Macro Micro Subdural Electrodes 의 안전성 경고

Safety alert

2013-03-01

2013-03-01

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20130301.html

Medical device safety alert: ad-tech medical instrument macro micro subdural electrodes the united states food and drug administration (fda) has posted a press release issued by medical device manufacturer, ad-tech medical instrument corporation, concerning its global recall of macro micro subdural electrodes. the recalled products were manufactured from june 2006 to march 2012, and distributed from 8 june 2006 to 14 march 2012. on 18 december 2012, the manufacturer initiated a recall of 115 macro micro subdural electrodes. there is a concern the microelectrodes are not flush with the silastic surface. as a result, there is the potential for abrasion of cortical brain tissue and the existence of fractured pieces remaining in the cortical tissue when the electrode is explanted, which may result in hemorrhage or damage to cortical fibers, leading to infarct or seizure activity. there has been one reported serious injury that may have been related to the use of the device. the manufacturer has notified its distributors and customers by recall letter and is arranging for the return of all available recalled product(s). for details, please visit the following fda website: http://www.Fda.Gov/safety/recalls/ucm341680.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 01 march 2013.