The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.The manufacturing record was reviewed and found no irregularities.According to the inspection result by sorc, following information were confirmed.- the coating of the insertion tube was peeled off more than 4 mm in width.- there was a chip on the tip of the insertion tube, air leak had occurred, and noise was generated on the image.- it was not possible to judge whether the breakage was due to stress or handling.From the above, it was possible that the coating was peeled off due to the same cause as other breakages, but it was not possible to determine whether the peeling was due to stress or handling, or other factors.The exact cause of the reported event could not be conclusively determined.
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Olympus medical systems corp.(omsc) was informed that during the incoming inspection for repair at olympus service operation repair center (sorc) on october 20, 2021, it was found that the coating of the insertion tube had been partially peeled off due to deterioration.There was no report of patient injury associated with the event.
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