Events

Recall of Sonopet Console (Ultrasonic Surgical Aspirator System)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Stryker 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-2014-RN-00769-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-07-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00769-1
  • 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
    Stryker has noticed a trend of complaints regarding insufficient irrigation to the tip of the sonopet system. lack of irrigation can potentially lead to excessive heat at the tip. in the case where the irrigation pump fails, saline would not be provided to the tip. as a result the cooling function would be lost and could potentially cause the tip to heat up resulting in tissue burns to the patient.
  • Action
    Stryker has updated the Instructions for Use (IFU) for Sonopet to include the following clarifications: · DO NOT use a rigid non-collapsible irrigation container. Failure to comply may cause the flow of irrigation to be drastically reduced and result in overheating of the handpiece tip and/or tip cover. Only use a collapsible irrigation container. · The irrigation tube must be properly routed through the irrigation pump with the pump cover fully closed and latched. Improper setup of the irrigation tubing may result in an inconsistent or lack of irrigation. · Provide adequate irrigation to the tip to avoid excessive heat that could result in tissue damage due to unintended contact. Additionally, all existing Sonopet consoles will have an instructional irrigation setup label applied to the side of the console. This action has been closed-out on 03/06/2016.

Device

Sonopet Console (Ultrasonic Surgical Aspirator System)
  • Model / Serial
    Sonopet Console (Ultrasonic Surgical Aspirator System)Catalogue Number: 5450852000All Serial NumbersARTG Number: 174364
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    DHTGA