uretero-reno videoscopes and uretero-reno fiberscopes 의 안전성 경고

Safety alert

2017-01-09

2017-01-09

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20170109a.html

Medical device safety alert: olympus uretero-reno videoscopes and uretero-reno fiberscopes medical device manufacturer, olympus, has issued medical device safety alerts concerning its uretero-reno videoscopes (model numbers: urf-v2 and urf-v2r) and uretero-reno fiberscopes (model numbers: urf-p6 and uf- p6r). for uretero-reno videoscopes, the manufacturer has initiated a corrective action following investigation of customer complaints regarding the breakage of the urf-v2/v2r insertion tube bending section during surgical procedures. to date, some of these complaints are associated with tissue trauma (including one complaint of perforation, and two complaints of insertion tubes which were stuck inside the patient and had to be surgically removed). for uretero-reno fiberscopes, the manufacturer has received complaints on the urf-p6/p6r insertion tube, and breaks of the bending tube, but these complaints have not resulted in any known adverse events. the manufacturer is aware of adverse event complaints on the urf-v2/v2r endoscopes which have a similar structure to the urfp6/p6r endoscopes. the manufacturer advises customers to inspect their inventory for the referenced devices and follow the recommended inspection procedures listed in the “instruction for safe use”. 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 9 january 2017.