Events

Retiro De Equipo (Recall) de Device Recall HydroThermAblator Endometrial Ablation System

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
    52780
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2209-2009
  • Fecha de inicio del evento
    2009-07-31
  • Fecha de publicación del evento
    2009-09-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-05-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83991
  • 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
    Endometrial Thermal Ablation Device - Product Code MNB
  • Causa
    Cracked procedure sheaths, incorrect care/use of device, and console malfunctions may result in fluid leaks and loss of a cervical seal that are responsible for burns.
  • Acción
    Boston Scientific issued an Urgent Medical Device Recall - Immediate Action Required notification to hospitals and distributors dated July 31, 2009 via Federal Express and requested the immediate discontinued use and segregation of Recall product for return and Complete and return the Reply Verification Tracking Form. An email was sent to Physicians to provide the recall information. Boston Scientific issued a Clarification letter dated August 6, 2009 via Federal Express as a follow-up to the July 31, 2009 Recall letter for the following reason: customers may remove product from the outer box and store it on the inventory shelf by the inner package only. If this is a practice at the facility, a customer must consider both the inner and outer packaging product codes when searching for affected recalled product as the UPN numbers on the inner and outer labeling are different. A reply verification tracking form for customers was provided in case they have located any additional product to return.

Device

Device Recall HydroThermAblator Endometrial Ablation System
  • Modelo / Serial
    Lot Numbers: 35421, 35422, 35423, 35424, 35425, 35426, 35846, 35847, 35890, 35891, 35892, 36038, 36039, 36040, 36041, 36042, 36047, 36048, 36104, 36105, 36141, 36142, 36143, 36146, 36147, 36148, 36214, 36215, 36234,36235, 36249, 36250, 36251, 36260, 36261 ,36370, 36371, 36372, 36467, 36468, 36682, 36683, 36684, 36685, 36686, 36688, 36689, 36690, 36693, 36694, 36695, 37049, 37098, 37099, 37149, 37150, 37151, 37154, 37192, 37218, 37219, 37220, 37221, 37222, 3and 7223.
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, Austria, Denmark, Finland, France, Great Britain, Italy, Netherlands, and Sweden.
  • Descripción del producto
    Boston Scientific HydroThermAblator Endometrial Ablation System- || HTA¿ System Procedure Set with Tenaculum Stabilizer and Disposable Heater Canister (5/bx) || Material/UPN/Catalog Number: M006560201 || System-HTA¿ System Procedure Set with Tenaculum Stabilizer and Disposable Heater Canister (ea) || Material/UPN/Catalog Number: M006560200 || Intended to ablate the endometrial lining of the uterus in premenopausal women with menorrhagia due to benign causes for whom childbearing is complete.
  • 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