Events

Safety Alert for HARMONIC ACE+ 7 Shears

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

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
    2015-10-07
  • Event Date Posted
    2015-10-07
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20151007b.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 harmonic ace+ 7 shears medical device manufacturer, ethicon, has issued a medical device safety alert concerning its harmonic ace+ 7 shears [product code: harh23, harh36, harh45]. the manufacturer is initiating a global voluntary recall (removal) of the harmonic ace+ 7 shears (harh23, harh36, harh45) because under extreme handling circumstances, damage, such as a hole, can occur in the tyvek lid due to an interaction between the advanced hemostasis (green) button and the tyvek lid which could compromise device sterility. the manufacturer has received no reports of adverse events for this issue and this recall does not relate to the functionality of the device. affected users are advised to use alternative product while waiting for replacement. according to the local supplier, the affected products are distributed in hong kong if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 7 october 2015.

Device

HARMONIC ACE+ 7 Shears
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Ethicon HARMONIC ACE+ 7 Shears
  • Manufacturer
    Ethicon

Manufacturer

Ethicon