Upon inspection of the returned endoscope, the distal bending section was locked in an angled position due to a defect found in the bending mechanism of the control section.According to the physician, the bending section was broken during the endoscopic examination, but angulation lock did not occur during the examination.It is likely that the angulation lock occurred sometime after completion of the examination.This is reported because there is a risk of health hazard if the angulation lock occurs during an examination and the device is removed forcibly.The operation manual describes the countermeasure for locked angulation on an endoscope.The subject endoscope model en-450t5/w is not marketed and sold in the united states.A similar model, en-450t5, is used in the u.S.Both models are similar in mechanical function and design.However, they differ in image field of view and observation range.No patient information available.Issue was identified while servicing the subject endoscope.
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Double balloon endoscopy examination was performed on a patient with obscure gastrointestinal bleeding (ogib).After reaching a deep part of small intestine, the endoscope's bending operation for down angulation was attempted, however the bending section did not bend.As there was still some observation range to be examined, the examination was continued using bending operation of right/left directions and completed.No health hazard to the patient.
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