Upon inspection and testing of the returned device, the reported issue (leakage from a-rubber) was confirmed and found to be caused due to damaged a-rubber.In addition to a-rubber falling off, service found the bending angle was out of specification due to wear of the angulation wire, the image guide bundle was broken, there was noise during angle operation, and the up down angle fixing lever was cracked.Scratches were observed on the eyepiece unit, and the angle lever due to external factors.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.
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The customer reported there was an air leakage from the bending section cover (a-rubber).The reported issue occurred during an air-check, after the intended procedure was completed.There was no patient/user harm or injury reported due to the event.The subject device was returned to an olympus service center for evaluation.Upon inspection and testing of the returned device, it was observed the a-rubber was broken and fell off.This report is being submitted for the malfunction found during evaluation of the device (a-rubber fell off).
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