Events

Recall of Procise EZ View with Integrated Cable(Electrosurgical electrode)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Smith & Nephew Surgical 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-00561-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-07-01
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00561-1
  • 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
    Smith & nephew surgical pty ltd. has initiated a recall of arthrocare corporation procise ez view with integrated cable wands, lot 1093290, due to a manufacturing inspection issue. affected lot of these devices have been released without meeting the dielectric specifications. in the event an affected wand is presented for surgery, the wand may develop a dielectric breakdown creating a small gap leading to arcing. this created arcing could lead to diminished ablation and coagulation performance and in rare instances a surgeon or patient burn. also, the decreased hemostasis resulting in injury or impairment could require additional medical intervention. to date there have been no reported adverse events related to this issue.
  • Action
    Customers are advised to immediately discontinue use of the affected lot and take steps to quarantine the device(s). Smith & Nephew Surgical will arrange for affected products to be returned and suggest alternate products. This action has been closed-out on 05/12/2016.

Device

Procise EZ View with Integrated Cable(Electrosurgical electrode)
  • Model / Serial
    Procise EZ View with Integrated Cable(Electrosurgical electrode)Product No.: EIC8875-01Lot Number: 1093290ARTG Number:221504
  • Manufacturer
    Smith & Nephew Surgical Pty Ltd

Manufacturer

Smith & Nephew Surgical Pty Ltd