Events

Avis De Sécurité sur Monopolar high-frequency resection electrodes

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par Olympus.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
  • Manufacturer
    Olympus

Manufacturer

Olympus