OLYMPUS urethro-reno endoscopes 에 대한 현장 안전성 서한

Field Safety Notice

Slovenia

AMPMDRS

Olympus has learned of a problem that requires your attention. this urgent safety notice applies to ulyfus urf-v2 and urf-v2r uretero-reno videos, urf-p6 uretero-reno fiber scopes and urf-p6r, and our records indicate that your establishment has purchased one or more of these products. urf-v2, urf-v2r and urf-p6, urf-p6r endoscopes are intended for use in endoscopic diagnoses and treatment within the ureter and kidney. the urf-p6 and p6r endoscopes are also intended for use in endoscopic diagnoses and treatment within the biliary tract (bile duct and hepatic duct).   olympus initiated this remedial action after investigating five adverse events with respect to the urf-v2 and urf-v2r endoscopes when fracture of the endoscope introductory tube fracture occurred during the surgical procedure. to date, these adverse events have included two cases of tissue damage, one case of perforation and two cases where the introductory tubes remained within the patient and had to be surgically removed. olympus is writing to inform you of this matter and to recommend specific actions.   olympus has received complaints regarding urf-p6, urf-p6r endoscopes related to deployment tube fractures - none of these cases have resulted in adverse consequences.