Events

Field Safety Notices about Devon™ Light Glove

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
  • 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
    The purpose of this letter is to advise you that medtronic is recalling its covidien devon™ light gloves distributed as single sterile items and in specific procedure kits. all lot numbers within expiry beginning with 630xxxxxxx and lower are affected. customers have reported that, on rare occasion, the devon™ light glove may split upon application to the devon™ light handle adapter. some of the reported splits resulted from difficult application of the light glove to the handle adapter. more recently, clinicians have reported finding splits in the light glove following surgery completion, where no difficulty in application of the light glove was encountered or finding splits directly out of the package. a split in the light glove causes a breach in the sterile field and can increase the potential for infection. medtronic has received notice of two patient adverse events (infection) in which light glove splits were found at the conclusion of surgery. medtronic requests that you quarantine and return any unused products of the item codes listed on attachment a. unused products should be returned as described in the required actions section below. if you have distributed the devon™ light glove products listed on attachment a, please promptly forward the information from this letter to those recipients. all unused products must be returned. .

Device

Devon™ Light Glove

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