PENTAX Medical Company has issued a Class 1 recall for the OF-B194 Gas/Water Valve, which is an endoscope valve that can leak CO2 into a patient’s intestines during a gastrointestinal procedure. One incident was reported in which a 71 year-old man suffered life-threatening intestinal perforations.
What You Can Do & How a Defective Endoscope Lawsuit Can Help
The Schmidt Firm, PLLC is currently accepting PENTAX Gas/Water Valve induced injury cases in all 50 states. If you or somebody you know was injured by a defective endoscope valve, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.
Intestinal Perforation During Colonoscopy Reported with PENTAX Gas/Water Valve
Problems with the PENTAX endoscope were first identified when Australian health authorities reported the case of a 71 year-old man who suffered numerous intestinal perforations. Doctors were performing a routine colonoscopy procedure to remove polyps in his intestines. They were using a PENTAX endoscope with the OF-B194 Gas/Water Valve.
During the procedure, the man’s abdomen became severely swollen. The doctors realized that his intestines were filling with CO2, but they were unable to shut off the valve on the endoscope. After the endoscope was removed, doctors noticed that it was leaking CO2 that could not be turned off. The patients required intensive medical treatment for numerous, small intestinal perforations. He ultimately needed surgical excision of part of his intestines.
What is the PENTAX valve used for?
The OF-B194 Gas/Water Valve is a component that is used with the PENTAX GI Video Endoscope. The endoscope is a long, flexible tube with a video attached to the end. Doctors insert the endoscope into a patient’s mouth or anus to view inside the gastrointestinal system. During the procedure, doctors must inflate the intestines with CO2 so they can see part of the intestinal tract.
What’s the problem?
The problem is that the OF-B194 Gas/Water Valve may have been assembled improperly. During a medical procedure, it could leak CO2 and doctors may be unable to turn off the valve. This could lead to over-inflation of a patient’s intestines, with life-threatening complications:
- Peritonitis (inflammation of tissue lining organs and inner wall of abdomen)
- Perforations
- Sepsis (whole-body inflammation caused by infection)
- Bowel perforations requiring surgery
- Death
Class 1 Recall of PENTAX Endoscope Valve
PENTAX and the FDA initiated a Class 1 recall of the defective OF-B194 valve on September 16, 2013. The valves were manufactured and sold from August 2009 – July 2013. A total of 704 valves were sold worldwide, including:
- 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
What You Can Do & How a PENTAX Gas/Water Valve Lawsuit Can Help
The Schmidt Firm, PLLC is currently accepting PENTAX Gas/Water Valve induced injury cases in all 50 states. If you or somebody you know was injured by a defective endoscope valve, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.
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