Events

Safety Alert for Versaport Bladeless Optical 5mm Trocar with Fixation Cannula

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

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
    2013-05-10
  • Event Date Posted
    2013-05-10
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130510.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: covidien versaport bladeless optical 5mm trocar with fixation cannula medical device manufacturer, covidien private limited issued a medical device safety alert concerning versaport bladeless optical 5mm trocar with fixation cannula. the affected code number are onb5lgf, onb5shf, onb5stf, onb5stf2c, onbfca5sh, onbfca5st and the affected lot numbers range are n2h0414x through, n2h0413x through, n2h0353x through, n2j0211x through, n2j0315x through and n2j0150x through. the special lot numbers (n2h0045x, n2h0166x, n2h0286x, n2h0357x and n2h0516ux) are not affected by this recall and are acceptable for use. covidien has received reports of seals disengaging from the cannula which may result in a component inadvertently disengaging into the patient’s cavity. no related adverse events have been reported at this time. the seal is located within the trocar body itself and when defective, may detach from the trocar and be pushed by the laparoscopic instrument into the body cavity. if detected, the detached seal should be removed. as with all foreign bodies, if undetected and left free in the body, the seal may lead to a complication, the nature of which is undetermined. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 10 may 2013.

Device

Versaport Bladeless Optical 5mm Trocar with Fixation Cannula
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Covidien Versaport Bladeless Optical 5mm Trocar with Fixation Cannula
  • Manufacturer
    Covidien Private Limited

Manufacturer

Covidien Private Limited
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DH