Events

Recall of ENDOWRIST STABILIZER - VACUUM SOURCE TUBING

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MINOGUE MEDICAL INC..

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
    28979
  • Event Risk Class
    II
  • Event Initiated Date
    2015-07-13
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    As a result of internal testing intuitive surgical has determined that the sterile barrier of the outer packaging for the vacuum source tubing set is subject to failure. some outer pouches exhibited pinholes during gross leak testing which could potentially result in compromising the sterile field.

Device

ENDOWRIST STABILIZER - VACUUM SOURCE TUBING
  • Model / Serial
    Model Catalog: 420187-05 (Lot serial: C11354); Model Catalog: 420187-05 (Lot serial: multiple. contact mfg)
  • Product Description
    ENDOWRIST STABILIZER - VACUUM SOURCE TUBING
  • Manufacturer
    MINOGUE MEDICAL INC.

Manufacturer

MINOGUE MEDICAL INC.