Events

Safety Alert for IMRI Registration Matrix for GE Head Support. Anvisa Registry n ° 80042070034.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Brainlab Ltda; Brainlab AG.

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
    1733
  • Date
    2015-11-16
  • 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
    As a result, movement of the Registration Matrix (which contains the RM and infrared markers required for navigation) may occur relative to the GE Head Holder and, as a consequence, to the patient's head. In the event of a very large movement, especially a significant rotational movement, the upper part of the recording matrix (weighing approximately 1.3 kg) may reach the patient's face, resulting in physical trauma and, in a worst case, in severe injury to the patient. In the case of minor movements, especially those related to performing an MRI acquisition and to the automatic recording performed by navigation, there is the potential for failure to correspond between the MRI data sequence and the patient's actual anatomy. The result of automatic registration must always be verified by the user to ensure that accuracy is adequate for the planned procedure. It is likely that, in most cases, any offset from the top of the iMRI Registry Matrix is ​​significant enough to be easily recognized during the verification. However, if an inaccurate record is not detected during user verification, a significant deviation can be added to the positions of the instruments virtually displayed by Brainlab navigation in the region of interest and this may mislead the user in making clinical decisions.
  • Reason
    The brainlab imri header registration matrix for ge head support enables automatic registration of images for navigation of data sequences from intraoperatively acquired mri images using a ge scanner. for acquisition of images and recording, the record matrix is ​​suspended above the patient by means of rail adapters, which hold the matrix and a flexible coil above the patient. it was detected by the manufacturer that fastening between the registration matrix and rail adapters can not always prevent slipping. the adhesion between the rails and their claws, when not observed necessary care, may not be able to hold the device in the desired position when large forces are applied to the registration matrix. this may occur, among other possible scenarios: (1) due to vibrations caused by transport or by irregularities in the floor; (2) when applying tension on the flexible coil cable; (3) when attaching the patient table to the termination stop while transferring the scanner to the surgical table.
  • Action
    The product is being collected by the company. Recommendations to Users: (1) Handle the iMRI Registry Matrix for GE Head Support with extreme care; (2) Do not apply great forces to the Register Matrix, for example, by leaning over the top of the die or by applying tension to the flexible coil cable; (3) Reduce transport distances with minimal involvement of the iMRI Registry Matrix for GE Head Support and the patient; (4) Avoid any vibrations or shocks during transport, for example due to uneven floors or touching the termination stop during transferring the scanner to the operating table; (5) If possible, perform automatic recording of intraoperatively acquired MRI images before locking the transport table in its final position (due to additional shocks during locking); (6) Use additional covers to increase product adhesion; (7) Carefully check the automatic registration result - after performing automatic recording of intraoperatively acquired MRI images, the result must be carefully checked. Company code for the field action: CAPA-20150821-001476. Check the instructions for users in the datalhes, available at http://portal.anvisa.gov.br/wps/wcm/connect/6ab377004a9d9db08fdcbf218f91a449/Assessment+of+Seguran+in+Campus_1733.pdf?MOD=AJPERES

Device

IMRI Registration Matrix for GE Head Support. Anvisa Registry n ° 80042070034.

Manufacturer

Brainlab Ltda; Brainlab AG
  • Manufacturer Parent Company (2017)
    Brainlab AG
  • Source
    ANVSANVISA