Events

Notificaciones De Seguridad De Campo acerca de cystoscopy bridge

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por OLYMPUS KEYMED.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2017-09-01
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    Olympus is implementing a field safety corrective action ("fsca") of the cystoscopy bridges and the working insert referenced above. cystoscopy bridges and working inserts are used for endoscopic diagnosis and treatment in urologic applications. olympus has initiated this fsca after receiving complaints about fragments of adhesive which detached from inside the working channel of the referenced cystoscopy bridge models. cracking, chipping, missing pieces, and delamination of the adhesive have been observed. investigations have confirmed that this adhesive can detach during the intended use of the cystoscopy bridge or working insert, e.G. when inserting an instrument through the working channel. as a result, a fragment of the adhesive may fall inside the patient's bladder or urethra and will need to be retrieved. although typically flushed out with irrigation fluid or passed naturally, the retrieval of large fragments of the adhesive could require additional surgical treatment. furthermore, the procedure can be prolonged resulting in extended anesthesia. .

Device

cystoscopy bridge
  • Modelo / Serial
    A20975A Working insert, with ramp, one way 13ZW, 149W, 14ZW, 159W, 15ZW, 162W, 168W A20976A Bridge, one way 146W, 147W, 148W, 149W, 14XW, 14YW, 14ZW, 151W, 152W, 153W, 154W, 155W, 156W, 157W, 158W, 159W, 15XW, 15YW, 161W, 162W, 163W, 164W, 165W, 167W, 168W, 16YW, 16ZW, 171W, 172W A20977A Bridge, two way 146W, 148W, 149W, 14XW, 14ZW, 151W, 152W, 153W, 154W, 155W, 156W, 158W, 159W, 15XW, 15YW, 161W, 162W, 163W, 164W, 165W, 166W, 167W, 168W, 169W, 16XW, 16ZW, 171W, 172W, 173W
  • Manufacturer
    OLYMPUS KEYMED

Manufacturer

OLYMPUS KEYMED