Events

Safety Alert for Endo-Surgery Proximate® PPH Hemorrhoidal Circular Stapler and Accessories 33mm and Proximate® HCS Hemorrhoidal Circular Staple and Accessories 33mm

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Ethicon Endo-Surgery.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2012-08-06
  • Event Date Posted
    2012-08-06
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120806.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: ethicon endo-surgery proximate® pph hemorrhoidal circular stapler and accessories 33mm and proximate® hcs hemorrhoidal circular staple and accessories 33mm medical device manufacturer, ethicon endo-surgery, has initiated a global voluntary recall for specific production lots of proximate® pph hemorrhoidal circular stapler and accessories 33mm (product code pph03) and proximate® hcs hemorrhoidal circular stapler and accessories 33mm (product code pph01) due to difficulty in firing the device which may result in incomplete firing stroke that may lead to an incomplete staple formation. the manufacturer advised all users to discontinue use of affected products. according to the local supplier, the affected devices were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 6 august 2012.

Device

Endo-Surgery Proximate® PPH Hemorrhoidal Circular Stapler and Accessories 33mm and Proximate® HCS...
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Ethicon Endo-Surgery Proximate® PPH Hemorrhoidal Circular Stapler and Accessories 33mm and Proximate® HCS Hemorrhoidal Circular Staple and Accessories 33mm
  • Manufacturer
    Ethicon Endo-Surgery

Manufacturer

Ethicon Endo-Surgery