da Vinci Xi 5 mm-8 mm Universal Seal and da Vinci Xi 12 mm & Stapler Universal Seal 의 안전성 경고

Safety alert

2016-05-11

2016-05-11

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20160511.html

Medical device safety alert: intuitive surgical da vinci xi 5 mm-8 mm universal seal and da vinci xi 12 mm & stapler universal seal medical device manufacturer, intuitive surgical, has issued a medical device safety alert concerning its da vinci xi 5 mm-8 mm universal seal (pn 470361-05 and 470361-06) and da vinci xi 12 mm & stapler universal seal (pn 470380-05 and 470380-06). the manufacturer is initiating a warning regarding use of the abovementioned products in intra-cardiac procedures. the manufacturer identified particulate during quality inspections of the insufflation stopcock on the da vinci xi 5 mm-8 mm universal seal. the particulate has the potential to be introduced into the cannula lumen when insufflation is connected. although there have been no injuries identified related to this issue, the manufacturer is initiating this warning for use in intra-cardiac procedures due to risk of foreign body embolism should particulates remain undetected and unintentionally left inside the heart. during abdominopelvic and thoracic surgery, if the potential particulate is undetected and unintentionally left behind, health risk is minimal due to the bio-inert properties of the high density polyethylene (hdpe) particulate, its small size and the benign particulate geometry. the potential particulate is no larger than 1/8" in length with no sharp edges. it is composed of hdpe, a bio-inert material. hdpe has been used as bone and cartilage implants since the 1940s with more than 30 years of follow-up results showing favorable response to hdpe implants. hdpe is non-ferromagnetic and, as such, an unrecovered particulate will not cause the patient harm if exposed to mri. the following instructions are provided to the affected users: until this issue is resolved, as an alternative to insufflation through the da vinci xi 5 mm-8 mm universal seal (pn 470361) or the 12 mm & stapler universal seal (pn 470380) during intra-cardiac procedures, use an angio-catheter, or veress needle, through the chest wall for initial access and to maintain insufflation throughout the procedure. do not use the da vinci xi 5 mm-8 mm universal seal or the 12 mm & stapler universal seal for insufflation, or open the stopcock during the procedure. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 11 may 2016.