FDA warns surgeons that cranial perforators may fail to disengage

Safety communication reports over 200 injuries caused by drilling into brains

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.

What kind of injuries come from a malfunctioning cranial perforator?

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.

FDA recommendations to surgeons to avoid malfunctioning cranial perforator injuries

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:

• Review and follow the instructions on the device's labeling for use for cranial perforators with an automatic clutch mechanism.
• Use correct techniques for cranial perforators with an automatic clutch mechanism including:
  • Select the appropriate cutting accessories based on the patient’s skull thickness.
  • Hold the perforator perpendicular to the inner table of the skull at the point of penetration throughout the entire drilling procedure.
  • Do not rock, rotate, or change the angle of the device during drilling.
  • Avoid using excessive pressure when nearing the point of perforation to prevent penetration into the brain.
• Be cautious when using a cranial perforator with an automatic clutch mechanism if you:
  • Perforate areas of the skull that have variations in bone contours and thickness such as the posterior fossa.
  • Perforate the skull of infants, children, or elderly patients because of varying skull consistency and thickness of bone.
  • Perforate a patient’s skull if there is diseased or fragile bone or the possibility of adherent underlying dura mater.
• Report any adverse events associated with the use of cranial perforators with an automatic clutch mechanism to the FDA and the manufacturer.

Contact the Cochran Firm D.C. for cranial perforator injury cases

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.