Events

Retiro De Equipo (Recall) de Teleflex(R) Percuvance(TM) Percutaneous Surgical System, Gripper Grasper

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 Teleflex Medical.

¿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
    78340
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0059-2018
  • Fecha de inicio del evento
    2017-10-18
  • 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=159243
  • 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
    Teleflex is recalling these products because the jaws of the tool tip may break, causing a fragment of the tool tip to fall off during use.
  • Acción
    Teleflex sent an Urgent Medical Device Recall 1st Notification letter dated October 18, 2017, via FedEx. The customers were instructed to take the following actions : 1. If you have affected stock, immediately discontinue use and quarantine any products with the product codes and lot numbers listed above. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Teleflex Medical. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document your receipt of this letter." For further questions please call (847) 572- 8014.

Device

Teleflex(R) Percuvance(TM) Percutaneous Surgical System, Gripper Grasper
  • Modelo / Serial
    (a) Catalog Number PCVJG5, Lot Numbers: 73E1700794, 73G1700271, 73G1700515, 73H1700081, 73H1700367  (b) Catalog Number PCVMD5, Lot Numbers: 73E1700796, 73G1700273,  73H1700083  (c) Catalog Number PCVHCA5, Lot Numbers: 73E1700798, 73H1700084  (d) Catalog Number PCVGG5, Lot Numbers: 73E1700793, 73G1700272, 73H1700082, 73H1700247  (e) Catalog Number PCVSC5, Lot Number: 73H1700569
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Australia, Belgium, Hong Kong, Japan, S. Korea and Singapore.
  • Descripción del producto
    Teleflex(R) Percuvance(TM) Percutaneous Surgical System, Components: || (a) 5 mm Atraumatic Johans Grasper, Catalog Number PCVJG5 || (b) 5 mm Maryland Dissector, Catalog Number PCVMD5 || (c) 5 mm Hem-o-lok Clip Applier, Catalog Number PCVHCA5 || (d) 5 mm Traumatic Gripper Grasper, Catalog Number PCVGG5 || (e) 5 mm Scissors, Catalog Number PCVSC5 || The Percuvance Percutaneous Surgical System is a family of instruments used to perform laparoscopic procedures. Without the need for additional insertion conduits (trocars), the 2.9mm insulated Shafts are inserted percutaneously with the assistance of an Introducer needle tool tip. The Shaft is then advanced retrograde through a 5mm, or larger, port to facilitate the extracorporeal attachment of interchangeable Tool Tips. These interchangeable tools can be used to grasp, retract, manipulate, cut, coagulate and deliver Hem-o-lok¿ ligating clips to soft tissue. Each Percuvance System Handle includes an integrated male cautery adapter that can be connected to most monopolar electrosurgical units (ESU) via a standard 4mm monopolar cable.
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical
  • Dirección del fabricante
    Teleflex Medical, 2917 Weck Dr, Research Triangle Park NC 27709-0186
  • Empresa matriz del fabricante (2017)
    Teleflex Incorporated
  • Source
    USFDA