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UreteroReno Videoscope
- Starting date:
- December 22, 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:
- Microbial Hazard
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-61772
Reason
There was an investigation of customer complaints regarding the breakage of the endoscope's 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. 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 Videoscope
Lot or serial number
All serial numbers
Model or catalog number
URF-V2
URF-V2R
Companies
- Manufacturer
-
Olympus Medical Systems Corp.
2951 Ishikawa-cho
Hachioji-shi, Tokyo
192-8507
JAPAN