US-based Pentax Medical initiated a voluntary nationwide recall of 76 PENTAX gas/ water valves, model OF-B194 on 16 September 2013.
The valves were offered as a separate purchase for use with PENTAX GI video endoscopes (90i/90k series and i10/k10 series).
The OF-B194 Valve has been found to have a manufacturing defect which may prevent users from turning off the CO2 gas flow during an endoscopic procedure with the potential for serious hazard to the patient, including: peritonitis, perforations, sepsis, death, and bowel perforations requiring surgical repair.
Customers who have OF-B194 PENTAX gas/water valves have been advised to immediately examine their inventory and quarantine and stop using the product subject to the recall.
Recalled OF-B194 gas/water valves were manufactured and distributed from August 2009 through July 2013.
A total of 704 valves were distributed worldwide in the following regions: Europe/Middle East/Africa (EMEA) 300 valves, Asia Pacific (APAC) 278 valves, 24 valves in Japan, 26 valves in Canada and 76 valves in the US.
All units distributed in the US and Worldwide have been recalled.
Products can be identified by the model number (OF-B194) stamped on the valve. Corrected valves have a circle before the model number (O OF-B194).
Pentax Medical voluntarily recalled the OF-B194 valve after becoming aware of a report to the Australia regulatory authority: A 74-year-old male patient admitted for routine Colonoscopy. Polypectomy performed in sigmoid on advancing to the caecum. Reached right side of colon and noticed Petechiae (discolouration due to minute haemorrhage within tissue). At this stage distended abdomen was noted.
Suction reported to not be effective in reducing the distension. An alternative CO2 valve changed in an attempt to halt the flow of CO2 into the bowel. Upon withdrawal of the colonoscope, CO2 was noted to be flowing from the scope despite valve not being depressed, which is irregular.
Patient had abdominal x-ray performed in recovery, a number of small perforations detected. Patient returned to operating theatre, right Hemicolectomy performed.
No injuries have been reported in the US to date.
PENTAX Medical has notified the US Food and Drug Administration FDA of this action.
PENTAX Medical Company distributed the product to medical facilities and Pentax sales representatives/field support staff in the US.
All affected medical facilities in the US have been notified of the action, have responded, and replacement OF-B194 valves have been provided by Pentax Medical.