Safety Alert for Reflective Marker Spheres for Surgical Navigation - DRMS ​​- used for Brainlab image guided surgery systems. Anvisa Registry n ° 80042070007.

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.

The Disposable Reflective Marking Spheres (DRMS) allow the system to detect the position of the patient and the instruments in the surgical field. Their disruption when in use on the patient can cause adverse events or loss of device viewing. To mitigate the potential effects of the problem cited in this alert, the product user must perform the following steps before each procedure using Brainlab DRS for Brainlab IGS systems: (1) Before opening the package containing the beads, visually inspect the beads on blister, looking for signs of separation between the two halves of the sphere. If there is any indication of separation of the beads, use another blister for the procedure and repeat this step with the new packaging. Discard all affected spheres and tell your Brainlab support representative of the problem. If there is no visual signal separating the ball, proceed to the next step; (2) Before beginning the procedure, tighten and tighten each DRMS ​​in the tool. When tightening, re-visually check to see if there is any evidence of separation between the two halves. If there is any evidence of separation, remove and discard the affected sphere. Replace your surgical gloves and then replace the separated ball with a new ball by inspecting as indicated above. If there is no evidence of separation, proceed with the clinical procedure. Be sure to discard and replace your surgical gloves whenever a ball with evidence of separation is detected during coupling to the tool and whenever it touches a separate sphere; (3) Caution: Do not attach the ball on the tool over the surgical area to minimize the risk of a ball, or any part thereof, falling on the patient or surgical incision. Also avoid attaching the ball to other sterile areas (such as surgical trays), to minimize potential contamination in case of separation from the ball; (4) Reminder: In general, do not use damaged or deformed marker balls (see also Brainlab Instrumental User's Manuals); (5) Reminder: If you use reflective markers in or near instruments that oscillate or vibrate, or when hammering instruments, examine the marking balls at regular intervals to ensure that they remain securely attached (see also Instrumental of Brainlab).