Events

Retiro De Equipo (Recall) de Device Recall Resolution II Clip

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 Boston Scientific Corporation.

¿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
    59476
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3056-2011
  • Fecha de inicio del evento
    2011-07-19
  • Fecha de publicación del evento
    2011-08-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-06-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102859
  • 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
    Ligator, hemorrhoidal - Product Code FHN
  • Causa
    Boston scientific has received reports where, following clip deployment, the alignment of the clip and delivery system does not allow for the withdrawal of the delivery system away from the clip, resulting in tissue trauma, increased bleeding and the clip being pulled off tissue as the delivery system is withdrawn.
  • Acción
    Boston Scientific sent an URGENT MEDICAL DEVICE RECALL letter dated August 12, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to forward the Medical Device Recall to their customers. Customers were instructed to: Immediately discontinue use of any affected product. Complete and return the Reply Verification Tracking Form by fax to 508-683-5578. Package and return any affected product to: Boston Scientific Corporation Distribution Center Attn: QA Returns 500 Commander Shea Blvd Quincy, MA 02171 For questions regarding this recall call 508-683-5578.

Device

Device Recall Resolution II Clip
  • Modelo / Serial
    Catalog M00522500: Lot 1ML1013103, ML00000004, ML00000129, Catalog M00522501: Lot 1ML1013104, ML00000071, ML00000148, Catalog M00522502: Lot 1ML1013102, ML00000042, ML00000131, Catalog No. M00522501: Lot 1ML1011201, 1ML1013101, 1ML1020202, 1ML1021402, 1ML1022202, ML1022213,ML00000013, ML00000019, L00000058,ML00000073, ML00000098, ML00000120,  Catalog No. M00522511: Lot 1ML1010605, 1ML1012602, 1ML1013105, 1ML1020203, 1ML1021403, 1ML1022203,1ML1022214, ML00000014, ML00000020,ML00000043, ML00000059, ML00000074,ML00000099, ML00000119, Catalog No. M00522512: Lot 1ML1011905, 1ML1020201, 1ML1021401, 1ML1022201, 1ML1022215, ML00000018,ML00000032, ML00000040, ML00000072,ML00000097, ML00000135, and ML00000137
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - including USA (nationwide)
  • Descripción del producto
    The Resolution II Clip, 155 cm size and 235 cm size, Boxes of 1, 10, and 20 clips consists of a pre-loaded, radiopaque single use clip on a flexible delivery system. || Endoscopic Clipping Device, Hemorrhoidal Ligator. The device is used for clip placement within the GI tract for hemostatis ( mucosal defects, bleeding ulcer, arteries, polyps); endoscopic marking; and anchoring to affix jejunal feeding tubes to the wall of the small bowel, as a supplementary method for closure of GI tract luminal perforation <20 mm that can be treated conservatively.
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Dirección del fabricante
    Boston Scientific Corporation, 100 Boston Scientific Way, Marlborough MA 01752-1234
  • Empresa matriz del fabricante (2017)
    Boston Scientific
  • Comentario del fabricante
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    USFDA