Events

Alerte De Sécurité sur CLINAC RADIOTERAPIC LINEAR ACCELERATORS - Registration 10405410001 and HIGH POWER RADIOTHERAPY LINEAR ACCELERATOR CLINAC - Registration 10405410010, Serial Numbers as listed in the appendix. http://en.wikipedia.org/w/index.php?/

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par VARIAN MEDICAL SYSTEMS BRASIL LTDA..

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1067
  • Date
    2011-07-08
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Varian's TrueBeam Clinacs and Systems utilize "rigid" physical beam modifying wedges (here referred to simply as "wedges" and excluding the functionality of "dynamic" wedges). These wedges are manufactured in various angles, dimensions and materials, with different configurations of bases for top and bottom fittings and in different configurations for Clinacs with MLC and without MLC. Varian was aware of two recent incidents in which the body of a 30 degree steel upper wedge separated from the wedge base due to the failure of the fastening screws. These incidents did not cause serious injury and in both cases occurred in Clinacs that had been in use for at least 7 (seven) years. In addition, at least one of the wedges had a history of periodic loosening of the fastening and re-tightening screws by the operator. It is likely that, at first, the fault only affects one or two fastening screws, leaving the wedge suspended by the remaining ones, which is a strong indication that others may fail. There are no records of occurrences in Brazil to date. Anvisa follows this field action.
  • Cause
    Separation between the wedges and their bases may occur. see annex: http://portal.Anvisa.Gov.Br/wps/wcm/connect/eedd6200478d48358e018e5c9a854df2/alerta_1067_aviso_de_seguranca.Pdf?mod=ajperes.
  • Action
    To Users and Professionals: (1) Inspect all rigid wedges immediately to identify any missing or cracked screws. If any wedge has one or more missing or cracked screws, put the wedge out of use and notify the company immediately. (2) Inspect all rigid wedges to identify loose screws and tighten if necessary. (3) Implement a program of monthly wedge inspections to detect loose or missing components. Company action plan: (1) Referral of Urgent Security Notice (attached) to customers; (2) Replacement of screws on all rigid wedges, according to a schedule established by the company (until March / 2012), in Clinacs installed before January 2004; (3) Analysis of the problem and subsequent communication to the clients about the conclusions.

Device

CLINAC RADIOTERAPIC LINEAR ACCELERATORS - Registration 10405410001 and HIGH POWER RADIOTHERAPY LI...

Manufacturer

VARIAN MEDICAL SYSTEMS BRASIL LTDA.