Events

Safety Alert for SURGICAL ROBOT SURGICAL SYSTEM, Single-Site Maryland Dissector; Single-Site Medium-Large Clip Applier; Single-Site Cadiere Forceps; Single-Site Needle Driver; Single-Site Fundus Grasper; Single-Site Crocodile Grasper; Single-Site Maryland Bipolar Forceps; Single-Site Curved Needle Driver; Single-Site Fenestrated Bipolar Forceps. Models: 428050-12, -13, -14; 428053-12, -15; 428055-12, -13; 428056-12, -13; 428058-12, -13; 428059-12, -13; 428080-04, -05; 428088-12, -13; 428093-12, -13. risk class III.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by H. Strattner & Cia Ltda; Intuitive Surgical, INC..

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
    1718
  • Date
    2015-10-20
  • 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
    According to the manufacturer the alert informs that in identifying the failure in the mentioned items, the customer should contact the company so that the material is replaced and the defective unit will be sent to the manufacturer.
  • Reason
    The instrument may not open after being fixed to a tissue, causing the user to use a method indicated to open the jaw of the instrument, releasing the trapped tissue.
  • Action
    Alerts users to follow the manufacturer's recommendations if the problem is identified. When the material presents the problem, the company must be informed so that the material is removed within 48 hours and replaced with a new unit.

Device

SURGICAL ROBOT SURGICAL SYSTEM, Single-Site Maryland Dissector; Single-Site Medium-Large Clip App...

Manufacturer

H. Strattner & Cia Ltda; Intuitive Surgical, INC.
  • Source
    ANVSANVISA