Sciatic Nerve Retractors 의 안전성 경고

Safety alert

2018-04-04

2018-04-04

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20180404.html

Medical device safety alert: synthes gmbh sciatic nerve retractors medical device manufacturer, synthes gmbh, has issued a medical device safety alert concerning its sciatic nerve retractors. the affected devices are identified as the following:- retractor f/sciatic nerve [part numbers: 03.100.013; lot numbers: t104992, t114599, t140390, t140674, t140675, t140676, t140677, t141539, t143644, t144855, t145296, t145589, t145819, t146660, t147930, t148624, t149725, t149726, t151370, t152806, t152807, t153692, t155648, t156708, t160394, t939640, t987813] retractor f/sciatic nerve long [part number: 03.100.014; lot numbers: t104993, t108115, t114598, t140566, t140665, t140670, t140671, t140673, t141540, t143687, t144854, t145585, t145590, t145932, t146657, t147929, t148552, t148553, t149727, t149728 t151369, t151488, t152808, t152809, t153884, t155649, t958061] the manufacturer is initiating a product removal of the above part and lot numbers of sciatic nerve retractors. these devices are part of the 3.5mm low profile pelvic system and intended for drawing back soft tissue during orthopaedic surgery. according to the manufacturer, there is the potential for micropores to form on the hollow handle of the sciatic nerve retractor. as the pores may increase in size, it is possible that fluids may enter the hollow handle during surgery. thus, even with diligent reprocessing/sterilization of the retractor, subsequent patients may be at risk for infection and adverse tissue reaction due to retained fluids leaking out during use. additionally, if the discoloration and/or moisture are not identified within the packaging of the affected sciatic nerve retractors preoperatively, there is a potential for surgical delay due to the time required to investigate and decide next steps. the users are requested to immediately review their inventory to identify and quarantine the affected products. according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 4 april 2018.