Alerta De Seguridad para GYNECARE MORCELLEX FABRIC CLEANER. MODEL: MX0100. Registro Anvisa 80145901131. Lots affected: See annex at http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2009/994_lotes_afetados.pdf.

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.

According to Johnson & Johnson do Brasil, there has still been no record of adverse event related to the problem. If the "duckbill" seal detaches from the morcellator and is allowed to remain inside a patient, there is the possibility of adhesions formation, secondary pain to the formation of adhesions, erosion to the organs of the abdominal cavity with possible subsequent hemorrhage and / or sepsis and obstruction secondary to adhesion formation. Anvisa's Technovigilance Unit is monitoring this case.