Events

Field Safety Notices about DS Titanium Ligation-Clips

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 Aesculap AG.

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
    Herewith, we would like to inform you that the instruction for use, chapter contraindications for the ds titanium ligation clips, has been extended with the “closure of the a./v. renalis during living kidney donation". this is a proactive action. we want to point out that there was no patient injury prior to this action.

Device

DS Titanium Ligation-Clips
  • Model / Serial
    FC171R FC174R FC175R FC177R FC178R FC179R FC181R FC184R FC185R FC187R FC188R FC191R FC194R FC195R FC196R FC197R FC198R FC199R FC204R FC205R FC206R FC207R FC208R FC209R FC214R FC215R FC216R FC217R FC218R FC219R FC230R FC231R PL450SU PL452SU PL453SU PL459SU PL462SU PL465SU PL468SU PL471SU PL475SU PL801R PL802R PL806R PL807R PL808R PL809R PL816R PL817R PL818R PL822R PL826R PL827R PL828R
  • Manufacturer
    Aesculap AG

Manufacturer

Aesculap AG