Cranial Navigation System – Standard Cranial Reference Array 의 안전성 경고

Safety alert

2012-08-14

2012-08-14

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20120814.html

Medical device safety alert: brainlab cranial navigation system – standard cranial reference array the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning cranial navigation system – standard cranial reference array manufactured by brainlab ag. manufacturing tolerances of the arrays influence the actual position of its marker spheres. the differences between the individual arrays are supposed to be very small, not significantly affecting navigation accuracy when the unsterile array is exchanged with the sterile array during surgery. however, according to the manufacturer, there are specific pairs of arrays that might add an inaccuracy of more than 1 mm to the registration result during the exchange due to the combination of their tolerance limits. this effect could potentially cause an inaccurate display of instruments by the navigation system in the region of interest, compared to the actual patient anatomy. if these inaccuracies are not detected by user verification of navigation accuracy as described in the user manual, this could lead to serious injury or ineffective treatment of the patient. customers are advised to remove the affected products from clinical use. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 14 august 2012.