www.fdanews.com/articles/175503-fda-releases-skull-clamp-warning
FDA Releases Skull Clamp Warning
February 26, 2016
The FDA has released a safety notice regarding slippage or movement of neosurgical clamps.
The agency says it received more than 1,000 reports — between January 2009 and January 2016 — involving slippage, resulting in more than 700 injuries.
The device is used to hold the patient’s head in place during surgical procedures and may include a head holder frame attached to the table.
The notice is not targeted at a specific manufacturer; causes of the slippage could range from device performance to poor maintenance.
Despite reports, the “overall benefits of these devices continue to outweigh the risks,” according to the FDA. — Anisa Jibrell