Events

Recall of Microtek Medical System Drapes used with da Vinci, da Vinci Si, da Vinci Si/S Systems

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Device Technologies Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2015-RN-00351-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-05-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00351-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
    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