Events

Retiro De Equipo (Recall) de BOX 01KBAR006116V PROC BYPASS

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 COVIDIEN MEDTRONIC.

¿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
    79974
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1828-2018
  • Fecha de inicio del evento
    2018-04-26
  • Fecha de publicación del evento
    2018-05-16
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164085
  • 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
    Staple, implantable - Product Code GDW
  • Causa
    Device may be missing a sled component. the sled component is responsible for staple deployment. this may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
  • Acción
    On April 26, 2108, all consignees were issued were issued Urgent Medical Device Recall notices and Return Forms via Federal Express or certified mail. On May 22, 2018, all consignees received an UPDATED URGENT MEDICAL DEVICE RECALL notice. The updated notice included NEW product which has been processed under FDA Ref # 80423. The notice informs customers of the potential for use of a device with a missing sled and the actions they should take to discontinue use of the product and return all inventory of the affected lots to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department. All in-control inventory and devices returned from customers will be reworked. **FOR INTERNATIONAL CUSTOMERS** Please be aware that the recalled units are packed within various convenience kits as identified on the Attachment B provided with your customer letter. Customers are also encouraged to EMAIL OR FAX THE ACKNOWLEDGEMENT FORM TO: - "Product purchased directly from Medtronic": feedback.customerservice@Covidien.com or fax to (800) 895-6140. - "Product purchased through distributor": FCAMITG@Covidien.com or fax it to (203) 492-7719.

Device

BOX 01KBAR006116V PROC BYPASS
  • Modelo / Serial
    Lot 0215227169
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide and US Nationwide
  • Descripción del producto
    BOX1073076GASB1 BBR GASTRIC BYPASS S(Item Code BOX1073076GASB1 BBR GASTRIC BYPASS S) || Product Usage: || The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the selection of the 2.0 mm, 2.5 mm, 3.5 mm or 4.8 mm single use loading unit. The Endo GIA universal staplers will accommodate any of the single use loading unit sizes that are available in the 30 mm, 45 mm and 60 mm lines.
  • Manufacturer
    COVIDIEN MEDTRONIC

Manufacturer

COVIDIEN MEDTRONIC
  • Dirección del fabricante
    COVIDIEN MEDTRONIC, 60 NIDDLETOWN AVE 2ND F, NORTH HAVEN CT 06473
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA