Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic diagnosis, treatment, and video observation. Model: EPK-i8020c
During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%). 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.
Nationwide
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1238-2025