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UreteroReno Fiberscope
- Starting date:
- December 28, 2016
- Posting date:
- January 12, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-61774
Reason
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.
Affected products
UreteroReno Fiberscope
Lot or serial number
All serial numbers
Model or catalog number
URF-P6
URF-P6R
Companies
- Manufacturer
-
Olympus Medical Systems Corp.
2951 Ishikawa-cho
Hachioji-shi, Tokyo
192-8507
JAPAN