Alerta De Seguridad para Ultrasound Video Endoscopy Evis Exera II, Brand: Olympus, Model GF-UCT-180; Registration: 80124630028, Serial numbers: 1511308,1511310,1110516, 1311111, 1100184, 1110285, 1110490, 1110518, 1411230, 1411254, 1411252, 1411267, 1411270, 1411271, 1411293.

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.

Olympus Optical of Brazil evaluates that there is at present no indication of changes in product safety and efficacy levels, however, as a risk preventive action, it is contacting its customers and distributing the revised operating manuals. Reprocessing instructions are an important part of the safe use of the product. There is a potential safety concern regarding instructions for using the MAJ-350 cleaning adapter and adding the MAJ-675 and MAJ-1534 to the list of reprocessable and reusable parts and accessories. In case MAJ-350 is not used for reprocessing, the following accessories a) suction cleaning adapter and / or b) the channel plug do not connect to the endoscope, the user would easily notice an error. Based on this, the manufacturer evaluates that the products have most likely been properly reprocessed by users.