-MA and 70-ZD-MAmicroTargeting STar Drive System (Motorised)Product Numbers: ST-DS-ME and 70-ZD-MEmicroTargeting Drive SystemProduct Numbers: FC1006 and 9033G0601microTargeting STar Drive System (Manual)Product Number: FC8001ARTG Number: 177545(Emergo Asia Pacific Emergo Australia - Stereotactic surgery system, neurological)
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia