Events

Field Safety Notices about Interwoven absorbent Polysorb ™ thread Endo Stitch ™ with Polysorb ™ thread Maxon ™ monofilament absorbent thread Monofilament absorbent thread Biosyn ™

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Medtronic.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2017-05-15
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
  • Extra notes in the data
  • Reason
    This precautionary measure is implemented because of the potential for incomplete sealing of the inner packaging, which it can causes the sewing material to break down too quickly. using products with this deficiency can increase it the possibility of tearing the thread. the aforementioned defect on the packaging does not affect the sterility of the product. so far it hasn't been no reports of serious injuries due to this issue. medtronic asks you to put any unused products with the codes or batches listed below in quarantine and return them. you can return unused products with the relevant product codes and batches to according to the instructions in the required actions section below. if you are interwoven absorbent polysorb ™ thread, endo stitch ™ control units with polysorb ™ thread, maxon ™ monofilament absorbent thread, or biosyn ™ monofilament absorbent thread listed in annex a, further distributed, information thereon notify these recipients immediately. all unused products with the relevant product codes and you have to return the series.

Device

Interwoven absorbent Polysorb ™ thread Endo Stitch ™ with Polysorb ™ thread Maxon ™ monofilament ...

Manufacturer

Medtronic
  • 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
    AMPMDRS