Events

Recall of da Vinci Xi EndoWrist Stapler 45 Instrument

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-2016-RN-01111-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-08-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01111-1
  • 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 has been a field failure overseas with the da vinci xi endowrist stapler 45 instrument, where the stapler remained clamped on tissue even when the stapler release kit was used. intuitive surgical has determined that this issue is the result of a bearing failure within the housing of the instrument. the bearing failure is associated with components from a specific bearing supplier and, as such, is found only in certain lots of instruments.If the instrument cannot be released from tissue during a procedure, then the stapler and the tissue it is grasping may need to be excised using an alternative stapling device or other surgical intervention. failure of the bearing may also cause an interruption in shaft rotation, resulting in minimal delay in the surgery while the instrument is examined and replaced with a new one.
  • Action
    Device Technologies is advising users to inspect their inventory and isolate any affected Endowrist Stapler 45 Instruments. Upon receiving notice of affected stock, Device Technologies will arrange for return of the instruments and provide replacement instruments. Opened Endowrist Stapler 45 Instruments are to be cleaned and sterilised before returning. This action has been closed-out on 11/05/2017.

Device

da Vinci Xi EndoWrist Stapler 45 Instrument
  • Model / Serial
    da Vinci Xi EndoWrist Stapler 45 InstrumentProduct Reference: IS4000 EndoWrist Stapler 45Product Code: INS-470298 Multiple Lot Numbers affectedARTG Number: 146826
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd