The Food and Drug Administration recently issued a safety communication to neurologists and surgeons warning that an important safety mechanism on a medical device known as a cranial perforator, which is used to drill a small hole into a patient's skull during brain surgery, may fail to disengage. If the device does not stop drilling after penetrating the skull, the perforator may unintentionally plunge into the patient's brain, causing serious injuries. The FDA reports that it has received more than 300 reports about these cranial perforators failing to disengage.
The cranial perforator’s defective component is a safety mechanism known as an automatic clutch mechanism. The automatic clutch mechanism is designed to cease the operation of the cranial perforator once the patient’s skull is penetrated, thereby preventing serious injury to the brain. The FDA warns surgeons to exercise caution when using cranial perforators and to review safety materials related to the operation of the device.
Injuries suffered from malfunctioning automatic clutch mechanisms may include hemorrhage (bleeding of the brain), brain contusions, cerebral tissue damage, and neurological deficits (decreased brain function). These serious injuries may result in the patient suffering from seizures, diminished speech capacity, prolonged hospitalization, and the need to undergo further treatment.
The FDA warns the malfunctions occurring with cranial perforators are not associated with any particular device and warns surgeons to follow proper techniques and procedures when using the device. For neurosurgeons using cranial perforators during brain surgery, the FDA recommends the following:
If you or a loved one suffered a serious injury due to a malfunctioning automatic clutch mechanism or any other injury related to undergoing a procedure involving a cranial perforator, contact The Cochran Firm, D.C. for your free legal case review. Our medical malpractice attorneys can investigate your case and determine if the surgeon or device manufacturer was at fault for causing your injury. We can also review your case for a potential product liability claim.