Pentax medical became aware of a report on (b)(6) 2020 stating that the pentax medical single use disposable distal end cap with elevator (dec), model oe-a63, unknown serial number, fell off during an endoscopic retrograde cholangiopancreatography(ercp) in the middle of the patient's esophagus.The physician could see that there was no cap on the pentax medical video duodenoscope, model ed34-i10t2, unknown serial number.The procedure required medical intervention to remove the dislodged distal end cap (dec) from the patient and was saved.Also a portion of the distal end cap (dec), the deflector level "plastic cap sled", remained attached to the distal end of the duodenoscope.There was reportedly quite a lot of damage to the esophagus of the patient caused by the distal end cap (dec).The injury was found by the physician in the ventricle as he switched to a gastroscope due to abundant bleeding.The doctor found normal ratio in the esophagus down to 22 cm, but with mucosa defect to 32 cm and large defect at 39 cm.The patient was subsequently hospitalized for two days and then discharged.
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