The device referenced in this report has not been returned to olympus medical systems corp.But was returned to olympus (b)(4).(b)(4) confirmed the reported device damage.(b)(4) found that the bending section of the subject device broke at the insertion tube side, an inner part of the bending section was protruding from the bending rubber.There was a hole in the bending rubber of the subject device and the subject device failed the water leakage test.The manufacturing record of the subject device was reviewed with no irregularity related to the phenomenon.The exact cause of the event could not be concluded at this moment.If additional and significant information becomes available, this report will be supplemented.
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