The cyf-vhr scope serial#(b)(4) was received for evaluation.Visual inspection of the received device condition was performed and determined that the bending section is curved.The bending section was manipulated and observed that the bending section movement is curving, not in a straight position, confirming the user's experience.Further inspection found evidence of discoloration of the bending section cover and the distal end tip was found detached, causing the bending section to curve in a upward angle.The instrument channel was inspected using the olympus boroscope and no signs of internal damages were found.The scope passed the cosmo leak test.Based on the device evaluation, the detached distal end tip is likely attributed to mishandling.As a precautionary measure, the instruction manual states the following; ¿do not twist or bend the bending section with your hands¿.Additionally, the instructions for safe use manual indicate that, damage to the bending section would happen if excessive force was applied while angulating in the opposite direction if there was no movement from the bending section; this would occur more so in a narrow environment.
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It was reported that the angulation control knobs is unable to straighten bending section and was stuck in retroflex position.The scope is not deflecting, off center and when it is straight, the scope is curving to the right.There was no patient harm or injury reported due to the event.
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