Events

Rappel de Microtek Medical System Drapes used with da Vinci, da Vinci Si, da Vinci Si/S 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-00351-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-05-13
  • 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-00351-1
  • 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
    There have been two issues identified with the da vinci surgical system drapes:1. the adhesive labels intended to keep the drape folded were found in some instances to be unintentionally overlapping multiple folds of the drape. this issue has the potential to cause small tears when the drape unfolds during the draping process that may lead to possible contamination of the surgical field. there is a slight increased risk for infection, primarily with surface contaminants, that could increase the chance of post-operative wound infection.2. some of the drapes used with the da vinci systems may exhibit a cloudy/waxy appearance. the cloudy appearance is due to increased presence of anti-static additive in the drape film. direct exposure to the waxy substance may cause skin irritation and sensitisation. the reaction is minor and limited to immediate contact area with no long-term health consequences.
  • Action
    Users are advised that the decision to discontinue use of the potentially affected drapes should be made on a case by case basis. Currently, there is no unaffected stock available for replacement. Prior to use, users are advised to assess drapes per the inspection instructions attached with the customer letter. This inspection is not required for drapes manufactured after 06 March 2015. This correlates to lot numbers greater than 066 as seen in the following format: D15066xx or DA15066xx. Device Technologies’ Product Specialists will provide training to customers with the inspection process. If users identify affected drapes during the inspection, please contact Device Technologies to arrange for returning the affected drapes. This action has been closed-out on 26/02/2016

Device

Microtek Medical System Drapes used with da Vinci, da Vinci Si, da Vinci Si/S Systems
  • Modèle / numéro de série
    Microtek Medical System Drapes used with da Vinci, da Vinci Si, da Vinci Si/S SystemsMultiple product numbers and lot numbersARTG numbers: 179469, 150916, and 98557
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd