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Gas/Water Feeding Valves (2014-07-14)
- Starting date:
- July 14, 2014
- Posting date:
- September 24, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-41485
Recalled products
- Gas/Water Feeding Valves
Reason
During a colonoscopy, patient experienced a perforation of the colon. Surgery was performed. After the colonoscopy the devices were flushed as per normal routine. During the after-use process it was observed that the CO2 flow through the colono scope couldn't be stopped by the CO2 valve of-B194. Patient subsequently passed away.
Affected products
A. Gas/Water Feeding Valves
Lot or serial number
All lots
Model or catalog number
- OF-B130
- OF-B194
Companies
- Manufacturer
-
Hoya Corporation
2-7-5 Naka-Ochiai, Shinjuku-ku,
Tokyo, Tokyo-to
161-8525
JAPAN