Events

Recall of EVOTECH Endoscope Cleaner and Reprocessor (ECR)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Johnson & Johnson Medical 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-00432-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2015-05-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00432-1
  • 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
    The evotech endoscope cleaner and reprocessor (ecr) may not detect an improper endoscope connection on two channels, and subsequently pass the cycle without cancellation if there is a disconnected scope. the likelihood of this occurrence is low, and asp has not received complaints or reports of adverse events related to this issue.The evotech ecr is designed to verify endoscope connections for each cycle. if an improper connection is detected, the system is designed to stop and cancel the cycle. this system detection, along with a user verification step stated in the user’s guide to verify the connections of the endoscope channels before and after the completion of a cycle, help to ensure that an endoscope has been processed properly.As a result sites may need to manually process endoscopes which may increase processing time. an accumulation of processing time may result in surgical delay or rescheduling patients.
  • Action
    A workaround is provided via the Customer Letter whilst a permanent fix is developed. This action has been closed-out on 03/03/2016.

Device

EVOTECH Endoscope Cleaner and Reprocessor (ECR)

Manufacturer

Johnson & Johnson Medical Pty Ltd