Events

Retiro De Equipo (Recall) de Cystoscopy Bridges

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Olympus Australia Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2017-RN-01158-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-09-06
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01158-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    The manufacturer owi has received complaints about fragments of adhesive detaching from the inside of the working channel of cystoscopy bridges. chipping, cracking and delamination of the adhesive may occur when inserting an instrument through the working channel. in the rare occurrence that an adhesive fragment may fall in to the patient it can be flushed out with irrigation fluid or passed naturally. the retrieval of large adhesive fragments may require additional surgical treatment and extended anaesthesia. to date, there have been no reports of adverse events or patient injury related to this issue worldwide.
  • Acción
    1. Users with affected lots should continue to use existing Cystoscopy Bridges until replacements are obtained. 2. Complete and return the supplied reply form to Olympus. 3. Check the delivery details and number of affected devices listed in the customer letter that need replacing from Olympus, and contact them on 1300 657 699 with any changes. 4. Upon receipt of the replacement Cystoscopy Bridges from Olympus dispose the affected bridges and use the replacement devices. 5. Users who have distributed or transferred any of the affected products to other facilities should forward this recall notice and please notify Olympus so that they can follow up with that facility directly.

Device

Cystoscopy Bridges
  • Modelo / Serial
    Cystoscopy BridgesBridge, one wayModel Number: A20976ALot Numbers: 14XW, 152W, 153W, 154W, 156W, 158W, 15YW, 164W, 165W, 169W, 16XW, 172WBridge, two wayModel Number: A20977ALot Numbers: 148W, 149W, 14XW, 14YW, 14ZW, 154W, 155W, 156W, 159W, 15XW, 163W, 166W, 169W, 171WARTG Number: 146365
  • Manufacturer
    Olympus Australia Pty Ltd

Manufacturer

Olympus Australia Pty Ltd