NORAS OR HEAD HOLDER

Description of Event or Problem

AS INFORMED BY THE HOSPITAL, AN INTRACRANIAL BIOPSY SUPPORTED BY THE BRAINLAB NAVIGATION SYSTEM LED TO AN INTRAOPERATIVE HEMORRHAGE. THE USER VERIFIED WITH A CT SCAN THAT THE ACTUAL APPLIED TRAJECTORY DIFFERED FROM THE PLANNED, INTENDED TRAJECTORY. THE NORAS OR HEAD HOLDER WAS APPLIED FOR FIXATION OF THE HEAD.

Additional Manufacturer Narrative

ACCORDING TO THE HOSPITAL, THERE HAS BEEN NEITHER ADVERSE EFFECT ON THE PATIENT NOR ANY ADVERSE CLINICAL EFFECT ON THE PATIENT EXPECTED. THE PATIENT HAD BEEN PUT IN OBSERVATION FOR 24 HOURS BY THE HOSPITAL. NEVERTHELESS, A RISK TO PATIENT HEALTH COULD NOT BE EXCLUDED FOR THIS EVENT. ACCORDING TO NORAS MRI PRODUCTS (B)(4) MEASURES ARE IN PLACE FOR THE NORAS OR HEAD IN ORDER TO MINIMIZE THE RISK AS LOW AS REASONABLY PRACTICABLE. THERE WAS NO QUALITY OR PERFORMANCE ISSUE OR MALFUNCTION OF NORAS OR HEAD HOLDER. THE NORAS OR HEAD HOLDER WORKS ACCORDING TO THE SPECIFICATIONS IF THE USER FOLLOWS THE INSTRUCTIONS. CORRECTIVE AND PREVENTIVE ACTIONS: THERE WAS NO QUALITY AND PERFORMANCE ISSUES OR MALFUNCTION OF NORAS OR HEAD HOLDER. ACCORDING TO OUR INSTRUCTIONS THE USER MUST FOLLOW THE SAFETY WARNING REGARDING THE FIXATION OF THE HEAD BY ALL FIVE POINTS. A FIXATION ONLY BY 3 LATERAL POINTS WOULD BE DEFINITELY INSUFFICIENT. THIS COULD LEAD TO HEAD INJURY, FALSE DETECTION OF MARKERS AND LESION AND REDUCED DIAGNOSTIC SAFETY. THERE ARE NO FURTHER CORRECTIVE AND PREVENTIVE ACTIONS INTENDED BY NORAS MRI PRODUCTS (B)(4) AT THIS POINT OF TIME.