Events

Field Safety Notices about Monopolar high-frequency resection electrodes

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
  • 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
    Olympus has initiated the implementation of the [field safety corrective action (fsca) / removal measure] for the above monopolar high-frequency resection electrodes. the electrodes are used for endoscopic diagnostics and treatment in urology and gynecology.   olympus has taken this [safety corrective action / removal measure] because it has received a large number of complaints about loop breaks at the distal end of said electrodes. investigations have confirmed that the loops can actually break during the intended use of the electrodes. the loop particle can then fall into the patient and need to be removed. in certain cases, additional surgical treatment is required to remove this particle. in addition, this can prolong the procedure and, consequently, the duration of the anesthesia.

Device

Monopolar high-frequency resection electrodes
  • Model / Serial
  • Manufacturer
    Olympus

Manufacturer

Olympus