Dear All,
On 15/1/2016 the U.S. Food and Drug Administration cleared the Olympus
TJF-Q180V duodenoscopes for modifications to the device design and labelling
with the intention of reduce the risk of bacterial infections.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm481956.htm
Olympus America Inc (“OAI”) has posted a voluntary recall to replace the
forceps elevator mechanism in all TJF-Q180V duodenoscopes (a flexible
gastrointestinal endoscope used in procedures such as endoscopic retrograde
cholangiopancreatography (ERCP) – see attached letter
Staff in you gastroenterology units will be interested in this recall and
should contact the manufacturer for additional information.
Regards
Glenys
Glenys Harrington
Consultant
Infection Control Consultancy (ICC)
PO Box 5202
Middle Park
Victoria, 3206
Australia
M: +61 404 816 434
infexion@ozemail.com.au
ABN 47533508426
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