Events

Safety Alert for Surgical motor. Pneumatic motor. Electric motor. System for bone surgery

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by N/A.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    939
  • Date
    2008-09-09
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Extra notes in the data
    Some characteristics of the surgical motor and improper device (domestic drill), related below, reinforce the need to ban the use of domestic drills from the routine of the health services. :) Health Product (Surgical Motor): 1. Allows the surgeon to control the rotation of the equipment from lowest to highest RPM. That is, the speed can be regulated by the surgeon and maintained in each range; 2. Some have an irrigation system that guarantees the cooling of the tools and the prevention of tissue necrosis due to excess heat; 3. It uses a self-locking drill which, after drilling the bone, automatically disarms; 4.The manufacturer is responsible for guiding the indicated sterilization method for your product. :( Improper devices (domestic drilling machine): 1.It does not show rotation control; 2.It can aspirate bone particles into the inside; 3.It can not be sterilized; 4.Oil lubrication can contaminate the surgical field; is protected from the risk of electric shock.
  • Reason
    Improper use of "domestic" drills in surgical procedures. "domestic" drills were not originally intended to be used as medical products. the marketing and use of this type of device in surgical procedures represent a serious risk to the health of the population and constitute sanitary infraction, because it is a product without registration in anvisa. to manufacture, import, distribute or market medical products in brazil, the company (manufacturer, importer, distributor) must have authorization from the sanitary surveillance and the product must be duly registered with anvisa.
  • Action
    The Technovigilance Unit warns of the risks of marketing, sterilizing and using in surgical procedures improper devices, such as a domestic drill, which are not designed for medical-hospital use. Companies (manufacturers, importers and distributors), services that perform sterilization of products for health and health services should be aware that it is prohibited to market, sterilize and use product without registration with ANVISA. The Annexes 1.NOTE TECHNICAL No. 129/2008 / GQUIP / GGTPS / ANVISA clarifies on the process of registration of products for use in health (http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2008/alerta_939_carta.pdf ) and 2. PROCESSING / GGTES / ANVISA advises on the cleaning and sterilization of drill for use in surgeries (http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2008/alerta_939_processa.pdf). The Technovigilance Unit is accompanying the work of the coordination of health surveillance of a state (VISA / STATE), which is articulated with other entities of the National Health Surveillance System (SNVS), with other areas of the health sector, as well as other public sectors, are adopting measures aimed at suppressing this irregular practice in their geographical area. These measures were planned and articulated in a way that did not harm the attendance of the population in the public and private hospitals of that state. The Sanitary Surveillance Center of the State of São Paulo released the communiqué CVS Nº 264/2008-TECNOVIGILÂNCIA / DITEP alerting to the problem and advising on the measures to be taken (http://www.cvs.saude.sp.gov. br / com_ler.asp? gt_codigo = 18 & cm; _codigo = 989).

Device

Surgical motor. Pneumatic motor. Electric motor. System for bone surgery
  • Model / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA