Events

Safety Alert for Sarns™ Sternal Saw I System

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

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
    2011-11-23
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111123a.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
    Field safety notice: terumo cvs sarns™ sternal saw i system medical device manufacturer, terumo cardiovascular system (terumo cvs), has issued an field safety notice concerning sarns™ sternal saw i system. terumo cvs has received one report of minute metal shavings leaking from the sarns™ sternal saw i system at the point where the saw blade is inserted into the saw hand piece. if metal shavings fall into the surgical site, the immediate and long range effect on the patient would be determined by the volume of metal and whether or not any other residue form inside the saw also leaked into the wound. the body would recognize the presence of the material as a foreign surface and would initiate an inflammatory response, which would range in severity from a mild localized response to a major systemic inflammatory response. either of these could lead to an increase in morbidity to the cardiac surgery patient. no patient injury and no impact to the surgical procedure were reported with this incident. terumo cvs is removing all sternal saw i system from the field. according to the manufacturer, hong kong is not affected. if you are in possession of the affected products, please contact your supplier for necessary actions. .

Device

Sarns™ Sternal Saw I System
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Terumo CVS Sarns™ Sternal Saw I System
  • Manufacturer
    Terumo Cardiovascular System

Manufacturer

Terumo Cardiovascular System