Events

Recall of PenAdapt(an aspiration sheath that fits over an electrosurgical pencil body and leaves the tip or blade exposed)

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-2015-RN-00422-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-05-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00422-1
  • 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
    During packaging verification testing, a breach in the sterile barrier was observed in some of the units tested. additional testing identified microscopic aluminium metal shavings and foreign particles estimated in size to be between 0.01inches x 0.015 inches to 0.03 inches x 0.04 inches in some of the units tested. it was determined that these particles were introduced during the manufacturing process and were sterilised within the tyvek pouch with the product. the potential hazards of this product issue include patient exposure to infectious material, potentially leading to patient infection, and patient exposure to sterile foreign material potentially leading to foreign body inflammation.
  • Action
    Customers are asked to check any PenAdapt items in their possession and quarantine any affected units immediately. A Stryker Representative will contact customers to coordinate an inspection of the affected items in quarantine. Any affected items will be removed by the Stryker Representative and a credit will be issued to the customer account. Stryker is also requesting the customers to review the patient records for issues that may have been associated with the use of the affected device, such as infection and/or inflammation.

Device

PenAdapt(an aspiration sheath that fits over an electrosurgical pencil body and leaves the tip or...
  • Model / Serial
    PenAdapt(an aspiration sheath that fits over an electrosurgical pencil body and leaves the tip or blade exposed)Item number: 0702045027Multiple lot numbersARTG Number: 171568
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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