FDA warns surgeons about malfunctioning brain mapping device
A machine used by physicians to conduct brain mapping procedures for patients with brain tumors and seizure disorders – including those caused by Traumatic Brain Injuries (TBI) – is being recalled because of a malfunction and short circuiting issue that can result in the surgeon resecting the wrong brain tissue. This recall is classified as a Class 1, which is the most serious type of recall, involving situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
The recall involves the CareFusion is recalling Nicolet Cortical Stimulator Control Unit, Nicolet C64 Stimulus Switching Unit (SSU) Amplifier and NicoletOne Software with Cortical Stimulator License. The problems include a software problem that incorrectly indicates stimulation is delivered to a different electrode than the one selected, and a short circuit that may develop between the cortical stimulator control unit and the stimulus switching unit amplifier. Both of these issues may result in the surgeon resection the wrong brain tissue. The surgeon may also fail to resect pathological tissue, potentially leading to continued pathologic processes and the need for re-operations.
The recalled devices are software were manufactured from May 7, 2009 through July 11, 2011. The recall affects 132 devices and 35 software licenses.
CareFusion has sent customers who have these devices an Urgent Field Safety Corrective Action Notification letter, which described actions NicoletOne software users should take. Healthcare professionals and patients should report any adverse reactions or side effects related to this device to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/report.htm.
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