Events

Recall of ULTRA-SOUND SCOPE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PENTAX CANADA 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
    134836
  • Event Risk Class
    II
  • Event Initiated Date
    2012-02-10
  • 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
    Hoya corporation/pentax life care division has determined that there is a possibility of cross-contamination for the eg-3870utk ultrasound gastroscope under certain conditions. the potential for cross contamination can occur when there is a clog in the balloon suction channel as there is no method to reliably force fluid specifically through the balloon suction channel when following the present cleaning and high-level disinfection procedure. if the channels are not meticulously checked prior to use the clog might not be detected. there are two known ways that a clog can develop: a. if the balloon is not used and fluid is suctioned from the body cavity using the balloon suction channel a clog can develop. (note that using the balloon suction channel to suction fluid from the body is inefficient due to the small size of the channel.) b. if body cavity fluid is suctioned into the balloon suction channel and a clog occurs the clog may be difficult to detect. the device with an undetected clog might be used in a subsequent patient. in the unlikely event that the scope passes the pre-procedure function check and is then used without the balloon the clog could potentially become dislodged and infused into the next patient resulting in the potential for cross contamination.

Device

ULTRA-SOUND SCOPE
  • Model / Serial
    Model Catalog: EG-3870UTK (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    PENTAX ULTRASOUND VIDEO GASTROSCOPE
  • Manufacturer
    PENTAX CANADA INC.

Manufacturer

PENTAX CANADA INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    HOYA Corp.
  • Source
    HC