Events

Retiro De Equipo (Recall) de Device Recall Starion Instruments 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
    55043
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2239-2010
  • Fecha de inicio del evento
    2010-03-09
  • Fecha de publicación del evento
    2010-08-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-11-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89744
  • 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/cauterization and accessories - Product Code GEI
  • Causa
    The starion instruments thermal ligating shears (stls) 35c and the starion thermal ligating shears (stls) 23c may turn on and remain on without the finger button being depressed. the devices may also work intermittently, incorrectly indicating the device is 'on".
  • Acción
    Starion distributed a "STLS Device Recall - Important Medical Device Information" letter dated March 9, 2010 to consignees. The letter identified the affected model and lot numbers. Consignees were asked to complete a inventory status form and fax to Starion. the letter included a shipping labe with a pre-assigned return authorization number. Starion will ship replacement after receipt of the inventory status form and returned product..

Device

Device Recall Starion Instruments Thermal Ligating Shears
  • Modelo / Serial
    STLS 23C: Model numbers 102-137D, Lot Numbers: 905029, 907007, 910016, 908022  STLS 35C: Model 102-138D, Lot Numbers: 907004 and 907008
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: USA states of CA, OH, MI, KS and MO and countries of Italy, China, Kuwait, and Germany.
  • Descripción del producto
    The Starion Instruments Thermal Ligating Shears 35C Model 102-138D and 23C Model numbers 102-137D allow the surgeon to position the distal jaws of the instrument around the region of tissue to be cut/cauterized. The surgeon squeezes the handle and depresses the switch, heating elements activates in the jaws. The heat is conducted to the tissue between the jaws to provide cutting/cauterization. For the simultaneous cutting and cauterization of soft tissue during surgery. Cutting 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