PENTAX has recalled for the OF-B194 Gas/Water Valve, a defective valve that is used on a gastrointestinal video endoscope. The valve can leak CO2 during an endoscopic procedure, which may fill a patient’s intestines and cause life-threatening bowel perforations. PENTAX issued a class 1 recall after one incident was reported in Australia.
Need a Texas Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was injured by a defective PENTAX Gas/Water Valve, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit in Texas.
Intestinal Perforation During Colonoscopy Reported with PENTAX Gas/Water Valve
PENTAX Medical Company became aware of a problem with the OF-B194 Gas/Water Valve after Australian health authorities reported the case of a 71 year-old man who was injured by intestinal perforations. The man was undergoing a routine colonoscopy to remove polyps in his colon.
In the middle of the procedure, doctors noticed that his abdomen was abnormally swollen. They were unsuccessful in halting the flow of CO2 into his bowel. When they removed the colonoscope, they noticed that it was leaking a small amount of CO2. The patient had an abdominal X-ray, and doctors noticed a number of small intestinal perforations. He required surgery to cut out the damaged portion of his intestine.
What is the product used for?
The PENTAX OF-B194 Gas/Water Valve is used with the PENTAX GI Video Endoscope. Gastrointestinal (GI) endoscopy is a modern medical tool that uses a long, flexible tube (called an “endoscope”) that has a fiber-optic video at the end. A doctor inserts the endoscope into a patient’s mouth or anus to view parts of the intestinal tract.
What is the problem?
PENTAX has concluded that the OF-B194 Gas/Water Valve may have been assembled incorrectly, which could cause it to leak CO2 during a medical procedure. Users may be unable to turn off the flow of CO2 gas during an endoscopic procedure, which could lead to severe consequences, including:
- Peritonitis (inflammation of tissue lining organs and inner wall of abdomen)
- Sepsis (whole-body inflammation caused by infection)
- Bowel perforations requiring surgery
Class 1 Recall of PENTAX Gas/Water Valve
On September 16, 2013, PENTAX Medical Company initiated a voluntary Class 1 recall of the defective valves. They were manufactured and distributed between August 2009 through July 2013. During that time, a total of 704 valves were distributed worldwide:
- 76 valves in United States
- 300 valves in Europe/Middle East/Africa,/li>
- 278 valves in Asia Pacific
- 26 valves in Canada
- 24 valves in Japan
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