Health Canada — Medical Devices · Canada · 2017-01-12 · Type II
🏛Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Archived by the issuing authority — kept for reference
Reported risk: The manufacturer, Olympus Medical Systems Corp. (OMSC), has initiated this corrective action following complaints on the URF-P6/P6R insertion tube, and breaks of the bending tube. These complaints have not resulted in any known adverse event. The URF-P6/P6R endoscopes are intended for use in endoscopic diagnosis and treatment within the ureter, kidney and biliary tract (common bile duct and hepatic duct). OMSC is aware of adverse events on the URF-V2/V2R endoscopes which have a similar structure to the URF-P6/P6R endoscopes. Olympus is providing a two-page instructions for safe use to remind customers of inspection instructions in the existing operation manual and also provide pictures and instructions to assist in performing the inspection.
Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.
ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.