Events

Retiro De Equipo (Recall) de COLLINS RADIOPARENT STERNAL BLADES

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por SYMMETRY SURGICAL.

¿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
    120619
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-04-09
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    The recall has been initiated due to an issue with the device breaking during surgical procedures where the sternum needs to be retracted. the device is breaking where the retractor blade assembles to the stainless steel retractor body. the device is not breaking where it comes in contact with the patient. use of this device may cause a risk to the patient and hospital staff if the device breaks at the retractor blade and retractor body connection point this could prolong the surgery.

Device

COLLINS RADIOPARENT STERNAL BLADES
  • Modelo / Serial
    Model Catalog: 50-8081 (Lot serial: 296160); Model Catalog: 50-8081 (Lot serial: 244576); Model Catalog: 50-8081 (Lot serial: 296156); Model Catalog: 50-8081 (Lot serial: 296155); Model Catalog: 50-8081 (Lot serial: 296153); Model Catalog: 50-8081 (Lot serial: 296141); Model Catalog: 50-8081 (Lot serial: 296139); Model Catalog: 50-8081 (Lot serial: 296136); Model Catalog: 50-8081 (Lot serial: 276514); Model Catalog: 50-8081 (Lot serial: 276513); Model Catalog: 50-8081 (Lot serial: 268920); Model Catalog: 50-8081 (Lot serial: 268916); Model Catalog: 50-8081 (Lot serial: 244584); Model Catalog: 50-8081 (Lot serial: 244582); Model Catalog: 50-8081 (Lot serial: 296157)
  • Descripción del producto
    Collins Radioparent Sternal Blades Nylon 4 3/4" Long 3" Wide 1 1/2" Deep
  • Manufacturer
    SYMMETRY SURGICAL

Manufacturer

SYMMETRY SURGICAL