Events

Recall of da Vinci Si EndoWrist One Vessel Sealer and da Vinci Xi EndoWrist Vessel Sealer da Vinci Si EndoWrist One Vessel Sealer

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-00222-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-03-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00222-1
  • 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
    Intuitive surgical has identified the potential for a certain, small portion of vessel sealers to exhibit interference in the proximal end (near the joint) of the instrument grips. this interference is due to manufacturing variability in some jaws. the interference can lead to contact between the instrument electrodes at the back of the jaws and subsequent shorting of the electrosurgical energy. the shorting behaviour can lead to extended activation times and insufficient energy delivery to thin, vascular tissue bundles, leading to bleeding if transected. this issue has been identified on a small population of vessel sealers only when used on thin, vascular tissue. there has been no impact identified to sealing performance on larger vessels or tissue bundles.
  • Action
    Device Technologies Australia (DTA) is informing the customers of the potential for insufficient energy delivery on a small population of Vessel Sealers only when used on thin, vascular tissue and providing instructions on alternative methods of sealing and transection. In caseWhere the customer does not wish to use affected Vessel Sealer instruments, DTA is offering a full credit refund for affected stock in its original packaging. This action has been closed-out on 08/08/2016.

Device

da Vinci Si EndoWrist One Vessel Sealer and da Vinci Xi EndoWrist Vessel Sealer da Vinci Si EndoW...
  • Model / Serial
    da Vinci Si EndoWrist One Vessel Sealer and da Vinci Xi EndoWrist Vessel Sealer da Vinci Si EndoWrist One Vessel Sealer Product Code: 410322-05; Order code INS-410322Multiple Lot Numbersda Vinci Xi EndoWrist Vessel Sealer Product Code: 480322-04; Order Code INS-180322Multiple Lot NumbersARTG Number: 132453
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd