Events

Field Safety Notices about Olympus KV-5 Suction Pump

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 Olympus.

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
    2016-02-15
  • 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 fsn has been issued to inform end users of an update to the kv-5 instructions for use regarding the use of disposable item maj-103 patient connecting tube. the text in the instructions for use has changed from: 'single patient list unless local or national hospital policy dictates otherwise' to 'single patient use'. there have been no adverse events reported prior to the update to the instructions for use relating to the maj-103. the update to the kv—5 instructions for use consolidates the text in line with current national hospital policy which requires patient connecting tubing to be single patient use. .

Device

Olympus KV-5 Suction Pump
  • Model / Serial
  • Manufacturer
    Olympus

Manufacturer

Olympus