The customer suspected device was returned for investigation.The olympus service center confirmed the reported event during inspection and testing.Upon evaluation of the returned device the following defects were found, biopsy channel clogged with foreign material (piece of tube), insertion tube wrinkled, bending angulations out of specifications, switch box cracked, universal cord buckled, angle rubber glues discolored, and distal end insulation out of specifications.The faulty parts were replaced, and the device was returned to the user facility.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
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