Events

Safety Alert for Bravo® pH Monitoring System, part number FGS-0312 (5-Pak) or FGS-0313 (Singles)

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

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
    2012-01-12
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120111.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: given imaging bravo® ph monitoring system, part number fgs-0312 (5-pak) or fgs-0313 (singles) medical device manufacturer, given imaging, has issued a field safety notice on bravo® ph monitoring system, part number fgs-0312 (5-pak) or fgs-0313 (singles). the manufacturer has received reports of failure of the bravo capsule to attach to the esophagus or failure of the capsule to detach from the placement device. occurrence of these failures may result in lengthened time for a bravo procedure, esophageal injury, and/or the need for additional procedures. upon investigations, the manufacturer determined that these failures have a combination of root causes including issues related to tolerances in certain manufacturing dimensions. the manufacturer will replace the affected devices. an "attention" label on how to perform the rescue procedure and an updated user manual are now being provided with all bravo devices. according to the local supplier, the affected product has been distributed in hong kong. if you are in possession of the product, please contact your supplier for necessary actions.

Device

Bravo® pH Monitoring System, part number FGS-0312 (5-Pak) or FGS-0313 (Singles)
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Given Imaging Bravo® pH Monitoring System, part number FGS-0312 (5-Pak) or FGS-0313 (Singles)
  • Manufacturer
    Given Imaging

Manufacturer

Given Imaging
  • 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