Events

Retiro De Equipo (Recall) de Device Recall Starion Instruments Real Hand ThermaSeal Thermal Ligating Shears

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Starion Instruments.

¿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
    55750
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1972-2010
  • Fecha de inicio del evento
    2008-06-26
  • Fecha de publicación del evento
    2010-07-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-10-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91719
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Causa
    Due to an improper fixture revision, device may be missing a screw at the jaw assembly, resulting in jaw components falling off during use.
  • Acción
    The firm submitted an MDR but determined that there was no risk to health. E-mails were sent on June 26, 2008, to consignees, describing the product, the problem, and action to be taken by consignees. The consignees were ask to provide a list of all unused ThermaSeal devices and their locations, to return the products to Starion from the lots noted and to provide a copy of the attached letter to their sales force and customers if they choose. If you have any questions, please call (408) 522-5200 ext. 326 or (408) 350-9934.

Device

Device Recall Starion Instruments Real Hand ThermaSeal Thermal Ligating Shears
  • Modelo / Serial
    Model Number N-10700, lot numbers 80419, 806009, 804037, 804035, 804036, 804019A.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution.
  • Descripción del producto
    Starion Instruments Real Hand ThermaSeal Thermal Ligating Shears, electrosurgical cutting and coagulation device and accessories, manufactured by Starion Instruments, Sunnyvale, CA || Intended use: Medical Device used for cutting and cauterization of soft tissue during surgery, and of natural or synthetic, non-metallic sutures during surgery.
  • Manufacturer
    Starion Instruments

Manufacturer

Starion Instruments
  • Dirección del fabricante
    Starion Instruments, 775 Palomar Ave, Sunnyvale CA 94085-2915
  • Empresa matriz del fabricante (2017)
    HOYA Corp.
  • Source
    USFDA