The United States Food and Drug Administration (FDA) has issued a safety communication warning regarding the safe use of cranial perforators with automatic clutch mechanisms.
Neurosurgeons use cranial perforators to drill burr holes in the skull during certain surgical procedures, and some devices utilize a clutch mechanism designed to automatically stop once the tip has penetrated the skull. However, the FDA warns that the mechanism can fail if the perforator is not used in complete accordance with the manufacturer’s directions.
According to an article published by Mesdcape, the FDA received over 300 medical device reports of situations in which such mechanisms failed to disengage. As a result, patients suffered more than 200 injuries including: perforation of the dura mater, hemorrhage, brain contusion, cerebral tissue damage and neurologic deficit. The FDA also indicated that such failures are not specific to any particular brand or manufacturer; so, caution should be exercised in using any perforator with an automatic clutch mechanism.
To learn more about the FDA’s recommendations and to read the entire safety communication warning, click here.
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