Events

Safety Alert for Trade name: Circular stapler -. Registration No. 80081350317 -. All models -. ALL LOTS

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by FLEX LAB COMERCIO DE MATERIAIS CIRURGICOS E HOSPITALARES LTDA..

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
    1309
  • Date
    2013-10-16
  • 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
    Manufacturer: RESOURCE MEDICAL DEVICES CO., LTD. - CHINA
  • Reason
    Mechanical failure in the stapling at the time of surgery, leading to the prolongation of the surgical act.
  • Action
    Company will amend the Indications for Use, Contraindications and Precautions, indicating that the product is intended for open surgery. UPDATED ON 12/13/2013: Company filed a notice to ANVISA with its distribution chain (Attachment) #. # UPDATED ON 12/12/2013: Company filed an amendment to the Instructions for Use of the product at ANVISA and sent a Notice to its distributors, as Annex # # UPDATED ON 01/29/2014: Anvisa granted the request to change the Instructions for Use of the product (Resolution RE Nº 75, dated 10/01/2014, published in the DOU - Supplement - Nº 8, dated 01/13/2014 / 204, pages 4 and 9. It should be noted that in item 1 of the Warnings and Precautions field, "1. Product intended exclusively for open surgery." Company has sent a notice to its distributors FIELD ACTION COMPLETED #

Device

Trade name: Circular stapler -. Registration No. 80081350317 -. All models -. ALL LOTS

Manufacturer

FLEX LAB COMERCIO DE MATERIAIS CIRURGICOS E HOSPITALARES LTDA.
  • Source
    ANVSANVISA