Under certain conditions, during endoscopic procedures using a combination of the Pentax Medical Video Processor EPK-I8020C and the Pentax Medical Video Upper GI Scope EG29-I20C, the observed image can become reddish or dark. Globally, Pentax has received 32 complaints related to this issue. The users have observed smoke-like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient, and may cause thermal injury to the patient’s mucous membranes.
These phenomena occur when substances such as mucus and blood attached to the light guide (illumination part) at the distal end of the endoscope absorb the illumination light from the light source to the maximum extent, causing it to heat up and coagulate. They are more likely to occur in OE (optical enhancement) mode but have also been observed with white light.
Although the existing instructions for use already include cautionary statements to contemplate the risk of harm observed, Pentax Medical is issuing this customer communication to further reduce the potential health risk.
Recall start date: February 18, 2025

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