Events

Rappel de Use of Tristel Trio Wipes System with GE TEE probe

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par GE Healthcare 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-2018-RN-00114-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-02-23
  • 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-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
    The tristel trio wipes system has been validated for efficacy and residual toxicity for tee probes that do not have visible signs of wear or damage, and when used in connection with shorter procedure times such as cardiac scans. further testing has identified a need for clarification of the previously communicated disinfection guidance for ge tee probes regarding use of the tristel trio wipes system. specifically, in-use experience and limited testing has revealed that the previously communicated disinfection methods using tristel trio wipes may not always be effective when used in connection with procedures that have long tee probe intubation times, such as cardiac surgeries, and/or with tee probes with visible signs of wear or damage in areas to be disinfected, both of which may increase the bioburden on the probe. ge recommends the additional use of a sterile sheath covering the tee probe when tristel trio wipes are being used as the sole method of disinfection.
  • Action
    Under conditions where the TEE probe has a long intubation time or shows visible signs of wear and damage, GE recommends the use of a sterile sheath covering the TEE probe in addition to disinfection using the Tristel Trio Wipes System.

Device

Use of Tristel Trio Wipes System with GE TEE probe
  • Modèle / numéro de série
    Use of Tristel Trio Wipes System with GE TEE probeAffected Product: TEE probe models: 6VT-D, 6Tc, 6Tc-RS, 6T, 6T-RS, 9T and 9T-RSMultiple affected probe types and part numbersARTG Number:123916(GE Medical Systems Australia - Transducer assembly, ultrasound, diagnostic, intracorporeal, oesophageal)
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd